At the time of Merger and Acquisition (M&A) of a company there are manifold considerations that need to be looked at. One such consideration, an important one, is the Intellectual Property (IP) of the company, especially in the form of patents. The due diligence of the patent portfolio plays a crucial role in not only understanding and evaluating the market value of the portfolio, but also to keep in mind the liabilities that may accrue to maintain such patents in various jurisdictions. Due diligence of the portfolio also ensures that all patents including family patents are docketed, screened, valuated, and transferred in an effective manner and to finally evaluate the value, market potential and liabilities of the acquiring patent portfolio. While it is important that due diligence of other IP forms such as trademarks, designs and copyrights are also performed, this article will primarily focus on the patent portfolio of the company.
IP Audits
To initiate due diligence of a patent portfolio, the first and foremost step is conducting an IP Audit wherein all granted patents and filed applications (collectively termed as patent documents) should be listed and compiled, followed by checking the legal status of the patent documents in every country they are filed or granted. In the case of patent applications, it is necessary to check if there are any pending actions against them in terms of responding to any office action or payment of any pending fees.
In case of granted patent applications, it is important to perform legal status checks of those patents. If the patent is expiring soon, it may not be of much value to the company. For granted patents, a check must be performed to see if any action is needed to maintain such patents.
Registered IP should be docketed to keep a watch on important official timelines such as responding to official communication or payment of renewal to maintain it. As part of docketing, it is worthwhile to note down the term of the IP which remains. For instance, if there remain only a few months for a patent to expire, it may not be best decision to transfer the patent to the buyer as transferring a patent requires amendments in its forms which may neither be advantageous to the buyer nor the seller.
Additionally, gathering information related to apposition, revocation, litigation or infringement of the patents of the company is also crucial.
Relevance of Patents for the Business
The patent portfolio that is to be acquired may contain certain patents may be irrelevant to the buyer’s business. In such cases, there may be not much use in transferring such patents the buyers’ company. Instead, alternatives such as out-licensing the IP may be explored, or, if the IP is not strong enough to be registered, it may be published as a research paper as well. Sometimes, companies also consider donating some of their IP or abandoning it or letting it expire, depending on the relevance and importance of such IP for the business.
Categorization of Similar Patents
In order to determine the valuation of patents, similar patents may be categorized together, and appropriate methodologies should be used to ascertain their collective value. Depending upon the value of patent portfolio, the decision to retain or license may be taken.
Transfer of Rights
Acquisition of a patent portfolio is complete only after the amendment is made in the name of the patentee and is done in the respective patent office. Therefore, it is pertinent to get in touch with the attorney who is in charge of the case to ensure that such amendments are made in time. This process also involves payment of certain sums as government and attorney fees.
Understanding Liability
The buyers must be aware of the fact that acquiring IP of another company brings a lot of liabilities with it. In order to get the IP transferred in the name of the buyers, at the time of acquisition, a lot of amendments are to be made in the official records in the office where such IP is registered. Most times buyers prefer in a change in the attorney handling such cases as well, which may lead to additional expenditure for them. Even after the IP is acquired and the required amendments are made in the official records, other liabilities such as annual fees to maintain the IP also have to be assessed regularly. Further, if any of the IPs are undergoing litigation or are opposed, due-diligence must be performed to ascertain the stage and the further course of action.
It is therefore evident that conducting exhaustive due diligence of patent portfolios is extremely important to understand the relevance, importance, value and liabilities before acquiring them.
Author: Bindu Sharma (CEO, Origiin IP Solutions LLP), Bhavya Sharma (BBA, LLB student of Jindal Global Law School)
Please contact us at info@origiin.com to know more about our services (Patent, Trademark, Copyright, Contract, IP Licensing, M&A of companies)
IP assessment, due diligence & valuation play an important role at the time of company acquisition for buyer and seller alike as it would help them gain clarity as to what they are getting in the form of IP and whether the IP is worth acquisition or not. Typically, the IP which exists in the company is either registered or unregistered. The registered IP is often in the form of patent, trademark, design, copyright whereas the unregistered IP may be in the form of know-how, trade-secret, protocols, processes, confidential information etc. Docketing of registered IP is much easier than assessing unregistered IP because identification of IP which exists in the form of know-how, trade-secret can be really challenging. Moreover, transferring such unregistered IP at the time of company acquisition could be quite prone to misappropriation if stringent processes and guidelines are not followed.
The IP audit, followed by IP due diligence is beneficial to assess a collective value. Some of the important considerations for buyer and seller alike are as follows:
IP Audit and Segregation of IP
Firstly, it is required to take stock of all IPs and segregate them on the basis of type, relevance and priority. The following steps may be helpful:
All forms of IPs, registered or unregistered, shall be listed. While it is easy to list the registered IP, it may be quite challenging to identify, docket and valuate the latter.
The first round of segregation of IP shall be done depending upon its type, registration status and its relevance to the business.
Legal status of registered or the filed IP shall be identified to ensure that the IP is not expired or abandoned. If any official formality is to be fulfilled with respect to such IP, it may be done to ensure that the IP remains active and enforceable. This step is significant to avoid what occurred between Ebay and Skype. After 4 years of Ebay’s acquisition of Skype, they learnt that Skype did not own many of its key intellectual property rights owing to which they had to abandon their plans to launch Skype’s Initial Public Offering in the share market.
The second round of segregation shall be done depending upon relevance of IP for the business.
In case of the registered IP, which is not relevant for the business, options of out-licensing or sale of such IP may be explored.
If there is an IP which is not strong enough to get registered, such IP may be published as a research paper as well.
Sometimes, companies may also consider donating some of their IP or let the IP abandon or expire. For instance, Disney’s Steamboat Willie, one of the first iterations of Mickey and Minnie Mouse is now available in public domain as the copyright protection has expired after a long period of 95 years.
Docketing of IP
Secondly, docketing is a process of managing, documenting and tracking deadlines and documents related to the prosecution of IP assets, such as patents, trademarks, designs and copyrights. After segregation of IP is done to identify the relevant IP, following steps shall be performed:
Registered IP shall be docketed to observe the important official timelines, such as responding to official communication, paying the renewal fee to maintain it. For instance, post-acquisition of Jaguar Land Rover, it can be observed that Tata Motors is filing several patents across the world since it has acquired the necessary intellectual property rights of Jaguar Land Rover.
As a part of docketing, it is also required to note down expiry date of IP. For example, if there are only a few months remaining for a patent to expire, it may not be worthwhile to transfer that patent from seller to the buyer as transferring the patent requires amendments to be done and the cost of amendment may be high.
Due diligence and Valuation of IP assets
Thirdly, registration certificates of the registered IP shall be reviewed to understand whether there is a clear title of IP assets and on this basis, the valuation of IP shall be determined. In 2007, Kingfisher airlines merged with Deccan Airlines and following the merger, the Deccan airlines was named as “Kingfisher Red”. This completely diluted the trademarks of both the companies and there was a lot of confusion between Kingfisher and Kingfisher Red. owing to which Kingfisher Airlines suffered heavy losses. This merging which resulted in the creation of “Kingfisher Red” caused degradation in the brand status of Kingfisher Airlines and the company was deprived of its premium value.
Liability and potential risk after acquiring IP
Lastly, Acquiring IP requires a lot of official formalities to be fulfilled in each country where IP is filed for or registered and Important considerations and liabilities to be considered for acquisition are as follows:
The buyer party must know that acquiring an IP comes with a lot of liabilities. For instance, transfer of IP from the seller to the buyer requires a lot of amendments in the official records of the office where IP is filed for or registered. Oftentimes, change of attorney also is preferred by the buyer for the purpose of prosecution which may cost extra. Post acquisition of IP and amendments in the official record, the buyer still has to bear liability in the form of annual renewal fee to maintain the IP For instance, prior to a court declaration in 2019, the ‘well-known’ status of the Vistara Airlines, a joint venture between TATA Sons Pvt Ltd and Singapore Airlines Ltd, remained under dispute since the requisite form and fees for inclusion of this trademark in Trade Mark Registry’s Well-Known trademarks was not done.
Further, if any of the IPs are litigated or opposed, due-diligence shall be performed to know what stage of litigation or opposition it is in and to observe what the further course of action will be. The failed merger between Indian pharmaceutical company Ranbaxy with Japanese Pharmaceutical company Daiichi Sankyo has several examples that the latter faced in terms of litigation hurdles, there was a settlement with US based pharmaceutical company Pfizer over a patent dispute; a settlement with Swiss pharmaceutical company Roche over a patent dispute; a payment of 500 million dollars to resolve a lawsuit and federal charges over the Indian company selling improperly manufactured drugs etc.
IP may be a valuable intangible asset playing a vital role at the time of M&A of the company. Prior to assessing the value of the IP, due diligence is necessary to understand legal status. The business relevance of IP as may be observed can be a game changer.
The concept of Intellectual Property Rights (IPR) in these modern times is progressing as people across the globe create more and more intangible assets with the use of their intellect and creativity. IPR protections various Intellectual Properties (IP) and fosters a sustainable mechanism to make it harmonious with growth. Patent is a subset of IPR, and it focuses on technical inventions, their application and process of manufacture. Patent grants exclusive right to prevent third parties from making, using, selling, offering for sale and importing the patented invention in the jurisdiction where patent is granted. But first, there are certain criteria laid out by the Indian Patents Act, 1970, which must be fulfilled for a product or a process to be considered as an invention; they are Novelty, Inventive Step and Industrial Application. In the case of Novartis AG vs. Union of India, we witness the standard requirements and importance of novelty and inventive steps in India. The Honourable Supreme Court of India clarified various terms stated under Section 3(d)[1] and applied the concept of Evergreening of Patents to solve the case effectively. The appeal was dismissed by the court on the basis that “Glivec” failed to show enhanced efficacy when compared to an already patented drug “Imatinib Mesylate”.
Facts
One of the largest multinational pharmaceutical corporations, Novartis AG, based in Switzerland, created a drug called “Imatinib Mesylate” and in 1992 filed it for a patent at the United States Patent and Trademark Office (USPTO), which was granted. In 1997, Novartis AG filed another patent application in the United States for a “Beta Crystalline” form of imatinib mesylate named “Glivec”, which was also granted a patent in the US. This same drug was also granted a patent in 35-plus countries[2]
Then, in 1998, Novartis AG filed a patent application for Glivec at the Madras Patent Office, India, which was facilitated via the TRIPS agreement. The application specified that it was a beta crystalline form of Imatinib mesylate and further illustrated that it helps to treat cancer, specifically Chronic Myeloid Leukemia (CML) and Gastrointestinal Stromal Tumors (GIST). Novartis AG claimed the superiority of Glivec over previously patented imatinib mesylate, as it had improved flow properties, thermodynamic stability and lower hygroscopicity[3].
Prior to the Patent (Amendment) Act, 2005, India didn’t grant product patents but only process patents as per Section 5[4] of the Patents Act, 1970. Until the section was repealed, Novartis AG couldn’t pursue a product patent for Glivec.
In 2005, the Madras Patent Office considered and later (in 2006) rejected the product patent application filed by Novartis AG for Glivec on the basis that it was not novel, that is obvious to a person skilled in the art and was anticipated by the prior publication of Zimmermann patent; Novartis AG had also wrongly claimed date of filing of the application in Switzerland as the priority date in India. Further, Section 3(d)[5] of the Patents Act, 1970 was applied, “the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.” and the patent office concluded that glivec was a new form of an already known substance which didn’t result in enhanced efficacy.
Aggrieved by the patent office’s rejection, Novartis AG filed multiple (one by the appellant and one by the Indian power of attorney holder) writ petitions in Madras High Court under Article 226[6] of the Constitution of India.
The appeals claimed Section 3(d)[7] of the Patents Act, 1970, to be unconstitutional, as it was alleged to be in contradiction to the TRIPS agreement and in violation of Article 14[8] of the Constitution.
In 2007, the Madras High Court transferred the case to the Intellectual Property Appellate Tribunal (IPAB) after its formation, along with the previous writ petitions challenging the order of the Assistant Controller. IPAB heard the appeal and reversed certain findings of the controller by approving Glivec’s novelty and nonobviousness but still rejected the application for a patent grant as the product was adequately being hit by Section 3(d)[9] of the Patents Act, 1970. As per IPAB reasoning, Section 3(d)[10] establishes high standards for patentability in India and stops the “evergreening of patents”, which is necessary for the benefit of the citizens of India, especially when it comes to life-saving drugs.
In 2009, Novartis AG filed a Special Leave Petition (SLP) under Article 136[11] of the Constitution before the Honourable Supreme Court of India, pleading against the order of IPAB.
Issues Raised
To define “Known Substance”, stated in Section 3(d)[12] of the Patents Act 1970?
To define “Efficacy”, as stated in Section 3(d)# of the Patents Act 1970,
Whether Section 3(d)[13] of the Patents Act, 1970, allow a certain amount of increase in bioavailability to be qualified as increased efficacy?
To compare the stated improvements of glivec with imatinib mesylate properties and judge the patentability?
Relevant Legal Provisions
Section 3(d)[14] of the Patents Act, 1970: “the mere discovery of a new form of a known substance that does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.
Explanation.—For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy”.
Article 27(1)[15], TRIPS: “Subject to the provisions of paragraphs 2 and 3, patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application. Subject to paragraph 4 of Article 65[16], paragraph 8 of Article 70[17] and paragraph 3 of this Article, patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced”.
Judgment
In 2013, the Hon’ble Supreme Court of India gave its final verdict, wherein the court rejected the patentability claim of Glivec, filed by Novartis AG. The court upheld previous verdicts of Glivec (a beta crystalline form of imatinib mesylate) as being a new form of an already-known substance with minor improvements. The court defined the word “Efficacy” as stated under Section 3(d)[18] of the Patents Act, 1970, apropos to “Therapeutic Efficacy” and “Known Substance” as something in public or traditional knowledge. Addressing the issue of a 30% increase in bioavailability, previously claimed by Novartis AG, the Honourable Supreme Court cleared that it would amount to an increase in efficacy, but Novartis AG failed to produce any proper evidence of the same (30% increase in bioavailability of Glivec when compared to imatinib mesylate). Further, the court tested all the other claims of improved flow properties, thermodynamic stability and lower hygroscopicity of Glivec with Imatinib Mesylate and found them to be of no value regarding enhanced therapeutic efficacy. No further documents were provided by Novartis AG, which claimed enhanced efficacy of Glivec over the previously patented drug imatinib mesylate. Lastly, no violation of the TRIPS agreement was found.
Conclusion
India is a developing country which is making a positive mark on geo-politics despite its demographic drawbacks. India upholds the responsibility of prioritising public health, and this judgment replicates the same. There was no violation of the TRIPS agreement because India successfully adopted Article 27[19] of TRIPS without contradicting it. Furthermore, the TRIPS agreement mandates countries to adopt the stated measures but gives member countries flexibility to adopt them at their convenience. The concept of Evergreening of Patents was used by the Honourable Supreme Court, especially in the context of the pharmaceutical industry, to stop big companies from exploiting public and welfare initiatives. Section 3(d)[20], among other areas, safeguards medicine availability to the public at large on a cheaper by price by stopping pharmaceutical companies from getting their inventions patented in perpetuity upon introducing minor changes; this means once the designated time of protection ends, those medicines will be available to the public for manufacture and trade at a cheaper price, without taking consent from the proprietor. Hence, the Honourable Supreme Court safeguarded all Indian citizens, especially the ones in need, from exploitation by the Pharmaceutical Industry. The high and fair criteria of patent protection in India promote fair competition and harmonise all industries. The court interpreted and defined the term “efficacy” as a tool to analyse the notion of invention and as a criterion to judge novelty and inventive steps. Ultimately, the Honourable Supreme Court gave clearance to Novartis AG to get patients over the drug Glivec, but the company failed to fulfill the established criteria.
Founded in January 2023, today our company ‘Blance’ is India’s one & only goal-centric recurring deposit marketplace. A unique solution that combines traditional RDs with the goal-based needs of retail investors, RDs on Blance provide 5x better maturity outcomes than a regular RD. While users save systematically they will unlock brand discounts, credit cards, loans, and insurance options on maturity.
In our journey forward, we aim to forge partnerships with NBFCs, Banks, and other deposit-taking entities. This collaborative effort will provide our investors with a comprehensive retail investment perspective. Additionally, we are committed to assisting new-to-credit users in initiating their credit journey. Through secured credit cards and loans offered by us, we empower users to build their credit scores, subsequently opening doors to further credit opportunities.
Although our app is currently in the Beta version, it is fully operational. We are gearing up for a complete launch in the coming months, marking the next milestone in our mission to revolutionize the landscape of recurring retail investments in India.
What is your growth and expansion Plan?
We plan to do a full launch in the coming months and also bring more NBFCs & Banks where users can save & get better maturity outcomes.
What is the story of your Trademark?
Choosing the name ‘Blance’ was a balancing act in itself! Derived from ‘Balance,’ it embodies the company’s mission. When it came to naming our company, two things were clear: 1st, the domain should be cost-effective, and 2nd, that it should reflect our company’s vision. ‘Blance’ stayed because it perfectly encapsulates our vision – striking a perfect balance of Savings, Credits, & Rewards in our users’ lives.
What are the core challenges you faced?
During the product development phase, we recognized that the fundamental challenge lies in the dynamics of demand and supply. While the demand is clearly evident, the supply side is fragmented and lacks unity. Integrating various entities such as Banks, NBFCs, and others onto a cohesive platform is pivotal but inherently challenging. Moreover, comprehending the demand side involves understanding the intricacies of the Indian/Bharat user’s psyche, which is no straightforward task. Simultaneously, delivering the right product that instills a sense of trust and safety adds another layer of complexity to the equation.
What is your success, Mantra?
Be consistent, be persistent, have patience, & relentless execution.
How do you keep yourself motivated to overcome the challenges you face?
We see the bright side of solving this problem can help millions of Indians: this keeps us motivated.
What would be one tip which you wish to give to budding entrepreneurs?
Build fast & test with real customers it will automatically show your right path to success.
Your hobbies
Listening to podcasts & music, going on cycling rides on weekends.
Author: Pooja Bhatia, Author and CEO, Inoberry LLC.
What is Technology Transfer?
Have you ever wondered where our world would be without innovation, knowledge, skills and expertise? Would we have vaccines protecting us from diseases including COVID? Technology transfer has been happening since time immemorial in various ways from generation to generation.
The importance of technology transfer can be illustrated by the indelible ink that has been used in elections for years. It was developed in the CSIR-National Physical Lab, patented by NRDC and licensed to Mysore Paints and Varnishes Limited (Earlier called Mysore Lac and Paints Limited).In the year 2022, DRDO reported that they have signed 1464 technology transfer agreements.
Technology transfer offers the following advantages:
Knowledge dissemination
Fosters innovation and economic development
Promotes practical application of scientific discoveries.
Competitiveness at national and global level
Job Creation
Capacity building
Attracts investment
Bridges the gap between research and real-world solution
Effective utilization of valuable knowledge and technologies
Benefits the society by offering solutions to its problems.
Technology Transfer is a complex process involving a number of steps to transfer knowledge, skills, innovation and technologies. Technology transfer can be of various types. The most common form of technology transfer is publications in journals, industry-academia collaboration and joint ventures. The following are other types of technology transfer:
Technology development and transfer: Creating solution to address the given problem statement provided by a company to another company or institutions and then transferring it.
Know-how transfer: When knowledge is transferred with or without associated IPRs, it is called as Know-how transfer.
Licensing: It is a process of allowing a third party or third parties other than the owner of the IPR to use, make or sell products or use or make or sell products using the process protected.
Assignment: It is a process of assigning rights of one party to other party to use, make or sell the IP protected product, process or innovation.
Spin-off formation: It is another form of technology transfer where IPR and/or technology and know how is licensed to a newly created startup or company based on the institutional technology or IPR.
Material transfer: is a form of technology transfer where IPR associated or non-IPR associated material is transferred for further testing, evaluation or research.
Technology transfer is a process involving the following steps:
Market assessment
Marketing
Deal Negotiation
Signing of Agreement
Each step of technology transfer requires skills and expertise to move it ahead.
Read more on the skills required in the upcoming write up.
Original Published at https://www.linkedin.com/pulse/what-technology-transfer-bhatia-vasaikar-clp-rttp-patent-agent-awfzc
Infographics, Summary Video and Listenable related to these articles available at Dhvaani Please contact us at info@origiin.com to know more about our services (Patent, Trademark, Copyright, Contract, IP Licensing, M&A of companies)
IP registration is very beneficial for many companies as it gives the owner the exclusive rights over their IP assets through which they can gain profits. In order to boost IP Registration in the country, there are multiple Government schemes available, using which IP expenses may be reimbursed, some of the being as follows, especially for the companies registered in Karnataka:
Scheme 1- By Ministry of Micro, Small and Medium Enterprises
This Scheme offers legal and intellectual property filing support including patents, trademarks, copyrights, designs, geographical indications (GI) etc. The programme also provides IP advisory, consultation, Patentability Searches, Technology Gap Analyses and IP commercialisation through establishment of Intellectual Property Facilitation Centres (IPFCs) across the country.
Eligibility Criteria
Under Ministry of Micro, Small and Medium Enterprises, IP reimbursement application can only be filed by start-ups who are registered under MSME (Udhyam registration).
In order to get Udhyam registration, the required documents are:
Pan card
Aadhaar card
Business address proof
Bank statement
GSTIN
Certificate of incorporation or partnership deed
Benefits of the scheme
Will enhance the awareness of Intellectual Property Rights (IPRs) amongst the MSMEs and to encourage creative intellectual endeavour in Indian economy;
Will help take suitable measures for the protection of ideas, technological innovation and knowledge-driven business strategies developed by the MSMEs for their commercialization and effective utilization of IPR tools.
Will provide appropriate support and facilities for the protection and commercialisation of IP for the benefit of the MSME Sector.
Offers assistance to Small and Medium Enterprises with effective use of IPR tools for technology development, market and business promotion, and enhancement of competition
Documents required for IP Reimbursement:
The following documents are required for MSME IP reimbursement:
Application form: This can be downloaded from the website of the Ministry of Micro, Small and Medium Enterprises (MSME).
Udyog Aadhaar Memorandum (UAM): This is a registration certificate for MSMEs.
Copy of the patent/trademark/GI registration certificate: This is proof that the MSME has successfully registered its intellectual property.
Statement of expenditure: This is a detailed account of the expenses incurred by the MSME during the registration process.
Receipt/proof of payment: This is proof that the MSME has paid the registration fees. Any query regarding the scheme, can be sent to mayapandey.dgca@gov.in
The Department of Electronics and Information Technology (DeiTY) has launched a scheme entitled “Support for International Patent Protection in E&IT (SIP-EIT)” to provide financial support to MSMEs and Technology Start-Up units for international patent filing. SIP-EIT Scheme captures the growth opportunities in the area of information technology and electronics. This scheme encourages indigenous innovation and also recognise the value and capabilities of global IP. In this article, we look at the SIP-EIT Scheme in detail.
Benefits of the Scheme
Financial support is provided for international filing in Information Communication Technologies and Electronics sector.
The Reimbursement limit has been set to the maximum of Rs. 15 Lakhs per invention or 50% of the total charges incurred in filing and processing of a patent application, whichever is lesser.
This support scheme can be applied at any stage of international patent filing by the applicant. However, the reimbursement will only be applicable to expenditures incurred from the date of acceptance of a complete application by DeiTY subject to the approval of the competent authority.
Eligibility Criteria
In general, to qualify for the SIP-EIT scheme, the companies should fall under any of the following criteria:
The company must be registered with the Micro, Small and Medium Enterprises Development (MSMED) Act, 2006 of Government of India.
The applicant must be a registered company following the Companies Act of Government of India and must fulfil the investment limits in plant and machinery or equipment as defined in the MSMED Act 2006 as amended from time to time
A company to be a registered Software Technology Park unit and its amount of investments in PME must be lower than the limits specified under the MSMED Act, 2006.
A company must be a technology incubation startup or an enterprise or located in an incubation centre/park and registered as a company. A startup must also have a certification from the incubation centre/park in case it is located on such premises. These companies, too, have to meet the investment limits for PME defined under the MSMED Act, 2006
Documents required
The applicants must furnish the following documents along with the Application Form to apply for the SIP-EIT Scheme:
In case you are an MSME unit under MSME Development Act 2006, then upload scanned copy of Registration Certificate in *.pdf format, Or
In case you are a Company under Companies Act of Government of India then upload scanned copy of Registration Certificate in *.pdf format, Or
In case you are a registered Software Technology Park of India unit, then upload scanned copy of such Registration, Or
In case you are a Technology Incubation Enterprise/Startup and registered as a company, then upload a scanned copy of Registration Certificate issued by a competent authority in *.pdf format and a certification from the incubation centre/park in *.pdf format.
Upload a scanned copy of last audited Balance Sheet in *.pdf format
If Applicant is an employee or Member of Board of Directors, it has to be substantiated by Documentary proof and uploaded in *.pdf format
Upload the copy of product brochure if any.
Upload the copy of latest Annual Report, if any.
Copy of official filing receipt (OFR) with Indian Patent Office or copy of waiver under section 39 of Indian Patent Act in case of patent application filed in countries outside India.
If you have applied for PCT/ Paris Convention or Direct International Filing, then upload the copy of proof of the same in *.pdf format (A consolidated copy can suffice)
Attach the copy of technical write-up of invention duly fill it up as per the format of technical writeup and upload the same in *.pdf format
Upload the patent search report in *.pdf format
Attach a duly filled scanned copy of Details for transfer of e-payments, as per the format and upload the same in *.pdf format.
Attach a scanned copy of Declaration form duly signed and sealed as per the format and upload the same in *.pdf format.
A statement by the auditor of the enterprise that they fulfil the criteria of investment in plant and machinery or investment in capital equipment (as the case may be) as stipulated in the MSMED Act 2006. Upload the same in *.pdf format.
Reimbursement given:
The Reimbursement limit has been set to the maximum of Rs. 15 Lakhs per invention or 50% of the total charges incurred in filing and processing of a patent application, whichever is lesser.
The applicants can visit the DeiTY website or ICT-IPR portal to apply for the SIP-EIT Scheme. Then the applicant has to fill out the application form in a prescribed format online. After completing, upload all the specified records along with the application form. The recommended applications will then be processed finally at DeiTY for the approval. Any query regarding the scheme, can be sent to ipr@meity.gov.in
Scheme 3-Karnataka Patent Reimbursement Incentive for Startups
The policy defines that the cost of filing and prosecution of patent application will be reimbursed to the incubated startup companies subject to a limit of Rs. 2 lakh (0.2 million) per Indian patent awarded. For awarded foreign patents on a single subject matter, up to Rs. 10 lakhs (1 Million) would be reimbursed. The reimbursement will be done in 2 stages, i.e., 75% after the patent is filed and the balance 25% after the patent is granted.
Reimbursement given:
Domestic patents
2 lakhs
Foreign patents
10 lakhs
Reimbursement in 2 stages 75% when patent is filed and 25% when patent granted
Eligibility criteria
The eligibility Criteria to avail of the benefit of the reimbursement on the filing of a patent application are as follows:
The applicant should be a Startup registered with the Karnataka Startup Cell with a valid Karnataka Startup Cell registration number
Only patents that have been filed by a startup within the validity of the Karnataka Startup Policy will be eligible to claim this reimbursement
Documents Required
The documents required for the Karnataka Patent Reimbursement Incentive for Startups are as follows:
KBITS registration number
Application Form
A copy of the patent filed at the appropriate authority
Certificate of Patent Grant from Patent Office
A detailed statement of expenses incurred towards the Patent Registration along with the copies of invoices & receipts from the patent authority and legal counsel as applicable
All Invoices submitted by the appropriate Patent Authority towards Government fees and legal agents
The certificate of Patent with a valid serial number must be furnished and valid form 27 to be enclosed.
The reimbursement amount will be released/disbursed on the seniority basis depending upon the Budget allotment of the State Government. Any query regarding the scheme, can be sent to startupcel@karnataka.gov.in
The well-known Android Operating System is a patented product whose patent is held by Google, but smart phone manufacturers such as Motorola, Samsung, HTC, LG, etc are also using it in their products. Similarly, Dolby Atoms, also a patented sound technology, whose patent is held by Dolby Laboratories, is used by service providers and device manufacturers such as Netflix, Amazon Prime Video etc. Ever wondered how? Well, these manufacturing companies are the ‘licensee’ of the patent owners who have licensed their technology to these market players. We will discuss about the concept of patent licensing and related patent validation in detail in this article.
Patent licensing is the process by means of which patent owner grants permission to other party or licensee to use the patented invention for a specific period of time in a particular jurisdiction in lieu of royalty. By granting license to use the patent, the patent owner is able to introduce his patented invention into the new markets through the licensee, who, in most of the cases, is a well-established company. By obtaining a license, the licensee gets to exploit the patented invention in terms of building, marketing and selling innovative products.
The process of patent licensing starts with discussions and negotiations between the patent owner, also called as Licensor and the licensee. Process of arriving at a license fee or royalty may be complicated at times as many factors play a vital role, such as, technical and feasibility of the invention, R&D cost, stage of technology, approvals and compliances for the patented product, market demand, status of patent in India and abroad..
Conducting a legal due diligence of the patent before licensing is an important step and it involves:
Verification of legal status of the patent as well as family patents to confirm if it is a granted patent or not, even though in several cases, licensee may be willing to license the invention at application stage itself.
Freedom to operate search is often performed to confirm if licensee has freedom to manufacture, use, market, sell the patented invention in specific jurisdictions or not.
Prior art search is usually performed to understand strength of the patent. If there is relevant prior art available, this indicates that patent to be licensed is easy to invalidate in court of law.
Invalidation or validation search is a kind of search wherein prior art is compared with the patent to assess the ease or difficulty involved in invalidating the patent. The term ‘Invalidation’ is often used when patent office declares a patent to be invalid as a result of pre/post-grant opposition or revocation of the patent. Before patent is granted and after its publication, there is a chance for third parties to oppose a patent application to prevent it from getting granted on the basis of statutory grounds listed under Section 25 (1) of the Indian patents Act 1970. Likewise, there are statutory grounds for post-grant opposition and revocation of patents also listed under section 25 (2) and Section 64 of the Act, respectively. It is important to note here that the Controller of Patents invalidates the patent only when opposition or revocation petition is filed by the third party (ies). Decision to invalidate the patent is taken by the Controller after reviewing arguments and evidence submitted by both the parties (i.e., opponent and patent owner). The steps and process involved to perform invalidation and validation search are the same but the outcome or opinion may be different. An invalidation search is performed to identify the grounds on the basis of which a patent can be opposed or revoked whereas validation search is primarily performed to find out how strong the patent is compared to the prior art and how strong is it to sustain a litigation. In simple words, we can say that when a search is conducted to validate the claims of a given patent, it is called a Patent Validity search and when it is used to invalidate the claims of a given patent then it is called Patent Invalidity Search. The prior arts which are taken into consideration to perform invalidity/validity search includes patent as well as non-patent literature.
As this search is commonly performed at the time of filing a petition to the Controller of Patents for opposition or revocation of a patent, the search results are really helpful to find out if the patent is strong or weak compared to the existing prior art. This may be useful for the licensee to take right decision with respect to licensing of the patent. If the patent is weak, it may not be able to give competitive advantage to the licensee and it may also prove to be ineffective to block the competitors. In future, if such patent is infringed by the third party(ies), there may be serious issues related to enforcing patent rights.
The ideal time to perform invalidation search is at the outset of the preliminary discussion on patent licensing between patent owner and potential licensee. The results of this search can play a very vital role during negotiation of the terms and conditions of license agreement. However, it is also important to understand that patent licensing is a complex process and in majority of the cases, the agreements are negotiated between relationship between the parties and their preference and hence invalidation search, though critical, is not the only factor that determines the value of the deal.
Conclusion
Invalidation or validation search is helpful to determine strength of the patent to be licensed. If done professionally, it may change direction of negotiations between the parties involved in a potential license agreement., In addition to invalidation search, based on preferences of the parties to the agreement, there may be several other factors responsible to determine deal value and other terms and conditions of the Patent Licensing Agreement, which the author shall discuss in the upcoming article.
Author: Bindu Sharma
Please contact us at info@origiin.com to know more about our services (Patent, Trademark, Copyright, Contract, IP Licensing, M&A of companies)
In the contemporary business landscape, Intellectual Property (IP) is emerging as one of the most important assets that a company owns. Intellectual Property is increasingly occupying a central role in any overall business and growth strategy of an organization. By effectively managing and optimizing IP, the organizations stand to derive maximum benefits and gain a competitive edge. However, IP Due diligence is extremely critical to identify the ways IP shall be identified, safeguarded, monetised & enforced.
IP due diligence & its objective
Every business possesses one or the other form of Intellectual Property and most of the times, such IP is either under-utilised or un-identified. Though it may not be required to register all IP assets, it is pertinent or rather crucial to identify it to take decision on whether it is worth registration or not.
Any investigation or exercise that aims to determine the health, validity and value of intangible assets like IP, forms part of IP due diligence. IP due diligence is a set of parameters required to have in a company to ensure that IP:
is not misappropriated or leaked from the company,
is protected in right legal framework,
is brought to the market at right time, either by itself or by licensing it out, and
infringement analysis is done at right time to prevent infringement of third party’s IP rights,
systems & processes are created to monitor unauthorized use of own IP by the third party (ies).
The primary objective if IP due diligence is to realize full value of IP assets by identifying them, take strategic decision about safeguarding them and further formulate a clear roadmap detailing the steps for the effective management.
Steps involved in IP due diligence
The main purpose of IP due diligence is to assess & optimise value of IP and mitigate the risk associated with its loss or infringement. The IP due diligence steps and strategies may be different for each company depending upon area of business, skill set of employees, kind of core IP and jurisdiction, however, this article focusses on the general steps. It is recommended to take expert legal advice to formulate customised steps for effective IP due diligence for your company’s specified needs.
Step 1: “As-is” IP assessment
Before we dig further into IP due diligence, it is crucial to understand and determine the IP that a company owns. Spotting IP and identification of right legal framework in which IP shall be registered is found to be challenging by majority of the organizations. Most of the IP can be registered in the form of patent, copyright, design or trademark. In addition to this, there may be a possibility to protect some form of IPs as trade secret as well. Certain steps like patent/trademark search right in the beginning may be extremely useful to create a stronger IP and give right direction to the R&D efforts. Investigations like patent landscape are helpful to understand global trends related to evolution of the technology.
Step 2: Leakage of IP from the company
Like any tangible form of property, IP also needs protection. However, owing to its intangible nature, sometimes it becomes challenging to take right steps to safeguard such crucial IPs. First of all, one must identify the channels through which IP leakage happens. Most of the times, IP leakage happens through ex-employees, consultants, customers etc, knowingly or unknowingly. Some of the ways to seal these leakage points are as below:
Have stringent agreements with employees, vendors, customers, consultants
Periodic IP sensitization programs in the company
IP Policy detailing security and confidentiality & security clause
Label confidential files as ‘Confidential’
Restrict access to confidential information of the company
Step 3: Strengthening existing IP
Review of literature is an important step in the new product development process because without knowing what is already been done, strong IP cannot be created. The wealth of knowledge available in the form of patents or paper publication can be immensely helpful to create more innovative products and reduce R&D cycle. At the time of new product development, if a thorough patent search is done and expert advice is sought, there may be a possibility for the companies to leverage some of the good patents which are either abandoned or expired or not filed in the desired jurisdictions. However, this shall always be done with expert advice and jurisdiction-based opinion on patent infringement risk.
Step 4: IP protection in right legal framework
Broadly speaking, a company may have IP which may or may not be registered. Invention, design, brand name can be registered as patent, design and trademark respectively whereas confidential information or trade secret can be protected by maintaining secrecy of it. In order to protect confidential information or a trade secrets, clear and stringent processes, policies and practices shall be devised. Some of the examples of trade secret are recipe of Coca-Cola, chicken recipe of KFC etc. For any information to be qualified as a trade-secret, following conditions shall be fulfilled:
Information shall not be known to the public,
It shall be valuable for business,
Owner should have taken sufficient measures to protect it.
Spotting IPs in a product, identifying the right legal framework to protect it at a right time shall be done by the experts sothat the product is protected in the best possible manner.
Step 5: Infringement risk assessment
IP infringement refers to unauthorized use or encroachment upon the IP rights of a third party (ies), and its consequences can be fatal. IP infringement risk analysis shall be done before the product launch to understand if there is any infringement risk. Jurisdiction specific opinion by the legal expert on IP infringement may be helpful to mitigate the infringement risk. Further, periodic IP audits shall be performed to identify external software downloads.
Step 6: IP commercialization
Creation of IP requires significant investment in terms of time, money, and resources. Every good investment should yield returns and therefore, it is reasonable to say that when companies spend money to create IP, they must explore the ways to recover that investment by commercialization of IP, either on their own by integrating such IP onto their products or licensing it out to other potential partners who may bring such IP in the market.
Step 7: Enforcement of rights
One of the reasons for the companies to spend money in R&D and IP registration is to attain competitive edge in the market and create a boundary for the competition. Therefore it becomes important for the companies to be vigilant about unauthorised use of IP by the third party (ies) and they should enforce their rights in case IP infringement happens.
Conclusion
IP due diligence is indispensable for any business aiming to create, exploit, enforce their IP in most effective manner, especially when competition is ever increasing, and business sustainability depends on being “ahead of the curve”. Establishing a strong and robust IP regime that incorporates proper processes, practices, policies and agreements with an aim to optimise benefits of IP created and owned by any company, is of paramount importance.
In 2019, two senior executives of a Bangalore-based IT company were arrested for allegedly stealing data from their employer’s company and using it for their own company. They accessed the company’s client list and used it for their own benefit. Upon further investigation by the company’s operations team, it was found that it was Intellectual Property (IP) that was stolen and the money diverted. In Navigators Logistics Ltd v. Kashif Qureshi & Ors., the court held in favour of the employees saying that the former employers cannot restrain them from using their customer list.
Today, most businesses are facing the threat of IP theft or leakage by the their members such as employees and even consultants. Intellectual Property (IP) is a valuable asset for any organization not just due to its market value, but also the amount of money and effort which goes in to create it. Due to its intangible nature, IP is easy to misappropriate & leakage of IP may happen due to inappropriate disclosure by employees, lack of safety measures or weak policies and agreements.
In this article, the term “IP leakage” refers to a situation where the IP of an organization is made available or accessible to third parties in a wrongful manner, causing a monetary or reputational harm to the organization. The term IP here includes registered and non-registered IP, technical and business information which is sensitive and confidential in nature.
For the organizations, identification and sealing of IP leakage points is necessary to realise the long term value of IP. Top 10 strategies to prevent IP leakage are listed below:
Figure out what is the IP in your organization
The first step to avoid IP leakage is to identify what is the IP in your organization and what its potential value for the business is. Without taking stock of existing IP and knowing the nature of IP, one will not be able to devise appropriate strategies to safeguard it. Typically in an organization, the IP is in the form of software codes, proprietary products, designs, new inventions, new products, business plans, know-how, confidential information etc. Once the IP is catagorised, one may figure out the ways to safeguard it.
Stringent Agreements with confidentiality clause
While transacting with external consultants, vendors, customers, employees where there is going to be an exchange of IP, one must execute an NDA (Non-Disclosure Agreement) to ensure the IP is safeguarded. Important documents such as NDAs, Service Agreements, MOUs, etc. must be reviewed by a legal expert to ensure that the clauses of such agreements sufficiently and appropriately cover the range of IP the organization possesses along with the knowledge of relevant governing laws, arbitration, return of confidential clause, indemnity and liability.
IP Policy
IP Policy along with an active IP committee may be extremely helpful in implementing right processes in an organization to handle IP. The IP Policy shall have clauses related to confidentiality and security of the information.
IP Sensitization programs
Periodic IP sensitization programs by internal or external speakers may play a vital role for the employees, firstly, to understand their roles and responsibilities with respect the safeguarding the IP of the company and secondly, to understand the risk they can impose on the current employer if they bring and use IP of their previous employer.
Physical security of the documents and files
Important documents and files should be segregated as highly confidential or moderately confidential based on their nature. All documents of confidential nature shall be labelled as “Confidential” and soft files shall have the word “Confidential” as header or footer.
Restricting access
Some areas in the organization where secret trials, experiments or research are being conducted, should be restricted and only limited number of people should be permitted to enter such areas. Having CCTV camera or restriction to use smart phones may further be helpful.
Registering IP
Wherever possible, IP should be registered in the form of copyright, patent, design because registration is a very effective way of safeguarding IP. The certificate of registration obtained from the Government can serve as evidence of ownership of IP. Once IP is registered, one can disclose it to others without a fear of losing it.
Exit interviews and induction for new joiners
When employees leave the organization, they take a lot of IP of the company with them in the form of experience and know-how. An exit interview to remind them of their responsibilities, liabilities and the agreements undertaken by them is a very effective step to safeguard IP of the company. Similarly, an induction program for the newcomers focussed on dangers of misappropriating previous employer’s IP plays an important role in sensitising newcomers about the guidelines and processes of handling IP.
IP audit
An annual IP audit is immensely useful in identifying any gaps in the IP processes adopted by the company. Audit also helps to take stock of existing IP, check their status to docket upcoming official timelines.
Using software to track transfer of data or information
Nowadays, there are many software technologies available in the market which may be used to track the transfer of data from electronic devices thereby helping in protecting the company’s IP.
Leakage of IP in an organisation may be detrimental to the business and hence special care has to be taken by the organisation to deal with such situations. Strategies that need to be adopted to safeguard IP may vary depending on the kind of business jurisdiction, but a few basic principles as stated above are simple steps that an organisation must adopt to safeguard their IP and prevent leakage to avoid any damages or losses.
A Non-Disclosure Agreement (NDA) is a formal commitment to refrain from sharing sensitive information with unauthorized individuals. It is crucial in a wide range of corporate transactions, employment agreements, negotiations, and any situation involving the exchange of confidential information. It is a legally enforceable contract that establishes a framework for safeguarding confidential and proprietary data, trade secrets, and other valuable information that contributes to a competitive advantage. NDAs foster trust and enable secure collaborations, business partnerships, and knowledge sharing without the risk of unauthorized disclosure or misuse. Failure to adhere to an NDA can result in legal repercussions, such as litigation or financial penalties.
There are essentially two main types of NDAs. A one-way NDA is utilized when one party discloses sensitive information without expecting reciprocal disclosure. Conversely, a mutual NDA is implemented when both parties are involved in sharing confidential material and have mutually agreed to safeguard it.
How does NDA protect IP?
Intellectual property (IP), which includes trademarks, patents, copyrights, and other forms of creative assets, plays a crucial role in establishing authority, quality, and distinctiveness in the dynamic and competitive business environment, where companies strive to set themselves apart and achieve uniqueness. Certain types of IP, such as trade secrets, are considered confidential due to the potential harm that their disclosure to competitors can cause. Therefore, companies are highly concerned about protecting their IP and employ various measures, including registration and the use of NDA. NDAs are particularly significant when sharing sensitive information with investors or venture capitalists, as they provide a legal framework to prevent unauthorized use or replication of ideas by individuals who have access to confidential data. By implementing a NDA, companies can effectively safeguard their IP, maintain their competitive advantage, and ensure the preservation of their innovative ideas.
Before engaging in collaborations or recruiting external parties, it is crucial to have a well-drafted non-disclosure agreement (NDA) in place. This ensures that any sensitive information, proprietary knowledge, or trade secrets shared during the course of your business relationship remain confidential.
When is an NDA needed?
Starting from the research and development phase, it is vital to require all individuals involved, including employees, contractors, consultants, or any other party with access to confidential information, to sign the NDA. By doing so, everyone is legally obligated to maintain the confidentiality of the information they have access to. Incorporating NDAs into your business practices establishes a clear framework that outlines the obligations and responsibilities of all parties. This not only safeguards your intellectual property but also fosters a culture of trust and confidentiality within your organization.
Some situations where NDA may be necessary are given below:
When two companies get into a joint venture to develop a new product and exchange their own trade secrets and technologies.
When a corporation licenses or transfers its technology, software, or other IP to another entity.
If you are presenting your work or invention to potential manufacturers or suppliers for manufacturing or distribution.
When enlisting the help of contractors, development teams, or consultants to assist with the conception, refining, or commercialization of your innovation
It is generally beneficial to have relevant parties (patent attorneys, patent agents, or patent search firms) sign an NDA prior to filing a patent application.
Participants in certain innovation challenges, or startup competitions may be asked to reveal details about their innovations or business plans.
It is always recommended to sign an NDA with all involved parties to ensure safety of your IP and confidential information. However, there may be certain situations where requesting an NDA may be deemed unnecessary and could potentially deter potential collaborators. If you will not be sharing any confidential or proprietary information, there may be no need for an NDA. Some other situations are:
If freelancers are not exposed to sensitive information that could benefit competitors, an NDA may not be required.
If you are still in the process of deciding whether or not to engage with a particular vendor or agency, they might be hesitant to sign an NDA if they have not yet secured you as a client. In such cases, it may be more appropriate to wait until there is a mutual agreement in place before requesting an NDA.
If the information or intellectual property is already publicly accessible, such as through publications, websites, or open-source platforms, there may be no need for an NDA.
In collaborative environments like open innovation projects or forums, where the goal is to foster idea-sharing and creativity, participants often rely on open collaboration principles and freely contribute without the need for NDAs.
Precautions to safe-guard IP
In case of an invention, it is best to at least file a provisional application before disclosing it. Provisional application can be filed even when the invention is not fully completed. After filing the provisional application, you have 12 months to file the Complete Specification.
It is of utmost importance to ensure that the NDA includes provisions that outline the consequences that will be faced if either party breaches the agreement. This step is crucial in making the NDA legally binding and enforceable. In the event that the terms of the NDA are violated, it is preferred to have the ability to pursue legal action to safeguard one’s rights. This may involve taking the matter to court, engaging in mediation, or seeking compensation for any damages incurred. By incorporating a clause that clearly states the repercussions of breaching the NDA, it strengthens the agreement and serves as a deterrent for the other party to comply with its conditions regarding the protection of your intellectual property.
Conclusion
Overall, having a comprehensive NDA in place is a critical measure to protect your intellectual property and preserve your business interests throughout the various stages of research, development, recruitment, and collaborations. It provides reassurance that sensitive information will be treated with the utmost care, minimizing the risk of leaks, misappropriation, or unauthorized use. Ensure that you have a solid NDA that covers all possible outcomes. Do a background check on the entity/person you want to hire or work with before signing the NDA and disclosing any IP.
Applying for a patent is often associated with very complicated and breakthrough inventions. Does it mean that simple inventions are not granted patents? Let’s try to understand first what is an invention as per legal definition and what all shall it have in order to get a patent. The section 2 (j) of Indian Patents Act 1970 describes the invention as:
A new product or process involving an inventive step and capable of industrial application;
Analysis of definition of invention depicts that in order to have a patent granted, the invention shall be either a product or a process to prepare or manufacture a product. Invention shall also have inventive step, or we can say that invention shall appear non-obvious to a person skilled in the art and shall have industrial application. In combination the invention shall fulfill the following three conditions:
New or novel meaning that there shall not be any prior patent, publication or use of the invention anywhere in the world.
Industrially useful and such use shall be consistent. Invention shall be capable of being produced or used in an industry any number of times as necessary.
Non-obvious to person skilled in the art or inventive step. This requirement of patentability is the toughest one to be determined and fulfilled. Non-obviousness is judged not from the perspective of a lay individual, but from the perspective of a person having ordinary skill in the art. This hypothetical person of ordinary skill represents a baseline against which the degree of innovation of an invention is measured.
Any invention, whether simple or complex if fulfils the above criteria of patentability may be awarded a patent. For example, post-it, invented and patented by 3M Corporation, basically is nothing but a piece of paper with a re-adherable strip of adhesive on the back. Post-it is a result of an initial discovery which was made by mistake in 1968. The scientist Spencer Silver at 3M Laboratories while conducting research to find a type of strong adhesive came up with the formula for a re-usable substance that adhered lightly to objects but could also be easily removed. However, the particular application of this substance was subsequently thought of by the researcher Arthur Fry. The biggest advantage of Post-it is that it can be used for temporarily attaching notes to documents and to other surfaces such as walls, desks, computer displays etc. It’s simple but extremely useful invention that was awarded a patent.
Looking at patentability of Post-it in terms of novelty, industrial utility and non-obviousness, the invention basically relates to “Small note sheets that have an adhesive strip along one of their edges”. Since there was no existing product prior to post-it, the invention was novel at that point of time. Invention was industrially useful as it gives a solution to a universal problem of inconvenience of having to remember an unending to-do list in both personal and professional life. And post-it enables people to stick notes to any surface without harming it. The basic elements of this invention such as paper and adhesive though existed in the prior art but their combination was found to be non-obvious and became a patentable product. The invention was considered to have fulfilled the criteria of patentability and was awarded a patent irrespective of its simplicity.
Other examples where simple inventions were granted patents are, paper clips which is nothing but a piece of wire bent into a certain shape but still there have been numerous patents on different paperclip designs over the years. Rubber bands, invented in the 1800s were patented in 1845 by Stephen Perry. No one has since improved on the basic rubber band design. The stapler, invented in the 1800s has evolved over the years and each variation has been patented at various times. The mechanism behind the stapler is so useful that today we even have medical staplers, which are used to staple tissue together during surgery. If you’ve ever dealt with a mess of cables coming out of your TV or your computer, you know how useful these Cable ties devices are. Hundreds of variations exist today, including cable organizers made with Velcro, plastic cases, and so on.
All the examples above show that patent is not always a result of high and complicated technology products and processes but the simple inventions do get a patent provided they are new/novel, industrially useful and sound non-obvious to a person skilled in the art. So, watch out the work or research you are doing, you may have something patentable. If it fulfils the criteria of patentability, probably you need to file a patent application for it!!
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In an era of technological advancements, innovations are on a verge of representing the qualitative approach of a changing society. On one hand, innovations have the potential of ameliorating the quality of life by significantly contributing to labor and production. On the other hand, such transitions also demand ground-breaking competitive advancements that can square up to the needs of changing dynamics of developments. The ideology of managing the adoption and flow of knowledge has become a crucial parameter for every country. Therefore, it’s of utmost importance to focus on scientific and technological research methods for fruitful exchange to maintain the aura of competition.
Technology Transfer comprises of transferring skills and knowledge of technological advancements through legal recourse such as licensing and assigning so that the accessibility of innovative developments is assured at a wider range throughout the globe. This phenomenon helps in exploiting the already existing knowledge about technological advancement and at the same time provides scope for further innovations. In the words of the World Intellectual Property Organization (WIPO):
“Technology transfer is a collective term for the mechanisms and processes that enable the development of a product or a technology used to manufacture products from the knowledge formed in public research organizations.”
The main parameters that function alongsidefor a successful technological transfer mechanism are academia and industry. Academia contributes to promoting and generating novel knowledge, whereas industry synthesizes such knowledge into a marketable entity, thereby making the two parameters act directly proportional to each other. This interface has a significant impact on economies driven by knowledge and innovations, which subsequently lead to an advanced modern society.
However, this interface doesn’t exist since time memorial. Educational institutions and industrial sectors had their separate ways, with no intention to cross paths. Their objectives were opposed to each other, back in the times, the former being rigid towards the traditional ways of spreading knowledge and the latter being flexible in adopting ways to generate wealth. Till the 19th century, universities were isolated from the various aspects of society whereas industrial organizations were practically involved in ameliorating the economic conditions. The idea that their interaction could help the country in its growth and development was only figmental.
The very first reason these two sectors started coming together was war. A majority of the technological advancements taking place in the 20th century were driven towards facilitating the war situation prevailing during that era. This led to the diversion of objectives in the academic sectoras scientists and researchers were expected to use their studies catering tothe needs of society. Another factor was the propagation of education as a basic right for all. This allowed education not being limited to only a few but presented as a commodity accessible to all. Research and innovations started developing simultaneously.
Innovations percolated the idea of being protected from infringements through emergence of intellectual property rights. Academic researchers that had the probability of generating industrial products sought protection through patenting their invention, which later were licensed to the preferred industry which would generate marketable products using the invention and would share the profits with the patent owners by paying contracted royalties rates. Hence, this led to the genesis of the technology transfer mechanism.
When talking about innovations, wars, and a leading economy, Israel comes to mind instantly. It has gained a considerable appreciation for its innovation-based economy and serves as an inspiration for all the developing countries. We have covered the innovation model of Israel and the reason behind its journey for becoming the Start-Up Nation in one of our previous articles in the Blog, which can be accessed here. In this article, we will address the successful technology transfer model of Israel and what lessons concerened thereto.
Israel has heavily invested in civilian research and development (R&D) projects and has been inspiringly successful in building a flourishing knowledge-based economy. The concept of technology transfer in Israel dates back to the 1960s and its model has been adopted by great nations such as the United States of America. The success rate of the Israel technology transfer model has led WIPO to consider it as the best practice in existence. Israel has three sectors devoted to R&D and there exists a clear demarcation between all three concerning their methodology of having an impact on the market. These three sectors include industry, academic, and government.
Industrial R&D is led by business entities who indulge in developing a product that can fit the market demand. Owing to the commercialization aspects, it receives a huge amount of funding, both public and private, as compared to the other two sectors. Academic R&D is mostly curiosity-driven, wherein the researcher is free to contribute to the pool of knowledge and embrace academic freedom. It is supported by the research center in academic institutions. Government R&D is devoted to public welfare. The research is generally necessity-oriented focusing on public health, education, agriculture, so on and so forth. Such research is either proposed via tenders or by specific governmental research institutes.
All three sectors operated independently and were concerned with their specific technology transfer mechanism till the late 1950s. The universities started coming up with Technology Transfer Companies (TTC), an independent legal entity, operating as a not-for-profit subsidiary of a particular university. The objectives of such TTC were to commercialize academic research on University’s behalf. These TTCs are regulated by statutes framed by the concerned university that governs the right and obligations of the research.
The first of its kind TTC was started by the Weizmann Institute of Science by the name Yeda Research & Development Co. Ltd. Its success has contributed to a paradigm shift in the technology transfer model in Israel, and at the same time, it has become a vanguard for several other TTCs that were established subsequently. It has also set a benchmark by being among the top universities around the world in terms of generating income from commercialized academic research. Faculties of the University also act as a consultant to private sectors that help in creating a link between academic and industrial sector. Its strategy of creating a harmonious balance between public interest and financial profits has made its technology transfer model exemplary for the rest of the world.
The role of the TTC includes but is limited to the following:
To check if the invention qualifies for patent registration
To deduce the probability of commercializing a particular innovation
To formulate market strategies for introducing a suitable innovation
To propose the innovation to specific industrial bodies who might be willing to introduce the resultant product in the market.
To facilitate the university and the concerned industrial entity with the licensing agreement, in case such proposal is successfully implemented.
To identify any research gap with the registered innovation that can hinder the commercial viability of the invention concerned.
To provide proper guidance to the researcher by suggesting ways that can fill the void created by the research gap, so that the innovation becomes compatible with the marketable standards.
The part of the share received from commercialization of academic research goes to the concerned University, which is utilized as funds for future research.
Israel has come up with another interesting concept called “Technology Entrepreneurship”. It is an amalgamation of technology and business, facilitated by academic institutions to introduce an innovative and marketable product.
Enstorage Inc., founded in 2007, by two business entrepreneurs (Mr. Eran Yarkoni & Mr. Nachman Shelef), and an academician (Prof. Emanuel Peled) was the first of its kind, which led to the genesis of such a concept. Such a business model is formed based on the intellectual properties associated with the technological innovation, which eventually decides the licensees willing to vouch for the result of such innovation. This arrangement has made all three R&D sectors in Israel come together and promote innovations in a manner that minimizes the risk of market failures and at the same time contributes to maintaining information symmetry.
Another major contribution for having such an advanced model of technology transfer is attributed to the Israel Tech Transfer Organization (ITTN). It is a private non-profit organization that provides a platform for technology transfer companies in Israel towards fruitful engagement. It facilitates these companies through synchronized affiliation with world-renowned universities and research institutions. The objective of having such an organization was to set up an authority to represent the interest of member companies before the government. It also helps in bridging the gap between local companies and global institutions, helping them engage in advanced technology transfer. It also promotes the awareness of innovations and research propositions, thereby enhancing the public accessibility of the same. As of now, there are fifteen organizations contributing to the cause for which ITTN was formed.
Israel Advanced Technology Industries (IATI) is yet another player in this field. It is an umbrella organization that aims to connect Israel’s tech ecosystem and act as a medium for integrating governments’ goals with the various sectors of the industry. It also provides accessibility to successful global R&D, business & financial enterprises to promote mutual R&D and engender business opportunities for its members. At present, it has a plethora of members that include academic institutions, incubators, investment entities, service providers MNCs, tech-transfer offices, etc.
Some of the successful technology transfers assisted by IITN are listed below:
An automated onboard driver assistant system. The technology uses algorithms that have an advanced Spatio-temporal classification technique that trains the system with static and dynamic visual information.
MobilEye Vision Technologies Ltd. & Yissum, the Hebrew University Technology Transfer
India has become a preferred destination for many multinational companies to establish and outsource their software development activities. Large investments are being made in the IT sector with expectations of ushering in technology and product development to the market.
A patent is a valuable tool for protecting an innovation. Once a given technology has been patented, the owner of the patent can enjoy a monopoly over the technology for 20 years. The term “patent” was once prevalent solely within the scientific industry but is now slowly gaining prominence in the software industry as well. One of the earliest filed patents on software was filed as early as 1962 for a British patent application entitled “A Computer Arranged for the Automatic Solution of Linear Programming Problems”. The invention disclosed an efficient memory management for the simplex algorithm and may have been implemented by purely software means. The patent was granted on August 17th, 1966 and appears to be one of the first. The patentability of software-related inventions is currently one of the most hotly debated topics within intellectual property circles, with software becoming patentable in recent years in most jurisdictions, with software patentability becoming valid in the US since 1982. The only patentability criteria is that the invention has to produce useful, concrete and tangible results. In Europe and Japan, the invention is patentable if it is sufficiently technical in nature. However, when it comes to India, the criteria for patentability of software inventions seems to be more stringent as compared to the criteria in most other countries.
The Indian Patent Office (IPO) has published the Draft Guidelines for computer-related inventions in 2016. This document is managed as a tool to be used by the IPO for streamlining the procedure of examination of patent applications related to computer-related inventions (CRI). In addition to this, the Draft Guidelines give some clarity on the scope of section 3(k) and section 3(n). According to Section 3(k) of the Indian Patent Act, “a mathematical or business method and a computer program per se or algorithms are not patentable” with the term “per se” relating to a computer program in isolation or standalone software. Thus, computer programs alone are not patentable, even though software products also come under computer program per se. It should also be noted that computer-implemented business methods are not patentable in India, unlike the US. The term “business method” includes all activities in a commercial or industrial enterprise relating to monetary transactions or transaction of goods and services such as marketing or sales-purchase methodology. With the development of e-commerce and associated B2B and B2C business transactions, it is possible to have claims drafted with certain technical features such as internet, networks, telecommunication and so on for business methods. If the claims are drafted with these parameters, the subject matter of the claims is considered while examining the patentability. If the matter of the claims relates to business methods, then such claims are not permitted under Section 3(k) of Indian Patent Act.
For a computer program to be patentable in India, it has to have a technical process or should be combined with hardware. This means that the invention should contain something more than a computer program to be eligible for a patent protection. An invention in which the technological advance is nothing more than a computer program is not patentable if the computer is suitable for the particular purpose without special adoption or modification of hardware or organization. However, an invention that relates to a particular manner of organizing the Central Processing Unit or other peripheral units, regardless of whether the invention is implemented by means of a program or special hardware facilities, is patentable. Thus, if a patent is claimed for some tangible device coupled with a software i.e. an embedded device in such a manner, the patent office considers that it is not computer program per se and is thereby patentable. Software that works with new or novel hardware is also considered as patentable.
The awareness on the importance of software patents in India is on the rise. Indian software giants who were filing patents only in the US are now filing patents in the Indian Patent Office as well. The nature of the software patent not only involves new operating systems and software but also includes inventions that we use in day-to-day life such as conversion of a TIFF into PDF, compression/decompression techniques, provision to have multiple network providers on the same cell phone, remote monitoring of data usage, etc.
In 2009, Apple applied for a patent for a ‘method for browsing data items with respect to a display screen associated with a computing device and an electronic device’ (Application No. 461/KOLNP/2009). The objections against the invention was that it was a merely a software program and thus falling within the scope of computer programs per se i.e., under the provision of section 3(k) of the Act.
In their response, Apple submitted that “the method constitutes a practical application of this computer software to an improved technical effect while presenting advantages and overcoming drawbacks of hitherto known techniques”. The outline of the argument is as follows:
Technical Need
Though a single browse window is sufficient, there is still a desire for improved methods and systems for browsing through media items.
A single browse window may be limiting to users who desire to browse through more than one media group at a given time.
Technical Advancement
The applicant submitted a point-wise response for technical advancement for 3(k) objections as follows:
Apple submitted that the graphical user interface includes an application window generated by the media application programme.
The application window concurrently includes a first browse window and a second browse window.
The first browse window displays descriptive information regarding a media file, while the second browse window displays images associated with one or more media files.
The content shown in the first and second browse windows are automatically synchronised when selections are made.
In May 2017, Kolkata Patent Office granted a patent to Apple for the Application No. 461/KOLNP/2009 titled ‘method for browsing data items with respect to a display screen associated with a computing device and an electronic device’.
Thus, it is concluded that even though guide lines are provided there are many aspects that need to be evolved for a better protection of software inventions in India to remove ambiguity regarding what is patentable or not under software inventions as well as the scope of technical advancement while considering the patentability of software inventions.
By Priyadharshini M
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Knowing the pulse of the competitor is extremely important for any business. In general, competitive benchmarking is performed to compare and measure the philosophies of an organization and practices with other organizations to help them to improve their performance in this competitive space. The current economy is often referred to as a knowledge-based economy where intangible assets have become the main source of revenue for most firms. Consequently, more than 65% of most firms’ value and revenue is sourced straight from intangible assets, such as patents. Competitive Benchmarking is a commonly used term and refers to the practice of comparing business processes, innovations, products/services and performance metrics of the best-performing companies to understand and learn from them to improve own business. In today’s competitive world, generating innovation and having the right business strategies both play a vital role to shape and direct businesses toward success. Competitive benchmarking plays an important role to understand the strategies and approaches of competing organisations. The strategies and approaches could involve processes such as designing a new product, creating an IP portfolio, setting product prices, assessing innovation in existing products, launching new products, compiling litigation data, and so on. Such information can potentially be very important for your business and can help you better position yourself in the market. Competitive benchmarking can additionally help you build the right business strategies to advance past your competitors in your industry. Innovation and IP portfolio are amongst the most valuable pieces of information that one can have about their competitors, offering a glimpse into their arsenal of assets and strengths. After expiry of a specific duration of time after a patent application is filed, the application is published and is made available on the official website of the respective patent offices to be viewed by the public. This timeline may have some variance depending on the country where the application is filed, but ordinarily all patent applications are published and can be viewed using free or paid patent databases. A patent is an extremely valuable source of information, especially with respect to technologies or products of your competitors. If a patent search is performed using technological details, previously unknown competitors may be revealed. In this way, information pertaining to patent portfolios can inadvertently help a company identify previously unknown competitors and their patent assets. New competitors can also help in recognizing new opportunities for licensing and acquiring technology. A typical competitive portfolio benchmarking answers the following questions:
What are my competitors doing?
What are the latest patent trends in my industry?
What is the current phase of innovation of my competitors?
Possible licensing candidates?
A few things to keep in mind:
Competitor profiling includes products in the market & under development.
Products protected by patent nationally and internationally are assessed
Identification of IP assets to visualize and understand their value in relation to their competitive environment is done.
IP portfolio of competitors is procured, with a specific emphasis on recently patented applications to see the current area of interest of competitors.
Periodic assessment of patents filed by the competitors or specific technologies may be done by generating monthly, quarterly or half yearly patent alerts.
Before competitive benchmarking is carried out, it is important to understand the purpose behind it. This ensures that the right steps are performed, and there is a reduced amount of redundant data generated. Identification of direct or indirect competition is done as the competitive benchmarking report solely depends upon the kind of companies chosen as competitors. Information about the competition, based on the driving purpose of competitive benchmarking is extracted and compiled. Threats and opportunities in the existing market may be understood better with competitive benchmarking. There could a great learning from the failure of specific products or businesses in the market as well.
Documentation of the invention before you approach a patent agent to draft the patent specification may be extremely helpful for you to explain the invention details to the patent agent. What all shall be documented and how much details are enough, has to be made clear before you proceed further with drafting specification.
Though one feels lazy writing the disclosure of the invention, honestly speaking, there is no substitute to documentation. Sooner or later, you have to document the invention so that interaction with your attorney is fruitful. It is always advisable to execute Non-Disclosure Agreement with the attorney to whom you will be disclosing the invention. The patent agent or attorney with whom you decide to work, may also make you fill Invention Disclosure Form (IDF) when you approach him to file patent application for you.
What is to be claimed?
Patent is a techno-legal document and you get protection over the subject matter you claim in the specification. Hence, identification of novel elements, which may relate to a product or process or utility, shall be done at first level itself. Once you are clear about what to claim, the detailed description of the invention in patent specification revolves around such novel elements and helps you to fine tune the invention as well as highlight novelty of the invention. The best way to separate out novelty of the invention is to perform a thorough global patent search and then remove the elements that are in public domain. Therefore, while documenting your invention, it is a good idea to list out novel elements of the invention.
Existing technical problem
In order to be patentable, your invention shall have an inventive step. One of the ways to assess inventive step is identification of the technical problem that your invention solves and the way your solution works.
The Indian Patents (Amendment) Act 2005 in Section 2(1)(j) and 2(1)(ja) respectively states invention means a new product or process involving an inventive step and capable of industrial application and inventive step means a feature of an invention that involves technical advance as compared to the existing knowledge or having economic significance or both and that makes the invention not obvious to a person skilled in the art.
Hence, you should always be clear about the prior art or existing knowledge or evolution of technology in order to know technical problem precisely and such technical problem shall be explained properly while documenting the invention.
Best mode
As you know that best mode disclosure in a specification is an essential part of a patent application, specifically a complete application that starts with preamble, “The following specification particularly describes the invention and the manner in which it is to be performed”. This clearly indicates that disclosure has to state the best mode of working the invention and at the same time, the disclosure has to be complete, without any gaps in the process.
Section 10 (4) of Patents Act, 1970, clearly states that every specification, whether provisional or complete, shall describe the invention and shall begin with a title sufficiently indicating the subject- matter to which the invention relates to. Every complete specification shall fully and particularly describe the invention and its operation or use and the method by which it is to be performed; disclose the best method of performing the invention which is known to the applicant and for which he is entitled to claim protection; and end with a claim or claims defining the scope of the inventions for which protection is claimed.
The disclosure of the invention shall be sufficient enough that a person skilled in the art shall be able to achieve the results without further experimentation. Incomplete documentation of the invention by inventor resulting in incomplete disclosure of the same in patent specification may be one of the grounds for patent revocation or invalidation. Hence it is important to disclose complete process that is executable.
Specifications often consist of background, description, claims, abstracts and drawings etc. Step wise documentation of the invention assists your agent to draft specification in a better manner. You may always prepare flow charts or drawings for easy understanding even though the drawings submitted by you often would undergo complete re-doing of the work to match standards of the respective patent office.
Documentation/Disclosure of the invention is integral part of the process of patenting. There is no substitute to it. The quality of the patent specification primarily depends upon the precise and clear information you provide to your patent agent. Even though it takes one or two days extra, it makes lots of sense to spend some time and write the invention description patiently.
The world of patents and their relevance is increasing all the time, with newer and more advanced technologies being patented every single day. Research and innovation driven companies must keep themselves updated at all times to keep up with this increase in innovation to best utilize new advancements and understand current scope and limitations of technologies. The purpose of patent alerts is to inform companies about patents that have been filed or published with respect to core technologies of the company. Patent alerts are sent out periodically, and the reports can be sent out monthly, quarterly, or half yearly as per needs of the company.
Patent alerts help companies to keep themselves updated with respect to latest developments in the core areas of their technologies to get valuable information, such as:
New products and processes for which patent applications have been filed, helping companies build their own products in a better manner.
A thorough analysis of existing patents, which may be useful to assess the chances of getting a patent for core technologies or new ideas by gauging the novelty, non-obviousness and industrial applicability of existing inventions.
Information about published applications can help companies who might want to oppose these applications.
New markets or new technologies that other companies are focussing at. This might provide the company with an overview of the kind of products other companies are planning to launch in given markets.
Patent watch can be done primarily in two ways:
Technical Patent Watch: Here, the core technology (ies) of interest may be listed out and related published patent applications or granted patents may be monitored in a technical area of interest. The latest prosecution status of pending patent applications may be monitored making it easier to keep in touch with latest happenings in the industry. Interesting patents that may be used and implemented to add value to existing products or technologies can also be listed out and explored.
Such patents may be considered for in-licensing. However, if they are not filed in the jurisdiction of interest or they don’t have a chance to be filed in the jurisdiction of interest, these patents may be used without any fear of infringement. When proceeding on this route, it is highly recommended to take opinion of an expert on the legal status of such patent (s) before implementation.
Competitor Patent Watch: Understanding the patent portfolio and patent activities of competitors may be of great business value to companies. For this purpose, competitor companies are listed out and their newly published patent applications or granted patents are monitored on a periodic basis. The companies can also monitor the latest prosecution statuses of pending or granted patent applications of competitor companies.
This information obtained by observing periodic patent alerts may prove to be a game changing strategy for any company.
Staying ahead of the competition is critical for sustainability today. With increasing focus on innovation, it becomes important to know about the recent trends in the area of patent filings. It is not only interesting to understand what competitors are doing, but also essential to learn how best to advance past them.
Origiin, with a skilled team of patent agents is one of the best patent companies in India offering patent services like, patent searching and patent filingin India and foreign countries. We provide periodic patent alerts to the innovation and research driven companies that want to keep themselves updated on recent technologies and competitors.
Deliverables: Patent alert report in excel sheet (including patent applications as well as granted patents) along with a PDF copy of all prior arts listed in the report, primarily, monthly, quarterly or half yearly.
Write to us at info@origiin.com to know more about our Patent Alert Service
A patent is a statutory right granted by the Government for a product or process which satisfies certain criteria of patentability. The term of a patent is often 20 years from the date of filing and is subject to certain terms and conditions. The claims of a patent determine the scope and kind of rights the patent grants to the patentee. Patent rights are territorial in nature, which means that an Indian patent for example is valid and enforceable only in India. If one wishes to have patent rights in foreign countries, the patent application must be filed in the required foreign countries within 12 months from the date of priority of the application filed in the home country.
There are few conditions that must be satisfied by an invention for it to be granted a patent. The invention can be a product or process and must have novelty, industrial applicability and must not be obvious to a person skilled in the art. Further, the invention must not fall into any category of inventions that are not patentable, as disclosed in section 3 and 4 of the Act. There are many benefits that a patent holds for patent owners and inventors. For companies and institutions, patents help generate a good image for them and thus enjoy a brand image in the market. If the invention has good potential in the market, patents could be a good source of revenue for the patentee. A patent may add value to a students’ professional records, helping them improve their odds of getting a job or good institutes to pursue higher education. When a patent application is filed, a date of filing is obtained, also called the priority date. The patent rights of a patent are calculated taking this priority date into account, making disclosure of the invention easier after a patent application is filed. This is particularly useful when the inventor is required to publicly disclose their invention at through publications or events. With a priority date secured, it becomes possible for the inventor to disclose their invention, additionally making it easier for business owners to obtain investments for their organization once the patent is filed.
Procedure of obtaining a patent in India
Once a new idea is conceived, the first step should be documenting the novelty of the idea in detail, along with the problems that the invention is attempting to address and solve. A basic understanding of whether similar documentation as the invention exist already must be assessed with a patent search. If the idea is novel, a patent specification must be drafted and filed in India as soon as possible to claim the earliest possible priority date. It must be noted that patent application shall be filed by a registered Indian Patent Agent only. After the publication is filed, it is published on the official website of Indian Patent Office (IPO) after expiry of 18 months from the date of filing, after which the application is examined by the patent examiner. If there are objections submitted by the examiner, the inventor must comply by all the objections. Once everything has been cleared between the inventor and examiner, the patent is granted. A periodic renewal fees is required to be paid by the applicant after patent grant to keep the patent in force.
After the application is published, there may be an opposition to the grant of the application. If such oppositions against the invention are filed within 12 months from the date of filing of the application, the oppositions are called pre-grant oppositions. However, if the same oppositions are filed within 12 months from grant of a patent, the oppositions are called post-grant oppositions. Further, if oppositions are raised after the elapsing of 12 months since filing the patent, the oppositions are called revocations. Oppositions and revocations can be handled by a patent attorney or patent lawyer who may or may not be a patent agent.
Importance of selecting the right patent firm
Selection of the right patent firm or agent is of crucial importance for inventors because a patent document is a highly complex document. It takes both a high level of both technical and legal skill to draft a patent application to accurately capture the essence of an invention. Subsequent prosecution after filing the application is also complex and intricate, further accentuating the need to employ the services of a skilled patent firm or agent. Other processes that the patent firm and agent undertake include maintenance of the patent application, responding to objections raised by the examiner, filing in foreign countries, and so on.
The two terms used most frequently in the industry are “patent attorney” and “patent agent” and is therefore of prime importance to understand the difference between the two. A Patent Agent is someone who possesses at the minimum an undergraduate degree in Science, has cleared the Indian Patent Agent Exam and has registered himself as a registered patent agent with Indian Patent Office. A patent attorney however is an advocate who practices Intellectual Property (IP) law and may or may not be a patent agent. Patent attorney or advocate is required to register himself with the Bar council of India as an advocate. For the processes of drafting, filing and prosecution of a patent application, a registered Patent Agent is required. On the other hand, a patent attorney can assist with handling of oppositions, revocations and lawsuits relating to patent applications. Patent agents and patent attorneys are hence people who have specialized knowledge and qualifications necessary for representing clients in obtaining patents and acting in all matters and procedures relating to patent law and practice. A patent agent may also be appointed by the inventor or applicant to perform various actions before the patent office on behalf of the applicant and in consultation with them.
Qualifications required to become a patent agent/attorney
In order to become a patent agent, the candidate is required to file an application to write the exam. The candidate must sit for the exam and clear it. The candidate must then request the Controller for Form-22, which is then to be filled and submitted along with a fee of 3200 INR for registration of the candidates’ name as a patent agent in the register of patent agents. The candidate must then pay an annual fee of 800 INR to ensure that their name is maintained in the register of patent agents.
Additionally, a person is qualified to have their name entered in the register of patent agent if he/she fulfill the following conditions:
He is citizen of India;
He is above the age of 21;
They have obtained a degree in science, engineering or technology from any university established under law for the time being. The institute must be active in the territory of India or must possess such other equivalent qualifications as the Central Government may specify in this behalf.
The Controller maintains a register called “Register of Patent Agents” in which the names, addresses, phone numbers, fax numbers, E-mail IDs and other relevant particulars of all persons qualified to be registered as patent agent are entered. The list of registered patent agents is available on the official website of IPO.
According to Rule 110, the qualifying examination for patent agents is conducted over a period of 2 days and consists of the following sections:
Paper I : Patents Act and Rules, 100 marks
Paper II: Drafting and interpretation of patent specifications and other documents, 100 marks
Viva Voce: 50 marks
Section 127, dealing with rights of patent agents explains that registered patent agent can draft, file and prosecute patent applications at the IPO (these actions include filing of patent, sending request for early publication or examination, reply to examination report, paying renewal fee, etc.). Every patent agent whose name is entered in the register shall be entitled:
(a) To practice before the Controller during prosecution process such as at the time of opposition to the grant of patent,
(b) To prepare all documents, transact all business and discharge such other functions (such as filing of patent, sending request for early publication or examination, reply to examination report, paying renewal fee, etc.) as may be prescribed in connection with any proceeding before the Controller under this Act.
According to section 128, Subscription and verification of certain documents by patent agents:
A registered patent agent can take authorization from their client on Form-26 [Form of authorization] so that they can act on behalf of their client. All applications and communications to the Controller may be signed by a patent agent.
Form-26 shall be executed on stamp paper of 100 INR denominations.
Factors taken into consideration for choosing the right patent firm/agent:\
When choosing a patent firm or agent, the scientific prowess of the firm or agent must be checked. In the case of a patent agent, they must be a graduate or post graduate in the domain of the invention for which the patent is being filed to ensure that they understand the invention well.
Each patent agent has their own unique ID, obtained from the patent office. Their registration number or even ID card must be checked before working with them.
The patent agent can be asked to show their previous patent applications that have been published or been granted patents which can be verified by checking the patent and publication numbers respectively. If the patents have been granted, a look at the objections raised by the examiner on their patent application can provide valuable insight into the quality of the patent agents’ work.
An essential skill required for drafting of patent specifications is command over the English language. The inventor must speak directly with the patent agent responsible for the drafting of their invention to properly understand whether the patent agent is capable of drafting their specification.
Since some inventions are highly technical in nature, the technical hold of the patent agent over the subject matter of the invention should be judged carefully.
Inventions often belong to more than one scientific domain. Therefore, it must be verified that the patent firm being chosen comprises a diverse group of patent agents, well-equipped to handle any kind of technical query.
Another point to be considered is the pricing that the firm quotes. Filing of a patent application involves official fees that are paid to the IPO and professional fees that are paid to the patent firm that carries out the patenting process.
Conclusion
The process of patent filing is tedious, and the quality of the drafted specifications plays an important role in the prosecution, grant and further commercialization of the invention. Selection of the right patent firm and agent for undertaking this complex procedure is thus crucial to the success of the patent. Experience of the patent firm or agent, quality of the work produced and the number of successful cases are some of the parameters to be considered before selecting the law firm.
Patent is a valuable intangible asset, more important today, as India initiates “Vocal for Local movement” because of which importance of patents is much more than before. Before we proceed further, lets understand what a patent is. Well, patent is a kind of Intellectual Property Right, granted by the Government to the inventor for new, useful and non-obvious inventions for a specific period of time. Patent protection for the invention is for 20 years from the date of filing, provided renewal fee is paid in time and patent is not revoked for any reason. Another interesting thing about a patent is that patent rights are territorial. Indian Patent is valid only in India and in order to get patent protection outside India, you must file separately in the countries where you want to have patent protection.
There are lots of advantages for the business to file for a patent
Disclosure becomes easy: As soon as you file a patent application, the receipt of filing application is generated that contains date of filing patent application, i.e., priority data and application number. Since you obtain date of priority upon filing application, disclosure of the invention becomes easy.
Protects your inventions: You can protect your invention legally by a patent as patent is a statutory right granted by the Government. Once you have a patent, you can prevent third party’s from making, using, offering for sale, importing the patented invention in the country where you have patent protection. Further, once you have patent, you can always license your patent and join hands with a progressive enterprise to bring product in the market.
Branding of company/products: After patent is filed, you can label your products as “Patent Applied for” whereas after grant of a patent, you can label the product as “Patented”. You can put status of “Patent applied for” or “Patented” on your web site, corporate presentations, and it helps you to brand your company/products better.
Better valuation of your company: Like your tangible property, Patent is also a valuable intangible asset. Using specific techniques, value of a patent can be assessed and this adds to overall valuation of your business. This may be useful at the time of acquisition/merging.
Enforcement of patent right: If your patent is infringed by third party, you can enforce your rights to stop using your patent. For example, VirnetX company had four patents (U.S. Patent Nos. 6,502,135, 7,418,504, 7,921,211 and 7,490,151), which Apple Inc infringed in its FaceTime Video calling service. Apple was sued by VirnetX and in this case Apple paid $368 million to VirnetX as damages.
There are several reasons for the companies to file for patents, however, initial due-diligence is important before filing for a patent to ensure that the patent adds value to the business. For any innovation and research driven company, following steps may be useful to set up right steps to create repository of new ideas and channelize them in right way:
Perform an internal Audit to take stock of ongoing research projects
Repository of new ideas shall be created. It is a good idea to create standard Invention Disclosure Form (IDF) where research team can document and submit invention to IP committee
You can screen and prioritize the inventions received and plan to file for patents for the shortlisted them
Identify right legal framework to protect them. There may be possibility of protecting the innovations as patent, copyright, design, trademark etc.
Finally, find out right consultant to help you, based on area of technology and experience of the consultant.
File your patent application to obtain application number and date of filing. To start with, you can file your application in India and later on, within 12 months from the date of Indian filing, you may, based on business needs, international application may be filed.
Patent could be a valuable asset for your company and systematic steps, processes and policies within the organization can help you in a big way.
A patent is statutory grant by Government for the inventions (a Product or a process) that are novel, industrially useful and non-obvious to a person skilled in the art. It gives its owner the exclusive right to prevent or stop others from making, using, offering for sale, selling or importing a product or a process, based on the patented invention, without the owner’s prior permission.
Date of filing patent application is very significant in patent law. The day of first disclosure of the invention to patent office is called as “Priority Date”.
A very famous example to prove importance of first filing or getting earliest priority date is telephone patent controversy in 1870s, where two inventors Elisha Gray and Alexander Graham Bell both independently designed devices that could transmit speech electrically (the telephone) and both men rushed their respective designs to the patent office within hours of each other, Alexander Graham Bell patented his telephone first. Elisha Gray and Alexander Graham Bell entered into a famous legal battle over the invention of the telephone, which Bell won. Today we all know Alexander Graham Bell as inventor of telephone.
In order to claim the earliest priority date, the inventor may be interested in filing provisional patent application. The filing of provisional application enables the inventor to have “Patent Pending” status for the invention. In case, the applicant has filed provisional application, the complete specifications shall be filed within 12 months of filing provisional application. Provisional application can only be filed in Indian Patent Office [National Office] and not at PCT or convention country. Immediately on receiving the Provisional Specification the Patent office accords a filing date and application number to the Application.
The main advantages of filing provisional application are:
Drafting provisional application is less-time consuming compared to drafting complete specifications, hence it is quick method of claiming the earliest priority date
Gives 12-month time to the inventor to take decision on whether he wants to file complete specification or not. This 12-month period is also useful for the inventor to assess the invention commercially.
Applicant has to file complete specifications within 12-months of filing provisional application.
Prime stages from filing patent application till the grant are as follows:
Filing application: You may file complete or provisional application in India to claim earliest priority. However, if you don’t wish to file in India and directly want to file in foreign country, Foreign Filing Permission is required from Indian Patent Office. If provisional application is filed, the complete application shall be filed within 12 months from the date of filing provisional application. The complete specification can be filed directly as a PCT application after taking necessary permission if required.
Publication: The application is published by patent office after expiry of 18 months from the date of filing. Date of publication is very significant as upon publication the invention forms part of prior art. After publication, in case anyone is interested, the application may be opposed on various grounds such as lack of novelty, non-obviousness, industrial application etc. Indian patent law also provides a provision for early publication of application before the expiry of 18 month on request by the applicant.
Examination: After publication, examination of the application takes place and on the basis of examination, examination report is sent by the examiner that has to be replied in a given period of time.
Grant of patent: After replying examination, applicant may hear grant of the patent and this is the time when payment of annual renewal fee to maintain patent is also to be made. Grant of patent is published and in case anyone is interested, the patent may be opposed on various grounds such as lack of novelty, non-obviousness, industrial application etc.
If the applicant is interested in filing patent application in foreign country (ies), it shall be done within 12 months from the date of priority. Once foreign filing is done, we will submit “Priority Document[1]”, obtained from India Patent Office to the foreign country or PCT as the case may be.
Foreign filing of application can be of 2 types:
Convention application: When an application is filed directly in a country which is a member of Paris Convention is called as convention application. For example, if you file in India and then directly file in USPTO, the application filed in USPTO is called as Convention Application.
PCT application: This is application filed though Patent Cooperation Treaty (PCT) which is a filing platform (does not grant patents) and enables you to file application in multiple countries within 30 or 31 months from the priority date. The PCT is only a patent filing procedure and does not provide for the granting of patents. The granting of patents is the responsibility of each individual member countries (Contracting States).
The above timeline provides a graphical representation of the PCT procedure and sequence. Typically, first patent application is filed national or regional patent Office. This patent application is commonly referred to as the local application
Filing a PCT application
PCT application is filed within 12 months from the filing date of local (first) patent application with the Receiving Office of national or regional Patent Office. It can also be filed directly with the Receiving Office of WIPO, if permitted by the national security provisions of applicant’s national law [Refer Section-39 of Indian Patents Act, 1970].
PCT application will have the same legal effect as a separate application filed in each PCT country.
International Search Report (ISR) and Written Opinion of the ISA
Every international patent application is subjected to an “international search” by an International Searching Authority (ISA). An Applicant of an International Patent Application is sometimes given the choice of having a search done on the invention at a patent office other than at the Receiving Office. The patent office which performs the search is called the “International Searching Authority.”
Indeed, not all Receiving Offices are qualified to act as International Searching Authorities, and therefore International Applications filed at such Receiving Offices are regularly referred to a different patent office than where the International Application was initially filed for purposes of having a search of the prior art made. Even when the patent office functioning as the Receiving Office also has the status of an International Searching Authority, agreements may have been entered into which allow another patent office to serve as the International Searching Authority at the election of the Applicant.
An International Search Report and a written opinion from the competent ISA will be provided to the applicant within 16 months from the filing date of local application. The written opinion complements the ISR by providing a preliminary non-binding patentability assessment of the invention taking into consideration the references contained in the ISR.
The recognition as an ISA and IPEA would be beneficial for India in several ways. International applications received by the WIPO under the PCT route sent to India for search and preliminary examination would generate revenues in the form of fees usually paid to ISA and IPEA. The new status would allow Indian companies and inventors to avail patentability search and obtain International Preliminary Examination report (IPER) and written opinions on a much faster and cheaper way.
International Preliminary Report on Patentability (Chapter I of the PCT)
ISA sends report on patentability to the applicant. After having considered the written opinion of the ISA, the applicant may decide not to continue with the assessment of PCT application and not file a demand for international preliminary examination[2]. In this case, WIPO will attach a cover sheet to this written opinion effectively converting it into the international preliminary report on patentability (Chapter I of the PCT). The international preliminary report on patentability (Chapter I of the PCT) is available for public inspection 30 months after the priority date of PCT application (the date of first-filed local patent application).
International Publication
The International Bureau of WIPO will publish PCT application on PATENTSCOPE® shortly after 18 months from the priority date of applicants PCT application. Publication provides technical disclosure of applicant’s invention fuelling greater technological progress and development.
PATENTSCOPE® is a free search service offered by the World Intellectual Property Organization (WIPO). It is made up of two databases, each with its own search interface.
Under PCT system, the applicant is given an option of supplementary international search carried out by participating International Searching Authorities, upon request by the applicant. The request for supplementary international search may be filed any time prior to the expiry of 19 months from the priority date. The supplementary search is completely optional but may be of interest in cases where a more complete overview of the prior art is desired, particularly in respect of specific languages. The supplementary international search service is not available across all International Searching Authorities. Those offering this service do so against the payment of a fee. The supplementary international search report prepared by the International Searching Authority should be available by 28 months from the priority date.
Filing of a Demand for International Preliminary Examination (Chapter II of PCT) (Optional)
This part of the PCT procedure is optional. If the applicant is not entirely satisfied with the contents of the written opinion, he may decide to continue the assessment of invention under the PCT by filing a demand for international preliminary examination with a national or regional patent Office that has been appointed as an International Preliminary Examining Authority (IPEA) under the PCT. Each PCT Member State has appointed at least one IPEA to perform international preliminary examinations for its applicants, referred to in PCT terms as the “competent” IPEA.
Applicant is given at least 22 months from the priority date of his PCT application to file demand for international preliminary examination with the competent IPEA.
International Preliminary Report on Patentability (Chapter II of PCT)
An international preliminary examination may optionally be requested (“demanded”) by the applicant. The international preliminary examination is conducted by an authorized International Preliminary Examination Authority (IPEA). This results in an International Preliminary Examination Report (IPER).
At about 28 months from the priority date, the IPEA sends an international preliminary report on patentability (Chapter II of PCT) containing the opinion of the IPEA for national or regional Offices to use in assessing the patentability of applicants invention. This report is a non-binding opinion on patentability and is only provided to applicants who have filed a demand for international preliminary examination.
National Phase Entry
National phase follows international phase. Entry into the national phase represents the end of the international phase of the PCT procedure and the start of the national patent grant procedure. During national phase the applicant can file patent application in the countries of his choice within prescribed time. A PCT application has to enter into nation phase with in 30 or 31 month from the priority date.
The international preliminary report on patentability (either under Chapter I or Chapter II), received during the international phase of the PCT procedure, will help the applicant to evaluate the chances of obtaining a patent in the countries of his interest. The international preliminary report on patentability also provides guidance to patent Offices on whether a patent should be granted for the invention.
Once entered in to the national phase, the patent application is subjected to the patent laws, regulations and practices of each country. Rejections on form and content may not be raised provided that they conform to the requirements of the PCT.
When a PCT application is filed in India at national phase, it is processed under following stages:
1. On receipt of an application, the Office accords a date and serial number to it. PCT national phase Applications and non-PCT Applications are identified by separate serial numbers.
2. All applications and other documents are digitized, verified, screened, classified and uploaded to the internal server of the Office.
3. Patent applications and other documents are arranged in a file wrapper and the Bibliographic sheet is prepared and pasted on the file cover, so that the files move on for storing in the compactors.
4. The Application is screened for:
a. International Patent Classification.
b. Technical field of invention for allocation to an examiner in the respective field.
d. Correcting/completing the abstract, if required. If found not proper, the abstract will be recasted suitably, so as to provide better information to third parties.
5. Requests for examination are also accorded separate serial number.
Advantages of PCT
The PCT is an important part of the international patent system and application filed at PCT is also called as international application or PCT application. It provides a worldwide system for the simplified filing of patent applications that:
Brings the world within reach
Postpones major costs and provides the applicant with additional time to consider his various patenting options
Provides a strong basis for patenting decisions
Used by the world’s major corporations, universities and research institutions when they seek international patent protection
A single PCT application has the same legal effect as a national patent application in each of the PCT Contracting States. Without the PCT, one may have to file a separate patent application in each country of interest.
[1] It is a certified copy of the application which is issued by Indian Patent Office and it is required by foreign country as a record or Indian filing.
[2] Filing demand for international preliminary examination is optional.
Patents contain a wealth of knowledge as disclosing the best mode of working the invention is one of the important requirements to get a patent.
The word ‘Patent’ originates from the Latin word, ‘patere’, which means ‘to lay open’. Patent is a techno-legal document granted to the inventor (s)/applicant (s) by the respective patent office, in order to claim legal rights over the invention and to prevent third parties from using it without consent of the patentee or patent holder. To be more precise, patent is a set of exclusive rights granted by a state (national government) to an inventor or their assignee for a limited period of time in exchange for a public disclosure of an invention. Generally speaking, in order to get a patent, the invention shall not only be novel, inventive and industrially useful but also disclose best mode of working known to the inventor at the time of filing.
In today’s fast-growing economy, innovation is adopted as a major strategy to achieve competitive edge in the market. Expectations of the consumer on one hand and competition on the other hand put huge pressure on the companies to introduce new products in the market. However, short product cycle and increasing competition put enormous pressure on companies to have sustainable innovations to become and remain competitive in the domestic and foreign markets. Appropriate protection of innovation is extremely critical, and the exclusive rights provided by a patent may be crucial for innovative companies to prosper in a challenging, risky and dynamic business climate.
The purpose of this article is to find out the ways companies can use patents to create stronger technologies/products, innovate better in less time and create more valuable products. In this document, we have used the terms “Patent” and “Patent Application”, where “Patent” literally refers to the granted patent, which provides exclusive rights for inventor or patentee for limited period of time, subject to certain conditions. A “Patent Application” refers to a request pending at a patent office for the grant of a patent for the invention described and claimed in the application.
Let’s understand more about patents, step by step in next sections.
Patents are WEALTH of knowledge
Patents contain a wealth of knowledge as disclosing the best mode of working the invention is one of the important requirements to get a patent. This means that an invention submitted to the patent office in the form of a patent, discloses the invention to the extent that a person with ordinary skills in the art understands it well and is able to replicate it independently. After filing a patent application, usually it is not immediately available for public viewing till expiry of a specific period of time, for example, 18 months in India. This means that a patent application is published only after expiry of 18 months from the date of filing. Usually, all national patent offices have their own databases, where a patent application is published. Therefore, the patent databases have extremely valuable information in the form of patent applications or granted patents.
In a patent specification, the description of the invention, supported with drawings and examples further help to understand the working of the invention. Since grant of a patent undergoes various steps including the examination of the patent application by patent examiner, the subject matter claimed in a patent is not just unique but also meets statutory standards. Therefore, patent is a wealth of knowledge.
2. Rights of a Patent holder
A patent gives exclusive rights to the patentee to prevent third parties from making, using, selling, offer for sale and import the patented product into the country where there is patent protection.
(1) Where the subject matter of the patent is a product, the patentee has exclusive right to prevent third parties, without his consent, from the act of:
Making;
Using;
Offering for sale;
Selling; or
Importing for those purposes that product in India.
(2) Where the subject matter of the patent is a process, the patentee the exclusive right to prevent third parties, without his consent, from the act of:
Using that process;
Offering for sale;
Selling; or
Importing for those purposes the product obtained directly by that process in India.
Any violation to these rights would generally deem to be patent infringement though in most of the legal regimes, there are certain exceptional acts where the use of patented invention without consent of the patentee doesn’t constitute infringement. In India, following acts are not deemed to be infringement:
Any act of making, constructing, using, selling or importing a patented invention solely for uses reasonably related to the development and submission of information required under any law for the time being in force, in India, or in a country other than India, that regulates the manufacture, construction, use, sale or import of any product.
Importation of patented products by any person from a person, who is duly authorized under the law to produce and sell or distribute the product, shall not be considered as an infringement of patent rights.
A patent specification has various sections, such as, title, background, description, drawing, abstract etc. but the most important section is ‘Claims’, that not only defines scope of the invention claimed but also defines legal rights of the patentee.
3. Can the patents owned by third party (ies) be used?
As we know that patents are wealth of knowledge for various reasons. A patent is a technical document and disclosure of best mode of working of the invention is one of the conditions on which it is granted. Unlike paper publication, a patent discloses a much better description of the invention along with examples and drawings to the extent that a person with reasonable skills in the art is able to replicate it without any further assistance. Grant of a patent undergoes examination process where complete scrutiny of the patent happens, which ensures that the subject matter of a patent is authentic, though it is generally believed that it is possible to invalidate a majority of patents. All over the globe, every day several patents are granted and each national patent office maintains data of all granted patents as well as patent publications. The good thing about such databases is that they are searchable where one can search, view, download and analyse the patents.
Let’s further understand how this wealth of knowledge in the form of patents can be effectively and smartly used to reduce R&D efforts. Now, the most important question that arises is, “Can these patents be used or implemented?” The answer is Yes and No. These patents can be used by you only if they are abandoned/expired or you have sought permission to use them or if they are not filed/granted in the jurisdiction of your choice. Using a valid patent, without due diligence can put you in a big trouble.
Let us analyse an infringement case between Philips and two companies namely, Anant Electronics and Futuristic Concepts Media Ltd who were using “digital transmission system” technology to manufacture VCDs using MPED 1 coding audio compression/expansion system in India. Philips had a patent protection (Patent no 175971) on this technology in India, which these two companies were unaware of. They were in fact infringing the patent granted to Philips. Delhi High Court ordered both the companies to stop manufacturing the VCDs that infringed Philip’s “digital transmission system” patent. Had they done infringement risk analysis before manufacturing and launching the product, they would have saved lots of time and money lost in litigation. Therefore, using technology protected by another company can drive one out of business and prior risk assessment is essential to prevent such disputes.
Abandoned, Expired and Lapsed patent
The three terms, Abandoned, Expired and Lapsed look very similar to each other and it is important to differentiate between them. An application (patent application) that has been declared abandoned is “dead”, and is no longer pending. There could be various reasons for an application to go abandoned, such as, failure to reply to office action, failure to request for examination or failure to submit complete application within prescribed time after filing provisional application etc. The term ‘Abandon’ is used generally with respect to the patent application.
The patent, which is no longer valid due to non-payment of renewal (maintenance) fees is called as ‘Lapsed patent’. Usually, a lapsed patent can be restored by making a request to the respective authority within specific time period. If lapsed patent is not restored in time, it fails to be in force.
A patent, which has run its full term in a country and is no longer protected in that geography, is called as expired patent. In other words, after completion of 20 years from the date of filing, a patent expires and is open to public. After expiry, the patent holder does not have any rights over the patent and hence, using such patent does not require permission of the patent holder. However, further due diligence is necessary to ensure the legal status of such expired patent. Once the patent is expired, it cannot be renewed or restored.
In depth analysis and due diligence by a legal expert is mandatory before using the abandoned, lapsed or expired patents. Following checklist is important to be looked into before deciding to use a patent owned by third party (ies):
Legal status of patent (active, expired, abandoned, lapse).
Countries or jurisdiction where it is filed/granted.
Countries where the patent application would be filed during national phase.
4. How to use patents to reduce R&D efforts?
Now we know that patents are wealth of knowledge and after proper due diligence, one can make make use of existing patents that are expired, lapsed or abandoned. Let’s see how they can be used to reduce R&D effort.
Let’s take an example, suppose you are doing research on the product that is meant for water purification, converting any water into portable and drinking water. Before starting the process of R&D and designing your product, you have two options.
Option I
The first option is to have discussion with your team of engineers and design the product. With this option, you can finalize the product which might be the replication of something that is already been patented/claimed/published or the level of innovation may not be high. If there is search in existing patents in the jurisdiction where you intend to manufacture, market or sell the product is not done, there may be likelihood of infringing the patent rights of third party (ies)
Option II
However, the second option is to outline the features that you want to see in the product and perform a broad patent search to pull and list all the related patent documents. Going through such list of patents gives you overview of the kind of work that is already been done by others, key players in the industry, countries that have the maximum number of such patents. Additionally, you can always perform a product search to know about the similar products that are already in the market, what price they are selling at, features of such products etc. With this kind of data in hand, you are certainly in a much better position to design a new product.
Now let’s see using existing patents, how can R&D cycle can be reduced and at the same time, you have more innovative product in hand.
Step 1: Assess the state of the art
In this technological progressive era, huge amount of data gets generated and added in the prior art every day. Where, on one hand keeping pace with technical progress in present times is a challenge, on the other hand, innovation has to happen to ensure sustainable growth. Till the time, you foresee the innovation and market demand in a given area of technology, it is impossible to create significantly creative and valuable products. Another issue in technologies such as electronics or software is that innovation cycle is too short, meaning that in no time after you market or commercialize the product, you may see next versions of the product floating around. Considering high cost of R&D and resources, output often is not that meaningful and sustainable.
In most of the companies, before designing R&D in a given area of technology, one of the most important step is often missed out, i.e. assessment of ‘state of the art’. Even though by means of product surveys, competitors’ products or otherwise, the products available in the market are often watched carefully but the wealth of technical information lying in the form of patents is largely ignored. It is important to note that few of the patented technologies actually never see the market, meaning that, there is huge amount of information, in the form of patents, which is not seen in the market. Hence, it is essential to assess state of the art before proceeding further with finalising the product features.
Step 2: Identify the patents that are of interest
State of the art search shall be done by an expert searcher using the specific and proper search strategies, else you might get patents in thousands and screening through them itself will become a huge task. If the search strategy is too narrow, you might miss out many good patents. Therefore, drawing outline of what is to be searched plays the most important role in extracting the desired patents.
Out of the patents, you got from the first round of search, screen through them and identify the ones that interest you.
Step 3: Due diligence
After going through the contents, process, composition of the patents that interested you, there are chances that you find good patents but don’t have capability or infrastructure to implement all of them. Hence, you should further screen through these patents and short list the ones that you actually want to implement or you have feasibility to implement them. Further, due diligence of these patents shall be done and opinion from an expert shall be obtained to know if it is safe to use such patents or not.
The patents that can be used safely include:
Patents that have lapsed and have no chance of restoration;
Patent applications that are abandoned and have no chance of restoration;
Patent/patent application not granted/filed in the countries where you don’t intend to use, market, sell or export them. However, if the international or convention application is filed, you would be required to keep track of such applications as they might enter into national phase after specific time.
Step 4: Patent infringement analysis
A patent gives exclusive rights to the patent holder or patentee to exclude third parties from making, using, selling, offering for sale and importing the patented invention. Violation of any of these rights is called as infringement. If any company wants to launch a product in particular market, it is essential to make sure that launch of such product is not infringing any third parties patent rights because infringement has fatal consequences.
“Freedom To Operate”, abbreviated as “FTO”, is a kind of patent search that is performed to determine whether a particular action, such as testing or commercializing a product can be done by a company without infringing valid intellectual property rights of others or not and whether such company is “Free To Operate” without any risk of patent infringement. Broadly defined, an FTO search means the ability to proceed with the research, development and/or commercial production, marketing or use of a new product or process with a minimal risk of infringing the unlicensed IP rights of others.
Performing the four steps described above will help you immensely to get idea on latest innovation that is happening in a given area of technology, identify patents of interest, and implement them onto existing products/processes after due diligence and finally infringement analysis to avoid infringement of third party’s patent rights.
Step 5: Review Litigation History
It is imperative to note that having a clarity and complete knowledge of litigation in the area of interest or commercial pursuit, will give additional confidence in the research planning and arriving at an appropriate business plan. Specifically, litigation details concerning patent or other forms of IP dispute is always a good guidance towards drawing ones boundary lines.
Advantages
We observed in four steps above that assessment of state of the art or existing patents along with proper due diligence can give you overview of evolution of technology in a given area of technology and using this information with appropriate due diligence can help you in multiple ways such as:
Over view of technical evolution
You get to know about the top companies working in this area and their core expertise. You might get opportunity to collaborate on R&D or further build business relationship with such companies.
2. Avoid re-inventing the wheel
Knowing about the latest patents, you don’t waste your time in re-inventing the wheel. This way you can start your research from the next level itself. State-of-art is a gold mine and before inventing further, it makes lots of sense to mine it. However, if there are no patents filed or granted in the given area of technology, you have more reasons to smile and be confident that this space is available for further research.
3. R&D efforts are more fruitful
Since this whole exercise gives enough exposure about the patents/patent applications filed or granted in a particular area of technology, you get better clarity on the steps to be taken for further development of product, direction in which R&D efforts has to be planned and of course, patentability assessment of your new ideas. This not only saves R&D effort and time but also helps you to come up with more innovative products having more sustainability in the market.
4. Patent infringement Risk assessment
During the search you may come across some patents that you would like to use or even implement on your current products or processes. However, you may have to further perform due diligence to ensure that you are not infringing any third party’s legal rights. If such patents are filed/granted in the jurisdictions or countries where you have or plan to have business, you can always look for in-licensing such patents.
5. Avoid litigation and related expenses.
Once an appropriate litigation research is done in the area of interest – one can avoid the pitfalls of getting similar litigations and save from possible litigation hassles and expenses.
Knowledge available in the form of patents is very valuable. Thorough analysis and due-diligence of published patent applications and granted patents can be very helpful to give right direction to R&D, create more innovative products and optimize R&D cycle.
Video games are amongst the most widely enjoyed forms of entertainment today. While video games are predominantly played by people in their adolescence, these games are making their way into a multimillion-dollar full-fledged industry that is based on competitive playing. With this level of involvement of games in the lives of people everywhere, it then comes as no surprise that there have been cases where popular characters of video games have come under the spotlight of intellectual property theft. Let’s take a look at a case riddled with twists featuring some of the world’s most popular movie and video game characters.
The case
When we picture the word “Mario”, we instantly imagine a character wearing a red plumber’s uniform, bouncing on platforms to save his princess from evil forces. And when we hear the phrase “King Kong”, our minds instantly jump to a massive gorilla waving his arms around, swatting at airplanes atop the empire state building. It may come as a surprise that the owning studios of these productions have in fact gone head-to-head in a rather interesting lawsuit regarding the theft of the idea of the popular oversized gorilla.
The movie King Kong was first released in the year 1933 by Merian C. Cooper. The production house for King Kong was RKO, which later went on to release subsequent sequels of King Kong in the following years. The movie franchise went on to do very well, earning their producers and directors large sums of money throughout the runtime of the movie. In the year 1981, Nintendo released their game Donkey Kong, where Donkey Kong was a large ape and would attempt to stop Mario (then called Jumpman) from reaching Pauline (Mario’s romantic interest, then called Lady). The game was a big hit and it was simply a matter of time before the game caught the eye of Universal Studios, who then apparently held the license for King Kong. Outraged at Nintendo and other game studios for blatantly copying the idea of King Kong, Universal Studios sternly ordered every agency selling products under the name of Donkey Kong to pay Universal Studios royalties for the misuse of Donkey Kong by way of cease-and-desist letters. Almost all the agencies reverted back with the royalty payments, except Nintendo.
Nintendo attempted to settle the suit outside the proceedings of a court in the year 1982 to which the Vice President of Universal Studios Robert Hadl responded by asking Nintendo to stop making copies of Donkey Kong. Nintendo’s attorney Howard Lincoln pointed out that the name King Kong had previously been used on multiple products that were in no way affiliated with Universal Studios, claiming that Universal Studios in fact did not have the rights to King Kong in the first place. Hadl then asked Nintendo to brace themselves for a lawsuit, claiming that Universal Studios saw lawsuits as a way of making money.
John Kirby was brought in by Lincoln to represent Nintendo in the case because he had a history of winning big-name lawsuits for companies like Sony. During the proceedings, Universal Studios claimed that Nintendo’s Donkey Kong and Universal Studios’ King Kong could easily be confused with each other and that the story line of the movie and game were also similar. To counterattack, Nintendo asked a representative to assure the court that the gameplay of Donkey Kong was in no way similar to the storyline of King Kong. Additionally, Nintendo went on to claim that Universal Studios did not own the rights for King Kong and shockingly enough, that Universal Studios were aware of this fact and still decided to demand royalties for King Kong despite knowing they did not have the rights for King Kong.
Historically, the rights of King Kong had always been a territory undefined. When King Kong was initially released by Cooper in 1933, the rights were firmly with Cooper. Later on, Cooper realized that other production houses were making movies with the character King Kong, and that he had no clear documents preventing them from doing so. Cooper tried to find papers to authenticate his rights but found that he had given the rights for only 2 movies to a production house called RKO Pictures and for a book written by his friend Delos W. Lovelace sometime in the decade of 1970, a whole decade before the release of donkey Kong by Nintendo. However, Cooper could not find documents stating that the license was given to RKO Pictures. During this time, Universal Studios wanted to make their own series of movies on King Kong but were stopped as the rights to King Kong were with RKO Pictures. Desperate to win King Kong, Universal Studios argued in court that the copyright on Lovelace’s novel (which was the only existing document proving ownership of any kind) had expired by then and that King Kong was therefore a public domain character. The court decided that King Kong was indeed in the public domain and therefore anyone could make their reproductions of the character as long as the story involving the character was not copied.
The presiding judge during the 1982 case of Nintendo versus Universal Studios kept all this in mind and reprimanded Universal Studios for knowing fully well that Universal Studios had themselves contested that King Kong was a public domain character but still asserted that they owned the character and even demanded royalties from agencies making use of King Kong. The presiding judge further ruled that the game Donkey Kong was not similar to the storyline of King Kong in any way and was “a parody” at best, thus solidifying Nintendo’s case against Universal Studios. The judge declared that any agency that had paid royalties to Universal Studios were free to demand the royalty fee back from Universal Studios and that all cease-and-desist letters from Universal Studios were rendered null and void. Further, the court found that a game released by a company called Tiger Electronics was very similar to Donkey Kong and thus ordered Tiger Electronics to pay Nintendo a sum of $58 million.
Universal Studios was the one to push this lawsuit against Nintendo in order to extract money from them by means of a character that they didn’t have the rights for. Universal Studios knew this in fact because a few years ago they themselves had gone to court to prove that King Kong was a public domain character, and anyone was free to use the character. Nintendo had initially planned to settle the matter outside of the court but went against the movie giant Universal Studios and even won with getting money from profits from a by-product of the ruling. This case shows us that it is never a good idea to underestimate the court or your opponents, and to assume that all secrets regarding ownerships and rights are out in the open for everyone to access. Universal Studios underestimated the court and Nintendo and subsequently ended up losing the case.
How does the sequence of life appear in a person over time?
Is there any external influence that controls our biological clock?
If so, how does our biological clock determine relationship of time in our physical world?
The Sense of time and its relationship to celestial events are well documented in our history. It is a wonder that our ancestors were able to come up with precise calculation of a year, including the leap year, which takes care of timing of revolution of mother Earth around our star, the Sun. The speed of revolution and rotation are constant and would remain so for the next 5 billion years to come, the remaining life span of Sun.
Year after year, the seasons change and we witness the marvel of Nature. The whole life system on earth responds to these changes appropriately. The axial tilt in the Earth’s axis and its revolution around the year are the main reasons for these seasonal changes that we see. In physical form, it is the duration and intensity of Sun light (with its heat energy) that brings about these variations on Earth.
It is not just photosynthesis – a mechanism by which the plant life harnesses the solar energy and convert them into organic energy / fuel. In animal kingdom, the Sun influences the diurnal cycle (day and night variations in body) and the seasonal cycles that directly influences ageing.
We see the world through our eyes. The light is conveyed through our retina (within the eyeball) to the rear end of the brain -the occipital lobes, through the optic nerves (the second cranial nerve). Here, the light and images are captured, are interpreted and associated with meaning. This is the visual pathway. The vision of timing of nature is also conveyed to the brain, through an interesting circuit, the lesser known – supra-optic pathway, which are nerves from the retina reaching the third eye – the Pineal Gland!
The third eye is often associated with religious visions, the ability to observe chakras and auras. In Taoism, Chinese religious sects such as Chan and Zen.
in Japanese, “third eye training” involves focusing attention on the point between the eyebrows with the eyes closed. In Hindu mythology, the third eye of Lord Shiva, though is described in forehead(by most) is also described by few to be actually located in the rear of the head, an analogy to pineal gland (Ref: https://blavatskytheosophy.com/the-third-eye-and-the-pineal-gland/).
I am not giving a neurosurgeon’s perspective of the third eye, rather, it’s a proven fact in medical science. The third eye does exist and gives the vision of life for the individual. The pineal gland, located in the third ventricle of the brain (at the rear portion of brain) is the anatomical third eye of the body. The light rays when reach our pineal gland, convey information of the average length of day (exposure to light), which over a period of time is interpreted as seasons. It secretes Melatonin in absence of light. A chemical indication of day night cycle within our body is set here.
The pineal gland in close association with the hypothalamus and pituitary gland sets the circadian rhythm of life. Which is the daily variations in our body with respect to day / night cycle, our timing of sleep & activity and energy needs. Through the influence on all hormones of the body, they together bring about short and long term changes in the body mechanism ultimately controlling the growth and ageing in a person.
The past decade of research has converged on an understanding that in many or perhaps even most instances, causality with respect to disease, disorders, and maladaptive development—as well as the preservation of health and maintenance of normative, adaptive development—is best viewed as an interplay between genome-based biology and environmental exposures. This understanding represents a clear departure from the historical views that human morbidities are attributable to either pathogenic environments or faulty genes.
Growth and ageing are natural. There are genetic codes set in a given individual, but are influenced significantly by the environmental factors. Healthy environment is not easy to find, thanks to mindless development that is happening around the world. Our quality of food, air and water are going to only deteriorate with time. Our lifestyle and stress further adds to these worries. Wellness is the concept which all of us should work towards, the best investment that we can do for ourselves.
Biological clock
The third eye is real, and its disturbance is now experienced by most of the population as lifestyle disorders. The biological clock has been re-set in all of us, probably due to over exposure to artificial light, more so with the advent of computers and smart phones. Early puberty, obesity, infertility, insomnia (lack of sleep) and early physical changes of ageing are quite common nowadays.
We cannot go back to the dark ages, however, we can make an attempt to follow a routine in life. With balance of work, activity and adequate sleep, we can at-least work towards the remedial measures.
Adequate physical activity & exercise, avoidance of coffee/tea after 4pm and early dinner can contribute to peaceful sleep. Of course, this is possible only when we can take our minds off our TV and phone! For people working on shifts/ night duty, it is an occupational hazard. They have to find ways not to miss their 6 to 7 hours of sleep.
To age graceful and lead a healthy life, one has to take efforts to combat stress and live a healthy lifestyle. Importance of sleep cannot be over emphasized. Sleep is essential for not only resting the body and mind, but to give the right sense of timing to our biological clock – the third eye.
FTO search, also known as a “clearance search” or “right to use” search, is a kind of search commonly performed to assess patent infringement risk upon new product launch. FTO analysis can save companies from many legal disputes, when it is done in advance, specifically, before launch of the new product. Patent filing is increasing globally and before any new product is manufactured, launched or sold in the market, it is important to thoroughly check the existing patents to be sure that none of the product components infringes upon or encroaches upon claims of any existing patents in a specific jurisdiction.
Before we understand relevance of FTO search, it is important to understand meaning of Patent infringement, which, in simple words means violation of patent rights in the country or jurisdiction where the patent has been granted. When a patent is granted, the patentee gets the right to prevent third party (ies) from making, using, selling, offering for sale or importing the patented product in the country where there is patent protection. Patent infringement happens when any third party, makes, uses, sells, offers for sale, or even imports a product or process claimed in the patent, without consent of the patent holder.
Purpose of FTO search is to assess the likelihood of patent infringement upon launch of new product in a specific country. The best time to do FTO search is at the time of designing the new product because its is easier to make changes in the product specifications and the infringement risk can be minimised or nullified easily at early stage of product development.
FTO search is performed by extracting all relevant patents in a specific country or jurisdiction where the product is to be manufactured or sold. Unlike patentability search, FTO search is limited to patents that are ‘in-force’ i.e. active and does not include patents which are abandoned or expired. However sometimes, looking into abandoned or expired patents also gives important insights and hence it is worth going through such patents quickly. Further, the FTO search is not confined to granted patents, but also includes patent applications because such patent applications may be granted in due course of time and may become a hurdle at the time of product launch. It is also required to keep track of patent applications periodically to track if they get granted or not.
FTO search is a very specialised investigation and analysis of patent documents, done by a skilled attorney, who possesses a good working knowledge of technology as well as law. The final opinion on infringement shall always be rendered by an advocate according to the laws of the jurisdiction. Generally, following steps are taken up to perform FTO analysis:
Steps to perform FTO search are as below:
Step 1: Product for which FTO has to be performed shall be segregated into finer components because there may be patents of other companies for such components and hence extracting patents for all components is important.
Step 2: Nomenclature of all components, as generally used in the industry, shall be listed sothat it is easy to formulate key words for the search as search shall be performed for each and every component.
Step 3: Patent search shall be performed for each component of the product with a timeline of around 22 years in the specific country for which FTO is required to be performed. For example, if the product is to be launched only in India, patent search may be confined to India. However, it is recommended to search in Patentscope database of WIPO also because there may be existing patent applications that might enter India at the time of PCT-national phase filing.
Step 4: Results of prior art search shall be categorised into In-force, Expired, lapsed, Abandoned patents and patent applications. For FTO search, “In-force patents” are most critical to be analysed. Additionally, monitoring “lapsed patents” from time to time is very important because they have a chance to be restored and become active again.
Step 5: Claims of patents, shortlisted in step 4 shall be compared with the product to be launched and claim charts shall be prepared for easy understanding of the extent of overlap. Claim charts give clarity on extent of overlap between product components and patent claims,
Step 6: Based on results of first 5 steps and claim charts, opinion on patent infringement shall be written based on laws of the country where the product is going to be launched. FTO report shall preferably be signed by an advocate.
VirnetX is an internet security software and technology company based in Zephyr Cove, Nevada. This company’s patent portfolio includes American and international patents in areas such as DNS and network communication. Since 2010, VirnetX has been involved in litigation with big companies like Apple, Cisco, Microsoft, etc. In December 2014, Microsoft and VirnetX settled patent disputes over Skype technology for $23 million. VirnetX, in another law suit with Apple was awarded $368 million in damages for FaceTime infringement.
FTO search is highly recommended to be performed by the companies before new product launch sothat patent infringement risk can be assessed and timely steps could be taken to mitigate it.
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Origiin, with a skilled team of patent agents is one of the best patent companies in India offering patent services like, patent searching and patent filingin India and foreign countries. We perform Freedom to operate analysis for all kinds of technology-based products as well as for the drugs for Para IV certification. We provide detailed jurisdiction based FTO report along with bypass options to help companies operate in safe manner by minimizing or mitigating IP or patent infringement risk.
Deliverables: FTO report with opinion on patent infringement risk in PDF, claim charts along with PDF copy of all prior arts listed in the report
Technology Transfer (TT), also called Transfer of Technology (TOT) refers to handing over or transferring a technology, knowhow, methodologies, processes, confidential information, trade secrets by the Technology Developer (TD) to the Technology Buyer (TB) and this transfer is completed by execution and signing of a Technology Transfer Agreement, very similar to the way sale deed is signed at the time of buying/selling of the house when ownership is transferred from seller to buyer of a house. The agreement, generally called as Technology Transfer Agreement has all terms and conditions agreed between the parties to complete the process of Technology Transfer. However, Technology Transfer is very sensitive in nature and is prone to getting exploited easily due to intangible nature of the technology. Therefore, lots of precautions need to be taken while entering into Technology Transfer arrangement.
Why to transfer a technology?
To develop a new technology/product, there is huge investment involved in terms of time, money and resources. After technology is developed, scaling up the technology to industrial level and bringing it to the market could be very challenging for the Technology Developer. On top of it, if Technology Developer doesn’t have clue about how to sell the technology, he may be wasting a lot of time without any substantial gain.
It is moment of great joy for the Technology Developer to see his technology working well at industrial level and reaching consumer effectively. In order to commercialize technology, usually Technology Developer, being scientist or researcher, does not have expertise, resources and bandwidth to manufacture, market and sell the technology on his own. Therefore, it makes a lot of sense for the Technology Developer to transfer technology to the suitable company that is already into manufacturing similar product (s) and has well established systems to manufacture, market and sell the product in given territory or the country.
If executed well, usually Technology Transfer is beneficial to both developer and buyer. On one hand, Technology Developer gets opportunity to join hands with the buyer and commercialize technology and on the other hand, the Technology Buyer gets opportunity to new technology which may add lots of value to his business.
Modes of transfer
as generally happens by means of licensing, assignment or joint venture. In licensing the Technology Developer permits the buyer to use technology for a specific period of time without transferring the ownership whereas in case of assignment, the Technology Developer transfers technology to the buyer permanently and in this process, ownership is also transferred. In joint venture, both developer and buyer come together, join hands and establish business jointly. Depending upon the preferences of the parties, the suitable mode of Technology Transfer may be worked out.
Further, the technology can be licensed in exclusive or non-exclusive manner. In case of exclusive license the Technology Developer (licensor) agrees not to grant license to any other company whereas in case of non-exclusive license, Technology Developer can grant license to more than one companies.
Steps to transfer a technology
Once technology is developed, the steps to be followed to transfer technology are as below:
Detailed documentation of technology to be transferred is very critical. If there is a possibility to register technology as copyright, patent or design, it should be done by the Technology Developer before Technology Transfer process is initiated. Novelty in the technology, problem statement, working of the technology, prototype details, feasibility studies shall be documented in detail. Specific emphasis shall be given to the extent of know-how, confidential information that developer discloses to the buyer because once this information is disclosed to the buyer, there is no way to recover it back. For this reason, it will be wise for the developer to register intellectual property wherever possible so that disclosure of technology becomes easier and safer.
It is advisable to make a BEDP (Basic Engineering Design Package) for the technology that is being transferred. This helps the Industry to simulate the manufacturing process of the technology and scale up the technology.
Technology Developer shall have idea about value of the technology. Initially relying on secondary market research data related to market need/size/preferences and applying right techniques, value of the technology shall be estimated.
At least 50-60 potential companies which may buy the technology shall be listed out and further contact details of top officials in the company shall be extracted.
Such companies shall be contacted, and positive leads shall be separated out for further follow up. Discussions with such companies may be initiated to finalize the deal. Usually lots of communications and negotiations happen at this stage.
Execution of the agreement is the final step where all terms and conditions agreed between the developer and buyer are converted to the agreement.
Precautions before entering into Technology Transfer agreement
After discussions and negotiations on terms and conditions, the parties enter into Technology Transfer agreement. For Technology Developers, precautions to be taken before signing the agreement are as below:
Technology Developer shall be clear about the kind of rights he is granting to the buyer and the jurisdictions to which such rights extend to.
Value of technology that Technology Developers is getting, and royalty/payment terms/applicable taxes shall be made clear.
Most of the times, Technology Developer is required to provide initial assistance to the buyer in terms of meetings or trainings the teams. In such a case, Technology Developers shall ensure that he is being paid for such trainings and his travel is also taken care of.
Term of the agreement, ways of terminating the agreement and effect of termination of the agreement shall be checked properly. Exit from the Agreement shall be smooth for both parties.
Other than this clauses on indemnity, Governing law, dispute resolution may be looked into thoroughly.
For Technology Buyer, following precautions are needed to be taken:
Check status of IP filed or granted in the name of the Technology Developer. If patent forms substantial part of the Technology Transfer agreement, it is required to get validation search done to check strength of the patent. Legal status, term of the patent and countries in which patent is filed/granted is also needed to be checked thoroughly. As a part of Technology Transfer, if Technology Developer is going to assign patent to the buyer, it is imperative to make note of prosecution details of the patent, especially renewal fee payable annually in different countries because if such IP is going to be assigned to the buyer, all liabilities and future fee payments also become responsibility of the buyer.
Scope of rights granted to the buyer shall be such that it should enable buyer to sell the end product smoothly without any hinderance.
Freedom to operate analysis shall be performed by the buyer to see if product made using the technology of the developer is safe to be launched in a given jurisdiction or not.
Invention of the Technology Developer may work well in the laboratory but in order to bring product in the market, scalability of the technology shall be checked. It is better to obtain prototype or feasibility studies data from the Technology Developer.
Case study: Jasmine Exporters in Tamil Nadu
Tamil Nadu is the leading producer of jasmine in India and the flowers produced in the state are being exported to various countries like Singapore, Malaysia, Sri Lanka & United States etc and due to long travel time, the flowers would get spoilt and lose fragrance. More precisely the post-harvest losses were 35-40% and this was causing a huge loss to the flower growers.
There was attempt made to solve this problem by working on the better packaging technology. The Indian Council of Agricultural Research (ICAR) along with National Agricultural Innovation Project (NAIP) sponsored project ‘Value Chain on Flowers for Domestic and Export Markets’ in collaboration with M/S. Vanguard Exports, a private successful flower exporter, developed a reliable export packaging technology that would cater to the near and far overseas markets.
R&D of the project was undertaken by Tamil Nadu Agricultural University (TNAU). The technology was disseminated to jasmine growers and entrepreneurs through training programmers and demonstrations. A total of 1280 Growers and entrepreneurs were trained through 26 training Programs in Jasmine growing area of Tamil Nadu.
The technology primarily involved treatment of flower bud strings with boric acid, followed by packing in ventilated corrugated fibre board (CFB) boxes with butter paper lining and the ventilation is made by making holes in the corrugated fiber boxes. After proper packaging the boxes are airlifted to respective destination. The packing in case of longer travel further involved packing of boric acid treated flower bud strings in aluminium foil lined light weight cardboard boxes. These boxes in turn are packaged in large thermocole boxes with intermittent ice gel packs to maintain the temperature and humidity inside the box. These thermocole boxes are transported in refrigerated vans to airport and then it is dispatched to the respective destination.
With this packaging technology, shelf life of flowers increased to 72 hours against 36 hours in normal packaging system and post-harvest losses were reduced from 40% to 10% and the export volume increased to 1000 kg/ day in 2013 (100%) from 500 kg/day in 2008. Before NAIP intervention, the net profit gained was only Rs. 9,250/day, and after the intervention it increased to Rs. 17,500/day. For Dubai market, the export volume increased to 900 kg/ day (2013) from 600kg/day (2008) and the net profit hiked from Rs.2,250/day (2008) to Rs.9,250/day (2013). Tamil Nadu Flower Growers’ Association, Sathyamangalam (3000 growers) was linked directly with jasmine exporters for marketing. Patent for the packaging technology was filed in the name of TNAU (1370/CHE/2010).
Technology Transfer is a very effective way to commercialize a new technology If worked out well, both Technology Developer and buyer can be benefitted by this arrangement. However, both parties shall be aware of terms and conditions they are agreeing upon to make this arrangement win-win for both.
Patent search is a process of identifying relevant patents and depending upon the purpose of patent search, the parameters like timeline, jurisdiction, subject matter can be defined while performing a patent search for a specific purpose. There are different types of prior art searches for different purposes, but broadly patent search can be classified in to six main categories namely:
Patentability or Novelty search (PAS)
Freedom To Operate (FTO)
Validity or Invalidity search
State of the Art search
Technology Landscape Analysis
Evidence of use search
A. Patentability search (PAS) or Novelty search
“Patentability search”, also known as “Novelty search”, is the most common type of search on patent/non-patent literature to assess novelty & patentability of the invention. While patentability search can be performed much earlier during the development of an invention, it is more commonly performed prior to submitting a patent application. Patent search is often done world-wide or globally using various paid or free databases.
B. Freedom To Operate (FTO)
FTO search, also known as “Clearance search” or “Right to use search” is conducted prior to launching a new product to check the patents that are in force in a country to ensure that upon launching the product, the company is not infringing any patent (s) of third party. FTO search is limited to patents that are ‘in-force’ and it requires in-depth analysis of the claims and legal status of patents identified. FTO is usually done jurisdiction-wise because patent rights are specific to jurisdiction, and FTO analysis should relate to particular countries or regions where a company wants to operate. If the company wants to launch products in the US, FTO is required to be done in the US alone but if the products have to be exported to four other countries, FTO shall be done in other four countries as well.
C. Invalidity/Validity Search
The purpose of validity/invalidity search is to determine whether a patent issued on an invention is valid or not in view of prior art. The main reason to perform this search is to either validate or invalidate one or more claims of a patent. In other words, when a search is conducted to validate the claims of a given patent, it is called Patent Validity Search and when it is determined to invalidate the claims of a given patent then it is called Patent Invalidity Search.
D. State of the Art search
The State-of-the-Art search is the broadest and the most general of all types of patent searches. It is essentially a market survey that ideally finds out what technologies already exist. State of the Art search results are valuable in many situations especially when a company is contemplating entry into a particular field of art. The State-of-the-Art search results may provide concrete evidence of the advisability of such a decision. To a company that is currently active in a particular field of art, the State-of-the-Art search results may lay out the path that must be followed to design around the current art.
E. Technology landscape
Technology landscape is an in-depth analysis of patents to understand the technology evolution, major players, current and upcoming competitors and changes in the timeline trend. The main purpose of technology landscape is to identify the white space or gap in the technology, and it provides a comprehensive scope to plan the future R & D, leading to innovative projects to bring out new products/process in an industry. The main purpose of technology landscape study is to understand the technology trends, strength of competitors, to learn latest technology advancement and analyse the patent activity related to technology of interest. Based on technology landscape analysis, appropriate IP strategy in compliance with business strategy is devised for the companies because a good IP strategy is a critical part of business plan and growth at any stage.
F. Evidence of use search
Purpose of Evidence of Use search, also known as EOU, is to identify potential infringement of the existing patents and is helpful at the time of technology transfer as proof of patent infringement can affect the terms and conditions of the transaction.
Patent search is performed to extract valuable data related to specific product or the invention and this data may be used in various ways depending upon the purpose of patent search.
The word “patent search” or “prior-art search” in patent law means any information that exists in the form of publication or patent or prior use, before the date of the filing a patent application. This knowledge (or “prior art” or “state of art”) may be in any form such as patent, scientific literature, publications (such as journal articles, proceedings of conferences, data books and display information from technical exhibitions), public discussions or news from anywhere in the world. The prior-art search is often performed by a patent attorney or a patent agent or a patent searcher and it is conducted through various patent and non-patent databases and other relevant technological websites to identify relevant prior-arts.
Novelty of an invention is always determined before inventive step because the technical contribution of the inventor can be assessed only by knowing the novel elements of the invention. The invention is not considered to be novel if information about the invention has already been disclosed in public.
The right time of doing patent search is at the stage of idea itself. Before investing time and money to develop the idea, it is extremely important to assess whether the idea is novel or already published or claimed by anyone else. Often the inventors assume that the idea is novel by looking at the products which are already in market and comparative analysis of such products with their idea makes them believe that idea is novel. The hard reality is that only small fraction of patents is commercialized, whereas a big chunk of patents, even though are not commercialized, but certainly form part of the prior art and may prevent an inventor from getting a patent on his invention.
Prior art search is performed at various stages of product/process development and the purpose of doing it may vary depending upon the requirements. The main reasons for which prior art search is done are:
1. Before filing for patent
Inventor may perform prior art search for his invention before filing for a patent to make sure that on the day of filing patent application, his invention is novel and there is no existing patent or publication of the invention before he files the patent application.
2. At the time of planning R & D
Due to heavy competition, today companies spend lots of time and resources for Research and Development. Patent search may be performed by researchers in a particular area of technology to assess the work already done and based upon such existing knowledge they can plan R & D in a better and effective manner. Prior art search gives a fair idea on the research already done in a particular area of technology and the inventor can work further on it instead of working again on the same area. Prior art search also provides ideas to refine and improve the invention by identifying whether the invention has significant improvement over existing inventions.
3. Before product launch
A company may perform prior art search before launching product in a specific market to make sure that it is not infringing patent rights of any third parties by the product launch. This search is called as “Freedom To Operate search (FTO Search)” or “Clearance Search”.
4. Technology Landscape studies for devising IP Strategy
The purpose of Technology Landscape study is to understand the technology trend, strength of competitors, to learn latest technology advancement and analyze the patent activity related to technology of interest. Based on Technology Landscape Analysis (also called as Patent Landscape Analysis), appropriate IP strategy, in compliance with business strategy is devised for the companies because a good IP strategy is a critical part of business plan and growth at any stage.
5. During opposition or revocation
If anyone wants to oppose or revoke a patent application or a granted patent, patent search is necessary to identify the grounds on the basis of which validity of a patent/application shall be contested.
6. Patent Licensing
Patent licensing is the process of transferring patent rights to third party by the patent holder for a particular period of time, in a given jurisdiction. At the time of patent license, patent search is performed to understand strength of the patent by comparing the patent to be licensed with the prior art.
The prior art or patent search is essential for innovation driven companies not only to plan research, take decision on patent filing but also to formulate appropriate IP strategies.
Therefore, it is imperative for the inventors to perform patent search at the stage of idea itself, assess chances of patentability as well as infringement of patent right of the third party (ies) before investing money and time in research. For the inventor to make a decision on the patentability of the invention, it is critical to get the search done in time.
A patent is a form of Intellectual Property Rights (IPR) and is a statutory grant by the Government that gives its owner the legal right to exclude others from making, using, selling, offering for sale or importing the patented invention in the territory wherein patent is granted, for a limited period of time.
Invention shall have novelty, inventive step and industrial applicability in order to get a patent granted. Patent is granted to the inventor only if these three conditions are fulfilled. The way to assess patentability of the invention before filing a patent application is by performing patentability search.
Patentability search (also called as novelty search or patent search or prior art search) is a kind of patent search which is often performed to analysis novelty of the invention before filing for a patent wherein prior arts, similar to the invention are identified, analysed and compared with the invention in detail to assess novelty of the invention. This helps further to draft patent claims in a better manner. This search is also sometimes performed to plan further research by analysis of the research which others have already done. It is highly recommended to search non-patent literature (research paper publications) also in addition to patent search, especially when the purpose of search is to assess novelty of the invention.
The search is often performed by patent professionals into several paid or free patent databases by using various search techniques such as key word search, International Patent Classification (IPC) based search, assignee search and so on. Further, patent professionals use various search strategies to yield the most relevant and accurate results corresponding to a particular invention.
In order to perform patentability search, following steps shall be taken:
Step 1: Identification of novel elements of the invention
The novel features may be listed out as novel feature 1, 2 and so on. This listing helps to formulate the key words and set right search strategies.
Step 2: Formulating right key words & framing search strategies
It is important to do basic research on the invention so that it is easy to identify keywords and their synonyms to ensure that prior art search is comprehensive, and no important prior art is missed during the search.
Step 3: Performing search in patent databases
Every patent office maintains its own patent databases comprising published applications and granted patents. Some of the commonly used databases includes espacenet, google patents, patentscope by WIPO and USPTO patent database. Search in these databases is free. However, there are more comprehensive databases, which are paid. Search shall be performed in these databases to extract the relevant prior art. Searcher shall focus on key words and search string formulation otherwise you may get a very high volume of search results and it becomes difficult to screen through it.
Step 4: Screening of prior art and categorizing them based on similarity with the invention
At the time of performing patentability search, the entire patent specification shall be read with special emphasis on the patent claims/embodiments and categorised as most relevant, relevant prior art.
Step 5: Comparison of prior art with novel elements of the invention
Comparison of prior art with novel elements of the invention shall be done for each novel element and finally the invention shall be assessed for patentability.
Step 6: The invention shall also be assessed to check if it falls under category of inventions not patentable in a specific jurisdiction.
In addition to meeting 3 conditions of patentability such as novelty, inventive step and industrial application, the invention shall not fall into any of the category of inventions not patentable. In Indian patent law, section 3 and 4 talk about the inventions that are not patentable in India. For example, the inventions that relate to computer software, traditional knowledge, atomic energy or the inventions that are injurious to human, plant animal life or environment are not patentable in India even though such inventions fulfil criteria of patentability. In step 7, invention shall also be assessed to check if it falls under category of inventions not patentable in a specific jurisdiction.
Step 7: Assessment of patentability of the invention in terms of novelty, inventive step and industrial application
In order to assess patentability of the invention and write opinion on patentability of the invention, the searcher shall be thorough with that different provisions of patent law. Based on finding of above 6 steps, opinion on novelty and patentability of the invention shall be written.
Novelty search is important to be performed before taking final decision on filing for a patent. If this search reveals similar or identical prior art, which is very close to the invention, inventor has a chance to improve upon the invention to minimise the objections to the grant of the patent during examination of the patent application.
Origiin, with a skilled team of patent agents is one of the best patent companies in India offering patent services such as, patent searching and patent filing, in India and foreign countries.
Deliverables: Patentability search report is written in word document with opinion on patentability considering statutory provisions along with PDF copies of all prior arts listed
Buying patent (s) is a very effective way for the companies to increase size of their patent portfolio and get access to the new and latest innovations without spending much time and money on R&D. In today’s highly competitive world, acquiring intellectual property, is increasingly becoming an important business strategy to increase companies’ offerings or differentiating itself with respect to competition.
By in licensing a patent, companies get permission from the patent holder to use the patented invention for a specific period of time in a given jurisdiction and therefore, buying a patent may also help companies overcome risk of patent infringement.
The sole difference between buying and in-licensing of patent is that in case of buying patent, ownership of the patent gets transferred to the buyer and when patent is licensed, there is no transfer of patent ownership from patent holder to the buyer but it’s only permission granted by the patent holder to the buyer to use the patented invention for a specific period of time.
In this article, we will discuss advantages of buying patents and important considerations before taking decision to buy patents.
Why should companies buy patents?
Innovation is key to success of any business today and in order to obtain a competitive edge in the market, innovative products, processes or services shall be created. Acquiring innovative patents or technologies could be one of the most effective ways to create innovative products. When the patent is granted to patent holder by the Patent office, the patent holder is granted specific rights in a specific jurisdiction which he/she can license or sell it to other in lieu of royalty or an upfront payment. Therefore, if both patent holder and buyer are interested, the ownership of patent may be transferred to the buyer by patent holder.
In 2017, InVisage was acquired by Apple Inc, along with its patent portfolio of more than 100 patents on Quantum Dot Technology for Advanced Cameras along with other technologies. This is how Apple got access to Quantum Dot Technology and thereby it helped enhance size of its patent portfolio and use the acquired technology in their latest cell phones.
In 2014, flash array vendor Pure Storage acquired 100 patents from IBM, which were related to storage technology to prevent litigation. This way, Pure Storage could not only build a robust patent portfolio but also got freedom to operate in a wider range by minimising patent infringement risk. Further, acquiring patents also improved valuation of the company.
There are various advantages of buying patents, such as:
Obtaining access to new/latest technologies and markets
Reduce R&D cycle, thereby reducing time to market
Remain “ahead of the curve” vis-à-vis competition
Minimise patent infringement risk
Increase size of patent portfolio
It may help in branding or marketing
Important considerations while acquiring or licencing a patent
Buying of patent is a cost to the company. Hence it becomes important that only useful and relevant patents are bought. Following points shall be taken into consideration before taking final decision to buy a patent:
a. Area of Technology: In order to buy patents, first of all, areas of technology in which patents are to be bought shall be identified. Reading through the entire patent specifications, especially the claims will be immensely useful to find out subject matter claimed in the patent. Further, the patent to be acquired should complement or enhance the current technology offerings.
b. Jurisdiction: The buyer should be clear about the jurisdiction where the patented invention is to be used. For example, if the business of a company is only confined to India and US, then, patents filed/granted in these two jurisdictions shall be searched. However, there is a possibility of existence of good and relevant patents in other jurisdiction where there may be opportunity for companies to use such patents without a need to buy them or in-license them. For example, if an Indian automobile company finds a good, patented invention in Brazil for which Indian patent is either not filed or timeline to file in India has expired, the Indian company may use such patent in the countries other than Brazil. Patent rights are territorial in nature and patent granted in Brazil is valid only in Brazil. Using such patent outside Brazil generally does not deem to be infringement of patent rights. However, thorough due diligence is needed in such cases to ensure that there is no patent infringement risk involved.
c. Searching right patents: There are free and paid patent databases from where list of published patent applications or granted patents may be extracted using various search strategies. You may shortlist the relevant documents, read through the abstract and if need be, full patent document may be downloaded and read to understand which is the right patent to be bought.
d. Legal status of patents: It is very important to check legal status of the identified patents so that you know if they are “in-force”, “abandoned” or “expired” patents. It is good idea to segregate the identified patents into various categories depending upon their legal status. It is important to note here that you must buy only “in-force” patents because expired patents anyways are available for you to be used for free. As far as abandoned patents are concerned, they may have a possibility to be restored. So, if you are interested in abandoned patent, you must watch it carefully and periodically to understand if it comes into force again or gets expired. So, your strategy to buy such abandoned patent will change accordingly.
e. Making offer to the patent holder: After you have identified the patents of interest and confirmed their legal status, the next step could be to extract name and contact details of the patent holders to contact them to show your interest in buying the patents. Discussion may be initiated with patent holders regarding buying of the patents. At the time of buying patents, before making an offer to the patent holder, one of the important action points you should be focussing at, is valuation of the patent to understand how much you are going to pay for buying the patent. There are various well-tested methods to assess value of a patent, however, lots of things depend upon how the parties want to proceed.
f. Check prosecution history of the patent and it’s renewal fee: After patent application is filed, there are various prosecution stages through which a patent application passes to get a patent granted. This prosecution history may give you very vital information on quality of patent, kind of objections the examiner raised before grant of patent. This information may be of great use at the time of negotiation the patent holder. Further, after a patent is granted, there is an annual renewal fee which is to be paid by the patent holder to respective patent office to keep the patent in force. Failure to pay this fee may result in expiry of the patent. Once you buy the patent, you will be responsible for paying this renewal fee. So, depending upon the term of patent left, you must estimate the amount of fee payable by you to keep the patent in force.
g. PatentAssignment: Patent assignment is the term used with respect to transfer of patent rights and ownership from patent holder to buyer of patent. Here the buyer becomes owner of the patent and patent assignment is completed by executing assignment deed between patent holder and the buyer. Copy of such Assignment Deed is submitted to the respective patent office and then Controller of patent makes changes in the official records.
h. Patent Infringement Risk: It is worth noting here that even if you buy a patent and own it legitimately, before implementing or using such patent, it is important to ensure that usage of such patent does not infringe any third party’s patent rights. Hence Freedom to operate search or infringement analysis is important to be performed before acquisition of the patent.
Conclusion
Buying a patent is an effective and powerful way to increase size of IP portfolio and own patents without spending much on R&D. However, like owning tangible property, IP ownership also comes with obligations and responsibilities. With proper due diligence and expert advice, this process can be made really effective and useful for the organization.
Indian patent law allows more than one person to come together and apply jointly for a patent. Upon grant of such patent, these applicants become joint/co-owners of the granted patent. Co-ownership of a patent might be unavoidable in certain scenarios when more than two parties have jointly invested or have common interests with respect to commercialisation of the patented product. Applicants who have joint ownership of a patent should be aware of the risks & legal ramifications involved because joint ownerships involve a great deal of shared investment and experience, both of which may be wasted if the applicants are not aware of risks and legal implications.
Co-ownership of a patent is dealt under sections 50 and 51 of the Indian Patents Act, 1970. Section 50 [Rights of co-owners of patents] lists out the rights of the joint owners as below:
Each co-owner is entitled to an equal and undivided share in the patent, unless there is an agreement to the contrary. Co-owners may be two or more and they shall own equal share in the patent, by default. However, this equal share in the patent may be changed by executing an agreement where there is a clear mention of share each co-owner holds.
Each co-owner is entitled to equal patent rights, as mentioned Section-48 [right of patentee], for his own benefit without accounting to the other person or persons. Each co-owner can independently commercialise the patent without seeking permission of other co-owner (s).
If a patented article is sold by one of the co-owners, the purchaser and any person claiming through him shall be entitled to deal with the article in the same manner as if the article had been sold by a sole patentee.
As stated above, when a patent is jointly owned, all joint owners can commercialise the patent independently without consulting the other co-owners; however, a license for such patent shall not be granted to any third party by any of the co-owners without consent of the other co-owners. Further, a share in the patent shall not be assigned by one of the owners without consent of the other co-owners or joint owners. If proper care is not taken with respect to this clause while entering into a joint ownership of a patent, this may lead to dispute amongst the co-owners. Further, when a patented technology is sold by any one of the co-owners of the patent, the right that the buyer of the property acquires in the technology will be the same rights he would have acquired if the patent were not jointly held.
A patent shall be treated as a movable property (property that can be moved from one place to another) and rules of law applicable to the ownership and devolution of movable property generally shall apply in relation to patents. Movable property includes personal items such as clothing, jewellery, household goods such as furniture, decorative items and appliances and so on. For better understanding, let us take the following example.
Let us consider a situation where a patent has two joint owners: A and B. According to Indian Patents Act, 1970 both of them have an equal and undivided share in the patent and both of them can exercise the rights granted to them under section 48 of the Act on their own without accounting or waiting for the other’s consent. Here, the patent should be handled like a movable property for the purposes of ownership and devolution of patent rights.
Though co-owners can enjoy equal patent rights and privileges, the problem starts when one of them wishes to assign or license the patent. If a patent has to be licensed in India, it has to be written, duly executed and registered. If A wants to license the patent to someone, A must obtain B’s permission. If B is not willing to consent to such licensing, the situation becomes complicated. In such circumstances A is left with only one option. A has to approach the Controller, seeking his power to direct B to agree to the licensing under Section 51 (1) of the Indian Patents Act 1970. This section empowers the Controller to give directions to joint owners regarding the sale or lease of the patent, grant of licenses etc. Powers of the Controller to give directions to co-owner in case of sale or lease or execution of instrument are as follows:
If a patent is co-owned, the Controller may give directions for the sale or lease of the patent or any interest therein or the exercise of any right under Section-50 to any of the co-owners. Such direction is given by the Controller only when application is made to him in the prescribed manner by any of the co-owners.
If any person registered as grantee or proprietor of a patent fails to execute any instrument or to do any other thing required for carrying out of any direction given under this section within 14 days after being requested in writing so to do by any of the other persons so registered, the Controller may, upon application made to him in the prescribed manner by any such other person, give directions empowering any person to execute that instrument or to do that thing in the name and on behalf of the person in default.
Illustration
Maya is registered as grantee of a patent and she fails to execute the instrument (license agreement) with 14 days after being requested by the co-owner of the patent. If the co-owner makes an application to the Controller, any other person can execute the instrument in the name and on behalf of Maya.
Before giving any directions under this section, the Controller shall give an opportunity for the following to be heard:
In the case of an application under sub-section (1) to the other person or persons registered as grantee or proprietor of the patent;
In the case of an application under sub-section (2), to the person in default.
No direction shall be given under this section so as to affect the mutual rights or obligations of trustees or of the legal representatives of a deceased person or of their rights or obligations as such, or which is inconsistent with the terms of any agreement between persons registered as grantee or proprietor of the patent.
Approaching the Controller for directions might turn out to be a time-consuming process. Also, it may lead to uncertainty as it will be the Controller who then will decide about the directions to be given. No directions will be given under this section so as to affect the mutual rights or obligations of trustees or of the legal representatives of a deceased person or of their rights or obligations as such, or which is inconsistent with the terms of any agreement between persons registered as grantee or proprietor of the patent. This situation may get further complicated if the ownership of the patent itself is in question. These possibilities make it imperative for the parties to take utmost care while entering into a joint ownership of a patent.
This whole complexity can be taken care of if both A and B enter into an agreement about how they would exercise the licensing rights each of them have in order to avoid such complexities later. So, a lot of hardships may be prevented if a little precaution is taken at the time of entering a joint ownership of a patent, specifically at the time of entering into an agreement about the licensing of the patent.
For various reasons, every inventor wants to file for a patent internationally after filing it in his/her home country. Sometimes it’s about the status that is associated with having a patent filed in the US or Europe, but having an international patent may also enhance the valuation of the technology which ultimately may impress investors and fetch better value to the inventor. Oftentimes, inventors drop the idea of filing for patent internationally because it is expensive, complicated, and long procedure. Laws across the countries are also not unified in terms of procedures, fee and timelines leading to more and more confusions at every stage,
It is firstly of crucial importance to understand the term “International Patent”. In reality, there is nothing called international patent or global patent. Despite there being ways to file for a patent internationally, there is no single authority to grant international patents with validity across the globe. Patents are required to be filed in and granted by each country where the inventor wishes to seek protection.
Two ways to file patent application internationally
There are 2 ways to file a patent in foreign countries. These are:
Patent Cooperation Treaty (PCT) Route
An inventor may file a single patent cooperation treaty (PCT) application or international application within 12 months from the date of filing a patent application in India. PCT is an international patent law treaty that provides a unified system for filing patent applications in each of its contracting states. It is a convenient platform to assist inventors that are seeking patent protection internationally (in the contracting states of PCT) for their inventions. It also helps patent offices with their patent granting decisions by providing comprehensive search reports for the patent application along with opinion on patentability. PCT publishes the patent application filed with it and maintains an online database called Patentscope which facilitates patent searches as well as gives public access to a wealth of technical information in the form of patents.
PCT examines the application, issues examination report and enables inventors to file their application within 30/31 months from the date of priority in any of the member states of PCT. After this, the patent is processed and granted by the national offices of the countries where patent protection is sought, based on the procedures and requirements of the respective offices. PCT enables patent filing in its member states & gives extra time to the inventor to decide about the countries they want to file their application in.
2. Convention Route
The countries which are members of the Paris Convention are called convention countries and an application filed in a convention country is called a convention application. Unlike PCT, convention application is required to be filed in the convention country within 12 months from the priority date.
Reasons to file international application
Filing international application without clarity on the reason to file is not a good idea. It does not help inventors in long run and may actually lead to a very stressful situation if the prosecution is left midway, further making the overall process financially cumbersome. Following parameters should be considered when deciding about the countries to file patent application in:
a. Your future business plans
Patents must be filed in the countries where the inventor wishes to expand the business in the future. It must be remembered that there is a specific time period within which inventors must file the patent application in specific countries. Once this period has lapsed, it is not possible to file an application at a later stage. Therefore, if it is desired by the inventor to expand the business in countries like the US or Japan 5 years later, it would make sense to file patents in these countries within the required time frame.
b. Potential of technology in given jurisdiction
Sometimes, it makes sense for an inventor to file for patent in some countries even if the inventor does not have business there. Countries like the US have a mature system of buying, selling and enforcing patents. If technology has good potential in a specific country, a patent should be filed in that country. Further, licensing and selling options may also be explored to facilitate easier transition of the patented technology to the market.
3. Your budget
Filing and prosecution of a patent is a long process and strictly regulated by several timelines. A patent may be lost if the inventor does not respond to the office in time or fails to pay the necessary fees. Further, there are standard expenses for each country and renewal fees to be paid post grant of the patent. This leaves a very small window for postponing expenses and timelines, making the overall process of getting a foreign patent extremely time consuming, complex and expensive. The tentative costs of filing, prosecution and maintenance must be assessed in advance and only then should a decision about foreign filing be taken.
Keeping in mind budget, type of invention and area of business, the decision to file patent internationally shall be taken.
Intellectual Property (IP) is a valuable asset for any research and innovation-driven company today. The creation of IP requires investment in terms of money, time and intellect and therefore, it is extremely important for the companies to claim legal rights on IP and prevent others from using the same. At this point of time, India is facing multiple challenges brought upon by COVID-19. Exports and imports have been significantly affected and due to this, it is becoming increasingly important for India to become self-reliant to reduce load on imports and boost local industry. It is now extremely important for startups, SMEs and MSMEs to not only realize the importance of innovation & IP but also to devise correct & effective strategies, processes and policies at the inception stage of ideas to make sure their innovation is well protected, enforced and eventually commercialized.
The most effective IP strategy is the one that is aligned well with the business goals of a company.
The most effective IP strategy is the one that is aligned well with the business goals of a company. For different companies, the importance, effectiveness & meaning of IP strategies may vary depending upon area and type of business, even though the aim of IP strategy may remain the same. Success of IP strategy is dependent upon formulation & implementation of IP practices, processes and policies within the organization.
Five of the most important components of any IP strategy are as listed below:
Reducing R&D cycle: Every company today, especially product development companies, wants to not only reduce time & expenditure on research and development, but also to develop more innovative products keeping in view of the market. Early entry of these innovative products into the market will results in the products having a competitive edge as well as longevity in the market. This can be achieved by strategically performing a comprehensive prior art search to assess the research already done and explore the ways that the existing knowledge can be utilized for existing products or design. Prior art search may reveal existence of IP having good opportunity to be in-licensed.
Protection of IP: For any organization, protection of IP at right time and under appropriate legal framework is essential. Trademarks, patents, designs, copyrights and trade-secret are the most important forms of IP. Multiple IPs can be registered for the same product, where if the product is an invention, then it can be registered as patent. Similarly, name of a product/company may be registered as trademark and literal/artistic/cinematographic/musical work may be registered as a copyright. Trade-secret is another powerful form of IP, which is not registered but owner of trade-secret shall take steps to protect it. KFC’s fried chicken recipe, McDonald’s Big Mac Special Sauce, the recipe of Coca-Cola and Google AdWords are a few examples of well protected trade-secrets.
Infringement risk analysis: For any product company, infringement risk analysis or Freedom to Operate (FTO) search should be an integral part of their IP Policy. This single step saves companies from big litigations and it should be made an integral part of any new product launch process. Let’s understand this with an example; two companies, namely, Anant Electronics and Futuristic Concepts Media Ltd were using “Digital Transmission System” technology to manufacture VCDs using MPEG 1 coding audio compression/expansion system in India. Philips had a patent protection (Patent no 175971) on this technology in India, of which these two companies were not aware of, thus infringing the patent granted to Philips. Delhi High Court ordered both the companies to stop manufacturing the VCDs that infringed Philip’s “digital transmission system” patent. Had they performed an infringement risk analysis before manufacturing and launching the product, they could have saved a significant amount of time and money. Using technology protected by another company can be fatal for any business and prior risk assessment is essential to prevent such undesirable scenarios.
Monetization of IP: Licensing or assignment are the most popular ways to monetize IP. Licensing is a method to transfer technology rights for a particular period of time, whereas assignment is a permanent transfer of rights. Licensing helps innovators to quickly collaborate with more partners and launch their product in the market quickly, whereas assignment of IP, usually worked out at the time of acquisition/merging, is a way to generate more money in a single transaction. Sree Chitra Tirunal Institute of Medical Sciences & Technology developed the technology for the manufacture of blood bags conforming to international quality requirements. They identified Peninsula Polymers Ltd. for setting up a plant based on indigenous technology and further provided equity assistance of up to 25% of the total equity. The production of the blood bags started for the first time in the country in 1987 by this company. Subsequently, Sree Chitra Tirunal Institute of Medical Sciences & Technology licensed this technology to a number of companies in India who not only met indigenous requirement of blood bags but also provided the product at an affordable price and exported their products to various countries such as the UK, USA, Germany, Netherlands, Kenya and Bangladesh.
Enforcement of IP: After registration, IP can be enforced by the innovator, if there is any violation. In Merck vs. Glenmark case, Delhi High court passed an injunction against Glenmark for manufacturing the generic drug Sitagliptin and using patented product of Merck as there was prima facie infringement of patent rights of Merck. Delhi High court passed injunction order against Glenmark from manufacturing and selling of Zita and Zitamet. Thereby, patent rights of Merck were protected and enforced.
There is another interesting case-study to see how IP rights can be enforced. VirnetX is an internet security software and technology company based in Zephyr Cove, Nevada. This company’s patent portfolio includes American and international patents in areas such as DNS and network communication. Since 2010, VirnetX has been involved in litigation with big companies like Apple, Cisco, Microsoft, etc. In December 2014, Microsoft and VirnetX settled patent disputes over Skype technology for $23 million. VirnetX, in another law suit with Apple was awarded $368 million in damages for FaceTime infringement.
An effective IP Strategy, aligned with business strategy plays a vital role for growth of a business. Devising strategy itself is not enough till there is a process to implement the same effectively.
Video Link:https://www.youtube.com/watch?v=fJXcXBp8lPI
Changing market dynamics and pressure to compete globally have encouraged the growth of ‘creative destruction[1]’trends, leading to worthy innovation. To run parallel to the novel needs and demands of the market, it is essential for every country to scrutinize the scope of innovation, which ultimately affects the economic progress of a nation. The Organization for Economic Co-operation and Development (OECD) defines innovation as, ‘the implementation of a new or significantly improved product or process, a new marketing method, or a new organizational method in business practices, workplace organization or external relations.’[2]
The impact of innovation on the growth and development of a country is multifold. An innovation economy is one, ‘which experience sustained growth through the creation and implementation of new technologies, product or processes in an ecosystem of inventors, entrepreneurs and investor.’[3] Mainly, four factors are attributed as contributory in shaping an innovation economy. These include economic incentives, to provide value to inventor to motivate them to invest in the innovation; financial stability; skilled human capital; and accessibility and smooth flow of information.[4]In addition to these, the Government is also required to play a role and provide its support in adopting such public policy that can help in leading the innovation driven economy.[5] This article will discuss and analyze the innovation model of Israel that led to its significant recognition throughout the globe.
Israel’s method of investing in innovation led to the creation of sustainable economic prosperity, subsequently leading to tremendous economic productivity and value
Israel is a small country in the Middle East with a population of only 8.5 million people. Despite its history of wars for freedom and continuous conflicts with neighboring countries, Israel has managed to maintain its reputation as an exceptionally prolific country in terms of nurturing an innovation-based ecosystem. Israel has long understood the importance of R&D and innovation, and how these concepts are an essential element for their country’s’ prosperity. Israel’s method of investing in innovation led to the creation of sustainable economic prosperity, subsequently leading to tremendous economic productivity and value.[6] Israel has seen a shift from being a knowledge economy to being recognized worldwide as an innovation economy. It has set an example for getting exceptional results with combined efforts of both their Government and private sector. It has been bestowed with the title of ‘Start-Up Nation’.[7]
The history of specific developments in Israel dates back to the 1960s, when Israel transformed into an emerging economy by transitioning from a country making no significant R&D contributions, to a country whose major focus was directed towards innovation led by novel R&D and technological creation.[8] The current figures may make someone believe that Israel has a rich history of strong industrial innovation, but around the year 1965, Israel saw a GDP growth of less than one percent with the lowest ratio of expenditure on R&D compared to any OECD countries except Italy.[9] The constant threat of war and terrorism that it experienced since its independence in 1948 had limited the prospects of stimulating growth.
Another significant problem faced by the economy was free immigration into Israel, resulting in an exponential rise of population in Israel during the time of its independence, almost doubling during the years of 1950-65.[10] The Government took this as an opportunity and started shaping the knowledge economy by investing heavily in education and training programs, which led to the rise of the skill and education level of the labor pool.[11] The shift was seen during the war phase of the 1970s when the focus was directed towards their defense industry which employed almost half of Israel’s scientists and engineers. Efforts were also made towards restructuring and privatization, to decentralize the economy.
During the mid-1980s, when Israel experienced an inflation rate of 375%, economic growth stunted abruptly. In response, Israel implemented a stabilization program focused towards financial reforms that helped in liberalizing the economy and bringing the inflation rate down to 20% by 1990.[12] From the 1990s onward, Israel shifted its economic model to transform into an innovation-based economy. This shift resulted in the economic growth reflecting a GDP growth of 5.9% on an average per year between the years of 1990 and 2000.[13]This growth also affected change in various domains throughout the country, including employment, inventions, etc.
By the year 2000, the employment rate in the Information and Communication Technology (ICT) sectors and software sectors rose to 87%.[14]Israel also saw a steady rise in the number of patent applications filed by Israeli inventors in the United States.[15] Companies started engaging in expertise likely to attract public offering to extend their link towards foreign capital markets. Interestingly, in a short span of time, Israel started representing the highest percentage of NASDAQ-listed companies in the world outside of the US along with significant recognition for most start-ups per-capita of any country.[16] It also became a country with the second largest Venture Capital industry.[17]
These achievements are the results of careful implementation of certain parameters with long-term planning mechanisms. This article will now discuss such parameters and the methodology of implementation of such factors by Israel in detail.
A. Foundation of Office of the Chief Scientist (OCS)
Israel realized the need for forming a strong base for building science and technology by the late 1960s. Israel started by creating a strong base to strengthen the roots of future prospective innovations. The Government took the decision to start building their ‘science economy’ which subsequently led to the formation of the Office of the Chief Scientist (OCS) in 1969 under the Ministry of Industry, Trade and Labor.[18] The OCS used to provide grants to encourage R&D activity, promoting innovations that carved the way for developments in various sectors. At the same time, Israel was also forced to invest in the military sector which boosted the R&D in the civilian and military domains. This led to a fruitful exchange of skills and technology between military and civilian sectors. The OCS also helped in building relationships with foreign companies by extending their co-operation through bilateral programs which resulted in access to global information.[19]
B. Focusing on Marketing and Business
Towards the end of the 1980s, Israel realized that a funding gap existed between growing startups and the potential market. Lack of financial intermediaries made it difficult for investors to trust startups enough to invest in them. This resulted in the failing of many companies, owing to their inability to sustain in the market. To counter this, the Government came up with a funding initiative called Yozma in 1993 which initially funded around 200 startups in Israel. These links with the foreign capital market came to fruition by pocketing successful IPO and acquisition deals from global companies, giving startups a much-needed financial boost. Furthermore, Israel saw foreign investment banks establishing their offices within the country and the emergence of Israel-specific funds by foreign venture capital firms. This indirectly helped market players to be aware of the global information which helped in better decision-making. Thus, it led to the harmonious development of entrepreneurship and innovation in Israel.
C. Government role in promoting R&D
Israel’s transition from a knowledge economy to a science economy and finally to a globally-recognized high-tech innovation economy reflects careful planning and significant efforts put forth by the Government to guide Israel’s path to global recognition. The need for a ground-breaking R&D is associated with the history of Israel freedom and subsequent wars and terrorism it faced owing to its political instability. To strengthen its military base, it started investing in military-driven technologies such as aviation and securities. It further extended it support for civilian R&D in the late 1960s, to compensate for a lack of natural resources.[20]
To develop a national science-based industry, the Government passed a law for the encouragement of R&D. The law provided incentives such as loans, discounts, tax exemptions, grants, etc. to promote industrial growth and to accelerate the exports. It was the first country to adopt the principle of ‘horizontal and neutral’ policies[21] to observe the market’s best practices that were best suited for commercialization.[22] The tax policies under these laws were framed in a startup-oriented manner to promote R&D initiatives.[23]
Some of the ground-breaking initiatives introduced by the Israeli Government are as listed below:
The Direct grant program: Under this program, the Government comprises a research team which selects firms based on their proposals and grants them 50% of their stipulated R&D budget. The firms that receive such grants are obliged to conduct all of their manufacturing in Israel itself. Grants are available for firms proposing to instill improvements in existing civilian or military products which are fixed at 30% and 20% respectively. Start-ups may avail 66% of their R&D cost for duration of two years, which should not be more than $250,000 per year. To create a balance in spreading economic benefits throughout the country, additional 10% grants are offered to those start-ups who choose to operate in certain specified geographical locations.
The MAGNET program: This program was introduced by OCS in 1993 with a vision to bring together companies and academic institutions to engage in practical research on innovative technologies. The Government provides an incentive in terms of 66% fund grants to encourage companies to tie up with research centers.
The Incubator program: This program is specifically focused towards the immigrants in Israel. By the early 1990s, immigration in Israel was at its peak. Although these immigrants were professionally skilled, they found it troublesome to form their base owing to the language barrier and their unawareness about market demands. To tackle this, the Government launched the incubator program in 1991 to support budding entrepreneurs amongst the immigrants. Incubators are physical locations with basic amenities, along with professional support systems such as lawyers, administrative staff, accountants, etc. The entrepreneurs are provided guidance on their business ideas along with funding for two years.
Bi-National Industrial R&D Foundation (BIRD): BIRD was launched in the year 1977 with the United States to promote the private industry in both the countries by encouraging harmonious development in marketing, manufacturing and R&D. Companies are eligible for conditional grants of 50% of the total R&D budget or $1.5 million, whichever is lesser. The repayment of such grants is required only if the companies are successful. This partnership helped Israel build a strong connection with the United States.[24]
MATIMOP: It is a Hebrew acronym for Israeli Industry Centre for R&D, launched to administer both international and bilateral cooperation agreements. It encouraged international companies to open their centers in Israel by providing tax reductions and other related relaxations as incentives.
D. Tackling Immigration to create a skilled human capital
Israel’s skilled human capital has helped tremendously in shaping its innovation economy. Its one-of-a-kind liberal immigration policy has helped Israel turn its disadvantage, i.e. a heavy influx of immigrants, into a profitable opportunity. This policy has contributed extensively in ameliorating Israel’s economic development. The Ministry of Immigrant Absorption was given the task to organize immigrants. Israel’s Government paid living expenses for immigrants in addition to teaching them regional languages, connecting them with professionals in their industrial domains, setting up incubators for immigrants and funding their startup ventures.[25]
E. Carving out human capital from Military base
Young people from the ages of 18 to 21 are required to serve the Israel Defense Force (IDF). There exist army units with different levels that admit people based on their score on a standardized test. Soldiers with the highest scores are placed with a unit specializing in military R&D. One such popular unit is unit 8200 which is known for its advancements in technology and intelligence. The culture of the IDF has shaped a lot of soldiers into entrepreneurs. Abilities such as taking impromptu decisions, shouldering responsibility, making quick decisions, analytical thinking, and loyalty have also contributed in shaping a business culture within the IDF.[26]
F. Promoting Intellectual Property Rights
Innovations, when shielded by private rights, encourage the nation as well as creators to indulge more in creativity and development. Israel recognized the importance of protecting intellectual property rights very early on. It revised its Patent Act in 1967 and increased the term of patent protection to 20 years including the application date. To enforce its patent rights in foreign countries, Israel became a signatory of all major treaties and conventions supported by the World Intellectual Property Organization[27](WIPO) and World Trade Organization[28] (WTO). Israel began including software under copyright protection in 1988, extending the protection period to 70 years. Creating ties with developed countries like the U.S. helped Israel to create an inexhaustive IP regime. This helped in fostering its innovation and creating a high-tech economy.[29]
Conclusion
Israel has earned a commendable name around the globe for its innovations. The R&D support provided to investors has credited Israel with plenty of profitable inventions. Around 250 companies with a global presence have R&D labs in Israel today, which includes Fortune 500 companies and tech giants like Facebook and Apple. Between a span of 1999 to 2014, Israel has started more than 10,000 companies, and is hence justified in claiming the title of Start-Up nation.[30]Israel is remarkable in that their relatively small population of approximately 9 million people is now competing with highly populated countries like the U.S. and China[31].As discussed above, the innovation sector flourishing in Israel is a result of its ability of converting its liabilities into assets.
For example, Israel tackled the lack of freshwater by developing world-class technology in drip irrigation, thereby focusing on desert agriculture. Israel also carefully planned its development in high-tech innovation to attract market leaders from developed countries. This led to only minor setbacks when their Arab neighbors decided to boycott Israeli products. Further, Israel has always focused on global customers to study the global market unlike other developing countries that helped its indigenous companies penetrate global market. Following the principle of ‘open innovation’, Israel helped startups to be guided by flourishing high-tech companies, thereby encouraging and mentoring entrepreneurs to contribute further to Israel’s economic development. This has also resulted in an exchange of ideas between enterprises, benefiting innovation on a whole and further contributing to Israel’s innovation index. By strengthening its intellectual property protection, Israel has aggrandized the value and utilization of innovations. Lastly, Israel’s history with innovation that resulted from an interplay between academic, industrial and Government sector reflects a strong foundation for Triple Helix Model of Innovation.[32]
List of 10 breakthrough innovations by Israel
S.No.
Product Name
Product Details
Developing company
Product Image
01.
MyEye
A visual assistance device wearable by a person that includes a camera and a processor. The processor captures multi-image frames from the camera. A candidate image of an object is searched in the image frame. The person wearing the device is notified of an attribute related to the object. For more details click here.
OrCam Technologies Ltd. [Jointly founded in 2010 by Prof. Amnon Shashua & Mr.Ziv Aviram]
This device absorbs moisture from the atmosphere to provide drinking water. It works as an Atmospheric Water Generator (AWG) with a defrost system. For more details click here.
A software that enables Advances Driver Assist Systems (ADAS) and is designed in a way to support the three pillars of Autonomous Driving- Sensing, Mapping, and Driving Policy. For more details click here.
A device used to facilitate at-home ultrasound, which docks with a patient’s mobile phone to deliver high quality images, which are stored on a remote drive and forwarded for clinical review or online consultation. For more details click here.
A compact handheld device that measures exhaled breath for early diagnosis of cancer. It won 2018 Innovation Award by the European Commission for Most Innovative project. For more details click here.
Technion Research & Development Foundation Limited. Invented by: Prof. Hossam Haick.
A tube-shaped device that opens up arteries to treat coronary heart disease and blockages without requiring open-heart surgery. For more details click here.
Epilady introduced the first epilator to the market in 1986, revolutionizing hair removal for ladies all over the world by providing a cost-effective, mess-free alternative to shaving and waxing. For more details click here.
A device equipped with a handheld examination kit and app that allows an individual to perform guided medical exams anytime and anywhere. For more details click here.
Tyto Care Ltd. Invented By: GILAD-GILOR David, Even Yehuda.
[5]HarryYuklea, ‘An Integrated Approach to VC Financing Policy: ‘The Plumber’s Model of Entrepreneurial Finance’ (2009) ERPN.
[6]MK Eli Cohen, ‘Innovation in Israel 2017 Overview, Israel Innovation Authority’, innovationisrael.org.il.
[7]Dan Senor & Saul Singer. ‘Start-up nation: The story of Israel’s economic miracle’ (Random House Digital, Inc., 2011).
[8]DanBreznitz, ‘Innovation-based industrial policy in emerging economies? The case of Israel’s IT industry’ (2006) Business and Politics 8.3.
[9]Daphne Getz &Vered Segal, ‘The Israeli innovation system: An overview of national policy and cultural aspects’ (2008) SamuelNeaman Institute for Advanced Studies in Science and Technology.
[10]MeirPugatch, Morris Teubal, &OdedaZlotnick, ‘Israel’s High-Tech Catch-Up Process: The Role of IPR and Other Policies’(2009) in Odagiri et at Intellectual Property Rights, Development, and Catch Up: An International Comparative Study: An International Comparative Study (2010), Oxford University Press, Oxford, England.
[12]World Bank, ‘Inflation Rate, Israel 1961-2009’ World Development Indicators.
[13]GDP Growth: Israel & OCED, 1990-2010, World Bank WDI Data; See above, supra note 7.
[14]GilAvnimelech&Morris Teubal, ‘Creating venture capital industries that co-evolve with high tech: Insights from an extended industry life cycle perspective of the Israeli experience’ (2006) Research Policy 35.10, 1477-1498.
[17]StefanoBonini&SenemAlkan, ‘The political and legal determinants of venture capital investments around the world’ (2014) Perspectives on Financing Innovation, Routledge, 161-192.
[23]AssafRazin& Efraim Sadka, ‘The economy of modern Israel: Malaise and promise’(1993) University of Chicago Press.
[24]GilAvnimelech, Martin Kenney & Morris Teubal, ‘The life cycle model for the creation of national venture capital industries: the US and Israeli experiences’, in Dr. Elisa Giuliani et al, Clusters Facing Competition: The Importance of External Linkages (Ashgate Publishing Limited2005).
[27]Berne Convention for the Protection of Literary and Artistic Works: Texts. Geneva: World Intellectual Property Organization, 1982; Paris Convention for the protection of Industrial Property, Mar. 20, 1883; Patent Cooperation Treaty, June 19, 1970.
[28] Agreements on Trade-Related Aspects of Intellectual Property Rights, Apr. 15, 1994.
[30]D Nordfors and B. Berger, ‘Technology Transfer Between Industry, Academia and Defense in Israel’ (2000) Swedish Academy of Engineering Sciences.
[31]David Yin, What Makes Israel’s Innovation Ecosystem So Successful, (Forbes, 9 Jan. 2017), <https://www.forbes.com/sites/davidyin/2017/01/09/what-makes-israels-innovation-ecosystem-so-successful/?sh=4322a5c370e4> accessed 21 May 2021.
[32]Drori, G., et al, ‘The helix model of innovation in Israel: The Institutional and Relational Landscape of Israel’s Innovation Economy’ (2013) Department of Sociology and Anthropology, The Hebrew University of Jerusalem.
There have been a lot of discussions and difference of opinions on whether an idea can be patented or not. Well, this indeed is a tricky question with an uncertain answer.
Filing for a patent requires the invention, as a product or a process, to be novel, industrially useful and inventive. As an inventor, while drafting patent specifications, one must disclose the best method known to him or her on the day of filing patent application. An issue arises that if the invention is just an idea, what is the best method of implementing the invention? At the same time however, all inventions originate from ideas. Therefore, it must be understood clearly that patents are granted only to inventions and not to ideas, provided such inventions fulfil certain statutory conditions as specified in patent law.
There are two ways to file for a patent, i.e., either a provisional patent application or complete patent application. If the invention is still in the development stage and is not complete yet, a provisional application should be filed. Some other reasons to file a provisional application are:
The earliest date of filing or priority date is required;
Conservation of time and money is a matter of importance;
It is unsure if the invention will be developed further or not;
The experimental data concerning the invention is not ready yet;
Investor will release fund only after inventor produces evidence that patent application is filed;
Changes are expected in the experimental data before completion of the work.
It is worth noting here that provisional application may be filed if the invention is at the stage of idea, provided that the idea is executable and is capable of being performed practically because at later point of time, at the time of filing complete application, best mode of performing the invention has to be disclosed. Further, the inventor should also keep in mind that the scope of provisional and complete application must remain same. A complete specification may be filed within 12 months from the date of filing provisional application. However, if the complete specification is not filed within this time period, the provisional application gets abandoned automatically without loss of confidentiality as the provisional application was not published.
Article 83 of the European Patent Convention states that an application must disclose the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art, and insufficient disclosure is one of the grounds for opposition of the patent.
United States patent laws explain that the patent specification must be complete enough so that a person of “ordinary skill in the art” of the invention can make and use the invention without “undue experimentation”. The laws further state that the disclosure must also contain the inventor’s “best mode” of making or practising the invention.
In India, section 10 of Patent Act sys that every complete application must fully and particularly describe the invention and its operation or use and the method by which it is to be performed. The Act also mentions that the application should disclose the best method of performing the invention which is known to the applicant and for which he is entitled to claim protection.
At the time of filing complete application, the best mode of working the invention must be disclosed. Failure to do so may expose the application to opposition before or after grant of the patent, thus leading to invalidation of the patent.In the Press Metal Corporation Limited vs Noshir Sorabji Pochkhanawalla case, it was held that it is the responsibility of the patentee to state clearly the nature and scope of what they claim in the patent, and that the patent specifications shall not contain ambiguous and obscure information.
In conclusion, an idea cannot get a patent as such if the idea not executable or cannot be converted to an invention. In order to claim priority date & protect the idea, it is recommended to file a provisional application if the invention is at the stage of an idea or experimental results of the invention are not complete and the invention is at a developmental stage. However, at the time of filing complete application, idea itself is not enough and inventor shall submit full disclosure of the invention along with best mode of working the invention.
We are here to help you and guide you in your innovation journey. Feel free to contact us at info@origiin.com or call or Whatsapp at +919845693459 to avail our expert services to register a patent. Click here to know more: Patent Registration
A Non-Disclosure Agreement (NDA) or Confidentiality Agreement is a legally binding contract that establishes a legal relationship between the two parties where one party discloses the confidential information, and second party receives it. However, NDA may also be two sided where both the parties disclose and receive confidential information to each other. The parties signing the NDA agree that confidential information which they got access to, will not be made available to any others in unauthorised manner because such unauthorised disclosure may put disclosing party at a big risk.
What is Confidential Information?
Confidential information is defined as information which is not in public domain, has economic value and the owner of such information has taken reasonable steps to safeguard it. Confidential information may be categorised into technical and business information. Technical information generally includes inventions, ideas, drawings, designs, software code etc whereas business information may be related to acquisition or merging, employee salaries, future plans, product launch, press release, financial data of the company. Any information which is in public domain cannot be named as confidential information. It is important to take utmost precautions to protect confidential information of the company. Other than physical measures, companies shall also have right policies & processes to safeguard it. Executing NDA is one of the ways to safeguard such valuable information wherein the parties disclosing and receiving the confidential information agree on specific terms and conditions to avoid misappropriation of the information.
When is NDA needed?
Businesses need to disclose business or technical information to third parties very often and it is important to take precautions before such sensitive information is disclosed. NDA is an important agreement to be executed in the instance when such information is disclosed and requires to be safeguarded:
Business or product information is to be revealed to external vendors/consultants to seek advise or to get the product manufactured.
Business/financial/product information is to be discussed with investors.
Intellectual Property, especially invention details are to be disclosed to the patent attorney.
Company information is to be shared with the employees.
Main clauses of NDA
Like any other agreement, NDA is signed between atleast two parties wherein one party discloses, and other party receives the confidential information. In some situations, both parties may disclose, or receive information from each other and such NDA may be called as mutual NDA.
The agreement starts with date of execution and full name & address of the parties. All the important terms used in the agreement, including the term “Confidential Information” shall be defined to avoid discrepancies at later point of time. Reason and purpose to execute the agreement shall be defined in the agreement along with obligation of both the parties.
Every agreement, including NDA, that is executed shall be have a specific term. Date of execution, term of the agreement and way of termination form a very important part of the agreement. Depending upon need and life of confidential information, term of NDA may be fixed. For example, if the purpose of NDA is to maintain confidentiality of the invention before filing for a patent, then, as soon as patent is filed for, the confidentiality of the invention may not be strictly required to be maintained.
Injunctive Relief forms part of most NDAs where disclosing party has the right to injunctive relief to stop the other party from breaching the agreement. Under this clause, the disclosing party can get a court order to stop the other party from breaching the agreement.
Apart from this, governing law, jurisdiction shall be specified to ensure that if any dispute happens, it is resolved with least difficulty.
Conclusion
NDA is one of the most commonly executed agreement and is used for various purposes. In order to be enforceable, the NDA shall have all the clauses of a valid agreement.
Evidence of Use search (EOU) Search is performed to help patent owners identify potentially infringing products in the marketplace. The purpose of EOU search is to identify products or processes in the market which are likely to infringe the patent holder’s patent or even patent application. In order to perform EOU search, thorough understanding of patent infringement and jurisdiction specific laws is important as it is a very sensitive search and any negligence in the process of performing search and analysis of the findings may prove to be dangerous for the organization.
Understanding of rights of patent holder as well as patent infringement is also critical for EOU search. In simple words patent infringement means violation of rights of the patent holder i.e., to prevent third parties from making, using, offering for sale, selling and importing patented product or product made using patented process in a given jurisdiction.
Advantage of EOU search is that the patent holder can get to know about the existing products in the market that may infringe upon his patent (s) and patent holder can take necessary action against the infringer by enforcing his patent rights.
The steps to be followed in order to perform EOU search are as below:
Step 1: Subject matter of patent shall be understood thoroughly, especially the claims. Claims is a part of patent document that seeks legal protection. Further patent claims shall be interpreted in best possible manner with help of case laws pertaining to the particular jurisdiction.
Step 2: Assessment of strength of the patent based upon the corresponding forward and backward citations of the patent document is important because this step determines strategy to be adopted to handle the infringing products found in the EOU search. Further, it is advisable to check legal status, expected expiry date of the patent as well along with chances of it getting invalidated in case any opposition or revocation is filed.
Step 3: A secondary research shall be performed to identity products available in the market that are likely to infringe claims of said patent of the patent holder. A very vital part of the investigation is to assess size and strength of the companies that are manufacturing the infringing products because this helps patent holder to have right strategies in place.
Step 4: Claim maps or claim charts shall be prepared in order to analyse the extent of the overlap of the identified product with said patent claims.
Step 5: Opinion on EOU shall be written based on jurisdiction specific laws. EOU report will typically have list of infringing products found, mapping of product components of features with patent claims, opinion on patent infringement, strength of the patent, strategies to be adopted to enforce patent rights etc.
Evidence of Use search (EOU) Search is an important search for the patent owners to identify potentially infringing products in the market sothat they can take necessary steps to address it.
Origiin, with a skilled team of patent agents is one of the best patent companies in India offers patent services such as patent searching, and patent filingin India and foreign countries. Origiin also provides value added search services such as Evidence of Use. Origiin, with in-house patent attorney can also help you in drafting and sending patent infringement notices based upon the derived EOU opinion.
Deliverables: EOU report, claim charts along with PDF copy of all prior arts listed in the report
A geographical indication (GI) is a sign used on products that have a specific geographical origin and possess qualities or a reputation that are due to its origin. In order to function as a GI, a sign must identify a product as originating in a given place. Some examples of GI are Mysore silk, Pashmina, Nagpur orange etc.
A geographical indication right enables the owners to use the indication to prevent its use by a third party (ies) whose product does not conform to the applicable standards. For example, in the geography or jurisdictions in which the Darjeeling tea as geographical indication is registered, producers of Darjeeling tea can exclude use of the term “Darjeeling” for tea not grown in their tea gardens or not produced according to the standards specified in the code of practice for the geographical indication.
A geographical indication shall be registered to claim rights over it and is usually obtained by acquiring a right over the sign that constitutes the indication. The steps to register GI are as below:
Steps to register a Geographical Indication (GI)
STEP 1: Filing of application (Fees for filing registration is 5000/- each class)
Please check whether the indication comes within the ambit of the definition of a Gl under section 2(1)(e).
The association of persons or producers or any organization or authority should represent the interest of producers of the concerned goods and should file an affidavit how the applicant claims to represent their interest.
Application must be made in triplicate.
The application shall be signed by the applicant or his agent and must be accompanied by a statement of case.
Details of the special characteristics and how those standards are maintained.
Three certified copies of the map of the region to which the GI relates.
Details of the inspection structure if any to regulate the use of the GI in the territory to which it relates.
Give details of all the applicant together with address. If there is a large number of producers a collective reference to all the producers of the goods may be made in the application and the G.I., If registered will be indicated accordingly in the register.
Please sent your application to the following address in India
The applicant must have an address for service in India. Generally, application can be filed by (1) a legal practitioner (2) a registered agent.
STEP 2 and 3: Preliminary scrutiny and examination
The Examiner will scrutinize the application for any deficiencies.
The applicant should within one month of the communication in this regard, remedy the same.
The content of statement of case is assessed by a consultative group of experts will versed on the subject.
They will ascertain the correctness of particulars furnished.
Thereafter an Examination Report would be issued.
STEP 4: Show cause notice
If the Registrar has any objection to the application, he will communicate such objection.
The applicant must respond within two months or apply for a hearing.
The decision will be duly communicated. If the applicant wishes to appeal, he may within one month make a request.
The Registrar is also empowered to withdraw an application, if it is accepted in error, after giving on opportunity of being heard.
STEP 5: Publication in the geographical indications Journal
Every application, within three months of acceptance shall be published in the Geographical Indications Journal.
STEP 6: Opposition to Registration (Notice of opposition to registration is 1000/- each class, 300/- in case of time extension & Counter statement to that notice is 1000/-)
Any person can file a notice of opposition within three months (extendable by another month on request which has to be filed before three months) opposing the GI application published in the Journal.
The registrar shall serve a copy of the notice on the applicant.
Within two months the applicant shall sent a copy of the counter statement.
If he does not do this be shall be deemed to have abandoned his application. Where the counter-statement has been filed, the registrar shall serve a copy on the person giving the notice of opposition.
Thereafter, both sides will lead their respective evidences by way of affidavit and supporting documents.
A date for hearing of the case will be fixed thereafter.
STEP 7: Registration
Where an application for a GI has been accepted, the registrar shall register the geographical indication. If registered the date of filing of the application shall be deemed to be the date of registration.
The registrar shall issue to the applicant a certificate with the seal of the Geographical indication’s registry.
STEP 8: Renewal (fees is 3000/-)
A registered GI shall be valid for 10 years and can be renewed on payment of renewal fee.
STEP 9: Appeal
Any person aggrieved by an order or decision may prefer an appeal to the intellectual property appellate board (IPAB) within three months. The address of the IPAB is as follows:
Intellectual Property Appellate Board Annexe 1, 2nd Floor, Guna Complex, 443, Anna Salai, Chennai – 600 018
As per the Indian Patent Law, one patent application shall relate to a single invention. However, if more than one invention is to be claimed in a single application, it is necessary to establish that the inventions so claimed in a single patent application have unity and they form a single inventive concept. The golden rule is that the claim (s) of a complete specification shall relate to a single invention, i.e. the concept of unity of invention shall be there.
According to Section 10 of the Patents Act 1970, if claims refer to a group of inventions, such inventions shall form a single inventive concept. The claims shall be clear and succinct and shall be fairly based on the subject-matter disclosed in the specification and moreover, a single inventive concept may be recognized between independent claims of different categories.
The invention comprising a polymer, process to prepare polymer and commercial utility of polymer can be claimed in the single patent application because even though the invention has three main components, all of them relate to a single invention and have unity. On the other hand, the invention relating to two independent formulations used to treat cancer and HIV/AIDS shall not be claimed in a single patent application as both formulations are independent of each other and hence lack unity of invention.
The purpose of this requirement of unity of invention is administrative, as well as financial. That is, the requirement serves to prevent the option of filing one patent application for several inventions, while paying only one set of fees, such as, fee for filing application, examination, early publication or annual renewal etc. Moreover, the concept of unity of invention also makes the technical classification easier.
Under Section 16 of the Indian Patents Act, 1970, if a single patent application has been filed with more than one invention and inventions so claimed lacks unity, the applicant shall be required to divide main application into divisional application (s). However, the further application (divisional application) and the complete specification accompanying it shall be deemed to have been filed on the date on which the first mentioned application had been filed, and the further application shall be proceeded with as a substantive application and be examined when the request for examination is filed within the prescribed period.
However, during the process of examination of the patent application, the examiner may also ask the applicant to divide the application into two or more applications and file divisional application. It is interesting to note that both parent application and divisional application will have the same priority date though divisional application is often filed later than parent application. For example:
Date of filing provisional application and priority date: 15th November 2006
Date of filing complete specification: 13th November 2007
Publication and examination of the patent application takes place and the Controller raises the objection that the invention lacks unity of invention and hence the application shall be split into two applications i.e., main parent application and divisional application. Here, the date of filing divisional application will be 10th Jan 2009.
In such a case, both parent application and divisional application will have priority date of 15th November 2006 even though the divisional application was filed 10th Jan 2009, which also mean that both parent application and divisional application expire on the same date irrespective of the date of filing.
A specification in respect of a divisional application under section 16 shall contain specific reference to the number of the original application from which the divisional application is made. The request for examination in case of divisional application shall be filed within 48 months from the date of filing or priority of the parent application or within six months from the date of filing the divisional application, whichever expires later. Request for divisional application shall be filed only after filing request for the parent application to ensure the requirement of section 16(3).
Moreover, the complete specification of a divisional application should not include any matter not in substance disclosed in the complete specification of the first application. The reference of parent application should be made in the body of the specification. A divisional application has to be filed before the grant for a parent application.
Though it sounds economical to club multiple inventions together and file for a single application, it is logical to follow the concept of unity of the invention and ensure that separate applications are filed for each invention.
Intellectual property (IP) is a term referring to creation of human mind in the form of a number of distinct types of expressions for which a set of rights are recognized under the corresponding regimes of law. Innovation plays vital role in sustainable growth of an organization and securing the organizations IP assets through proper planning is essential for utilizing the IP assets later for commercial success.
In case of Indian IT industry, whether it is into services or products or both, IP typically means patent, copyright, design, confidential information, trade secret, brand name and domain name etc., wherein handling confidential information or trade-secret needs a lot of care for the reason that it is not registered and moreover, we don’t have adequate laws to protect them. Though there are several IP related issues, however, drawing line between proprietary IP and client’s IP may become a challenge at times, especially when the company is bound by stringent agreements.
IP policy in simple words, is a guideline that defines IP as per company’s business; provides guidelines for creation, protection, exploitation, disclosure, ownership of IP; sensitizes employees about aspects of IP and at the same time guides them regarding the precautions that need to be taken to safeguard company’s IP as well as prevent or minimize IP infringement risk. IP policy also provides guidelines and procedures for disclosure & non-disclosure of intellectual property whether protectable or not; and to develop and enhance environment of innovation and generate creative & novel IP compatible with business goals of the company.
Coverage of policy
Typically an IP policy is applicable to the employees of the company; however, if company works with outside vendors, Freelancers or consultants etc, coverage of policy may be extended to them as well as they have to be involved in the process of creating IP for which ownership and confidentiality issues need to be addressed clearly in the policy.
Meaning of IP
Defining meaning of IP, depending upon core area of business is essential. IP may include Patent, Copyright, Trademark & Domain name, Design, Confidential information or trade-secret that might be proprietary in nature or created by employees during course of employment or by the consultants as a part of contractual relationship with the company. The kind of IP that shall be included in the definition purely depends upon business area and strategies of the company.
“Sensitization of the employees on confidential information and consequences of misappropriating is necessary from time to time. Whom to disclose, when to disclose, how to disclose such information, shall be made clear in the policy. Liability of the employee during course of employment or even after termination or resignation must be dealt with carefully.”
Ownership
Since IP is created by the employees during the course of employment, company would prefer having ownership of such IP with itself. However, in case of patent, the application for a patent shall be filed by true & first inventor, its assignee or legal representative. Therefore, it is extremely important to list out the inventors whose names are going to appear on the patent application, right in the beginning of the project to avoid arising of disputes later on. However, inventor may further assign rights to the company; so that ownership of the patent is with the company. Similarly, in case of copyright, applicant is the company and the employee who creates the work is called as author. When company decides to file application for copyright registration, the author (s) is required to give NOC (No Objection Certificate) to the Copyright Registry stating that he/she has created the work during course of employment and he/she has no objections if the work gets registered in the name of the company. However, proprietary IP, confidential information is exclusive property of the company unless company specifically authorises employee to disclose, use or own it.
Security and confidentiality
Even though most of the organizations have implemented multiple security measures to prevent the loss, misuse and alteration of any confidential information under its control, employees must strictly follow the security measures, which are extremely crucial to secure technical and business information of the company. First of all identification of trade-secrets is very important and it can be best protected by segregating it into low, moderate and high confidentiality type and further by limiting access to it. Employment and non -disclosure or confidentiality agreement may further be used as tools to safeguard confidential information of the company. Labelling documents as “Confidential” is an appropriate way of communicating information as Confidential and serves as an express notice to indicate nature of the document.
Sensitization of the employees on confidential information and consequences of misappropriating is necessary from time to time. Whom to disclose, when to disclose, how to disclose such information shall be made clear in the policy. Liability of the employee during course of employment or even after termination or resignation must be dealt with carefully.
Record of work
Systematic & periodic record of work, research, ideas is extremely critical to serve as an evidence to establish ownership (copyright) or inventorship (patent or design) and date on which intellectual property was created or developed by employee. It could also be helpful to find out infringement of intellectual property, if performed by an employee. Record book shall not be permitted to be taken outside the premises of the company and crucial data or descriptions should be signed and dated by the creator, supervisor, or coordinator of the project.
Liability of employee
Before expecting employees follow the IP policy, they shall be explained essential clauses of NDA and employment agreement that they sign at the time of joining. This will sensitise them about their duties as well as liabilities towards the company. At the time of termination or resignation, exit interview must be conducted and copy of agreements signed at the time of joining must be handed over to the employee to remind him his responsibilities as well as liabilities. Getting confidential or any sensitive information from prior employer and incorporating such information in the work may land up in a very undesirable condition and any such practice must be strictly discouraged by the company.
Idea Disclosure
As far as patents are concerned, the process starts with conception and disclosure of idea. Here again, the activities such as whom to reveal the idea, how to take idea forward, effort needed to convert idea to executable invention, defining inventors, royalty percentage or reward upon commercialisation of the idea, are few of the critical issues that must be addressed in the IP Policy. However, maintaining confidentiality of idea, documentation, assessment of novelty and business relevance of idea and discussion with patent attorney, filing for patent in India or foreign country requires documentation of the process so that there is coordination between date of filing a patent application and disclosure in the form of product launch. Moreover, in the process of patenting, there are several critical timelines and fee that need to be marked and updated from time to time.
IP Policy is important for any organization today and it is helpful to document the way company handles its IP, liability of employees and confidentiality/security of knowledge and data.
Celgene corporation is a subsidiary of Bristol Myers (BMS), an American multinational pharmaceutical company, headquartered in New York City. BMS is one of the world’s largest pharmaceutical companies. One of the main drugs manufactured by Celgene is an immunology drug against cancer, namely Lenalidomide sold under the trade name Revlimid, used to treat (MM) Multiple Myeloma and (MDS) Myelodysplastic Syndromes.
Natco Pharma is an Indian multinationalpharmaceutical company based in Hyderabad, which makes finished dosage formulations and active pharmaceutical ingredients (API). It is the market leader in branded oncology medicines in India, and among the country’s top three producers of hepatitis C drugs. A settlement agreement was agreed upon between Celgene Corporation and Natco Pharma which allowed Natco to initiate generic launch of the drug in March 2022. The agreement allowed Natco Pharma to begin manufacturing “mid-single-percentage” of Revlimid’s total volume, with this specified figure gradually increasing over time to one-third of Revlimid’s numbers.
Followed by Natco Pharma’s license to sell volume-limited amounts of generic lenalidomide in the U.S. beginning on a confidential date after March 2022, Dr Reddy Laboratories was also granted the license to sell volume-limited amounts of Revlimid in U.S after March 2022.
In 2017, Celgene Corporation filed a patent infringement suit against Dr Reddy Laboratories. . The settlement agreement between Celgene and Dr Reddy Laboratory remains confidential. But in a settlement of all outstanding claims in this litigation, Celgene has agreed to provide Dr. Reddy’s Laboratories with a license to sell volume-limited amounts of generic lenalidomide capsules in the U.S. beginning on a confidential date after March 2022 subject to regulatory approval. Dr. Reddy’s was also granted a license to sell generic lenalidomide capsules in the U.S. without volume limitation beginning on January 31, 2026. The earliest licensed entry of any generic lenalidomide in the U.S. continues to be March 2022, based on the settlement executed.
In an agreement between Celgene corporation and Alvogen in 2019, Celgene Corporation was able to settle disputes and reach a settlement with Alvogen over the sale and manufacturing of the anti-cancer drug. Alvogen is an American pharmaceutical company which has about 350 different medical and non-medical products, and it markets the products under the brand name pharmaceutical companies. Both Celgene and Alvogen reached a settlement and licensed Alvogen to sell generics up to single-digit percentages of Revlimid volumes sometime after March 2022. Alvogen had already launched a Revlimid generic earlier in some European countries. Global pharmaceutical company Alvogen reached the settlement of their litigation relating to patents for Revlimid (lenalidomide) with Celgene Corporation along with Oral oncology and specialty pharmaceutical Lotus Pharmaceutical Co. Ltd.
Celgene Corporation settled its patent dispute with Natco Pharma,Dr Reddy Laboratories and Alvogen respectively and all three companies can now roll out unlimited generics in the U.S. after January 31, 2026.
In March 2021 Cadila Healthcare settled its patent suit with Celgene Corporation over the anti-cancer drug Revlimid. Cadila Health (also known as Zydus Cadila) is an Indian multinationalpharmaceutical company headquartered in Ahmedabad, Gujarat, India primarily engaged in the manufacturing of generic drugs. In 2021 both Celgene and Cadila Healthcare will file a consent judgement which is a judgement specifying the settling disputes between the parties. This suit will be filed before the US Court which prohibits Zydas from marketing the generic drug before its patent expiration.
In June 2021, Celgene settled a patent infringement suit with Sun Pharmaceutical Industries Ltd, an Indian multinational pharmaceutical company headquartered in Mumbai, Maharashtra. This litigation was regarding submission of an Abbreviated New Drug Application (ANDA) for a generic version of Revlimid (lenalidomide capsules) in US by Sun Pharma. Celgene agreed to grant a license to Sun Pharma, for a specific volume in exchange of royalty to manufacture and sell the drug, subject to the U.S. Food and Drug Administration approval. Celgene granted Sun Pharma a license to sell a certain limited quantity of generic lenalidomide capsules in the U.S. subject to USFDA approval, beginning on a confidential date, sometime after March 2022.
The Patent Act, 1970 comprehends several proceedings from filing of the application till the grant of the patent. Examination of the patent application is one such process. In general, once the patent application is filed, a request for examination is filed in Form 18 u/r 24-B within 48 months from the date of priority. The filing of request for examination is followed by examination of the patent application by the controller.
Conventionally, the timeline for the grant of a patent was tedious and overlong. A provision to file for an expedited examination of application has been provided u/r 24-C of the Patent Rules, 2003 with amendments in 2016 and 2019. An expedited examination of application is filed in Form 18-A. A request for expedited examination of patent applications has to be filed along with a request for publication unless already published. In addition, a request for examination filed can also be converted to an expedited examination by filing Form 18-A under applicable grounds.
The grounds to apply for expedited examination include:
India has been included as competent ISA or has been elected as IPEA
Small entity
Start-ups
Natural person
Department of Government
Institution established by government
Government company
Institution financed by the government
A significant reduction in the span of grant of the patent is seen with expedited examination of patent applications. Under expedited examination of patent application, the examiner examines the application and makes a report within 1 month but not exceeding 2 months. Further, the controller issues a first statement of objections within 1 month from the date of receipt and the controller shall dispose the application within 3 months from the date of receipt of last reply to the first statement of objections,
The expedited examination of patent applications was introduced for start-ups initiatives under the 2016 amendment of Patent Rules, 2003. Later, the grounds were expanded under the 2019 amendment of Patent Rules, 2003. On filing a request for expedited examination, the applicant receives the first statement of objections within 2 months from the date of receipt and the applicant may receive a grant within 1.5 years from the date of filing/priority.
To promote start-ups, the IPO & DIPP has been taking many initiatives to speed up the patent grant process. A request for expedited examination has to be filed along with Form 28 and evidence for start-up which include a certificate of recognition by DIPP has to be filed.
The grant of a patent under expedited examination for start-ups assists in generating revenue for the research and development. Additionally, the grant of a patent assures authenticity of the invention for the investors. The grant of patent further provides complete protection against infringement which is a crucial aspect for start-ups. The market-value and market-presence are increased for the invention of a granted patent. With an early grant of patent, a complete public disclosure of the invention becomes feasible. Essentially, misuse and duplication of an invention can be prevented at a faster rate. Also, fast-tracking of examination and grant of patent application keeps the competitive inventions at check. For start-ups having patent rights, the company value is increased potentially in the market.
The expedited examination of patent applications has brought in an accelerated timeline for patenting procedures. The global IP standards are being coped with expedited examination of patent applications. In case of start-ups, filing an expedited examination of patent application followed by an early grant attracts funding and prevents counterfeiting of their invention. In addition to providing protection to the invention, the competition with the existing market is withstood upon grant.
By Anagha MS
Contact us at info@origiin.com to avail services in Patent, Trademark, Contracts, Patent Licensing, M&A
Parle Products introduced Parle-G way back in 1938. The biscuits themselves have had a long journey attaining global recognition, with the brand undergoing reimaging in 1982. One may wonder why an exceedingly popular and successful brand had to undergo reimaging after so many years of being introduced to the market and becoming a hit among consumers. The answer lies in an understanding of trademarks.
India has developed Intellectual Property Laws and awareness in the recent past and is still making constant developments in these laws, resulting in IP protection being a new yet essential field in the Indian Legal System. However, Parle Products, having been started during the Swadeshi Movement, has been around for a longer time. Like any successful business, Parle Products gauged the changing legal environment surrounding brand protection in India and adapted to these changes by reimaging ‘Parle Gluco’ and renaming it as ‘Parle-G’.
In order to understand the relevance of this particular change, it is important to understand two important limitations to trademark registration which in turn protects brands and other related intellectual property. First, if a trademark consists of a descriptive element, describing the specifics of the kind of product, such a trademark cannot be registered. Second, certain words, by virtue of them being used commonly to refer to a thing, belong to the public at large for use and cannot be owned by a private entity. These trademarks are called “Publici Juris Trademarks”.
In the case of ‘Parle Gluco’, because of the grounds mentioned above, Gluco could not be registered as a trademark. Gluco for Glucose biscuits is descriptive of the specifics of the kind of biscuits those were and cannot be used exclusively by one company. For example, in the case of M/s Hindustan Development Corporation Ltd. v. The Deputy Registrar of Trade Marks, the word ‘RASOI’, which is primarily associated with cooking, could not be registered as a trademark for cooking oil. [1]
Further, the term Gluco describing Glucose, a natural substance, is “publici juris”, that is, it belongs to the public at large, for anyone to use, and cannot be owned exclusively by a private entity. Thus, in Parle Gluco, ‘Gluco’ is considered to be the non-distinctive part of the brand name and therefore cannot be registered as a trademark. Similarly, in SBL Ltd v. Himalayan Drug Company, using “Liv” for “Liver” was considered as the non-distinctive part of the mark as it is common practice to use “Liv” for “Liver”, making it “publici juris.” [2]
With the rising popularity and demand for glucose biscuits, many other biscuit companies started selling ‘gluco’ biscuits. There existed unfair competition for Parle as it had created a consumer base for its Gluco biscuits which was now being divided among the many different alternatives, with no distinguishing brand name unique to the glucose biscuits started by Parle. In order to restore its consumer base and ensure brand loyalty, ‘Parle Gluco’, a brand name which could not be registered, was changed to ‘Parle-G’, a registered trademark and a unique product of Parle Products, in a reimaging done by Everest Brand Solutions.
The reimaging helped create a unique identity for the glucose biscuits started by Parle Products and helped restore its popularity amongst its loyal consumers.
By: Ria Mishra
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Intellectual property (IP) refers to creations of the mind, such as inventions, designs, name of products and services, literary and artistic pieces of work, etc. To protect these creations of the mind, law comprises provisions in the form of patents, trademarks, copyrights, and so on. These rights are collectively called Intellectual Property Rights (IPR), where IPR is a kind of legal right provided by the Government for the protection of creations, provided the creations fulfil certain conditions. IP can be protected and registered under different legal frameworks depending on the type of IP.
IPR law is amongst the rare breed of law practices where professionals with varied backgrounds in domains such as engineering, biotechnology, chemical engineering, pharmaceuticals, and so on are fairly successful despite their seemingly unrelated backgrounds. Patent law is a domain of IPR law that requires practicing professionals to have a sound technical and theoretical understanding of science because patents primarily relate to core technologies, inventions and related work. Due to the ability of STEM graduates to understand technical aspects of technologies or technical inventions, most companies prefer them over advocates to handle the tasks of patent searches, drafting/filing/prosecution of patent applications and more.
It is interesting to note that in order to file patent application on behalf of the client in India, it is important for a person to be a registered Indian patent agent. A registered patent agent is a person who is firstly at least a graduate in science, has secondly cleared the Indian patent agent examination and lastly has registered themselves as a registered patent agent. Due to this, a patent agent who may not be an advocate becomes authorised to draft, file, prosecute patent applications on behalf of the clients. A person who is registered as an advocate with the Bar council but not as a patent agent is not authorised by the patent office to act on behalf of any client and draft/file/prosecute their patent application in India. The list of registered patent agents is published on the official website of Indian Patent Office (IPO).
Two terms used most frequently in the industry are “patent attorney” and “patent agent”, and it is therefore of prime importance to understand the difference between the two clearly. A patent agent is someone who possesses at the minimum an undergraduate degree, has cleared the Indian patent agent examination and has registered himself as a registered patent agent with the IPO. The Indian patent agent examination is generally conducted by the IPO once a year. A patent attorney on the other hand is an advocate who practices IP law and may or may not be a patent agent. Further, a patent attorney must be registered with Bar council of India as an advocate. An advocate is not eligible to write the Indian patent agent exam if he is not a graduate of a scientific domain. These limitations for advocates often results in a loss of direction for them regarding what potential opportunities await them if they want to practice IPR and in particular patent law. In this article, we will try to explore the areas of IPR for advocates to practice in.
Patent law
Before a patent application is filed, typically a patent search is performed to assess novelty of the invention. A patent application is published after an expiry of 18 months from the date the patent application is filed, where this date is called the priority date or date of filing. After the application is published, there may be an opposition to the grant of patent and this opposition is called as pre-grant opposition. However, if the opposition is filed within 12 months from grant of a patent, the opposition is called post-grant opposition. Further, if opposition is raised after the elapsing of 12 months from the date of grant of the patent, it is called revocation. An advocate who is not a patent agent can handle such oppositions or revocations before the Controller of Patents or IPAB (Intellectual Property Appellate Boards).
Advocates can also conduct their practice in the following areas:
Patent or IP audits at the time of acquisition & merging of companies where there may be a need to check legal status of patents, and docketing of the same for upcoming deadlines, renewal fee calculation, etc.
Valuation and commercialisation of patent. Negotiations and drafting of technology transfer-related contracts may also be required to be done by an advocate at the time of such transfer.
Docketing of patent cases and coordination with foreign attorneys regarding foreign patents is required by most law firms and this can also be undertaken by advocates.
Searches such as freedom-to-operate searches can also be carried out by advocates. Specialized searches such as these are usually performed by patent agents but advocates have a vital role to play in claim interpretation and referring right statues along with case-laws. In fact, several companies require such FTO reports to be signed by advocates.
Portfolio management of innovative companies to look after legal-commercial strategies, planning regarding portfolio creation and management, licensing of technologies, etc.
Trademark law
The number of trademark applications filed in trademark registry are far more as compared to patents. In fact, the number of disputes, infringement cases and related litigation matters are also very high compared to patents. Due to this, trademark is a very potential area for advocates to specialise in and must be an advocate in State Bar Council but for non-advocates, it is important to be a trademark agent to file and prosecute trademark application and must have to clear and qualify the examination of Trademark Agents Examination However, there is no need for an advocate to be a trademark agent. The scope of work includes:
Advising clients on selection of trademark for new products and services
Trademark searches to give opinion on strength of the mark
The trademark agent/attorney helps in choosing an apt trademark after ensuring compliance with the legal norms and thus reducing the chances of rejection of trademark application. The filing of the application has very specific requirements that can be dealt with by ease by a trademark attorney in India. In case there are any objections to the trademark registration, it is upon the attorney to reply to the objection and provide with an alternative. Trademark attorney also provide important advice about the nuances of trademark infringement.
Copyright Law
Copyright laws are very necessary to protect your original works and determine the ownership of creative output such as written works, music and motion pictures. In problems related to copyright issues and cases, the copyright attorney helps in getting the authority and ownership of original works. The Copyright Attorneys in India help creators of unique work in filing an application that needs to be submitted for copyright registration. They also help in prosecuting and registration of patents, designs meant for industrial sector, trade mark, etc. They not only help in the filing of the application but also its licensing, renewal and carrying out its enforcement.
In case, after filing an application for copyright registration, there are any defects, these defects are communicated to the applicant. Copyright attorney can go through this application and help the applicant to identify the defects and remove them.
Other forms of IPR
Further, for an advocate, all areas for filing, prosecution of applications for registration as well as enforcement are open in case of , design, Geographical Indication (GI), etc.
Conclusion
IPR is a potential area to for advocates to continue their practice. However, it is to be understood clearly that an advocate is not authorised by the Indian Patent office to draft/file/prosecute patent application in India or PCT. Despite this, there are numerous opportunities for advocates in other areas of patents, trademarks, copyrights, GI etc.
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Cross border trade refers to trading of goods and services between two commercial entities or consumers and commercial entities across state borders. This gives consumers a huge range of commodities to choose from and provides commercial entities with a plethora of opportunities and new markets to exploit. Cross border trading and outsourcing to meet necessary requirements has been an important part of civilizations since the inception of the barter system. The motivations of cross border trade and expansion of markets lies at the very foundation of international relations. While cross border trade is not new by any means, the role that it plays today in markets across the globe is unprecedented. This is a boon of modern technology and the internet marketplace.
It is estimated that by 2022, cross border shopping will take up about one-fifth of the e-commerce space along with sales recording a whopping 627 billion dollars. The Indian market, ranked ninth in cross-border growth, is showing growth projections of upto 4% of the total retail trade by 2025.
While the scope for profit and promotion has increased manifold with the popularization of cross border trading, additionally has spiked the risk of infringement of Intellectual Property Rights (IPR), duplication and counterfeit of the products.
The protection of intellectual property on a global scale can be a complex issue, a tight rope to walk while balancing national autonomy at the same time as to drive further into global existing markets. The risk of IPR infringement exists at multiple areas in the transit of goods. The many working aspects of the supply chains further complicate the issue.
Protection for IPR exists at various levels, internationally which simply implies that the said protection of property extends across numerous regions and nationally. The World Intellectual Property Organization (WIPO) founded in 1967 is the foremost intergovernmental organization working towards ensuring protection of intellectual property rights across borders. International conventions such as the Paris Convention and the Hague Agreement for Industrial property and designs, and the Madrid Agreement regarding deceptive indication and false goods date back to the 19th century, India is party to most of these agreements except The Hague Agreement. However, the protection these treaties offer extends only to the territories of member countries; this magnifies the risks that exist in the countries that are not signatories to the treaty. Though this protection includes goods being exported, imported and also those in transit i.e only passing through these member states, it is not adequate.
While international conventions grant rights, aid in easing the application procedure across member states and in some cases even outline procedural aspects they do not provide for mechanisms to enforce these rights. Territorial or national enforcements of these rights leave space for multiple interpretations, some of which can be unjust and ill motivated. This also happens due to IP rights registered and enforced in bad faith, as is the case with Chinese patents, copyrights and designs.
In recent times ecommerce giants such as Amazon and popular clothing sites like Shein have faced slander for copying designs from small time designers, a piece of clothing designed in interior North America might very well gain immense popularity in cities far away without the designers ever getting any deserved (or even legal) recognition. This speaks to the potential and scope of IPR infringements and the impact it carries.
As of today six BIPOC have been awarded copyrights, for choreographies they created that went viral during the first set of lockdowns imposed world-wide and are highly used and recognised amongst young adults. These copyrights now ensure credit is given to them in case these are used in games or movies. Though considering the multiple languages and regions that produce cinema and e-games the scope of infringement is wide and questions of justness and ease of the process of redressal in such cases arise. This copyright in a global sense would be granted under the WIPO Performances and Phonograms Treaty of 1996, the issue of justice in case of violation remains open ended so far.
The latin maxim Ubi jus ibi remedium est used in various areas of law, including contract law, supports the idea that the existence of right also implies the need for a remedy, rights that are not justiciable are no rights at all. Like most practices of international law, the conventions and agreements under the WIPO and IPR protection purview is not by nature applied in its whole essence, the application and adoption lie with the member states as sovereignty of nations is priority.
But sovereignty cannot take precedence in the face of blatant violation of rights of individuals. It is also important to note that WIPO does have an Arbitration and Mediation Center, traditional methods of recourse and redress are still lacking.
Simply put, there is a need for an intergovernmental organisation, a neutral adjudicator. This could be in the form of an appellate dispute resolution body on an international level, exercising the powers of review and recall, or in terms of separate councils for different continents consisting of members elected by various states exercising the powers of regulation.
While many approaches can be thought of, to solve this problem, the root of all such approaches must be with the intention of maximum utility and enforcement of all intellectual property rights across the world.
Intellectual property rights (IPR) are elemental in modern-day business strategy. Technology transfer transactions provide income to several companies operating in countries all across the globe. These countries immensely benefit from the taxation of IP related transactions leading to the growth of their economies. Thus, to promote more of such ventures, willing countries pledge to follow international treaties such as the Trade-Related Aspects of Intellectual Property Rights (TRIPS), which contain several provisions to govern trade-related matters between countries in respect of IPR. Certain tax exemptions and deductions are also provided to native companies in other member states to provide an incentive to enhance their business income. In the Indian context, it has been observed that an efficient IP taxation regime and royalty policy would persuade creators to produce more original and artistic work and expand the number of technology or know-how transfers into the country.
The following article provides a basic understanding of how income derived from IPR transactions are taxed under the Income Tax regime in India.
Taxation Policy in India w.r.t. Intellectual Property Rights
The taxation structure in India provides that income from intellectual property rights (IPR) are segregated according to the nature of the transaction. If an individual authors a book, creates music or is the sole inventor of a medicinal cure, then in those situations, the Income Tax Act of 1956 (the ‘Act’) provides for certain tax deductions which will promote tax planning. Once the nature of the transaction is determined, it is easy to identify whether the amount paid is taxable or would be allowed as a deduction. The categories under which IP can be taxed are –
Deductions – In the pre-existing stage of an IP, the cost which is incurred on analysis, manufacturing, i.e., capital spent on research and development is treated as an expense and is to be deducted from the gross income received for the calculation of income tax.
Income – Income from an IPR either by assignment or licensing is treated as Capital gains or income received from royalties under the Income Tax Act, 1961.
Goods and Sales Tax – Tax on the sale of IP, transfer of IP, licensing of IP and assignment of IP are covered under the GST Act.
What is intellectual property according to tax law?
As per the definition of ‘capital asset’ in Section 2(14)[1], a capital asset has an all-embracing connotation except if it expressly excludes a certain item. It includes ‘property of any kind,’ which undoubtedly incorporates intellectual property. The Act does not define intellectual property as such but the difference between tangible and intangible assets is examined in Section 2(11)[2]. Intangible assets, as per the definition, include ‘know-how, patents, copyrights, trademarks, licenses, franchises or any other business or commercial rights of a similar nature.
Royalty
Section 9(1)(vi)[3] of the Income Tax Act elaborates the definition of royalty. Royalties are taxable as income or as a business expense. It is to be noted that regardless of the conditions mentioned in Section 9(1)(vi)[4], if the IP is located in India, then the consideration for its use or disposal will arise in India and will be taxed according to Section 5(2)[5] of the Income Tax Act. Income by way of royalty is taxable under the Income Tax Act for a resident except in respect of:
any right, property or information used or services utilized outside India or
To make or earn any income from any source outside India.
Royalty income is taxable for a non-resident in respect of –
any right, property or information used or services utilized in India or
To make or earn any income from any source in India.
If such income is payable due to an agreement made before the 1st day of April 1976, and the agreement is approved by the Central Government, such income cannot be taxed.
In CIT Vs. Koyo Seiko Co. Ltd[1999 233 ITR 421 AP] it was held that royalty excludes any consideration which would be chargeable under the head of ‘Capital Gains’ and is assessable to capital gains tax at the rates applicable. Thus, royalty is any consideration, including lump-sum amounts but excluding those which would be the income of the recipient chargeable under the head capital gains, for:
The transfer of all or any rights (including the granting of a licence) in respect of an invention, patent, secret formula or process, model, design, trademark or similar property;
The imparting of any information concerning the working of or the use of an invention, patent, secret formula or process, model, design, trademark or similar property;
The use of any invention, patent, secret formula or process, model, design, trademark or similar property;
The imparting of any information or the use or right to use concerning technical industrial, commercial or scientific knowledge, experience or skill; (but not including the amount referred to in Section 44BB[6].)
The transfer of all or any rights (including the granting of licence) in respect of any copyright, scientific, artistic or literary work including films or videotapes for use in connection with television or tapes for use in connection with radio broadcasting, but consideration for the sale, distribution or exhibition of cinematographer films.
The render in of any other service about the activities mentioned above.
Expenditure and Deductions
While determining tax liability, the aim and object of the expenditure should be kept in mind to decided whether it is a capital expenditure or revenue expenditure. A revenue expense is deductable from the chargeable income of a business, while the expenditure incurred on capital is not. The Supreme Court in the case of Assam Bengal Cement Companies Ltd. v. CIT [1955 SCR (1) 876], observed that if the expenditure is made for acquiring or bringing into existence an asset or advantage for the benefit of the business it is attributable to capital expenditure. On the other hand, if it is made for running the business or using it to produce profits, it is a revenue expenditure.
Section 32 (1)(ii) – Depreciation of an intellectual property asset as an expenditure [7].
Depreciation of an asset is considered to be a business expense and the section accounts for such depreciation of IP to be an expenditure for computation of Income Tax.
Section 35A – Expenditure on the acquisition of patents and copyrights [8]
When the consideration is paid in a lump sum, the depreciation over the acquired patent and copyrights shall be claimed over a period;
When the consideration is paid periodically, the depreciation can be claimed as an expenditure fully incurred for business.
Any expense undergone after 28th February 1966 but before 1st April 1998 on the acquisition of patent rights or copyright for a business committed actions will be allowed for each of the previous years on an amount equal to the appropriate fraction of the amount spread over fourteen years.
Section 35AB – An assessee who has paid any lump sum consideration to acquire any know-how for the use of his business, the expenditure for the same shall be deductable in six equal instalments for six years in the following manner [9]–
1/6th of the amount paid shall be deducted while calculating the profits and gains of the business for the previous year;
the balance amount shall be deducted in equal portions for each immediately succeeding the previous five years.
Section 80 GGA – deduction in respect of certain donations for scientific research or rural development [10].
The research work for the development of intellectual property such as a patent comes under the category of scientific research. Under present laws, expensed deductions and additional weighted deductions are permitted to everyone for research and developmental expenditure. For the tax years 2017-2018 to 2019-2020, the weighted deduction is limited to 150% after which it will be reduced to 100% of the expenditure.
Section 80 O – no deduction in respect of royalties from certain foreign enterprises [11]
40% for the assessment year beginning on the 1st April 2001,
30% for the assessment year beginning on the 1st April 2002,
20% for the assessment year beginning on the 1st April 2003,
10% for the assessment year beginning on the 1st April 2004,
No deduction from 1st April 2005 onwards.
Section 80 QQA – Specific provision for copyright products [12]
A deduction of 25% shall be allowed from any income obtained by an author in the exercise of his profession on account of any lump sum consideration for the assignment or grant of right in the copyright of any of his works, except for the following –
Dictionary
Thesaurus
Encyclopedia,
Any book that has been added as a textbook in the curriculum by any university for the degree of graduate or postgraduate course of the university, or
Book which is written in any language specified in the 8th schedule of the constitution or any other language as the Central Government by notification in the official gazette specifies for the promotional need of the language.
Section 80QQB – deductions made in respect of royalty income of authors of certain books other than text-books [13]
Section 88 RRB – Specific provision for patented goods and services [14]
In some cases, the total income earned on a patent can be divided into royalty and additional income other than royalty. The income received as royalty is only eligible for tax deductions. When income is received as a royalty, the whole income or Rs. 3 lakhs (the lesser amount) shall be deducted. If a compulsory license is being granted for a patent, the terms and conditions of the license agreement shall decide the status of the income to allow deduction under this section which shall not exceed the amount of royalty.
Basic qualification criteria for an inventor under this section-
The individual must be an Indian resident.
Original patent holders are only eligible to tax benefits.
The patent under this section should be registered under the Patent Act of 1970, either on or after April 1, 2003.
Section 115BBF – concessional tax rate on the exploitation of patents [15]
10% concessional rate of taxation is applicable on royalty income from the exploitation of patents granted under the Patents Act, 1970. The following criteria must be satisfied –
The patentee should be an eligible Indian taxpayer,
The total income of the patentee must include income by way of royalty in respect of the patent developed and registered in India,
At least 75% of the expenditure is incurred in India for the invention, and
No other expenditure is allowed under the tax provisions if the concessional tax rate under this section is availed.
The benefit of Section 115BBF can be used in any year but the patentee is required to continue to avail of the benefit for the next 5 years. If the option is not exercised in any of the next 5 years, the benefit under the section for the next 5 years following such year in which option is not exercised, shall cease the exist.
Startups and SME’s
A Startup is an industry that has been in existence for not more than seven years and has a turnover not exceeding twenty-five crores whereas an SME is an enterprise with an investment of up to one crore in Plant and Machinery. A startup primarily focuses on the innovation and development of products and processes. Startup-India is an initiative of the government which intends to catalyze the startup culture in India to build a strong and inclusive ecosystem for innovation and entrepreneurship in the country and to provide IPR facilitation, better tax benefits and easier compliance procedures. The special tax exemptions to promote such startups are –
Section 80 IAC: Income tax exemption for recognized startups [16]
After getting recognition as a startup, this section provides that for any three consecutive years out of a block of 7 years (10 years for startups from the Bio-Technology Sector) from the date of its incorporation, tax exemptions can be availed. The eligibility criteria for the same is –
The entity should be a recognized startup,
Only private limited companies or limited liability partnerships are eligible,
The startup should have been incorporated after the 1st of April 2016.
After getting recognition, a startup may apply for Angel Tax Exemption. Eligibility Criteria for this section is –
The entity should be a DPIIT recognized startup
The aggregate amount of paid-up share capital and share premium of the startup after the proposed issue of shares, if any, does not exceed INR 25 Crore.
Other Benefits for Startups regarding IPR:
Patent applications and facilitation helpline will be speedily available.
The entire fees of the facilitators for any number of patents, trademarks or designs that a startup may file shall be taken up by the Central government and the cost of the statutory fees shall be paid by the startup.
Startups shall be provided with an 80% rebate in the filing of patents.
Government Scheme for MSMEs– Support for International Patent Protection in E&IT (SIP-EIT) Scheme
This scheme of the Government of India provides financial support to MSMEs and technology startups for international patent filing. The reimbursement limit provided in it has been set to a maximum of INR 15 lakhs per invention or 50% of the total charges incurred in filing and processing a patent application, (the lesser of the two). This scheme can be availed at any stage of international patent filing by the applicant. The reimbursement, however, will only apply to expenditures incurred from the date of acceptance of a complete application by DeiTY which has to be approved by a competent authority.
Conclusion
Today, several entities derive most of their income from their IP assets and thus enforce the importance of IP and the need for a more enabling taxing regimen. In India, the current economy is witnessing rapid growth in micro and small sector enterprises with great abilities to compete at a global level. Most of these enterprises do not protect their intellectual property due to several reasons such as lack of awareness, lack of funds, exhaustive procedures etc. and are not well equipped to take their businesses to the next level. Awareness of tax planning and a supplementing taxing regimen is the way forward to make a win-win situation for both the Government and the competing parties.
For various reasons, every inventor wants to file for a patent internationally after filing it in his/her home country. Sometimes it’s about the status that is associated with having a patent filed in the US or Europe, but having an international patent may also enhance the valuation of the technology which ultimately may impress investors and fetch better value to the inventor. Oftentimes, inventors drop the idea of filing for patent internationally because it is expensive, complicated, and long procedure. Laws across the countries are also not unified in terms of procedures, fee and timelines leading to more and more confusions at every stage,
It is firstly of crucial importance to understand the term “International Patent”. In reality, there is nothing called international patent or global patent. Despite there being ways to file for a patent internationally, there is no single authority to grant international patents with validity across the globe. Patents are required to be filed in and granted by each country where the inventor wishes to seek protection.
Few things are required to be focused on, when filing a patent outside India. For a resident of India, Section 39 [Residents not to apply for patents outside India without prior permission] of Indian Patents Act 1970 states that the patent must be filed in India first and can be filed in any foreign country within a period of 12 months. Once this 12-month period expires, the inventor loses the chance of filing outside India.
Two ways to file patent application internationally
There are 2 ways to file a patent in foreign countries. These are:
A. Patent Cooperation Treaty (PCT) Route
An inventor may file a single patent cooperation treaty (PCT) application or international application within 12 months from the date of filing a patent application in India. PCT is an international patent law treaty that provides a unified system for filing patent applications in each of its contracting states. It is a convenient platform to assist inventors that are seeking patent protection internationally (in the contracting states of PCT) for their inventions. It also helps patent offices with their patent granting decisions by providing comprehensive search reports for the patent application along with opinion on patentability. PCT publishes the patent application filed with it and maintains an online database called Patentscope which facilitates patent searches as well as gives public access to a wealth of technical information in the form of patents.
PCT examines the application, issues examination report and enables inventors to file their application within 30/31 months from the date of priority in any of the member states of PCT. After this, the patent is processed and granted by the national offices of the countries where patent protection is sought, based on the procedures and requirements of the respective offices. PCT enables patent filing in its member states & gives extra time to the inventor to decide about the countries they want to file their application in.
B. Convention Route
The countries which are members of the Paris Convention are called convention countries and an application filed in a convention country is called a convention application. Unlike PCT, convention application is required to be filed in the convention country within 12 months from the priority date.
Reasons to file international application
Filing international application without clarity on the reason to file is not a good idea. It does not help inventors in long run and may actually lead to a very stressful situation if the prosecution is left midway, further making the overall process financially cumbersome. Following parameters should be considered when deciding about the countries to file patent application in:
Your future business plans
Patents must be filed in the countries where the inventor wishes to expand the business in the future. It must be remembered that there is a specific time period within which inventors must file the patent application in specific countries. Once this period has lapsed, it is not possible to file an application at a later stage. Therefore, if it is desired by the inventor to expand the business in countries like the US or Japan 5 years later, it would make sense to file patents in these countries within the required time frame.
Potential of technology in given jurisdiction
Sometimes, it makes sense for an inventor to file for patent in some countries even if the inventor does not have business there. Countries like the US have a mature system of buying, selling and enforcing patents. If technology has good potential in a specific country, a patent should be filed in that country. Further, licensing and selling options may also be explored to facilitate easier transition of the patented technology to the market.
Your budget
Filing and prosecution of a patent is a long process and strictly regulated by several timelines. A patent may be lost if the inventor does not respond to the office in time or fails to pay the necessary fees. Further, there are standard expenses for each country and renewal fees to be paid post grant of the patent. This leaves a very small window for postponing expenses and timelines, making the overall process of getting a foreign patent extremely time consuming, complex and expensive. The tentative costs of filing, prosecution and maintenance must be assessed in advance and only then should a decision about foreign filing be taken.
Keeping in mind budget, type of invention and area of business, the decision to file patent internationally shall be taken.
Video Link: https://www.youtube.com/watch?v=vdBEv1F_vk4
A patent is a form of Intellectual Property Rights (IPR) and is a statutory grant by the Government that gives its owner the legal right to exclude others from making, using, selling, offering for sale or importing the patented invention in the territory wherein patent is granted, for a limited period of time.
Invention shall have novelty, inventive step and industrial applicability in order to get a patent granted. Patent is granted to the inventor only if these three conditions are fulfilled. The way to assess patentability of the invention before filing a patent application is by performing patentability search.
Patentability search (also called as novelty search or patent search or prior art search) is a kind of patent search which is often performed to analysis novelty of the invention before filing for a patent wherein prior arts, similar to the invention are identified, analysed and compared with the invention in detail to assess novelty of the invention. This helps further to draft patent claims in a better manner. This search is also sometimes performed to plan further research by analysis of the research which others have already done. It is highly recommended to search non-patent literature (research paper publications) also in addition to patent search, especially when the purpose of search is to assess novelty of the invention.
The search is often performed by patent professionals into several paid or free patent databases by using various search techniques such as key word search, International Patent Classification (IPC) based search, assignee search and so on. Further, patent professionals use various search strategies to yield the most relevant and accurate results corresponding to a particular invention.
In order to perform patentability search, following steps shall be taken:
Step 1: Identification of novel elements of the invention
The novel features may be listed out as novel feature 1, 2 and so on. This listing helps to formulate the key words and set right search strategies.
Step 2: Formulating right key words & framing search strategies
It is important to do basic research on the invention so that it is easy to identify keywords and their synonyms to ensure that prior art search is comprehensive, and no important prior art is missed during the search.
Step 3: Performing search in patent databases
Every patent office maintains its own patent databases comprising published applications and granted patents. Some of the commonly used databases includes espacenet, google patents, patentscope by WIPO and USPTO patent database. Search in these databases is free. However, there are more comprehensive databases, which are paid. Search shall be performed in these databases to extract the relevant prior art. Searcher shall focus on key words and search string formulation otherwise you may get a very high volume of search results and it becomes difficult to screen through it.
Step 4: Screening of prior art and categorizing them based on similarity with the invention
At the time of performing patentability search, the entire patent specification shall be read with special emphasis on the patent claims/embodiments and categorised as most relevant, relevant prior art.
Step 5: Comparison of prior art with novel elements of the invention
Comparison of prior art with novel elements of the invention shall be done for each novel element and finally the invention shall be assessed for patentability.
Step 6: The invention shall also be assessed to check if it falls under category of inventions not patentable in a specific jurisdiction.
In addition to meeting 3 conditions of patentability such as novelty, inventive step and industrial application, the invention shall not fall into any of the category of inventions not patentable. In Indian patent law, section 3 and 4 talk about the inventions that are not patentable in India. For example, the inventions that relate to computer software, traditional knowledge, atomic energy or the inventions that are injurious to human, plant animal life or environment are not patentable in India even though such inventions fulfil criteria of patentability. In step 7, invention shall also be assessed to check if it falls under category of inventions not patentable in a specific jurisdiction.
Step 7: Assessment of patentability of the invention in terms of novelty, inventive step and industrial application
In order to assess patentability of the invention and write opinion on patentability of the invention, the searcher shall be thorough with that different provisions of patent law. Based on finding of above 6 steps, opinion on novelty and patentability of the invention shall be written.
Novelty search is important to be performed before taking final decision on filing for a patent. If this search reveals similar or identical prior art, which is very close to the invention, inventor has a chance to improve upon the invention to minimise the objections to the grant of the patent during examination of the patent application.
Origiin, with a skilled team of patent agents is one of the best patent companies in India offering patent services such as, patent searching and patent filing, in India and foreign countries.
Deliverables: Patentability search report is written in word document with opinion on patentability considering statutory provisions along with PDF copies of all prior arts listed
Timeline: 3-5 business days
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Competition takes numerous forms in commerce, but in the pharmaceutical industry there is one market segment of specific characteristics and interests. This market incorporates community pharmacies providing legend medications based on physician prescriptions, and brand name distinction is the basis for competitiveness. The leading pharmaceutical houses license patents to one another and not to the remaining enterprises in the industry. Each licensee markets the replicated product under a distinct trademarked name, as is a customary practice.
An over- simplification of licensing is monetizing an intellectual property of the invention by allowing third parties the right to exploit the patented invention in exchange of royalty. Along with the patent rights, often, there is also transfer of know-how, experience, methodology, processes etc. Subject to the provisions of the licensing agreement, when an invention is given for licensing to a licensee, the organization is empowered with the ability to manufacture, distribute and sell in specific jurisdiction and for a specific period of time. The inventor is given royalties by the licensee as a consideration for the said patent license agreement.
Patents are designed to encourage private sector companies to spend in research and development (R&D). There are disparities in how different industries rely on the patent system. Because of two factors, the pharmaceutical sector is particularly reliant on the patent system. One, the technology is uncomplicated to reverse engineer, and two, the industry has no entrance hurdles. This is why the pharmaceutical industry has been at the center of the argument about patents.
In India, there was a remarkably extensive debate on the relationship between patents, and development, which emerged shortly after independence. Attempts to develop a distinct patent system began in 1948 and indicated in the Patents Act of 1970. There was a debate about whether India should join the Paris Convention until around 1986. Another round of discussion was sparked by the inclusion of so-called Trade Related Aspects of Intellectual Property Rights (TRIPS) as a negotiating subject during the Uruguay Round of multilateral transborder trade related negotiations of the General Agreement on Tariffs and Trade (GATT). The implementation of the TRIPS agreement in India has been a source of contention since 1994.
Patent Law in India
Patent rights were initially introduced in India in 1856, and the Patent Act 1970 (“the Patents Act”) was passed in 1970, abolishing all earlier laws. India is also a signatory to the Paris Convention for the Protection of Industrial Property, which was established in 1883, as well as the Patent Cooperation Treaty, which was established in 1970. Any invention that meets the criteria of novelty, non-obviousness, and industrial utility can be the subject of a patent, according to the Patents Act. Some of the non-patentable inventions under the Patents Act encompass techniques of agriculture or horticulture, mechanisms for the medicinal, surgical, curative, prophylactic or other treatment of human beings, animals or plants or substances acquired by a simple admixture, culminating only within the agglomeration of the properties of the components, etc. With respect to pharmaceuticals, in the particular instance of substances deliberately designed for use or capable of being utilized as food, drugs or medicines or substances developed by chemical processes, patents are only issued for the manufacturing techniques of such compounds, not for the substances themselves. As a result, pharmaceutical products are now unprotected under Indian law.
The Patents and Designs Act 1911 established a product patent regime for all inventions in India. In 1970, however, the government passed the new Patents Act, which made pharmaceuticals and agrochemical products ineligible for patent protection.
“Thereby, under our established patent laws, molecules, which are products of chemical processes, are as such non-patentable in India,” the exclusion was initiated to break India’s ’s dependency on imports for drugs in bulk, formulations and to provide for the development of a self-reliant indigenous pharmaceutical industry. This restriction, combined with the prohibition on admixtures that result in the aggregation of qualities in which the components have no synergistic effect, significantly limits what can be patented in India. Although chemically manufactured “activities” have functional properties, they are not patentable in India. In India, typical pharmaceutical compositions in which the ingredients operate as admixtures are equally ineligible for patents. Only the process, i.e. the method of generating the product, is patentable in such instances.”[1]
The paucity of protection for product patents in pharmaceuticals and agrochemicals has had a considerable impact on the Indian pharmaceutical industry, leading to the development of remarkable expertise in reverse engineering of drugs that are patentable as products throughout the industrialized world but are unprotected in India.[2]
As a result, the Indian pharmaceutical sector flourished quickly by manufacturing less expensive versions of a number of patented pharmaceuticals for the home market, and then aggressively expanding into the global market with generic drugs once the international patents expired. Furthermore, the Patents Act establishes a number of measures to avoid patent infringement and improve medicine accessibility.
The legal recourses of bringing the patented product in the markets: Once patent is granted, in order to generate revenue, the commercialization of the patent becomes essential. For a patent holder there are three recourses established in order to make money from his property (i.e. patent). The first option involves patent licensing wherein the patent holder transfers patent rights to the third party for a specific period of time without transferring the ownership of the patent in exchange of royalty. Second course of action is the patent assignment wherein patent holder permanently transfers the ownership of his/her patent to the third party and such third party then becomes owner of the patent. The third is to bring patented product in the market via a Joint Venture (JV) wherein both patent holder and third party join hands to build and establish new venture in collaboration. All these modes may be explored by both patent holder and third parties to find out the most effective way of collaborating.
Compulsory licensing is a license granted by the Government under certain specific circumstances. On the expiration of three years from the date of securing the patent, any individual engaged in working the patented innovation may apply for a compulsory license with respect to the invention. The mandate of the controller of patents being satisfied that the reasonable requirements of the public with regard to the patented invention have not been met or that the patented invention is not accessible to the public at a reasonable price may direct the patent-holder to grant such a license on the conformity with the terms and conditions.
In addition to compulsory licensing, the Patents Act includes a provision for “right licenses,” under which the central government can apply for an order that the patent be endorsed with the words “right licenses” after three years from the date of the patent’s sealing, on the grounds that the reasonable requirements of the public with respect to the patent have not been met.
Patents for certain compounds that are not food items or drugs as such but that are capable of being used as food items or medications are presumed to be endorsed with the words “license of right” instantaneously on fulfillment of three years from the date of the sealing of the patent. Endorsing a patent with the terms “licensing of right” has the effect of allowing anyone interested in working on the patented innovation in India to obtain a license from the patentee. Even if he or she currently has a license under the patent, the grant of a license would be on mutually agreed-upon terms. If the parties are unable to reach an agreement on the terms of the license, they can apply to the patent controller for a settlement.
As mentioned earlier, a simplification is that by granting a license, a patentee allows others to create, use, or exercise an invention that would otherwise be prohibited. The licensing of a patent transfers a set of rights that are time, geographical, and scope of use limited. A patent license might be voluntary or compulsory.
Voluntary licensing: A voluntary license is the one where patentee, at his or her discretion, grants another person permission to create, use, or exercise the patented invention through a written agreement. In such a license, neither the Indian patent office nor the central government plays any part.
–Exclusive License Agreement: A license that is confined to a specific field or subject, such as a market, territory, time period, or context, is covered by an exclusive license agreement. A technology application, a manufacturing method of the products, a geographical area, or the production of a certain product could all be covered by the agreement.
Exclusive does not imply that the license is “one and only license” but rather that the licensor agrees not to grant any additional licenses with the same rights that fall within the field or scope of the agreement. The licensor has the authority to issue an unlimited number of licenses with different rights within the same field or licenses with the same rights in a different field.
Anyone who infringes on any licensed rights within the field or extent of the agreement is subject to legal action by the holder of an exclusive license. In this case, the licensee becomes almost owner of the patent
Non-Exclusive License Agreement: On the contrary, the non-exclusive license is the one wherein patent holder may grant such license to more than one party.
ii. Involuntary licensing: An involuntary license is granted by patent holder to the company under specific circumstances where the company infringes patent rights of the patent holder and wants to continue using the patented invention. This is the kind of license which is granted only when there is likelihood of patent holder filing law suit against company for patent infringement, and to avoid it, company undertakes the license or permission to use the patent from the patent holder.
iii. Compulsory license u/s 84: A compulsory license is a statutory license that the Controller of Patents can award to a third party under specified conditions. A compulsory license under the Patent system is an involuntary contract imposed and enforced by the government between a willing buyer and an unwilling seller. Compulsory licenses allow someone else to manufacture a patented product or process without the patent owner’s permission. Under section 84 of the Patents Act, 1970, a compulsory license may be granted on the following grounds:
(i) The public’s reasonable requirements for the patented innovation have not been met, or
(ii) The patented invention is not available to the public at a reasonable price, or
(iii) The patented invention is not used in the Indian territory. Compulsory licenses, on the other hand, can only be awarded after a three-year period has passed since the patent was granted.
A compulsory license to manufacture and sell a product is granted under Section 92 to any company that applies for one, and a license U/S 92 is granted in the event of extreme urgency or a national emergency.
In certain exceptional circumstances, compulsory license U/S 92A is granted for the export of patented pharmaceutical products.
The World Trade Organization’s Impact on Pharmaceutical Patents
As briefly mentioned earlier the World Trade Organization (WTO) was established in 1995, and it has since ushered in a massive paradigm shift in global trade. The agreement on Trade-Related (Aspects of) Intellectual Property Rights (TRIPS) was negotiated during the Uruguay round trade negotiations of the General Agreement on Tariffs and Trade (GATT), and “the pharmaceutical industry was one of the primary reasons for incorporating intellectual property issues into the GATT framework.” India signed the GATT on April 15, 1994, making it mandatory to comply with the agreement.
Consequently, India must comply with the TRIPS Agreement’s patent and pharmaceutical industry minimum standards. The availability of patents for both pharmaceutical substances and process inventions must now be included in India’s patent legislation. Any invention of a pharmaceutical product or technique that meets established requirements will be given a patent for a minimum term of 20 years.
Patent licensing’s significance in the pharmaceutical industry
Licensing is often regarded as one of the most essential means of transferring technology to developing nations. It usually includes the acquisition of production rights for innovative goods or services, as well as distribution rights, as well as the sale of basic technical information and know-how contained in the corresponding good, i.e. service. Licensing entails the transfer of intellectual property associated with an innovative product, such as a service, that is the subject of the license agreement[3].
The relationship between licensing, technology diffusion, and intellectual property protection is more complex and multidimensional than in other technology transfer channels. According to Maskus[4], one of the most important reasons is the diversity of license agreements. License agreements can be established between companies in the same joint venture or between companies that are completely unrelated. These contracts typically cover a wide range of topics, including technical assistance, the transfer of codified knowledge, the transfer of knowledge and skills, and the transfer of intellectual property rights.
Today, every country seeking a highly wealthy economy implements its growth strategy through a channel of increasing degrees of implementation mechanisms for the exercise of rights to industrial property protection. The pharmaceutical industry’s need for patents to safeguard inventions plays a prominent role in society’s progression and is one of the determinants of economic growth. Building a reliable and efficient system in the research process is associated with the costs that occur during the creation of new chemical supsatncii suspatnici as active in order to treat is associated with the costs that occur during the creation of new chemical supsatncii suspatnici as active in order to treat. Due to various unpredictable occurrences (such as a worldwide pandemic), the length and duration of the research stages are challenging to anticipate. Therefore, it’s not uncommon for it to take several years from baseline to first patent registration. To ensure stringent patent rights and to safeguard other parties, the first patent application should be filed as soon as possible, usually following the first detection of a successful operation. Patents are intended to create exceptions, but firms are not accustomed to doing so. The patent owner has the right to sell his or her patent. Some experts suggest that the existence of positive powers is justified by the right of disposal, particularly the right to derogate from the patent’s use by granting a license.
The monetary value of a patent or its licensing might vary substantially, making it difficult to determine.
Case Studies involving Patent Licensing of drugs
1. Celgene Corporation for Cancer drug Revlimid: Sun Pharma negotiated an agreement with Celgene Corporation, a wholly-owned subsidiary of Bristol Myers Squibb, to resolve patent litigation in the United States involving the generic version of Revlimid (lenalidomide capsules). Revlimid is a drug that is used to treat cancer.
Celgene will provide Sun Pharma a license to Celgene’s patents required to manufacture and sell a limited amount of generic lenalidomide capsules in the United States commencing on a confidential date after March 2022, pursuant to the conditions of the settlement. This will mandatorily be subjected to USFDA approval.
Sun Pharma will also be able to manufacture and sell an unlimited number of generic lenalidomide capsules in the United States starting January 31, 2026, under the terms of the license. Before this case between Celgene and Sun Pharma, other Indian companies, Cipla Ltd., Natco Pharma Ltd., Cadila Healthcare Limited and Dr Reddy’s Laboratories Ltd. and the U.S.-based Alvogen had settled patent litigations with Celgene. Celgene granted a patent license to all these companies, required to manufacture and sell an unlimited quantity of generic drug in the United States beginning after January 31, 2026.
Merck for Molnupiravir: Merck entered into non-exclusive voluntary licensing agreements for molnupiravir with five Indian generics manufacturers namely Cipla, Dr Reddy’s Laboratories, Emcure Pharmaceuticals, Hetero Labs Limited and Sun Pharmaceutical Industries
The purpose of this license agreement was to expand access to Molnupiravir, an experimental oral antiviral Covid-19 therapy. Molnupiravir is an oral antiviral agent being studied in a Phase 3 trial for the treatment of non-hospitalized patients who have been tested positive with COVID-19 virus. Merck has been developing molnupiravir in collaboration with Ridgeback Biotherapeutics.
MSD Pharmaceuticals which is a trade name of Merck & Co. entered into these agreements to accelerate the production and availability of the antiviral molnupiravir in India along with in other low and middle-income countries (LMICs) following approvals or emergency authorization by local regulatory agencies.
Compulsory licensing: P.H. Kurian, India’s Controller General of Patents, Design and Trademarks, marked his last day in office on March 9, 2012, by issuing a landmark judgment granting the first-ever compulsory license to an Indian generic pharmaceutical company, Natco Pharma, to manufacture and sell a generic version of Bayer Corporation’s patent-protected anti-cancer drug ‘Sorafenib Tosyalte’ (NEXAVAR).
This significant development is prone to alter the complexion of India’s pharmaceutical industry. Many contentious issues are raised by this decision, including whether “local manufacture” of a protected innovation is required in India, and what drug price is “reasonable” under the current patent framework.
Trastuzumab is a type of antibody that is used to treat breast cancer. It is manufactured by Roche Pharmaceuticals and sold under the trade name Herceptin®. In India, this medicine was patented.[5] Each year, around 25000 Indian women are diagnosed with breast cancer. Only 5-6 percent of Indian patients have access to the medicine, according to research.[6] The underlying issue was the drug’s expensive cost. A month of therapy costs roughly INR one lakh. In 2013, the Indian government took a step forward in addressing this issue by initiating the process of giving Herceptin® compulsory licenses.[7] However, Roche chose not to pursue the patent in India later in 2013.[8] The company took this decision since there were no biosimilars of Herceptin available in India at the time, forcing patients to purchase Roche’s products. At the same time, the company may be spared from having to get a compulsory license.[9]
However, it has undoubtedly opened the market for the generic version of the drug. Many large Indian pharmaceutical companies have been working on biosimilars to Herceptin®. Compulsory licensing, if implemented, may make this feasible. Biocon Ltd., based in India, and Biocon Inc., based in the United States, collaborated in 2014. Mylan Inc. suggested selling Herceptin under the brand name CanmabTM. They proposed that it be sold in two dosage sizes. The MRP for a 440 mg vial is INR 57,500, whereas a 150 mg vial is INR 19,500.
Furthermore, this price is only 25% less than Roche’s original drug pricing.[10] In 2014, the High Court ordered Biocon to establish that their product had undergone adequate testing, after Roche claimed that the drug makers could not have completed acceptable clinical trials in such a short time. Biocon, on the other hand, disputed the allegations.[11] It is a tremendous hope that a cheaper version of the life-saving Herceptin will be available in the Indian market. All of this may be conceivable as a result of the threat and consequence of mandatory licensing.
Novartis & Cipla License deal: Novartis has a patent on indacaterol, which is commercialized under the brand name Onbrez® in India. This medication is used to treat chronic obstructive pulmonary disease (COPD). In the late 2014, Cipla, an Indian generic pharmaceutical manufacturer, introduced a petition with the DIPP, asserting that COPD had reached epidemic proportions in India. It further asserted that the demand for Onbrez® imported in India by licensee Lupin was only 0.03 percent of the population, which was insufficient. Furthermore, the drug’s cost is excessive. As a result, Cipla requested that DIPP issue a compulsory license for Onbrez® under Sections 92 and 66[12]. Cipla introduced a generic version of Indacaterol, promising to sell it for over 42% less than Novartis. However, the Health Ministry determined that this application lacked a solid foundation and advised Cipla to make a new application under Section 84[13].
Taking into account the recent events the imposition of world-wide pandemic, Israel issued compulsory license to allow the government to import generic versions of Kaletra: For the sole purpose of medicinal treatment of COVID-19 patients.
This authorization is the first time Israel invoked Section 104 and Section 105 of the Israeli Patents Law, 1967 for public non-commercial use. Israel issued compulsory license to allow the government to import generic versions of Kaletra.
Royalty Rates
In pharmaceutical licensing agreements, an initial payment was historically acknowledged to protect any one or a combination of the following: a fee for disclosure of know-how, an advance payment for patentable improvements to be granted within the agreement period, and settlement for a patent dispute. Royalties, which the licensor considers the “rent”—which includes a profit for the drug’s sales are linked to the initial payment. The initial payment has recently become an integral component of contracts of ever-increasing complexity and magnitude. A single licensing deal for an innovative drug might incorporate an initial payment generally ranging from a few millions to several tens of millions of dollars. Royalties of up to 20% on net sales may also be included in a transaction. In the pharmaceutical industry, initial payments and royalty rates have tended to rise.
This pattern can be attributed by the considerable factors mentioned below:
The task of discovering new drugs has gotten increasingly complex.
Pharmaceutical companies must constantly discover and/or get new compounds that show promise of becoming innovative development pharmaceuticals because it takes more than ten years and at least a few hundred million dollars to introduce a new drug to market.
Internal R&D efforts at pharmaceutical corporations have not been entirely successful, resulting in a pipeline of new drugs that is insufficient.
Licensing operations must be used to supplement pharmaceutical companies’ R&D deficits. These variables have combined to produce fierce competition for crucial licensing possibilities.
Therefore, it’s no coincidence that initial payments and royalties have increased dramatically in pharmaceutical licensing transactions. Nonetheless, the magnitude and correlation between initial payments and royalty rates in the agreement should be determined on a rational and objective basis.
Negotiating mutually appropriate royalty rates is always fascinating and demanding for the licensing professional. Royalty rates on sales in the pharmaceutical sector have ranged from a few percent to over ten percent. In terms of determining the rates, one theory is that the minimum royalty should be set at a rate that covers the cost of licensing the patent and know-how. At research-oriented pharmaceutical companies, the most typically seen research and development expenditures to sales ratio is between 7% and 15%.
Conclusion
During the last two to three decades, the conventional chemical-centered pharmaceutical industry appears to have reached a plateau, with new inventions becoming a rarity. One of the reasons why developing new pharmaceuticals is becoming more expensive is as a result of this. The liberalization process, which began in 1991, has aided in the development of policies aimed at attracting overseas investment and establishing India as a transnational manufacturing base. Inflows of foreign direct investment and technology transfers have resulted in an atmosphere conducive to India’s industry’s dynamic growth and greater competitiveness.
India is gradually making inroads into global markets, competing with international quality standards and pricing criteria. Although R&D is critical for maintaining a competitive edge in the global marketplace, the Indian pharmaceutical industry’s future is highly reliant on patent protection. While economic analysis does not offer the rationale for value judgments, it is an economic reality that the extremely low volume pharmacy must pass on its higher average expenses to the consumer. The duplication of patent-licensed pharmaceutical products on the shelves of community pharmacies has a finite cost to the consumer.
Furthermore, TRIPS and the Doha Declaration viewed compulsory licensing as a crucial measure for providing health benefits to people without regard to race, caste, creed, or even country. These regulations allow for flexibility because each country’s and disease’s requirements change. These laws, as well as the flexibility they provide, should not be subjected to political pressure and should be used to serve the public as well as the patent holder.
Thus, this article tries to provide for a better understanding of the patent licensing regime in the pharmaceutical industry and the direct ripple of effects on the economic standings of the corporations alongwith implications on macroeconomics of the country at large.
[1] Pradubuddha Ganguli, Gearing up for patents: The Indian scenario, p. 47
[2]“TRIPs and Pharmaceuticals: Implications for India”, http://www.cuts-india.org/1997-8.htm#Pharmaceutical
The provision of Section 3(k) of Indian Patent Law, that says computer software per se is not patentable till it has technical applications, puts most of the inventors down. Knowing the fact that software patent in India is tough; the next question from the inventor is that, if not patent, can we at least get a copyright?
The fact of the matter is that the statutory right that one gets in the case of patent cannot be substituted by a copyright and it is important to understand difference between the two. Copyright and patents fall under separate legal regimes and for one single product, one may file for patent as well as copyright.
Prime difference between copyright and patent is that copyright protects only expression of the idea but not the idea itself, whereas, patent protects the concept as well. For example, if there is a product, meant for administration of a hospital, the idea or concept is administration of a hospital, which does not get protection under copyright law. However, the way code has been written is the expression of the idea and the author who has written the code has copyright over it. If any other person writes another code (without copying code from first author), he also has his copyright on the product. On the other hand, if there is a patent for the product, the patent holder can prevent everyone else from making, using, selling, offering for sale or even importing the patented product in the jurisdiction (s) where he has valid patent rights.
Independent creation of copyright is not an infringement whereas the same is not true for a patent. This means that if the work is not directly copied from the copyright holder, and created independently, it is not deemed to be copyright infringement. On the other hand, independent creation of patented product is deemed to be infringement.
As soon as patent application is filed, the applicant may write ‘patent applied for’ or ‘patent pending’ on the product, whereas copyright notice, such as ‘(c) copyright, Origiin IP Solutions LLP’ can be written without registration as well. Though copyright is an inherent right and needs no formal registration as such, but registration becomes important and registration certificate serves as a proof of ownership in case of copyright infringement or even in case of merging/acquisition or to obtain funding/loan from bank or venture capital.
Novelty-Critical Requirement
Novelty is the most critical requirement for a patent which means that before the date of filing a patent application, there shall not be any disclosure of the invention. Whereas copyright, though requires originality in the work, does not have novelty as a critical requirement that enables one to file backdated application as well. Term of a patent is 20 years from the date of filing whereas term of copyright is 50-70 years from the date of death of last author.
It is interesting to note that copyright registered in any country which is a member of Berne Convention hold good in all countries which are members of Berne Convention. In order to get patent rights in multiple countries application shall be filed separately in each country. Though we have single patent application filing platform like PCT, patent rights are granted only by national offices.
Case study
In order to understand difference between copyright and patent, lets have a look at Stac vs Microsoft, an interesting court case in the USA, which Microsoft lost and was required to pay $120 mn for its willful infringement of #4,701,745 (a compression software patent). Stac had a software patent on the algorithm for its PC hard disc data compression software product. Microsoft expressed interest in working with Stac and in the process copied the compressed algorithm of the Stac product. Microsoft then wrote its own code to execute the Stac algorithm and used the code in MS DOS 6.2 product. Stac sued Microsoft for patent, trade secret, and copyright infringement.
A permanent injunction was given against Microsoft and was ordered to pay Stac $120 mn. Calculation of the damage was calculated on basis that Microsoft had included the infringed code which prevented Stac from marketing millions of copies of its separate data compression software. After litigation, for about a week, a lobotomized version of DOS was shipped with the compression feature disabled. DOS manuals were shipped with stickers on the cover warning to ignore the chapter on compression. MS finally got license to use the algorithm in DOS and agreed to pay $1 mn per month for 43 months and to purchase about $40 mn of Stac convertible preferred stock.
Since Microsoft did not copy the source code and wrote a new code for same algorithm, Stac could only prove patent infringement in the Court but not copyright infringement as independent creation of the work is not copyright infringement. Patents can protect the basic concept of a software product, regardless of the actual source code but copyright only protects source code.
Before you decide between copyright and patent protection for the software product, it is essential to understand the difference between the two so that you are clear about what rights you are getting. Though both patent and copyright have their own pros and cons, it makes a lot of sense to consider registration process based on requirements.
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A patent gives exclusive rights to the patentee to prevent other from making, using, selling, offering for sale and importing the patented product into the country where the patent is granted. Any violation to these rights without the permission from the patentee would generally cause patent infringement. However, there are certain exceptional Acts where the use of patented invention without consent of the patentee doesn’t constitute infringement. Section 107 of Indian Patents Act details such exceptions.
In certain countries including India, the generic drug makers are allowed to use the patented invention without the consent of the patentee for development and submission of information required under law. This provision is called Bolar-like provision or Regulatory provision. This provision came into existence from the case of Roche Products v. Bolar Pharmaceuticals. Roche is a discovery based pharmaceutical whereas Bolar is a generic drug maker. Roche holds a patent over the drug Valium. Bolar intended to submit an Abbreviated New Drug Application (ANDA) to the FDA for a similar drug containing the same active ingredient as to Valium. Hence Bolar used the patented chemical in its experiments, before its patent expiry in order to determine if the generic version is bioequivalent to Valium. Roche responded to this by filing a suit for patent infringement. The District Court of Eastern District of New York declined Roche’s appeal saying that no infringement had taken place owing to the experimental nature of Bolar’s work. The Court of Appeal for the Federal Circuit however disagreed with Bolar’s argument as it intended to sell its generic product in competition with Roche’s Valium, soon after its patent expiry and stated that the exemption does not apply to experiments which have commercial objective. Bolar argued that such violation of exemption would extend the monopoly of Roche over Valium even after its patent expiry. Thus in 1984, in response to Roche v Bolar judgement, and in an attempt to promote competition by simplifying authorisation for generics while maintaining appropriate protection for the interests of research-based pharmaceutical manufacturers, the US Congress passed the Drug Price Competition and Patent term Act (known as Hatch-Waxman Act). This law permits the use of patented products in experiments for the purpose of obtaining FDA approval and it established the modern system for FDA approval of generic drugs.
Another instance where an exception made for infringement is in the case of Parallel import. A parallel import is said to occur when a product sold by a patent holder in one country is exported by a buyer to another country with the price for the same patented product being higher. The purpose of the parallel import is to check the abuse of patent rights and to control the price of the patented product. Pharmaceutical companies follow the practice of differential pricing of drugs according to the purchasing capacity of the prospective consumer in a target country. As a result, the same drug may be expensive in a developed country and relatively cheap in developing countries. This principle of differential pricing forms the basis of parallel trade. It enables countries in which drugs are expensive to import them from cheaper markets.
On March 23, 1995, a decision regarding parallel imports was delivered by the Tokyo High Court. BBS Kraftfahrzeug Technik A.G. (“BBS”) of Germany held both German and Japanese patents for certain aluminum automobile hubcaps. The hubcaps were legitimately purchased in Germany by a Japanese company which was engaged in the export of the relevant goods to Japan where an affiliated Japanese company was engaged in the sale of the goods. These two companies were virtually under the same management when the goods were imported into Japan for sale at a price lower than that charged by BBS dealerships in Japan. Subsequently, BBS filed suit for patent infringement in Tokyo District Court in June of 1994. The district court found that the two companies had infringed the BBS Japanese patent. However, on appeal the judgment in favor of BBS was reversed. In reversing the district court, the High Court held that the patentee’s right to enforce its Japanese patent against the imported goods had been exhausted since the patentee had legally transferred title to a rightful purchaser of the patented product.
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This landmark judgement is the first “process patent” case in India that actually demonstrates the difficulties and uncertainties that arise in establishing that products are identical. It highlights the significance of Section 104 A of the Patents Act, 1970. In July 2015, Delhi High Court vacated the order of interim injunction granted in Jan, 2015 in favor of Symed Labs Ltd. (hereinafter referred as Symed) for the infringement of their process patent of LINEZOLID against Glenmark Pharmaceuticals (hereinafter referred as Glenmark), a leading Indian pharmaceutical company. Brief facts of the case are as follow:
On April 12, 2013 Symed, a Hyderabad based company that manufactures Active Pharmaceutical Ingredients (API) filed a suit before the Delhi High Court seeking an interim injunction restraining Glenmark from infringing Symed’s process patents in their manufacture of Linezolid (sold under the brand name LIZOLID).
Linezolid, a drug used to treat infection caused by gram positive bacteria that are resistant to several other antibiotics.
Symed alleged Glenmark for infringing of its patents (Patent No. IN213062 & IN 213063). The ‘062’ patent was granted for “Novel Intermediates for Linezolid and related compounds” while the 063 ‘patent’ was granted for “A novel process for the preparation of Linezolid and related compounds”.
Symed moved an application under Order XXXIX Rules 1 and 2 of the CPC, seeking an interim injunction restraining Glenmark for the manufacture of intermediaries for Linezolid.
The Single judge of Delhi High Court had granted an ad interim injunction on 19 Jan 2015, restraining the Defendants, through their officers, directors, agents, and distributors from manufacturing, selling, offering for sale, advertising, or directly or indirectly dealing in the production of Linezolid manufactured in a manner so as to result in infringement of the Symed’s registered Patents IN213062 and IN213063 till the disposal of the suit.
After this, on appeal Glenmark approached the Division Bench of the Delhi High Court.
Issues
The main issues before the Hon’ble Court were:
Whether the ad interim injunction granted to Symed was valid?
Whether the Single Judge failed to adhere to Section 104 A (1) (b) of Patents Act, 1970?
Arguments
By Plaintiff i.e., Glenmark
They argued that as per Section 104 A (1) (b) of the Patents Act, 1970 the initial burden of proof rests on the patentee to show that the product manufactured by the other party is identical to the product manufactured by the patented process.
They further contended that the Linezolid API manufactured by them is not identical to the Linezolid API manufactured by Symed.
Glenmark challenged the validity of the suit on the ground of lack of novelty. They further asserted that the pre-suit lab reports did not indicate the presence of CHFA, whereas, the post-suit reports showed the presence of CHFA (Chloro hydroxprophyl fluro morpholinyl adlaniline).
Glenmark also stressed that the presence of Zodiac-4 and PHPFMA in the final product does not amount to infringement as these intermediates are produced by processes of manufacture of Linezolid already known in the art.
They contended that merely because a product is known as Linezolid API, does not mean that the same is identical to the product manufactured by the patentee.
By Defendant i.e., Symed
The patents are directed towards a more commercially safe and viable process and as disclosed in the prior art was tedious and cumbersome.
They argued that the presence of CHFA (claimed in ‘062’) and PHPFMA (claimed in ‘063’) makes the patent noel as these products are exclusively formed during the process of production of Linezolid.
They further contended that the presence of these intermediate compounds in the final product would indicate that it has been manufactured by the patented process.
They argued that a sample test of Glenmark’s drug was taken, analyzed and the presence of these intermediate compounds i.e., PHPFMA, CHFA and Zodiac-4 were detected.
Further they stated that presence of these intermediates indicates that Glenmark is infringing Symed’s patents.
Judgement
Court relying on various judgements held that:
“On 17 Jul, 2015, the Hon’ble Delhi High Court reversed the order passed by Single judge and vacated the order of injunction against Glenmark. The Justices have made it clear that Glenmark may use any other process which may be a development of the Glenmark process/ Upjohn process as indicated in the expert report of Prof. S.W. Baldwin so long as it doesn’t infringe Symed’s patented process. It was also made clear that this is an interim arrangement and supersedes all interim orders passed till date and shall continue till the disposal of the suit. This interim arrangement shall be without prejudice to the rights and contentions of the parties in the suit and the counter claim. The court noted that it was incumbent upon the single judge to prima facie come to a finding that the API of both Glenmark and Symed were identical. Furthermore, there is no finding rendered prima facie or otherwise that both the drugs are identical. They directed Glenmark to maintain accounts and file the same in court. The court also observed that the Single Judge didn’t go into the point regarding the applicability of Section 104A of Patents Act, 1970. The Court held that both the processes are not identical, and the Glenmark’s process doesn’t infringe the patent. According to report of Prof. Baldwin the two claimed intermediate compounds discussed above (PHPFMA and CHFA) do not appear in the Glenmark process for making Linezolid. It has been agreed by both the parties that Glenmark shall manufacture Linezolid through its process/ Upjohn process indicated by the expert report and shall not use the patented process of Symed i.e., IN213062 & IN213063.”
This case has evoked considerable interest in terms of it being a process patent case in pharmaceutical field and also in terms of how courts should interpret Section 104A in the course of the infringement suit.
In this case, Glaxo Group Ltd. and Ors. (Hereinafter referred to as Glaxo) instituted a suit seeking permanent injunction against S.D. Garg (hereinafter referred to as Garg) to restraint them from infringement of their Trademarks “ZANTAC” and “ZINETAC”. Brief facts of the case are as follows:
Glaxo is the proprietor of the mark “ZINETAC” and “ZANTAC” for which registration was obtained in the year 1985 and 1981 respectively. And, the trademarks were used with respect to medical product containing “Ranitidine Hydrochloride” which is primarily used for treatment of gastric ailments.
Garg received the permission from Drug License authority for their medicine “GENTAC” and accordingly they have been selling their medicine under the mark “GENTAC”.
Hence, the suit was brought by Glaxo contending that Garg is infringing their rights by use of mark “GENTAC” which is deceptively similar to their marks “ZANTAC” and “ZINETAC”.
Arguments
By Glaxo i.e., Plaintiff
That “ZANTAC” is an invented term, having no dictionary meaning thereby containing high degree of distinctiveness. And, Glaxo has been using the two trademarks i.e., “ZANTAC” and “ZINETAC” consistently and extensively to the extent that a common man associates the marks for treatment of gastric ailment.
That although the product of Glaxo and Garg are administered in different forms, it will not affect their position in the suit for infringement. Putting forth the precedent set in Cadila Health Care Limited v. Cadila Pharmaceuticals Limited {AIR 2001SC 1952}, it was contented by Glaxo that in a suit for infringement, the confusion which infringing product is likely to cause is to be considered rather than the manner of administration of product.
That both the parties are selling similar class of medical products, and there is hardly any difference between their marks and that of Garg’s. Such action amounts to passing-off and infringement of marks of Glaxo.
That this is not the first time Garg has attempted to ride upon hard-earned reputation and goodwill of Glaxo. Hon’ble Delhi Court had passed injunction relief in favour of Glaxo, when a suit was brought against Garg wherein, they started to infringe the mark of Glaxo, “BETNOVATE” by using a deceptively similar mark, “BECNATE”.
By Garg i.e., Defendant
That Glaxo cannot claim protection of their trademarks since the registration of mark “ZANTAC” is dummy, no medical product is sold by Glaxo having such mark and no evidence has been produced before this court for the use of mark “ZINETAC”.
That there can be no possibility of confusion between the mark “GENTAC” and marks of Glaxo, because firstly Garg’s product is sold in form of injection whereas Glaxo’s product is sold in form of tablet. And secondly because, both the marks are used in respect of “Schedule-H” drugs which can only be sold by chemist on prescription of registered medicinal practitioner.
That Drug Licensing Authority has given approval for the medicine, “GENTAC”, to be sold to the public and accordingly Glaxo cannot prevent them from manufacturing the medicine.
Judgement
Hon’ble Delhi High Court observed that while adjudicating upon suit for trademark infringement, it is required to consider mark in its entirety. While citing the decision of Hon’ble Supreme Court in Cadila Healthcare(supra) court observed that since the marks in question are with respect to medicinal preparation a higher degree of scrutiny is to be done.
The Court was unpersuaded by the contentions of Garg that since the marks in question are with respect to ‘Schedule-H’ drugs which can only be procured through valid prescription there wasn’t any likelihood of confusion in the mind of the buyer. It was observed by court that:
“It does not obviate or negate the likelihood of confusion by an illiterate person or one under stress, given the very high degree of phonetic similarity between the two competitive names for the same cure. The degree of caution in medicinal and surgical products in greater so as to avoid causing any harm to the unsuspecting consumer……. It is important to note that the English language is not the primary language to many in this country. There is a very large percentage of population who are unaware of the English nuances of the language. The rural population, who are yet to acquire fluency in the language, may be confused by the phonetic similarity between the two classes of the medicinal products. Though the medicines are used in the treatment of the same ailment, it does not negate the possibility of side effects from the medicines.”
Thus, contentions made out by Garg were rejected by court and it was held that Glaxo has made out a case of infringement and passing off by Garg, Glaxo is entitled to protect their trademarks and decree was made out in favour of Glaxo.
A patent is a powerful intellectual property right that grants an inventor an exclusive monopoly for a certain period of time given by the government. It establishes a legally enforceable right to prohibit others from stealing the innovation. Patents may be divided into two categories i.e. product patents and process patents. A patent which is given for product protects the rights to the finished product, and anybody who is not a patent holder might be barred from producing it for a certain amount of time, even if they employ a different procedure. A process patent allows anybody, not just the patent holder, to make the protected product by altering specified production procedures. In the 1970s, India switched from product to process patenting, allowing it to become a major producer of generic medications on a worldwide scale and allowing businesses like Cipla to offer anti-HIV medications to Africa in the 1990s. However, owing to TRIPS Agreement requirements, India had to change the Patents Act in 2005 and transition to a product patents regime in the pharmaceutical, chemical, and biotech industries.
The waiver of intellectual property rights will eventually surrender ownership rights to the employer and function as a bill of sale. It is better to acquire a waiver to avoid a legal struggle. Moreover the IP waiver is not same as compulsory licence. The waiver should address the following points:
Use that is permitted
Royalties
Other controversies
If exemptions are granted, vaccine developers will be required to share their expertise in the highly complicated manufacturing process. This is the first time a waiver of this nature has been approved. A decision that comes closest is from two decades ago, when WTO members approved a temporary waiver allowing impoverished nations to import low-cost generic medicines for HIV, TB, and malaria in the face of public health emergencies. That interim waiver was subsequently extended indefinitely.
At this critical time of Covid 19, the world is struggling to cope with the crisis. In order to meet requirement of vaccine, it is important that more number of companies get into vaccine manufacturing which is hindered to a large extent due to existence of patents. At this time, it is imperative to maintain balance between public health and patent rights and this has happened earlier also in the history. In this regard, India and South Africa presented an application to the World Trade Organization (WTO) in October 2020 for a patient waiver in connection to the prevention and treatment of Covid-19, including health items and technology. In May 2021, 62 co-sponsors, including India, South Africa, and Indonesia, presented a new plan. In June 2021, the European Union offered a counter-proposal proposing for a multilateral accord to promote Covid-19 vaccine manufacturing by licensing and abolishing export restrictions rather than suspending patents. New discussions will be based on that document and proposal from India and South Africa. On the revised proposal, the WTO’s TRIPs counsel agreed to begin text-based negotiations. The IP waiver might allow middle-income nations to produce Covid vaccines with emergency use authorizations (EUAs), such as those produced by Pfizer, Moderna, AstraZeneca, Novavax, Johnson & Johnson, and Bharat Biotech.
The majority of manufacturing is now concentrated in high-income nations, with middle-income countries relying on license or technology transfer agreements to produce. Pharmaceutical businesses argue that ramping up manufacturing capacity will take a long time, which is one of the reasons they oppose the move. The accord is likely to be the focus of the WTO’s next ministerial session, which will take place in late November.
India and South Africa have petitioned the World Trade Organization (WTO) in October 2020 to waive certain provisions mentioned in the “Trade Related Aspects of Intellectual Property Rights” (TRIPS) Agreement that might obstruct timely access to inexpensive medicinal goods to fight Covid-19. The nations had urged the Council for TRIPS in order to suggest a waiver on the implementation, execution, adoption of application, and enforcement of four articles of the agreement’s second part “as soon as practicable.” Copyright and associated rights, patents, industrial designs, and the protection of secret information are all covered in the section- 1, 4, 5, and 7. The proposal said that poorer nations “in particular” may confront institutional and legal challenges while utilizing TRIPS Agreement flexibilities.
Vaccine manufacturers like Adar Poonawalla of the “Serum Institute of India” (SII) stated that the DPA had prevented the export of plastic bags, filters, and specific media required in the creation of their version of the “Novavax vaccine”. The US had discovered sources of “particular raw material” that were “urgently” necessary for the development of Covishield, SII’s version of the “AstraZeneca vaccine”, and they would be “immediately” made available for India, according to the White House on April 25, 2021. Despite their continued resistance, the European Union, the United Kingdom, and Switzerland decided to participate in text-based negotiations for which a draft has been provided. Japan, Brazil, Australia, and a number of other countries agreed to participate in the negotiations in order to develop a means for adopting IP waivers as well as a deadline for doing so. However, the agreement is only for discussions. Because the WTO is based on consensus, any of the 164 member nations can veto a decision. Another question is whether the waiver would cover only vaccinations or will also include medications, treatments, and devices, as well as raw materials and inputs and technologies, in order to stop the spread of the coronavirus.
Other “serious obstacles” in scaling up manufacturing and marketing of Covid-19 vaccines, according to the “International Federation of Pharmaceutical Manufacturers and Associations” (IFPMA). These include trade obstacles, supply chain bottlenecks, raw material and ingredient shortage in the supply chain, and affluent countries’ reticence to share dosage with impoverished ones. The paucity of raw materials has become an increasing challenge when it comes to ramping up production; numerous firms rely on certain suppliers, and their options are restricted. Furthermore, utilizing rules like as the American Defence Production Act, nations like as the United States have prohibited shipments of essential raw materials required in the production of various Covid-19 vaccines. Some Indian businesses had to postpone the manufacture of Covid vaccines as a result of this. According to a story in the Financial Times, Mahima Datla who is the managing director of Biological E, which manufactures the J&J vaccine in India, US suppliers have advised worldwide clients they may not be able to fulfil their orders due to the Act.
A large number of nations are concerned about the sluggish rate of manufacturing, which they believe will not result in a large portion of the worldwide population getting immunized rapidly. The global economy would be unable to recover without effective immunization, affecting the lives and livelihoods of millions of people.
Innovation is the key to sustainable growth for any business today and patents play a vital role by securing innovations and obtaining competitive edge in the market. Patent filing is increasing globally and hence keeping yourself updated with the latest trends and progress of technology is important for any business.
Patents are excellent source of technical information, primarily for the reason that inventions are not only disclosed systematically in the patent specification but also the best mode is disclosed to meet statutory requirements in most of the jurisdiction. Therefore, the patent databases contain valuable information that can be used to add value to an invention.
Staying ahead of your competitors in the world where innovation is happening in every area of technology is not easy. In order to improve quality of innovation, avoid duplication of work, filing quality patents and giving right direction to R&D, it is essential for the companies to be updated with latest inventions for which patents are being filed for/published/granted/expired.
However, keeping track of the kind and number of patent applications published, granted, abandoned or expired is a big challenge today. On one hand, knowing latest happenings in the area of patents helps business in multiple ways, on the other hand, with growing data & increasing number of patent filing, extracting desirable information is extremely tough.
Generating periodic (weekly, monthly or half yearly) patent alerts is one of the most effective tools to track the latest happenings in the area of patents. Published/granted and even abandoned/expired patents can be monitored on regular basis in the technical area of interest to get valuable information on:
New products/processes for which patent applications have been filed and build up own products to ensure that the same invention is not replicated and also to assess likelihood of patent infringement. In addition to this, since the patents technically disclose the invention, thorough review of the same might be extremely useful to assess chances of getting patent for your core technologies or new idea by knowing novelty, non-obviousness and industrial applicability of the invention.
By knowing published applications, one might want to oppose the applications, which may not be subject matter of a patent or grant of which might affect the business adversely, though there are several other reasons to oppose a patent application or a granted patent.
New markets or new technologies that your competitors are focusing at. This might give you overview of the kind of products they are planning to launch in given markets.
Patent watch can be done primarily in two ways:
Technical Patent Watch: Here you may list out core technology (ies) of interest and monitor newly published patent applications or granted patents in a technical area of interest as soon as they are published. One may also monitor latest prosecution status of pending patent applications. This way it will be easier to keep in touch with latest happenings in the industry and one may also come across interesting patents that may be used and implemented to add value to existing products or technologies.
Such patents may be considered for licensing or if they are not filed in the jurisdiction of interest or they don’t have a chance to be filed in the jurisdiction of interest, it may be used without any fear of infringement. However, it is highly recommended to take opinion of an expert on the legal status of such patent (s) before implementing it.
Competitor Patent Watch: Knowing patent portfolio and watching patent activity of the competitors may be of great business value. Competitor companies may be listed out and their newly published patent applications or granted patents may be monitored on periodic basis. However, one may also monitor latest prosecution status of pending patent applications or latest legal status/continuation applications of granted patents of competitor companies.
This information obtained by observing periodic patent alerts may prove to be a game changing strategy for any company.
Staying ahead of your competitors is critical for sustainability today. With increasing focus on innovation, it becomes important to know about the recent trends in the area of patent filings. It is not only interesting to watch what your competitors are doing or the latest technologies for which patents are being filed or granted in given jurisdiction, but also, it gives you platform which you can use to fine tune your existing products and assess chances of infringement.
Please contact us at info@origiin.com to know more about our services
In this landmark judgement the Division Bench of the Delhi High Court upheld the order of a single judge restricting Indian pharmaceutical company Cipla Ltd (hereinafter referred as Cipla) from selling pharmaceutical products containing INDACATEROL, a respiratory drug which was patented by Novartis AG (hereinafter referred as Novartis). This drug was used to treat chronic obstructive pulmonary disease (COPD) and was sold in India under the brand name ONBREZ. Novartis manufactured this drug in Switzerland and was sold in India by Lupin. Brief facts of the case are as follows:
In November 2014, Cipla had launched a cheaper generic version of this drug under the brand name ‘UNIBREZ’.
Cipla had priced its drug at Rs 130 per pack as compared to Rs 677 for Onbrez by Novartis (about 1/5th of the price)
After this, Novartis filed a patent infringement suit before Delhi High Court seeking permanent injunction restraining Cipla from infringing its patent over Indacaterol along with an application of interim injunction.
On 9 Jan 2015, the Single Judge of Delhi High Court granted temporary injunction restraining Cipla from selling its generic version.
However, the said injunction was granted only until a determination of compulsory license application if filed by Cipla.
Further if no application is filed the interim injunction would continue until the final disposal of the patent infringement suit.
After this, on appeal Cipla approached the Division Bench of the Delhi High Court
Issues
The main issues before the Hon’ble Court were:
Whether the interim injunction granted to Cipla was valid?
Whether Cipla’s manufacture and sale of ‘Indacaterol’ (under brand name ‘Unibrez’) infringe the said patent (Patent No. IN 222346)?
Arguments
By Plaintiff i.e., Cipla
They argued that Novartis’s patent must be revoked under Section 92(3) and Section 66 of the Patents Act, 1970 alleging that COPD has reached ‘epidemic’ proportions and Novartis’s product Onbrez has less availability.
They contended that the general principles regarding working of patented inventions stipulated in Section 83 of the Indian Patent Act would govern and sit over the right of patentees provided by Section 48 of the Act.
Cipla contended that the generic version is cheaper and available at 1/5th price of Onbrez. They further alleged that Novartis was importing Onbrez at a lower quantity and a very high price.
They argued that public interest is an important aspect while considering the grant of injunction. Therefore, the patented product must be available at a reasonably affordable price.
By Defendant i.e., Novartis
They argued that it is not essential that the patent must be worked by manufacturing the patent product in India. They further said that they have fulfilled the requirements of patients in need and have supplied the drug according to the demand.
Right of patentees under Section 48 was in no manner reduced by the provisions of Section 83. This section is not in respect of the rights of the patentees. Therefore, the element of public interest, which is sought to be introduced by Cipla through the route of Section 83 of the said Act, would not, in any way, impinge upon the rights of the patentees.
They contended that there is a huge amount of financial investment in the research and development of the patented drug ‘Indacaterol’.
Further they stated that Cipla was able to sell its drug at a little cheaper price as it has not invested in the research and development of the drug which depletes the efficacy and safety of the drug.
Judgement
Court relying on various judgements held that:
“On 9 March 2017, the Hon’ble Delhi High Court upheld the decision of Single Judge and rejected Cipla’s appeal and held that Novartis had established the prima facie validity of its patent and Cipla had not been able to make a credible challenge to it. Therefore, the submission of invalidity of patent was set aside and it further held that Novartis is entitled to an injunction as per Section 48 of the Patents Act, 1970. The Court further held that it is not necessary for a patent to manufacture in India. Even imports will fulfill the purpose. It was held that all the considerations under Section 83 are directed towards the authorities, to exercise power under the said Act which also includes the power of compulsory licenses under Section 84. Hence the general principles under Section 83 of the Patents Act, 1970 don’t curtail to the rights of patentee under Section 48 of this Act. Lastly on the question of public interest it was held that Cipla was unable to prove that public interest would be disserved by the grant of an injunction. The Court, therefore, refused to interfere with the Single Judge’s grant of injunction and dismissed Cipla’s appeal.”
This judgement is well reasoned and reflects a balanced approach in cases of patent infringement and compulsory licensing. It was pointed out by the Court that the ground of compulsory license is no defense in patent infringement suits where the patent is prime facie valid. Hence, such patents must be protected at all costs.
Innovation and growth have always been synonymous to each other, ultimately leading to development. Business ecosystems are largely dependent on these innovations and diffusion of technology plays a crucial role in shaping the future of these organizations. The term ‘technology transfer’ indicates the movement of knowledge, skills, know-hows and other valuable assets of the organization which is driven by profit. The concept of technology transfer is age old and has been rightly referred by Mansfield as, “One of the fundamental processes that influence the economic performance of nations and firms is technology transfer”.
Economists have long recognized that transfer of technology is at the heart of process of economic growth, and that the progress of both developed and developing countries depends on the extent and efficiency of such transfers. In recent years, economists have also come to realize (or rediscover) the important effects of international technology transfer on the size and patterns of world trade.
Meaning of Technology Transfer
The process of disseminating knowledge, skills and other know-how that manifests in the form of technology from its owner (individual or an organization) to another person or organization is known as technology transfer. It is also popularly known as Transfer of Technology. Various stakeholders amongst whom technology transfer takes place includes universities, business organizations, research and innovation societies and others. Such transfer takes place with the motive to share skills, knowledge, technologies, methods of manufacturing and other related profit motives. The transfer is further done with an intention to provide improved accessibility to a wide range of users who can then further develop and exploit the technology to develop new products, processes, applications, materials or services.
Types of Technology Transfer
Technology transfer can be broadly classified into vertical and horizontal technology transfer.
Vertical Technology Transfer- This chain of transfer includes basic research to applied research, applied research to development and from development to production. It is also known as internal technology transfer. This type of transfer is mostly carried out between research associations, universities, and governments, among others.
Horizontal Technology Transfer- When technology which has already been put in place or use within one organization is further transferred and used in another place, the transfer is known as horizontal technology transfer. It is also known as external technology transfer. This type of transfer takes place between private companies, small and large business organizations, among others.
Methods of Technology Transfer
Technology transfer can take place using the following instruments.
Licensing- An agreement between the owner of the technology (Licensor) and the receiver (Licensee) which gives the right to use the technology developed or owned by the transferring individual or company for a specified time period is known as licensing. The two broad categories of licensing include the one which grants exclusive rights to use the technology and another which grants non-exclusive rights wherein the owner reserves the right to further transfer the technology to other company apart from the receiver. It may also include the right to sub-license, permitting the licensee to grant someone else the right to use the technology.
Joint Venture Agreement- The company executes a joint venture agreement with respect to technology transfer for a particular business with a vision to incorporate long-term cooperation between the parties, motivation of all participants in the successful transfer and to incur lower costs as compared to working independently.
Franchising- It is one of the most preferred methods of transferring technology. The companies generally transfer technical know-how or skill involved under this type of agreement.
Original Equipment Manufacturer- It is a kind of sub-contracting agreement wherein a foreign company transfers a relevant portion of its technologies and a local company manufactures according to the specifications in the agreement. Such agreement enables local companies and firms to absorb technologies and restructure their production mechanism.
Buy-Back Contracts- It is a form of agreement between stakeholders from developing countries and large foreign companies, wherein a foreign company supplies industrial equipment in exchange for profits derived from the sale of raw materials or goods produced. This kind of technology transfer is often used in the construction of new plants and other related business.
It is interesting to note that a considerable amount of knowledge and technology exists today that enables the development of approaches and can effectively plan and implement business processes. What needs to see the light of day is a well-funded and potent mechanism for executing technology transfer between the stakeholders in order to ensure uninterrupted economic advancement.
Delhi High Court in its recent judgement opined that the “doctrine of necessity” can be invoked to hear urgent matters under IP laws. This case deals with the writ petition filed by Mylan Laboratories (hereinafter referred as Mylan) asking for a stay on the order passed by Deputy Controller of Patents and Design against them. Mylan has to approach the Delhi HC due to the vacant seats of appropriate officers at the Intellectual Property Appellate Board (IPAB) and hence Mylan challenged that the previous order passed against it cannot be heard. Brief facts of the case are as follows:
Mylan challenged the order passed by the Deputy Controller of Patents and Designs, dismissing the pre-grant opposition filed by Mylan and granting the patent in respect of ‘Methods of Evaluating Peptide Mixtures’ to the respondent.
On 17th May 2019 Mylan filed an appeal with the IPAB along with stay application.
Mylan approached the single judge of Delhi High Court for urgent hearing of his stay application as the IPAB was not functioning due to non-availability of Technical Member (Patents) since May 4, 2016.
After this, on 21st May 2019 the Court directed the Deputy Registrar to file a status report regarding the vacancies at IPAB.
On 24th May, 2019, Deputy Registrar submitted a report according to which a total of 3,935 cases are pending before the IPAB across all its benches due to vacancies.
Further as per this report the post of technical member for patents and trademarks have been vacant since May 4, 2016 and December 5, 2018, respectively. Moreover, no technical member for copyright has been appointed till date.
Issues
The core issue involved in this case was whether the Chairman of IPAB can hear matters in the absence of a technical member.
Arguments
By Plaintiff i.e., Mylan
Mylan contended that the available technical member i.e., of plant varieties protection should hear pending patent matters along with the Chairman of IPAB.
They argued that as per Section 115 of the Patents Act, 1970 a scientific advisor should be appointed to adjudicate pending disputes.
They contended that presence of a technical member is necessary to dispose of matters as per Section 116 of the Patents Act, 1970 which deals with the requirement and appointment of a technical member.
They also contended that the Chairman should hold the office till his successor is appointed by the government.
They further argued that the doctrine of necessity must be invoked to hear urgent matters and the orders passed should not suffer invalidity due to lack of quoram.
By Union of India
The Chairman isn’t empowered to hear appeals alone, with technical member who is qualified under Section 116(2) of Patents Act.
They contended that appointment of technical member has been initiated hence; there is no need for interim measures.
In this case the court had appointed amicus curiae to put forth its submissions as to the status of the cases pending before the IPAB and provide its suggestions.
Submission by Amicus Curiae
It suggests that for filling up of vacancies on a fast track basis, the Trade Marks Act should be amended to allow single-member benches along with division benches.
It also suggested the appointment of Ad-hoc members to fill in vacancies to avoid pendency, which is a suitable solution to resolve the pending cases.
Judgement
Court relying on various judgements held that:
“On 8th July 2019 the Hon’ble Delhi High Court ordered the Chairman, IPAB and the technical member of the plant varieties protection to hear the stay application filed by Mylan and to dispose it off within six weeks. The court further clarified that the Chairman, IPAB and Technical Member are at the liberty to hear urgent matters under the IP Laws i.e., Trade Marks, Patents and Copyright. The single judge of Delhi High Court invoked the doctrine of necessity. It held that the legislative intent is of the continuity of the IPAB and not its cessation because of a vacancy in its technical membership. It further said that the orders passed would not suffer invalidity on the ground of lack of quorum. The Chairman, IPAB is at liberty to proceed with hearing an urgent matter, even in the absence of a Technical Member or he can take the opinion of a scientific expert as has been notified under section 115 of the Patents Act.”
This is a surprising decision given by the Delhi High Court on several grounds. The doctrine of necessity, which the Court applied in this case, is an exception to the rule of “Official Bias”. The legislative intent is not only that of adjudication, but that of correct adjudication supported by the necessary expertise. The provisions of all the intellectual property laws very clearly mandate the requirement of a Technical Member for the IPAB. The legislative intent here is that of the need for technical expertise and efficient adjudication. Ideally, the Court should have directed the executive machinery to appoint the requisite technical members immediately, instead of directly stepping into the shoes of the executive.
In the present case, Delhi High Court passed an order holding that the discretionary reliefs provided under Section 34 and Section 38 of the Specific Relief Act 1963 are not applicable in patent disputes. Bristol-Myers Squibb Holdings Ireland Unlimited Company (hereinafter referred as BMS) instituted a suit for patent infringement and sought permanent injunction against Natco Pharma (hereinafter referred as Natco). Brief facts of the case are:
Two Indian patents bearing numbers IN 243917 and IN 247381 containing the Markush structure and the specific compound APIXABAN respectively were the basis of conflict in this case.
Natco Pharma was planning to launch a generic version of Apixaban under the probable brand name “Apigat”.
BMS sought for permanent injunction against Natco for APIXABAN (Patent No. IN 247381), valid till Sep, 2022, before the Delhi High Court. “Apixaban” used in the prevention and treatment of thromboembolic diseases.
In June 2019, Natco on the other hand had filed a suit under Section 34 of Specific Relief Act, 1963, in the District Civil Court, Hyderabad against BMS seeking a declaration that APIXABAN is covered by a senior patent (Patent No. IN 243917) but not claimed therein, and hence open for public use.
Before Delhi High Court BMS disclosed that they were also the owner of the senior patent which was permitted with a Markush claim encompassing trillions of compounds inter alia also generically covering APIXABAN. They also believed that the manufacture of APIXABAN by Natco also infringed the senior patent.
Natco filed an application under Section 10 of CPC, 1908 seeking a stay on the ground of pendency of the prior instituted Hyderabad suit. They also wanted to seek a proclamation of non-violence under Section 105 and groundless threats under Section 106 of the Patents Act, 1970.
Issues
The main issues before the Hon’ble Court were:
Whether the proceedings in an infringement suit are liable to be stayed under Section 10 of the Code of Civil Procedure (CPC) owing to a declaratory suit previously filed by the other party in a different civil court?
Whether the reliefs provided under Sections 34 and 38 of the Specific Relief Act 1963 are applicable in a patent infringement?
Arguments
By Plaintiff i.e., BMS
BMS contended that the senior patent (Patent No. IN 243917) contains a Markush structure which could result in millions of compounds. It has a wide coverage but doesn’t specifically disclose Apixaban. Therefore, Apixaban is not the subject matter of protection in Patent IN 243917.
They argued that this infringement suit and the declaration suit in Hyderabad are not of the same subject matter and hence, Section 10 of CPC is not valid. This patent infringement is about IN 243381 and not the senior patent IN 243917.
Further they contended that Hyderabad suit has been filed under Section 105 of the Patents Act, 1970 but the requirement under the said provision have not been fulfilled by Natco.
By Defendant i.e., Natco
They argued that the patent held by BMS (Patent No. IN 243917) covers ‘Apixaban’ but doesn’t specifically disclose it in the claims and thereby surrenders to the public.
They further argued that BMS is trying to secure monopoly by ever greening their patent. They contended that the senior patent claims ‘Apixaban’.
They contended that the Hyderabad suit was instituted under Section 34 of the Specific Relief Act, 1963.
They contended that since the Hyderabad suit was instituted prior to the suit by BMS, the suit before the Delhi High Court was liable to be stayed until the proceedings in the Hyderabad suit were concluded.
Judgement
Court relying on various judgements held that:
“On 23rd Jan 2020, the Hon’ble Delhi High Court observed that the patent related affairs were subject to Patents Act, Thus the defendant could not seek declaration of non-infringement under Specific Relief Act, 1983. The court considered the non-obstante clause in Section 105 of the Patents Act which specifically excludes Section 34 of SRA, 1983. The Court also observed that the Defendant in the Hyderabad Suit was effectually questioning the validity of the senior patent which cannot be adjudicated by a Civil Court under the scheme of the Patents Act. Furthermore, the Hyderabad Civil Court was not a competent court to grant reliefs sought in the Delhi Suit as well as the Hyderabad Suit, which is one of the compulsory pre-requisites for entertaining an application for stay of a subsequent suit under Section 10 of The Code of Civil Procedure (CPC) Therefore, in the light of the following observation the Court dismissed the application of Natco under Section 10 of CPC for a stay of the Delhi suit, and relegated the matter to trial.”
This judgement simplifies the legal position that any issue with regard to patents is to be agitated within the contours of the Patent Act and not beyond. By the way of clever drafting one cannot defeat or delay the valuable rights of patent owners.
Technology Licensing is a contractual arrangement in which the licensor’s Intellectual Property (IP) such as, patents, trademarks, service marks, copyrights, trade secrets, or other intellectual property may be transferred to a licensee for a specified period of time. A Licensing Agreement involves two main parties, namely the licensor (party that owns concerned IP) and a licensee (party that enters into contract to use IP). The consideration in the form of royalty is one of the important clauses to be finalised before executing the license agreement between the parties involved.
Technology Licensing is an essential tool for companies that are smaller in size, or do not have the R&D resources that their competitors possess, to stay relevant in a particular industry. In such cases, licensing helps them to close the gap with their competitors by allowing them to gain access to the resources and innovations that they need[1].
Difference between License and Assignment
Licensing and Assignment are different modes of technology transfer. Assignment is when the assets or IP is permanently transferred by the owner (i.e. assignor) to the buyer of the IP (i.e. assignee), by way of sale or transfer. This results in a one-time payment of consideration or a lump sum payment of royalty for the IP, by the assignee. The assignor transfers all rights, including title over the asset, to the assignee.
Licensing on the other hand involves the owner of the intellectual property (i.e. licensor) permitting the a third party including company or an organisation (i.e. licensee) to use the IP as per the terms of a licensing agreement, while maintaining ownership, resulting in continued earnings in the form of a licensing fee.
Technology Licensing can be done in the following different ways:
Licensing
Assignment
Joint venture (JV)
As mentioned earlier, licensing is an act of providing authorization by the licensor to a third party to use the licensed asset, as per the terms and conditions of the licensing agreement. A License Agreement is important as it enables the patent holder to provide the required permissions for an entity with the resources to bring his ideas to fruition.
An assignment is when the licensor transfers wholly, or in part, their right, title and interest in their technology.
In a JV, a new JV Company is formed and the requisite assets such as the patented technology are either licensed or transferred to this JV. Both companies contribute assets to such a venture, and the company giving the technology is both licensor and licensee in this case.
The licensor agrees to transfer his rights of the patented intellectual property that they developed, for a duration determined by the license agreement. During this time, the licensee is entitled to benefits and has rights to the patent’s interest. A patent license must be in writing to be legitimate, according to Section 68 of the Patent Act[2] . It was in the case of PVR Pictures Ltd. v. Studio 18[3], that the Delhi HC held that term sheet agreement shall not amount to a license agreement. A licence agreement can aid in the development of a mutually beneficial commercial partnership. Unlike, when a patent is sold or transferred to another party, the licensor retains ownership of the patented innovation.
Technology Licensing enables an organisation or any other party to utilise some technology that may otherwise be protected by intellectual property safeguards, such as a patent, copyright, etc.
Why should one license? There are notable benefits of doing so. Firstly, in the case of licensing, there is very little requirement of coordination between the two parties, and is similar to a commercial transaction involving a buyer and a seller. Secondly, the licensees can determine what technologies they want to license before paying for it, saving them money that would have otherwise gone into R&D. Thirdly, the transaction is instantaneous, which gives the company control over the technology much faster than if they were to develop it in-house.
In a Technology Transfer, the assets that get transferred include know how, methods, techniques, products etc, along with registered IP, such as, patent, copyright, design, trademark etc. Payment may be in the form of a lump-sum royalty, a running royalty (depending on volume of production), or a combination of both.
A Technology Transfer (TT) agreement may be:
Exclusive
Non-exclusive
Exclusive Licensing: The licensee has an exclusive right to use the IP, as per the terms of the licensing agreement. This agreement is such that even the licensor is not allowed to use the licensed asset for the duration as specified by the license agreement. Exclusive license may be issued on either a territorial basis (for instance, India only) or on a global basis (for the entire world).
Non-Exclusive Licensing: In non-exclusive licensing, the licensor may license out their assets to multiple licensees at the same time. Unlike an exclusive license, all licensees are permitted to use the license as per the terms of the license agreement. The licensors are also free to use the assets that they licensed to others.
There are different kinds of technology licenses. Licenses may be availed to get all the IP rights that are necessary to reproduce, make, use, market, and sell products based on a type of technology (e.g., a license to develop a new software product that is protected copyright or any other form of IP protection). A license may be procured to get the IP rights necessary in order to create and market a product that complies with a certain technical standard or specification.
For example, a group of enterprises have agreed on a technical standard to ensure interoperability of devices and owners of IP essential to practice the standard, pool their IP rights and license it to anyone who wishes to use the standard on reasonable and non-discriminatory terms.
Ericsson and Oppo are two companies who entered into a Global Patent license agreement. This agreement covers a cross licensing agreement covering 2G, 3G and 4G patent portfolios from both the companies. Besides, cross-license, the agreement also includes business cooperation on a number of projects related to 5G such as device testing, customer engagements.
The case of Dunlop India Ltd. v. Forech India Ltd[4] involved a license for making conveyor belts, based on a license agreement between the two parties. In GE Plastics v. Commissioner of Customs, Mumbai[5], a JV with Indian Petrochemicals Corporation Ltd. (IPCL), a technology licensing agreement was in question.
The following are the pros and cons of Technology Licensing:
Pros:
It enables a company to enter a new market very quickly. Additionally, financial and legal risks are minimised when technology licensing is used.
Licensing also enables companies to overcome any stringent tax barriers or any other hindrances that would otherwise increase the costs if they opted to develop their own technologies.
Licensing can also be used for the acquisition of technology from outside the region through arrangements such as cross-licensing agreements/ grant back clauses.
Licensing also is a major tool for enterprises in developing nations, to make use of comparatively lower licensing rates and to make profits without spending significantly on R&D.
Cons:
Licensing a technology to an external company results in the weakening of the licensor’s hold over the technology itself.
Licensing a technology also results in lesser profits as compared to directly leveraging the technology oneself.
Conclusion
Licensing is a useful tool for companies to compete in an effective manner. However, they must be well aware of the pros and cons mentioned above. They must also take special care to use licensing only when they need it, as it may create a recurring dependence on external organisations to develop technologies for them. It may not be an effective strategy, if companies are attempting to differentiate themselves from their competitors in the market space.
In conclusion, if a firm wants to take their rivals head on, and do not have the time or resources to develop their own technology, licensing is the most practical and cost-effective tool they can use to remain competitive.
By: Aditya Datha
Symbiosis Law School, Hyderabad
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A patent is a statutory grant provided by the Government for novel, inventive and industrially useful inventions, including both products and processes. Getting a patent for an invention is an exciting time for an inventor, however, it is important to commercialise the patent so that the patented product becomes a source of revenue for the inventor and is able to see the market.
Most patents don’t generate money in their existence due to various reasons, such as:
The patent might be too early to the market, thereby, it is hard for the inventor to find potential buyers.
If the prototype or proof-of-concept is not ready, it becomes difficult to convince buyers because buyers would be interested in looking into scaling up the patented technology of the inventor.
The patented technology may be complex and manufacturing the patented product might not be possible without seeking permission from other patent owners.
If the patent is poorly drafted and claims of the patent specification are not strong, enforcement of the patent becomes difficult even if the buyer replicates the technology after seeking the permission of the patent holder.
Having a patent granted or registered imparts a set of right to the owner of the patent (also called patentee), opening up various options that a patentee can use in order to make money from the patent, such as:
Patentees can manufacture and sell their patented product themselves or through joint ventures by partnering up with other companies.
Patentees can license their patented products or technologies to companies for an exchange in lumpsum payments, royalties, or both, by permitting companies to manufacture, market and sell the patentee’s patented products or technologies.
Patentees can assign or sell their patents to other entities or companies & earn money.
Patent licensing is the most used method for patentees to commercialize patent or technology to generate revenue. Patentee can license his patent and introduce it to the market to earn royalties and sign deals with investors and other companies. Let us now discuss the differences between patent licensing and patent assignment along with their pros and cons.
Patent licensing
The dictionary meaning of the word “license” is permission. By entering into a patent licensing arrangement, the patentee grants a license or permission to the company to manufacture, market and sell their patented products in specified markets. Licensing of patents and technologies is completed by executing a Technology or Patent License Agreement comprising of all terms and conditions which both parties must agree upon mutually. The term of the license may be the same or less than the term of the patent itself, as the term of a patent starts from the date of grant and lasts for 20 years forth. However, in most of the cases licensing does not just involve using a patent but also involves sharing of knowledge, experience and expertise that the patentee has. Therefore, even if the patent expires, the licensing relationship continues. By executing a license agreement, the patentees get to push their products into new markets by taking advantage of the manufacturing, marketing and selling expertise of the company or the licensee, and the company gets to use innovative and new technologies of the patentees.
In case of patent licensing, the patentee doesn’t transfer ownership of the patent to a company but rather a set of rights for a specific period of time. The patent license may be exclusive or non-exclusive in nature. In exclusive licenses, the patentee grants a license to only one party whereas if the agreement is non-exclusive, the patentee may grant it to more than one party.
Let’s consider a situation relevant to our current scenario. An independent researcher has invented a formula that can cure Covid-infected patients who contract the deadly black fungus disease. The patentee gets a patent for this formula, but due to a limitation of resources, he cannot afford production of the same. In such a case, he can either grant permission (i.e. license his technology) to any drug manufacturing company (exclusive licensing) or to several other drug manufacturing companies (non-exclusive licensing) to produce, distribute and sell the drug on a massive scale in return for some royalty fees. However, if the drug is vital for a greater public health concern, and if there is an increased demand in the market or the price of the drug is too high for the general public to afford, then the licensing will fall under a specific category called compulsory licensing in which government can license the patent associated with the drug without the permission of the patentee for large scale production and affordable accessibility.
In licensing, some important points to be considered by both parties are:
Term of the patent
Scope of rights granted
Value of technology and royalty fees
Stage of technology (idea, prototype, etc.)
Market size
Patent prosecution and renewal responsibilities
Terms of termination
Dispute resolution measures
Governing laws
Liabilities and indemnities
Patent assignment
Assignment means permanent transfer of rights. In this way, patent assignment is a kind of selling of the patent by the patentee to a company. When assignment occurs, amendments in the patentee name are also required to be done formally where patent assignment deed along with prescribed forms and fees is required to be submitted to the patent office. There are various advantages of patent assignment for the patentee. Upon patent assignment, the patentee usually gets a lump sum amount of money and is relieved of renewals and all other statutory obligations with respect to the patent. For the company or patent buyer, assignment is a simple and easy way to acquire a patent portfolio without performing in-house research and development.
Patent licensing and assignment are two popular options to exploit patent rights. Both have their own pros and cons and is hence advisable to seek expert advice before entering into any kind of agreement, to make good use of the opportunity.
Author Bindu Sharma
Acknowledgement: I would like to thank Raghu Ram V, Udit Sharma & Himani Jaruhar for helping me to finalize this article
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In this case, Sun Pharma Laboratories (hereinafter referred to as ‘Sun Pharma’), one of the leading Indian pharmaceutical company, came before court for the relief of permanent injunction to restrain BDR Pharmaceuticals (hereinafter referred to as ‘BDR’) from using trademark which is structurally and phonetically similar to that of Sun Pharma’s mark. Brief facts of the case are as follows:
Sun Pharma is carrying business of manufacturing and marketing pharmaceutical products for several decades and in the year 2009 they came out with the product LABEBET. LABEBET contains LABETALOL salt which is primarily used for treating hypertension and related issues. They also got the mark “LABEBET” registered in class 5 on 30th October, 2009 and since then they have been using this mark to sell their product in the market.
Sun Pharma while performing trademark search in the registry came across application of the mark “LULIBET” dated 30th May, 2016, which was used by the BDR Pharmaceutical to market their product. And thus, Sun Pharma brought a suit of injunction to restraint BDR from further uses the mark “LULIBET” which is deceptively similar to registered mark of Sun Pharma “LABEBET”.
Arguments by the parties
By Plaintiff i.e., Sun Pharma
That Sun Pharma is registered proprietor of the trademark “LABEBET” in class 5 since 2009 for medical and pharmaceutical preparation and is entitled to exclusive right of using the same by the virtue of section 28 of the Trade Marks Act, 1999 and that the action of BDR by using deceptively similar mark amounts to infringement by the virtue Section 29 of the Trade Marks Act.
That the mark “LABEBET” when compared with the mark of BDR i.e., “LULIBET”, is structurally and phonetically similar.
That both the products are sold in retail chemist shop, hence confusion and deception are likely to occur. Further, the possibility of patients with fungal infection consuming tablet of Sun Pharma cannot be ruled out. Thus, applying the test of imperfect recollection there is no doubt that public at large are bound to get deceived with such similarities.
That Sun Pharma could not oppose the application of BDR when it was filed before Trade Mark Registry as the publication inadvertently escaped their attention, hence the present suit.
That the contentions of BDR, that the marks are based on the salt/molecule from which product is formed, and that there are various other similar products available closely resembling to the mark of Sun Pharma against whom no action was initiated does not strengthen their arguments.
By Defendants i.e., BDR
That BDR is the honest user of the mark, their mark is not deceptively similar to the mark of Sun Pharma, and that their mark was published in the Trademark Journal in the year 2016 which was not opposed by Sun Pharma and they cannot seek injunction for the same at the later stage.
That the BDR derived the mark “LULIBET” from the salt/molecule upon which the product is based i.e., ‘Luliconzole’ which is used as lotion/cream for fungal treatment whereas Sun Pharma’s mark is based upon the molecule ‘Labetatol’ which is used as tablet/injection for curing hypertension. This, according to BDR form a crucial factor while comparing both the marks.
That Sun Pharma did not coin the mark LABEBET, it is just based upon the salt/molecule from which product is derived and that there are large number of companies having trademark with the prefix LABE.
That till the date of suit, no confusion was reported for the said marks and further the subsequent delay on part of Sun Pharma to initiate litigation shows that they are only attempting to stop progress of BDR Pharmaceuticals.
Issues
The main issues before Hon’ble Delhi High Court were:
Whether the mark of BDR is structurally and phonetically with the mark of Sun Pharma?
Whether the delay caused in filing opposition to the mark of BDR will deter Sun Pharma from claiming injunction?
Judgement
Court relying on various judgements held that:
“The marks have to be compared as a whole. They have to be judged by their look and their sound. The nature of customers who are likely to buy the goods has also to be considered in my opinion. If the two marks are compared as a whole the mark of the defendant is phonetically, visually and structurally, similar to that of the plaintiff. A person of average intelligence and imperfect recollection is likely to be deceived or confused. That apart as noted by the Supreme Court in Cadila Health Care Limited vs. Cadila Pharmaceuticals Ltd. (2001(5) SCC 73) where the medicinal products are involved the test to be applied would be stricter than should be applied for non-medicinal products. In the case of non-medicinal products, a confusion only creates economic loss but in the case of medicinal products, it may have adverse consequences on the health and life of the individual”.
It was further observed that delay in objecting or delay in bringing an action would not be sufficient to deter Sun Pharma from claiming injunction. And as such medical products are involved in the case which are sold through retail medical shops, court is bound to adopt stricter approach and thus the claim of BDR that both the product is sold in different form and has different usage will not make them escape liability.
No solid grounds were ultimately found to refuse injunction and thus decree was made in favour of Sun Pharma.
By: Dhruv Dangayach, Ramaiah College of Law
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In this case, Wyeth Holdings Corporation and Ors. (Hereinafter referred to as Wyeth), who is the registered proprietor of the mark “FOLVITE”, filed an opposition for registration of the mark, “FOLV” applied by Burnet Pharmaceuticals (Pvt.) Ltd. (Hereinafter referred to as Burnet), on the grounds that Wyeth is the registered user of the mark “FOLVITE” and if registration is allowed to the mark of Burnet it will lead to infringement. Brief Facts of the case are as follows:
Wyeth on 6th September 1946 made an application for registration of mark “FOLVITE” which was advertised in the Trade Marks Journal and on 28th April 1949 got registration of mark “FOLVITE” in class 5 in respect of a “nutritional factor of Vitamin B Complex in the treatment and prevention of vitamin deficiencies and anemias”.
Burnet, who initially adopted the mark “FOLACID” for its products, changed in to “FOLV” for which permission was granted by Drugs Control Authority in December 2000. Later Burnet sought registration of mark “FOLV” in class 5 which was proposed to be used. When advertised in Trade Marks Journal it was duly opposed by Wyeth.
Subsequently, registration of the mark “FOLV” as proposed by Burnet was refused by Registrar of Trademark for which appeal was preferred by Burnet which was pending before Intellectual Property Rights Appellate Board at time of institution of this suit. Briefly stated, the grounds on which registration was refused by Registrar are as follows:
Burnet’s mark is similar to that of Wyeth and there exists likelihood of confusion since Wyeth has acquired reputation in the market.
The mark proposed to be used by Burnet is visually and phonetically similar to that of Wyeth.
Wyeth being a long and extensive user has acquired a reputation in the market and the use of a deceptively similar mark was likely to cause confusion to the public at large.
And the suit at hand has been instituted for infringement and passing off.
Arguments
By Wyeth i.e., Plaintiff
That the mark “FOLVITE” was invented by Wyeth, and the said mark has earned a substantial reputation in the Market. The mark of Wyeth when compared in whole with the mark of Burnet i.e., “FOLV”, it can be seen that Burnet has used a deceptively similar mark which is likely to cause confusion. Further, use of the mark by Burnet for similar ailment and purpose increases such a chance of confusion.
That Burnet initially adopted the mark “FOLCACID” which they later changed to “FOLV” for which no proper explanation had been provided on affidavit, which puts a benefit of doubt on Burnet claiming to be the honest user of the mark “FOLV”.
That the contention of Burnet that Wyeth had delayed in moving the court which indicates that Wyeth had acquiescence with the business and the mark of Burnet is not true. This could be inferred from the fact that Wyeth has not abandoned their right to sue for infringement or passing-off.
Reliance was placed by Wyeth on the decision of Hon’ble Supreme Court in the case of Cadila Healthcare Ltd. Vs. Cadila Pharmaceuticals Ltd. {[2001]2SCR743} wherein it was held by the court that in case of deceptive similarity in medicinal products a strict approach has to be adopted to protect people at large from dangerous consequences of confusion caused due to such deceptive similarity.
By Burnet i.e., Respondent
That there is no phonetic or structural similarity between the mark of Burnet and mark of Wyeth as a registered trademark is not infringed, when a mark when used in relation to goods or services, indicates inter alia the kind, quality, intended purpose or another characteristic of the goods and services.
That Wyeth had delayed in moving the court which shows that they have acquiescence with business and trademark of Burnet.
That the mark of Wyeth and mark of Burnet is based on the common element ‘Folic acid’ and when a mark consists of a common element, which in case of Wyeth means “FOL” derived from ‘Folic Acid’ and VIT derived from ‘Vitamin’, greater emphasis has to be given on uncommon elements i.e., letter ‘E’ which cannot be made as a ground for instituting suit of infringement.
That the judgement of Supreme Court in Cadila Health Care Ltd. v Cadila Pharmaceuticals (supra) is not applicable to all classes of medicinal products but only to those where both the drugs are meant for curing the same ailment but the compositions are different, but in the present case, both the composition of both the drugs are same.
Issue
The core issue before Hon’ble Bombay High Court was whether the trademark of Burnet i.e., “FOLV” is deceptively similar, phonetically and visually, to the trademark of Wyeth i.e., “FOLVITE”?
Judgement
Hon’ble High Court of Bombay in this case, while citing various precedents observed that, while comparing the marks, they are to be considered as a whole, their structure has to be kept in mind and the court must look at the marks through the eyes of the purchaser having imperfect recollection. Based on such it was held the mark of Burnet, “FOLV” is deceptively similar to mark of Wyeth, “FOLVITE”
As to the contentions of Burnet, that the judgement in the case of Cadila Healthcare (supra) will not be applicable to present suit because the observation of Supreme Court must be confined to drugs having different composition, the court observed that the judgement has to be considered in its entirety, the ambit of judgement cannot be restricted by artificial process of construction, it was further observed by the court that:
“It would be inappropriate for the Court to apply a stricter standard only to a particular class of medicinal preparations. If the Court were to do this, it would have to make artificial distinctions from case to case based on whether or not the Court considers that a confusion arising out of the medicinal product in issue may or may not have disastrous effects on health and life. Such an approach is impermissible………Undoubtedly, where the competing drugs are meant to cure the same ailment but the compositions are different, mistaking one for the other may result in deleterious consequences. But, merely because the two competing marks are used for drugs with the same composition that would not justify applying a lower standard of scrutiny. For, even in such a case, the public interest lies in protecting the consumer against an unwary purchase of a deceptively similar product”
Further the argument of Burnet that, while comparing trademark more emphasis was to be placed on uncommon parts, was not accepted based on the following reasons:
The mark “FOLVITE” does not have any English meaning, it is an invented term.
Wyeth Mark is a composite mark; it is not open for Burnet to break down the mark. As long as mark is registered it is not open for Burnet to question the validity of registration by virtue of Section of 31(1) of the Act.
The mark of Wyeth is registered as “nutritional factor of vitamin B”, hence it would be impermissible to equate Wyeth’s mark as preparation of ‘folic acid’ alone
Thus ultimately, it was held by Court that the mark of Burnet is deceptively similar to mark of Wyeth and that Wyeth has established prima facie case for grant of interim relief.
In this case, the two companies i.e., Cadila Healthcare and Cadila Pharmaceuticals had taken over the business of Cadila Group and one of the conditions of such takeover of Cadila Group was that, both the companies got equivalent right to use the name ‘CADILA’. The suit was brought before the court by Cadila Healthcare when it came to their knowledge that Cadila Pharmaceutical is using the mark “FALCITAB” which is similar to their mark “FALCIGO”; and that the mark was applied by Cadila Pharmaceutical for similar drug.
Hence, though this suit Cadila Healthcare claimed for injunction against Cadila Pharmaceutical to restrain them from using a mark which is deceptively similar and is likely to cause confusion. Brief facts of the case are as follows:
Cadila Healthcare manufactured the drug “FALCIGO” which was used for treatment of cerebral malaria known as ‘Falcipharum’. They applied for Trade Mark registration in class 5 and obtained permission of Drug Controller General (India) to market the drug on 20th August, 1996 and 7th October, 1996 respectively, and have been manufacturing and selling their drug throughout India under the mark “FALCIGO” post such approvals.
Cadila Pharmaceutical got permission on 10th April, 1997 from Drug Controller General (India) to manufacture drug containing “Mefloquine Hydrochloride” which was also used for treatment of ‘Falcipharum’. They manufactured and sold the said drug under the mark “FALCITAB”
For the use of same, civil suit for injunction was filed by the Cadila Healthcare claiming that Cadila Pharmaceutical is passing-off their product under the pretext of same drug for treatment of similar disease and the same is likely to cause confusion.
Arguments
By Cadila Healthcare i.e., Appellant
It was contended by Cadila Healthcare that similar mark had been used by Cadila Pharmaceutical for treatment of similar disease which is likely to cause confusion and deception.
That the contention of Cadila Pharmaceutical that the mark is used in ‘Schedule L’ drug which is sold only to hospitals and clinics hence there is no chance of confusion does not hold true as chances human error and confusion cannot be ruled out even if it is handled by trained medical practitioner.
That Cadila Pharmaceutical is passing off drug of Cadila Healthcare by using the mark “FALCITAB” for another similar drug.
By Cadila Pharmaceutical i.e., Respondent
Cadila Pharmaceutical contented that the prefix “FALCI” of their mark “FALCITAB” was taken from the disease ‘Falcipharum’, and it is common practice in pharmaceutical industry to name a drug after the disease it is claiming to cure.
They also contended that the said drug in dispute is ‘Schedule L’ drug and not ‘Schedule H’ drug, which means that the drug would not be sold in retail chemist shop, it will only be sold to hospitals and clinics. As a result, there could not be remote chance of confusion and deception.
Issue
The core issue involved in this case was whether the mark of Cadila Pharmaceutical i.e., “FALCITAB” is similar to the mark of Cadila Healthcare i.e., “FALCIGO”?
Proceedings
Before Trial Court
The injunction application of Cadila Healthcare was dismissed by The Extra Assistance Judge, Vadodara. It was observed that the two drugs “FALCIGO” and “FALCITAB” differed in appearance and formulation, and they can only be sold to hospitals and clinics which diminishes the chance of confusion and deception compared to when these are to be sold to individuals.
Before High Court
An appeal was preferred before High Court against the decision of Trial Court, Hon’ble High Court affirmed with the decision of Trial Court and after examining various aspects held that the likelihood of confusion caused to an unwary consumer is not there and there is little chance of passing off.
Before Supreme Court
At the forefront Hon’ble Supreme Court said that, through this judgement it does not tend to interfere with the decision and findings of lower court, the judgement is passed only to set out principles which are to be kept in mind while dealing with issue of passing off especially in medical products.
Hon’ble Supreme Court examined in detail various precedents of domestic and foreign jurisdictions, and it was observed by Supreme Court that howsoever detailed and minute the foreign precedents are, the same could not be made applicable to India where there is no common language, where large percentage of people are not literate and only few people know English language. Purchasers of India are to be kept in mind before any pronouncement as the confusion of the identity of the product itself could have serious effects on the public health.
It was further observed by court that even though the drugs in question are ‘Schedule L’ drugs which are sold only to hospitals and clinics, it does not rule out the possibility of confusion among professionals dispensing medicines.
And lastly, Hon’ble Supreme Court laid out various factors to be considered in case of passing off, for deciding question of deceptive similarity which are as follows:
“The nature of the marks i.e., whether the marks are word marks or label marks or composite marks, i.e., both words and label works.
The degree of resemblances between the marks, phonetically similar and hence similar in idea.
The nature of the goods in respect of which they are used as trademarks.
The similarity in the nature, character and performance of the goods of the rival traders.
The class of purchasers who are likely to buy the goods bearing the marks they require; on their education and intelligence and a degree of care they are likely to exercise in purchasing and/or using the goods.
The mode of purchasing the goods or placing orders for the goods; and
Any other surrounding circumstances which may be relevant in the extent of dissimilarity between the competing marks”.
Conclusion
Through this judgement, Supreme Court gave a meticulous interpretation of various precedents and laid out factors to be considered while dealing with infringement or passing off suits, especially when it involves medicinal products. It was laid out by the court that before granting permission to manufacture a drug, the applicant has to satisfy Drug Controller General that there will be no confusion or deception in market by using a certain brand name. Though Hon’ble Supreme Court did not interfere with the decision of the lower court and gave them directions for expeditious disposal of suit, it however laid down the principles and factors which are to be kept in mind while adjudicating upon passing off suits and for deciding question of deceptive similarity.
This is a landmark case in the history of Indian patent system. On April 2013, the Supreme Court of India confirmed the rejection by the Indian Patent Office of a patent application (Patent number: 1602/MAS/1998) filed by Novartis International AG (hereinafter referred as Novartis) a Swiss drug maker. It was regarding beta crystalline form of imatinib mesylate and is the most stable form which Novartis formulated into an anti-cancer drug “Gleevec”. The Supreme Court (hereinafter referred as “the Court”) considered that Gleevec did not qualify as a patentable “invention” under Section 3(d) of the Indian Patents Act. Brief facts of the case are as follows:
Novartis, one of the largest international pharmaceutical company filed an application as per the TRIPS agreement before the Madras Indian Patent Office in 1998 for grant of a patent for an anticancer medicament ‘Gleevec’.
This drug was used against “Myeloid Leukaemia” and “Gastrointestial Stromal Tumours”, made from beta crystalline form of “Imatinib mesylate”.
The Indian Patent Office rejected this application in 2006 based inter alia on the failure by Novartis to show “significantly enhanced efficacy” of the beta crystalline form over its original salt as required under Section 3(d) of the Indian Patents Act, 1970.
The said drug did not exhibit any major changes in the therapeutic efficacy over its pre-existing form.
In 2006, Novartis filed 2 writ petitions in Madras High Court under Article 226 of the Constitution of India. The first appeal stated that Section 3(d) of Patents Act, 1970 is unconstitutional and second appeal was against the order passed by Madras Patent Office.
The Madras High Court held that the alleged offending provision is not a violation of Article 14 of the Constitution of India and transferred the case to the Intellectual Property Appellate Board [IPAB] in the year 2007.
The IPAB overturned the patent controller’s findings on novelty and inventive step of beta crystalline form. However, Novartis alleged invention did not satisfy the test of Section 3(d). It is to prevent ever-greening of already patented product. Hence, IPAB rejected the appeal and refused to grant patent to Novartis.
Section 3(d) of the Indian Patent Act, 1970 is as below:
“the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant, is not patentable.”
After this, Novartis filed a Special Leave Petition before the Supreme Court of India in 2009 against the order passed by IPAB.
Issues
The main issues before the Hon’ble Court were:
Whether the invention was inconsistent with respect to Section 3(d) of the Indian Patent Act, 1970?
What according to Section 3(d) of Patents Act, 1970 the meaning of Efficacy and a known substance?
Whether the claim by Novartis i.e. Beta crystalline form of “imatinib mesylate” more efficacious than the derivative form of “imatinib mesylate” is valid?
Arguments by the parties
By Plaintiff i.e., Novartis
Novartis contented that there is no clarity as to what constitutes “enhancement of efficacy” and “significant enhancement of efficacy” as required; therefore, the law is vague and led itself to arbitrary decision.
Novartis challenged the IPAB’s finding on Section 3(d). They argued that this provision related to “discoveries” doesn’t apply to its patent application which satisfies the criteria of novelty, inventive step and industrial application and is an “invention” under Section 2(1) (j) of the Patents Act, 1970.
Furthermore, they argued that the IPAB’s holding paid no attention to the fact that they held the beta-crystalline is an invention and passed the novelty test and then they applied Section 3(d), relating to discoveries and refused to grant a patent to Novartis invention.
Disputing the IPAB’s holding that the term “efficacy” means therapeutic efficacy, they argued that one term in the statute could not have two different meanings. It was only the beta crystalline form of imatinib mesylate that had therapeutic effect unlike the original forms.
They pleaded that improved biodiversity and thermodynamic stability are properties that improved efficacy and the beta crystalline form of imatinib mesylate manifested both these properties.
Section 3(d) could only be applied for substance already in existence and urged that such efficacy had never been established for imatinib, it is not possible to demonstrate enhanced efficacy of the beta-crystalline form of imatinib mesylate.
By Defendants i.e., Union of India & Ors.
Various arguments were brought before the Apex Court but the focus was on proving that:
Beta crystalline form of imatinib mesylate is neither new (novel) nor is it non-obvious due to publications about imatinib mesylate in Cancer Research and Nature in 1996, and that the efficacy as referred in the section 3(d) should be interpreted as therapeutic efficacy and not just physical efficacy.
The respondents also quoted extensively from the Doha Declaration, they took excerpts from parliamentary debates, various petitions by NGOs, WHO, etc. to highlight the public policy dimension of the arguments relating to easy affordability and availability of life saving drugs.
Judgement
Court relying on various judgements held that:
“The Hon’ble Supreme Court held that imatinib mesylate lacked novelty, as it was already included in the claims to the original substance imatinib. The court analyzed a number of scientific articles that describe not only the free base i.e. imatinib but also its salt form i.e. imatinib mesylate. Court also stated that a patent holder cannot claim a wide scope of an existing patent in infringement litigation but then claim a narrow scope of the same patent in the context of examining novelty of a salt derivative. The court accepted the IPAB’s views that the beta crystalline form could not be considered novel, it did not meet the requirement of enhanced efficacy under Section 3(d) of the Patents Act and therefore constituted no patentable “invention”. The term efficacy refers to “therapeutic efficacy”. The true intention to enact section 3(d) was to prevent the concept of ever-greening of patents and thus without fulfilling the test in Section 3(d) no patent can be granted. It was also held that improved bioavailability does not necessarily result in improved therapeutic efficacy. Novartis claimed 30% increase in bio-availability which was held insufficient. This patent doesn’t bring out any improved efficacy in beta form. In this case, the Court emphasized that Novartis had failed to submit any evidence to show that increased bioavailability of the beta crystalline form actually increased the therapeutic effect of the substance on the human body. The court further said that Section 2(1) (j) defines “invention” to mean, “A new product, but the new product in chemicals and especially pharmaceuticals may not necessarily mean something altogether new or completely unfamiliar or strange or not existing before. It may mean something “different from a recent previous”. Thus, in view of the findings it was held that the beta crystalline form of imatinib mesylate, failed the test of invention and patentability.”
The Supreme Court made it clear that India is a developing country and medicines should be available at an affordable price to safeguard the lives and protect the interests of billions of people. A reasonable and liberal approach must be followed to grant patents. Hence, the appeal filed by Novartis is dismissed. The judgement against ever greening of pharmaceutical patents garnered international support from various organizations.
The landmark case took place between F.Hoffman-La Roche Ltd. (hereinafter referred as Roche), a Swiss Multinational Health Care Company & Pfizer, a US based Company on one hand and Cipla Ltd. (hereinafter referred as Cipla), an Indian Multinational Pharmaceutical Company on the other. Pfizer and Pfizer Products, Inc. as joint applicants were granted a patent [Patent Number 196774] for a drug named ‘Erlotinib’. The patented item was introduced into the Indian market by Roche in the year 2006 under the brand name ‘Tarceva’. Meanwhile Cipla claimed of selling generic version of ‘Erlotinib’ under the brand name ‘Erlocip’.
Brief facts of the case are as follows:
In February 2007, Roche claimed to have a patent for ‘Erlotinib’ and sold the drug under the brand name ‘Tarceva’. In January 2008, Cipla intended to launch a generic version of the drug. This led to infringement between Roche and Cipla.
In 2008, Roche’s plea in the Delhi High Court for grant of an interim injunction to restrain Cipla to manufacture, offer of sale, sell and export of the drug ‘Erlotinib’ was rejected.
On appeal the bench upheld the decision and said that Roche failed to build up a prime facie case of infringement. Thus, the appeal was dismissed with costs at Rs 5 lakhs to be paid to Cipla by Roche.
After this, the SLP filed by Roche was also dismissed.
After the final decision of Single Judge by Delhi HC it was held that Roche didn’t had sufficient evidence to prove that Cipla’s brand ‘Erlocip’ infrined it patent ie. ‘Erlotinib’.
On appeal, the matter was decided by a Division Bench of Delhi High Court.
Issues
The main issues before the Hon’ble Court were:
Whether Cipla’s product, Erlocip which is Polymorph B of the compound ‘Erlotinib’ infringes the Roche’s patented compound ‘Erlotinib’.
Whether Roche’s patented compound ‘Erlotinib’ is a valid patent?
Arguments by the parties
By Plaintiff i.e., Roche
They claimed that ‘Erlotinib’ is a novel compound and is not a salt, polymorph, etc of any known substance. Hence, Section 3(d) of the Patents Act, 1970 is not applicable.
They argued that ‘Erlocip’ by Cipla is “Erlotinib Hydrochloride” and claimed that the manufacture of Polymorph B of this compound is in itself a sufficient infringement of Roche’s patent.
Furthermore, they argued that if a patentee’s rights were not respected then it would be contrary to the public interest of encouraging further research.
They also contended that while determining the balance of convenience it is reasonable and appropriate to consider the use and accessibility of the invention in the territory, its manufacturing in India isn’t necessary.
By Defendant i.e., Cipla
Cipla argued that the patent was hit by Section 3(d) of the Patents Act, 1970 as ‘Erlotinib’ was a derivative of a known patent ‘Quinazoline’. They alleged that Roche had not proved that there was “any improved efficacy of the said drug”.
They further argued that Roche’s product was highly priced. Roche’s tablets were priced around Rs 4800 whereas; Cipla’s tablets cost aound Rs 1600. They contended that this was a matter of life saving drugs therefore it should be made at an affordable and cheaper price to the public at large.
Furthermore, they argued that Roche didn’t file any data to demonstrate that ‘Erlotinib Hydrochloride’ in patent had a higher therapeutic efficacy.
They defended that “Erlotinib Hydrochloride” was a mixture of two polymorphs A and B and to get the claimed compound it was necessary to separate both the polymorphs. This defeats the inventive step of the alleged invention and this material information was withheld by Roche.
Judgement
Court relying on various judgements held that:
“In 2015, the Hon’ble Division Bench of Delhi High Court held that Cipla’s product ‘Erlocip’, which is claimed to be a polymorph B form of the compound ‘Erlotinib’, infringes Roche’ patent and affirmed its validity as well. It set aside the Single Judge decision dismissing the suit for injunction filed by Roche. The bench further stated that this compound may exist in various polymorphic structures; however, any such structures will be subsumed within this patent. Therefore, ‘Erlocip’ (Polymorph B) by Cipla will infringe this patent. The judgement laid down several guidelines and steps that should be followed in every infringement of patent suit. It was said that to pass the correct test, Cipla must map its product against Roche’s patent claims. In order to test the obviousness the first step is to see who is a Person of Ordinary Skilled in the Art (POSA) and its characteristics. Further, Polymorph B was rejected because it didn’t show enhanced therapeutic efficacy. The charges alleged by the applicant are in the physical properties and not in the therapeutic efficacy. This amounts to ever greening tendency which has been prohibited by Section 3(d) of the Patents Act, 1970. In the present case the drug was a life saving drug and affects people at large. It was manufactured in India, at a comparatively lower price. The Court further said that Cipla has been unsuccessful in satisfying the tests laid down to establish prime facie that the patent was obvious. Subsequently the Court directed Cipla to render accounts concerning the manufacture and sale of ‘Erlocip’ for the calculation of damages. It however, didn’t grant a permanent injunction against Cipla.”
Cipla then filed a SLP against the decision, which was admitted by the Apex Court in the year 2016 the Court directed to appoint a technical expert and adjourned the matter. After a series of legal proceedings, the Pharma majors finally reached a settlement, withdrawing all pending litigation, including the SLP. This settlement possibly marks the close of the first Pharma patent case in India in the post Trade-Related Aspects of Intellectual Property Rights (TRIPS) era.
In this case, Astra- IDL Limited (hereinafter referred to as ‘Astra’) filed the suit for permanent injunction against TTK Pharma Limited (hereinafter referred to as ‘TTK), to restrain TTK from infringing Astra’s mark “BETALOC”, which was registered under class 5 in respect of Pharmaceutical Preparation, by use of mark “BETALONG”. Astra herein claimed that TTK is using the mark which is deceptively similar to that of Astra’s, and TTK is passing off their goods as that of Astra’s. Brief facts of the case are as follows:
That Astra is a public limited company and is carrying on business of manufacture and sale of medicinal products. Astra got registration of their mark i.e., “BETALOC” on 16th June, 1977 in class 5 of Trade Mark Merchandise Marks Act, 1958 (hereinafter referred to as Act). And since then, they have been using the said mark in respect of drug for the treatment of hypertension, angina pectoris, arrythanias etc.
That Astra in month of November 1987 got knowledge of the mark “BETALONG” which was also used by TTK in respect of drug for treatment of hypertension, angina pectoris, arrythanias, etc.
Subsequently, Astra served a cease-and-desist notice dated 18th November 1987 upon TTK. The said letter was duly replied, wherein TTK refused to oblige by the requisition of cease-and-desist notice. Hence, the suit was filed by Astra claiming that TTK has adopted the mark “BETALONG” with dishonest intent and has infringed the mark “BETALOC” registered in the name of Astra.
Arguments
By Astra i.e., Plaintiff
That Astra is carrying business with the registered mark “BETALOC” since 1977 and by the virtue of such registration and continuous usage they have acquired proprietary right in the mark “BETALOC” and hence they are exclusively entitled to use the mark in class 5 of the Act.
That even after serving cease-and-desist notice TTK has been using the mark “BETALONG” which is deceptively similar to their mark. And by such usage TTK is taking the advantage of reputation and goodwill acquired by Astra, by passing-off the goods as that of Astra’s.
That the contentions of TTK that drugs being sold through chemist on prescription of medical practitioner diminishes the chances of confusion is not true. Relying on precedents Ranbaxy Laboratories Ltd. vs. Dua Pharmaceuticals Pvt. Ltd., {1988 (8) PTC 273 (Del)}; and Burroughs Welcome (India) Ltd. vs. G. K. Sharma and King Scientific Research Centre, {(1989) 14 IPLR 60} it was contended that although drugs are dispensed on prescription, marks being deceptively similar can cause confusion.
By TTK i.e., Defendants
That the product manufactured by TTK when taken in appropriate doses blocks the effect of ‘Catecholomines’ (certain type of hormone which causes hypertension) acting on ‘beta receptors’ (located in heart) and such blocking effect is longer than other drugs. And therefore, in the mark “BETALONG”, ‘BETA’ is taken from the ‘beta receptors’ and ‘LONG’ represents longer duration for which the drug blocks ‘Catecholomines’; and such mark is coined without any reference to Astra’s mark “BETALOC”.
That due to such abovementioned distinguishing feature of TTK’s drug it is well recognised among medical practitioners and such practitioners are not likely to get confused by alleged similarity between Astra’s mark and TTK’s mark.
That the drugs in question are ‘Schedule-H’ drugs which can only be sold by chemist holding license on prescription of registered medical practitioner, the chances of confusion are substantially reduced. For such reliance was put on M/s. Johann A. Wulfing v. Chemical Industrial and Pharmaceutical Laboratories Ltd. {AIR1984Bom281}; and Sterwin A.G. v. Brocades (Great Britain) Ltd. {1979 RPC 481}.
That the marks in question have to be analysed in detail. It was contented that the letters ‘LOC’ in Astra’s mark, “BETALOC”, do not convey any meaning and when taken together they are short, terse and sounds soft. Whereas the word ‘long’ in TTK’s mark has specific meaning, lengthy duration and pronunciation is lengthened and not terse. Therefore, the two marks by no means can be called deceptively similar.
Issue
The core issue involved in this case was whether the mark of TTK i.e., “BETALONG” is deceptively similar to the mark of Astra i.e., “BETALOC”.
Judgement
Hon’ble High Court of Bombay, relying on the decision of Supreme Court in the case of Corn Products Refining Co. v. Shangrila Food Products Ltd., [1960]1SCR968 observed that mark has to be observed in totality to decide upon question of deceptive similarity. It was observed by the court that:
“In the instant case in deciding whether the word ‘Betalong’ is deceptively similar to the word ‘Betaloc’, each of the two words must, therefore, be taken as a whole word. The words are so similar that there is reasonable probability of confusion between the words both from the visual and phonetic point of view. It is not a matter for microscopic inspection, but to be taken from the general and even casual point of view of a customer walking into a shop. As observed above in the instant case, apart from the syllable ‘ng’ in defendants’ mark, the two marks are identical”.
Further, it was observed by court that it cannot close its eyes to the factual reality that, in India the scheduled drugs which were supposed to be sold on prescription were sold without prescription in India, which reduced the weight to be given to this factor when evaluating deceptive similarity. The two marks in question are so deceptively similar that it “outweighs the weightage to be given to the factor that the goods are scheduled drugs.”
Thus, it was held that the mark of TTK i.e., ‘BETALONG’ was phonetically, visually and structurally similar to the mark of Astra i.e., ‘BETALOC’
By: Dhruv Dangayach, Ramaiah College of Law
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In this case of trademark infringement, an exemplary amount of Rs. 1.5 crore was awarded by the Hon’ble Bombay High Court in favour of Glenmark Pharmaceuticals Ltd. (hereinafter referred to as ‘Glenmark’). Galpha Laboratories Ltd. (hereinafter referred to as Galpha) was found to be ‘habitual offender’ for trademark and copyright infringement. What makes this case interesting is, firstly the Galpha’s decision to not contend the suit and secondly the exemplary damages awarded by Hon’ble Bombay High Court. Brief Facts of the case are as follows:
Galpha’s mark “CLODID-D” was alleged to be infringing packaging and trade dress of Glenmark’s mark “CANDID-B”. It was further alleged that Galpha has copied word mark, art-work, colour scheme, font style, manner of writing, trade dress of the Glenmark’s product “CANDID-B”.
With regards to Curetech Skincare, the position was made clear that they were only the contract manufacturer of the product of Galpha. The copy of contract manufacturing agreement was also supplied by Curetech according to which art-work, labels and marks were provided by the Galpha, and they are not claiming any right over the disputed mark.
The main dispute pertaining to infringement of trademark of Glenmark by Galpha was contended before the court.
Arguments
By Glenmark i.e., Plaintiff:
That this is not the first time Galpha is infringing their trademarks, an earlier cease and desist notice was cited by Glenmark, wherein Galpha was asked to stop infringing upon the trademark of Glenmark, “ASCODIL”, by using deceptively similar mark “ASCORIL”, to which an unconditional apology and undertaking was provided by Galpha.
That apart from copying Glenmark’s trademark, Galpha has copied marks of various other pharmaceutical companies for which suits are pending. Further in the case of Win-Medicare Pvt. Ltd. Vs. Galpha Laboratories Ltd. & Ors {2016 (65) PTC 506 (Del)}, Delhi High Court has observed that Galpha is a ‘habitual offender’.
That apart from infringement, there are several other instances wherein medical products of Galpha were found to be “Not of standard quality/Spurious” by Central Drugs Standard Control Organization, various articles were cited wherein it was revealed that Galpha has violated standards set out by Food and Drug Administration (FDA).
That on basis of such repeated infringement and violation of standards a stricter punishment has to be awarded upon Galpha to deter them from any such illicit acts in future
By Galpha i.e., Defendant:
Galpha, surprisingly, admitted to all the allegations put forth by Glenmark and contented that they should have been more precautious and diligent before adopting and using the trademark and that they are willing to submit themselves to the decree of court.
Issue
Whether Galpha by use of mark “CLODID-B” is infringing upon mark of Glenmark, “CANDID-B”?
Judgement
The marks in dispute were presented before the court and the court took notice that the mark of Galpha, “COLDID-B” is nothing but a direct copy of mark of Glenmark, “CANDID-B”. It was observed by court that “Drugs are not sweets. Pharmaceutical companies which provide medicines for health of the consumers have a special duty of care towards them. These companies, in fact, have a greater responsibility towards the general public”. Strict approach was followed by Bombay High Court, and based on the evidences and documents produced by Glenmark, the court observed that there is no doubt that Galpha is a habitual offender with a set mode of operation of copying brands of other to make profits.
Further it was observed that Galpha has copied trade dress, colour scheme, art-work, font style and even manner of writing of Glenmark’s product, and keeping in mind the strictness to be followed in medical products; habitual disregard by Galpha to rights of others; and keeping public interest at priority, Hon’ble High Court of Bombay imposed Rs. 1,50,00,000/- as the exemplary costs on the Galpha.
Thus, by the documents and evidences produced before the court, it was observed that Galpha is not only a habitual infringer but also habitual offender of law, medicine being directly related to public health needs more scrutiny and hence, Galpha cannot escape its liability by pleading that they accept all the charges and submit themselves to the suit. They have to be responsible for their actions and Rs. 1.5 crore was awarded as an exemplary damage to deter Galpha from any infringement and violation in future. Court while passing such judgement relied not only on Trade Marks Act but also on general principle of law.
Apex laboratories, herein is the manufacturer of pharmaceutical products and on 16th March 1988 it adopted the trademark “ZINCOVIT” for their product, subsequently, it obtained the registration and has been using the said mark for its products.
In February 2006 Apex Laboratories came to know about the mark of Zuventus Healthcare i.e., “ZINCONIA”, which has been used for manufacture and sale of similar product as that of Apex Laboratories. For the same infringement case was brough, and an ex-parte injunction was subsequently obtained. The said decision was challenged before Delhi High Court by Zuventus, wherein the ex-parte injunction order was vacated by Single Judge holding that there is no similarity between the mark “ZINCOVIT” and “ZINCONIA” and that the word ‘zinc’ is common name in trade. Appeal to such order was made by Apex Laboratories which was the subject matter of this case.
Arguments
By Apex Laboratories i.e., Appellant:
That the mark of Zuventus, “ZINCONIA”, is deceptively similar to the mark of Apex, Apex is the registered proprietor of the mark “ZINCOVIT” and has been extensively using the mark since registration, thus injunction is ought to be given in favour of Apex Laboratories.
By Zuventus Health Care i.e., Respondent:
That the Apex laboratories is not the exclusive proprietor of the mark “ZINCO”, there are several other registered owner of the mark “ZINCO”, moreover mark of Apex, “ZINCOVIT” and mark of Zuventus, “ZINCONIA”, are not visually and phonetically similar and the essential features in both the marks i.e., colour combination, scheme of writing are entirely different.
Issue
Whether the mark of Zuventus Healthcare Ltd. i.e., “ZINCONIA” is deceptively similar to mark of Apex Laboratories i.e., “ZINCOVIT”?
Judgement
Various precedents were cited before Hon’ble Delhi High Court by the counsel of both the parties, taking them into consideration it was held by the court that the medicine of Apex Laboratories and Zuventus, contains common element zinc; therefore, the word ‘zinc’ is common to trade and public juris. Apex Laboratories cannot claim exclusive use over the word ‘zinc’. It was also observed that while comparing for infringement a mark has to be taken as whole, it would not be right to spilt the mark for purpose of injunction just because they contain the word ‘zinc’ and Apex cannot claim exclusivity by using such mark.
Thus, it was held that the marks are not visually and phonetically similar so as to cause confusion and the order of Single Judge for vacating the order of interim injunction was upheld.
The role of a patent agent has been a source of curiosity since enactment of the Patents Act 1970 (the Act). The provisions relating the patent agents have been comprehensively amended in 2002 amendment enforced from 20th May 2003. One of the most commonly asked questions is whether it is important to be patent agent especially when there is huge scope for people who are expert in patent searches, who may or may not be patent agent. In this article, lets analysis, who can be a patent agent, what are advantages of the same and how are the job prospects better if one is a patent agent?
Patent specification required to filed for obtaining a patent is invariable termed as a techno-legal document as it is a combination of technical description and the claim, which are purely legal in nature. The patent specification discloses technical details of the invention and defines scope of the invention by restricting legal rights to the claims. Since by nature, a patent is a technical document, in order to draft patent specifications, one needs excellent writing skills and expertise as well we deep understanding of the subject matter and knowledge about the patent law. For a person to work in the area of patent law, he has to have cocktail of all these attributes.
Who is a patent agent?
Technically/legally speaking the patent agent is a person so registered under the Patent Act. However, in practice the Patent Agent is a person, which is the link between the inventor and the patent authorities, such as, the Controller, who facilitates the work of grant of patent by assisting the inventor, the Controller or his subordinate officials. He has exclusive right to do certain acts in the process for obtaining a patent and has exclusive right to practice before the Controller. The Patent Agent is also allowed to appear before patent office of other PCT member country in respect of national phase of the corresponding application.
The patent agent should have thorough knowledge of the Patent Act and rules, Patent Co-operation Treaty provision and prosecution therein and also comparative knowledge of procedures in other important countries such as US, EP, Japan and China.
Who can become a patent agent?
A person for being eligible to register himself in the register of the Patent Agents under the Act must have qualification prescribed under section 126. These qualifications are as follows:
The person shall be a Citizen of India;
He must have completed 21 years of age;
He shall possess a Degree in Science, engineering or technology from recognized university or other equivalent qualification as prescribed by the Government; and
Should have passed the qualifying examination conducted by the Patent Office or Should have worked as examiner or discharged functions of Controller for not less than ten years.
Additionally, he also must have paid such fee as prescribed. The Act does not define the degree in science, technology or engineering, hence, these terms are open to interpretation. The equivalence of qualification should be as per notification made by the Government in this regard. For example there are graduations awarded by Universities in certain subjects like Mathematics, Statistics, Geography in both Science and Arts. The Diploma Holders in engineering or Bachelors’ degree in engineering from a foreign university, who are equally knowledgeable as graduates are not allowed to appear. Their case needs to be considered sympathetically by the Government. Prior to 2002 amendment, there was no such restriction. The restriction though well intended must also take into consideration of various diploma holders in science, technology and engineering who may be equally learned in science, technology and engineering but might not get opportunity to be a bachelor for various socio-economic reasons.
“However, one must understand that being a patent agent is not everything. There are several proceedings under the Act which take place in the courts and being an Advocate is always of great advantage. Even if one does not wish to practice in courts, in addition to patent law, sound knowledge of law of interpretation, contracts, Indian Constitution is of great value to attain better hold on the subject”.
Those Agents who are already registered before the amendment shall subject to payment of renewal fees continue to be registered so irrespective of their qualifications. Before 2002 amendment came into force any Advocate under the Advocate’s Act could register himself as a patent agent, without appearing for examination, however after the amendment came in to force on 20th May 2003, even an Advocate also needs to be a science, and engineering or technology graduate and is required to appear for the patent agent examination conducted by the Patent Office.
What are the advantages of becoming patent agent?
There are many advantages of being a patent agent, more so after the 2002 amendment to the Act. Prior to 2002 amendment, Section 132(a), nothing in the chapter XXI relating Patent Agents prohibited any person not being a Patent Agent who was duly authorised by the applicant from drafting any specification or appearing before the Controller and an Advocate from taking part in any proceeding under the Act except drafting specification. The situation has dramatically changed after the 2002 amendment. Now the Patent Agents only have exclusive right to practice before the Controller as spelt out in Section 129(2). Except the applicant himself, even advocate cannot appear in general but can appear on behalf of the party in proceeding under the Act only if the party is also taking part in the said proceedings. Thus the role of the patent agent in the patent prosecution has been significantly enhanced by the said amendment in 2002. Only patent agents can prepare all documents, transact all business and discharge such other function as prescribed under the Act and the role of other authorised persons and advocates has been considerably limited.
A registered patent agent also gets added weightage and advantage over others in securing jobs if he/she does not want to practice independently. The Advocate firms will employ them as they only can appear before the controller for prosecuting the patent applications filed by the firm. The registered patent can also practice before the IPAB even if he is not an Advocate. It is interesting to note that a registered patent agent can also act as an agent for design registration under the Designs Act 2000.
However, one must understand that being a patent agent is not everything. There are several proceeding under the Act which take place in the courts and being an Advocate is always of great advantage. Even if one does not wish to practice in courts, in addition to patent law, sound knowledge of law of interpretation, contracts, Indian Constitution is of great value to attain better hold on the subject.
Patent Agent Examination
The qualifying patent agent examination is conducted by the office of the Controller. The particulars of the examination, the curriculum and qualifying marks are given in Rule 110. Upon passing the examination, the successful candidates are required to follow a registration process as provided in chapter XV of Patent Rules.
The examination consists of two written exams and viva. Paper 1 relates to Patent Act and Rules, Paper II relates to drafting and interpretation of patent specifications and other documents. Each written paper carries maximum 100 marks. The Viva carries 50 marks.
The Rule 110 (3) regarding qualifying marks has been amended after the decision of the Delhi High Court in Anvita Singh V/s Union of India and Others in 2012 and Renu Bala case. The amended rule 110(3) reads as follows:
110(3) A candidate shall be required to secure a minimum of fifty marks in paper I and paper II and shall be declared to have passed the examination only if he obtains an aggregate of sixty percent of total marks.
The amended rule has practically reduced the viva redundant as one need to only have compulsory appearance in the viva. If a candidate secures 150 marks in both the written papers and only appears for viva.
The detailed nature of the paper I and paper II is as follows:
Paper 1: Total 100 Marks
It is divided into part A1, A2 and B.
Part A1 (30 Marks)
15 multiple choice questions Each question carries two marks;
Candidate to answer all the questions in this section; and
To choose the right answers from maximum six choices and maximum two correct choices.
Part A2 (10 marks)
True or false, 10 questions one mark each.
Part B (60 Marks)
8 Subjective type questions. Candidate to answer any 6 questions.
Paper 2: Total 100 Marks
It is divided into part A, B1 and B2.
Part A (40 Marks)
Consist of 6 questions of 10 marks each and the candidate to attempt any 4 questions. The questions will relate to drafting and interpretation of patent specifications and other documents
Part B (60 marks)
It consist of parts B1 and B2.
Part B1 is compulsory and will consist of 1 question relating to drafting of claims and abstract from a given description of an invention.
Part B2 consists of 2 questions and the candidates will be required to attempt any 1 question. Out of the two questions, one question will relate to general engineering and the other question will relate to field of chemistry/life sciences.
The prospecting patent agents may refer to old papers available on the patent office website to understand nature of questions asked in the examination.
Job opportunities for a patent agent
A patent agent, being an expert in patent law as well as technology shall have good opportunities not only in IP department of any R&D oriented firm but also the law firm. Areas of work could be patent specification drafting, filing, prosecution and performing patent searches of various kinds. However, clearing the patent agent exam and registration as a patent agent alone is no more than a certification. In the super specialized area like patents, one need to work really hard and acquire skills and expertise for long term and sustainable career growth. Career of a patent agent can always extend to more specialized areas, such as, patent valuation, technology commercialization, IP management etc.
A patent assignment is an act by the patent owner in which the patent owner permanently transfers the patent’s exclusive rights. This transfer of rights is documented in the official patent record. In a patent assignment, the assignee must pay the assignor a consolidated amount and can collect profits from the patented invention subsequently. This qualifies as a consideration.
Patent licensing allows for the creation of value from innovation as well as the advancement of certain other strategic corporate objectives. Bilateral licensing transactions are the hallmark of the ‘traditional’ patent-licensing industry. It is moreover characterized by consequential transaction costs borne by the parties and information asymmetries that threaten to shrink the market over time. An exclusive license encompasses all of the patent’s rights licensee receives except the title. In this instance, the licensee enjoys the same rights as the patent owner, with the exception of the ability to transfer the patent to another individual or company. This restriction exists simply because even though the agreement allows the rights to be transferred; the patent owner retains ownership of the title.
The rights in lieu of the license agreement are predominately granted to the licensee and in accordance to the terms of the said agreement cannot be transferred further. Ergo, patent licensing is only for a limited term, when the license period ends, the owner reclaims his exclusive rights to his invention.
Professor David Teece asserted in an unconventional paper[1] that the ability to construct value from invention was dependent on interrelate assets like marketing, production, and after-sales assistance. Innovators frequently lack direct ownership or control over these assets, forcing them to license out the commercialization process.[2] Licensing can also be used to impact market demand and competitiveness. Patents are licensed out to restrict competitors from further conducting research and development.
This article states the various practices involving the re-assignment clarifying the ownership of the Patent Agreements.
Infringement Litigation
The patentee (licensor) has the sole right to sue for infringement under the Indian patent system.[3] The only statutory exceptions are the exclusive license and the licensee to whom a compulsory license has been granted.[4] A non-exclusive licensee is not allowed to sue for infringement in his or her own name.[5]
Preventing a third party from infringing on the patent, on the other hand, serves the interests of both the licensor and the licensee. Unlicensed usage by a third party will result in ULR fees being charged to the licensor. Similarly, the licensee will be concerned about an infringing competitor who has not been subjected to ULR payments, the expressions of the mutual interest. It may be however become problematic as the expenses of contesting the infringement are more than the patentee’s personal returns, (s)he may not be motivated to file the claim.
Patent buyouts
At least two instances during the early nineteenth century, when both patents and prizes were employed to encourage discovery, Governments integrated the patent and prize systems by purchasing patents. Patent buyouts are appealing because they provide the chance to eliminate monopolistic pricing distortions and duplicate research incentives while increasing rewards for innovative research. It’s crucial to investigate how they implemented the patent buyouts in practice.
Patents scarcely incentivize original research owing to the fact that potential inventors will not consider consumer surplus while deciding whether or not to pursue it. By purchasing the patent for Daguerreotype photography and releasing the technique in the public domain in 1839, the French government blended aspects of the patent system and direct government sponsorship of research. Daguerreotype photography was quickly embraced over the world after the patent was bought out, and it underwent significant technical advances. Patent buyouts like these have the capacity to eradicate monopolistic price distortions and inefficient reverse engineering incentives while further stimulating original research. Determining the price is a major difficulty for any patent buyout mechanism.
The government would propose to buy out patents at this private value times a fixed markup that would roughly cover the gap between the social and private value of inventions. Inventors could have the option of selling or preserving their patents. Government-purchased patents are usually released into the public domain.
However, in order to encourage auction participants to be honest about their appraisals, the government would select a few patents at random and sell them to the highest bidder. Encouragement of invention through such a process would necessitate greater discretion from government officials than the current patent system, but somewhat less discretion than that exercised by the National Institutes of Health.
Patents also restrict research by generating excessive motivation to produce alternatives for patented assets while providing too little incentive to develop complements. Firms can steal rents from existing patent holders by producing replacement inventions. The minimal information available implies that this issue could be intense. Mansfield, Schwartz, and Wagner (1981) discovered that 60 percent of patented discoveries were reproduced within four years, with the average imitation cost being two-thirds of the original cost of development. Potential complementary invention developers, conversely, will have insufficient incentive to create these inventions if they must first invest in developing supplementary inventions before negotiating license arrangements with original patent owners [Green and Scotchmer 1982]. Sometimes, due to asymmetric information, agreements between owners of complementary patents are not achieved, and inventions go underutilized.[6]
Grant Back
Many patent license agreements fail to address licensee improvements, allowing the licensee to file improvement patents of their own, potentially rendering the licensor’s technology obsolete or even preventing the licensor from commercializing its own product with the enhancements. By including “grant back” provisions in license agreements, a licensor can ensure that when licensing out patents covering its technology, any improvements by the licensee are granted back to the licensor. A licensor can ensure that when licensing out patents covering its technology, any enhancements made by the licensee are granted back to the licensor by incorporating “grant back” terms in license agreements.
Literature in relation to Employee-Employer Patent Ownership
By omitting to add a “deemed ownership” provision in the Patents Act of 1970, Indian policymakers missed the mark. Section 39 of the UK Patent Act, Section 132 of the Israeli Patent Act, and Section 6 of the Chinese Patent Act have all codified similar provisions. This deeming theory is founded on the “duty to invent” principle, which states that a person who has a duty to invent cannot have a patent registered in his name. This premise is based on the idea that if an employee has exploited the company’s facilities, technological know-how, or resources, the employer should not be barred from the benefits.
As a corollary, an employee who created the invention during his or her “course and scope of employment” is unable to get a patent in his or her own name. In Darius Rutton Kavasmanek v. Gharda Chemicals, the Bombay High Court was introduced this argument of “duty to invent.” The court, however, refused to evaluate the issue since it was an injunction appeal, and it could not opine on the merits of the case. In addition to the “duty to invent” argument, the “shop-right” principle, which originated in the United States, can be used to address the ownership problem. Regrettably, it has yet to be implemented in India. Even if there is no agreement for royalties, shop-right is a non-exclusive and non-transferable license with the employer to use the innovation without paying royalties. Even if the employee, who is the patent owner, sells his interest in the patent, the employer retains his shop-right in the patent under this doctrine.
When global firms are involved in Research and development activities and their inventors are Indian employees, the above-mentioned flaw in Indian patent law is very troublesome. According to Section 39 of the Patents Act, any resident of India who applies for a patent or causes an application for a patent to be filed in a country outside of India must first obtain authorization from the Controller of Patents.
For instance, a US corporation wishes to submit a patent in the US, but the inventors are Indian employees who live in the country. It might now be argued that the Indian employees, by their patent assignment agreement, have ‘caused’ the patent application to be filed in the United States, necessitating clearance from the Indian Controller of Patents. This is a significant impediment to the employer-company receiving a patent in a timely manner. Such unnecessary delay in an area as dynamic as intellectual property is likely to have an influence on the utilization of resident Indian personnel for invention. Incorporating such a provision that assigns patent ownership to the employer/company, on the other hand, will go a long way toward resolving such issues.
It’s worth noting that the United States Patent Act makes no mention of patent ownership between employers and employees. However, the courts have established a number of precedents that benefit employers“It is feared that if a corporation is denied the advantages of its success, it would cease to subsidize and experiments will go,” the court held in Goodyear Tyres and Rubber Company v. Miller in the United States. In future judgements, Indian courts could take cognizance of this and set better precedents to potentially enable occlude loopholes in the patent law.
With India’s existing patent ownership framework, the employer bears the threat of not owning the invention despite making significant investments. Employers may be hesitant to invest in research possibilities as a result of this. An equivalent approach in India, as in the United States, the United Kingdom, and other nations, would undoubtedly aid in the resolution of patent ownership disputes between employers and employees. If the invention was developed using the employer’s resources and during the course of employment, the employer should be given a say in the patent, even if there is no pre-assignment / assignment agreement for the same involving the abovementioned principles.
There clearly is a dilemma revolving the true ownership of the Patents developed under employment and the legal literature of various countries reflect the very same. The question of ownership, however, in India remains with the employer (with the assignment of intellectual property in the course of employment) development during an employment.
There is a certain exception which that outruns the private benefit and focuses on public good.
Compulsory License
Compulsory license occurs when the government grants authorization to any individual or organization to use, sell, or manufacture a patented design or product for the public good, regardless of the patent owner’s wishes. Compulsory licenses are commonly given in the pharmaceutical industry and in products that meet the standards set forth in Section 84 of the Patent Act 1970. On March 9, 2012, Natco Pharma Ltd. received the first compulsory license in India for making a generic version of Nexavar, a patented Bayer Corporation drug.
Compulsory licensing is provided under Chapter XVI of the Patents Act of 1970 as an essential precaution for defending the public interest. Any interested party can request compulsory license after three years if the invention is not fairly available to the general public. The central government has the authority to file an application with the controller, requesting that the controller endorse a patent with the ‘license of right’.
The provision of the central government was repealed by the amendment. Furthermore, required adjustments were made with regard to whether the public requirements were fulfilled, if the innovation is not manufactured in India or if the patentee refuses to accord a license, by removing a presumption that the public’s requirements are fulfilled based on local manufacture. The amendment also granted the controller the authority to issue a forced license in the event of a national emergency. There is also a provision that allows a third party to apply for a compulsory license even though the invention is not manufactured in India. This shift also allows the controller to revoke the compulsory license if the circumstances that led to it cease to exist.
In simple terms, the choice to assign or license is based on the most profitable commercialization route available to the patent holder. And, while making a decision, the advantages of receiving royalties or alternatively receiving a lump sum price, giving away title, or simply surrendering the rights to commercialize the invention in a certain location for a set length of time must always be evaluated against one another. Assignment may occasionally seem more beneficial than licensing.
Regardless of the fact that the law safeguards a patentee’s interests, the patent holder must prepare an appropriate assignment or license agreement to avoid any potential disputes regarding the ownership. Intellectual property rights have only recently come to the attention of the general public. Where industrial property is adequately protected, which in turn raises the country’s economy, a comprehensive understanding of intellectual property rights is vital. The entire legal infrastructure was furnished by the Government of India. Software, traditional knowledge, plant varieties, and geographical indications have all been accorded specific legal provisions. Among these provisions, certain remedies are only available to the owner of the intellectual property; hence the determination of ownership and proper re-assignment becomes vital.
[1] David J. Teece, “Profiting from Technological Innovation : Implications for Integration, Collaboration, Licensing and Public Policy”, 15 Research Policy 285 (1986).
[5] Pravin Anand, T. Saukshamaya & Aditya Gupta, India, in Patent Litigation : Jurisdictional Comparisons 201, 203 [Massimo Sterpi et al. (eds.), 2011]; Suchita Saigal, Parul Kumar & Aditya Verma, Licensing Intellectual Property Rights’ Use, in The Law of Business Contracts in India 92, 96 (Sairam Bhat edn., 2009).
[6] The Quarterly Journal of Economics , Nov., 1998, Vol. 113, No. 4 (Nov., 1998), pp. 1137-1167
It is known to us that the types of patents filed at the Indian Patent Office are of two types, i.e. Provisional patent applications and complete patent applications. Briefly, a provisional application is a preliminary patent application which is drafted and filed to secure an early date of priority. However, a complete patent application is the final application which is filed, examined and prosecuted by the Indian Patent Office.
Much like the patent system in India, the Australian patent system also allows the filing of standard patents and provisional patents. In addition to this, the Australian Patent Office also enables the inventors/applicants to file for an innovation patent, which seems to be attracting the attention of many Indian innovators in recent times. In this article, we will briefly read about standard patents and innovation patents and understand the difference between the two.
Standard Patent Applications & Innovation Patent Applications
Standard patent application: The standard patent application filed by inventors at the Australian Patent Office is identical to the complete patent application filed at the Indian Patent Office. Once granted, the standard patent application provides 20 years of protection to an invention from the date of filing of the application. The criteria followed by the Australian Patent Office is much like that of the Indian Patent Office, i.e. for an invention to be patentable in Australia, the invention must satisfy the below-mentioned criteria:
Novelty
Non-obviousness
Industrial applicability
Once filed, the Australian Patent Office takes 6 months to a couple of years to examine the standard patent application to ensure that the patent meets their legislative requirements after which the patent will be granted.
Innovation patent application: An innovation patent application provides an inventor with tight timelines and low budget an opportunity to secure a granted patent. The innovation patent is meant for patents which have a short technological lifecycle such as computer-related invention which become redundant in a short span of time due to the dynamic nature of technology. An innovation patent provides protection over an invention for a period of 8 years from the date of filing and is particularly awarded to inventions which do not meet one of the criteria of patentability, i.e. inventive step.
The criterion for granting an innovation patent is that the invention must have an innovation step rather than an inventive step, i.e. the invention must have features which are better than the existing patents and these incremental features must contribute substantially to the working of the invention. The innovation patent protects such incremental features of an existing technology and is granted in a short span of one month from the date of filing the patent application as the innovation patent application does not necessarily undergo examination before being granted. However, the innovation patent is not legally enforceable if it is not examined before being granted. The examiner at the Australian Patent Office examines the innovation patent application upon filing a special request subsequent to which the examiner checks if the application is matching the legal requirements as per Patents Act, 1990.
Unfortunately, the Australian Patent Office has decided to phase-out the concept of innovation patent in order to provide an equal opportunity for all applicants. The last day to file an innovation patent application is 25th August 2021 and the applications which have been filed on or before 25th August 2021 will continue to remain in-force till their expiry as per Patents Act, 1990.
Standard Patent Applications vs Innovation Patent Applications
Innovation Patent Application
Standard Patent Application
Criteria of Patentability:
· Novelty
· Industrial applicability
· Innovative step
Criteria of Patentability:
· Novelty
· Industrial applicability
· Inventive step
Anatomy of the patent application:
· Title
· Description
· Up to 5 claims
· Abstract
· Drawings
· Forms
Anatomy of the patent application:
· Title
· Description
· Any number of claims
· Abstract
· Drawings
· Forms
Application is granted if patentability criteria is satisfied. However, cannot be enforced legally without examination.
Application is granted if patentability criteria is satisfied as per Patents Act, 1990.
Examination is optional if legal enforceability is required. The request for examination maybe applied by anybody.
Examination is mandatory. Request for examination is applied only by the applicant.
Grant certificate is provided only if the patent application is examined and meets the requirement of patentability. The patent can be enforced only after certification.
Grant certificate is provided is patent is granted.
Patent is published after grant and certification in the Australian Official Journal of Patents
Patent is published after 18 months from the date of priority and again after certification.
Conclusion: If an applicant wants to file for an innovation patent, the application must be filed on or before 25th August 2021.
Author: Dharini Dinesh
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The COVID-19 pandemic has reignited the long-running debate over how to successfully balance corporate profits with public health. A large number of scholars and activists contend that World Trade Organization (WTO) intellectual property (IP) rules prevent developing countries from obtaining necessary pharmaceuticals. There are many who argue that intellectual property restrictions ought to serve as a driving force for pharmaceutical businesses. Currently, countries are arguing over whether to suspend WTO regulations in light of the pandemic. At the outset in October 2020, South Africa and India asked the World Trade Organization (WTO) to suspend regulations safeguarding trade secrets, patents, industrial designs, and copyrights in favour of “COVID-19 prevention, management, or containment up until vaccination campaigns have been implemented worldwide and the majority of people have acquired immunity.[1]For the length of the pandemic, India and South Africa seek to offer all WTO members the freedom to refuse to grant or enforce patents and other intellectual property rights pertaining to COVID-19 vaccines, medications, diagnostics, and other technology. India and South Africa submitted a waiver request, stating that prompt access to reasonably priced medical supplies, such as medical masks, diagnostic kits, ventilators, and other personal protective equipment, is necessary for an efficient response to the COVID-19 pandemic. Similarly required are immunizations and drugs for the care and prophylaxis of critically ill individuals. As per their declaration, “there are serious worries regarding how they will be made available promptly, in sufficient quantities, and at affordable prices to fulfill worldwide demand while novel COVID-19 diagnostics, treatments, and vaccinations are developed.[2] Later during October, the WTO members failed to come to the requisite consensus to move forward with the sought waiver. The European Union, the United States, the United Kingdom, and other wealthy countries opposed the request for waiver.[3]
20 years have passed since the prolonged fight over access to HIV/AIDS medications under the multilateral trading system came to an end. This is when the dispute regarding waiver of patents initially occurred. Many nations, particularly those in sub-Saharan Africa, were unable to afford the expensive HIV/AIDS medications that were invented by pharmaceutical corporations in affluent nations during the height of the epidemic at the turn of the century. The patent holders kept from reducing their prices since they had spent billions of dollars researching the drugs. The extended discussion regarding whether patent rights should override the provision of reasonably priced medications for individuals suffering from fatal illnesses deteriorated the reputation of the firms, including the nations endorsing them, and the WTO itself. Members of the WTO could, when establishing or modifying their regulations and laws, adopt measures that were considered necessary to protect public health, provided that these measures comply with the provisions of this Agreement,” as stated in Article 8 of the WTO Agreement on the Trade-Related Aspects of Intellectual Property Rights, or TRIPS Agreement.
Additionally, the TRIPS Agreement’s Article 7 states that intellectual property rights must be protected and enforced in a manner conducive to social and economic welfare.[4] It is arguable that these two WTO IP standards are considerably broad enough to include any reasonable health precautions that a WTO member would implement in the event of a pandemic or other medical emergency. However, there was confusion among the participants over the specific application of these regulations during the HIV/AIDS pandemic. Typically, licensing is used to “resolve the inherent tension between the protection of intellectual property and the need to make and distribute affordable medicines,” as noted by Jennifer Hillman of the Council on Foreign Relations. This allows the patent holder to allow others to make or trade the protected product, usually at a price and with some supervision from the patent holder to ensure control.[5] The Doha Ministerial Declaration from 2001 has been interpreted by the WTO as granting each member the authority to issue mandatory licenses for pharmaceuticals and medicines. WTO members approved a waiver in 2003 that released developing nations from TRIPS Agreement requirements and permitted them to import less expensive generic medications from nations with patent protection. After being revised in 2017[6], this waiver is still an important component of the WTO’s compromise between defending intellectual property rights and guaranteeing access to necessary medications. Although private medicine makers oppose compulsory licensing, it is an essential component of the WTO agreement.
The WTO treaty strikes a compromise by allowing mandatory licensing in cases of medical emergency. The arguments made in favor of the proposed COVID-19 waiver have mainly been the same and are reminiscent of the discussion surrounding HIV/AIDS. Early on in the worldwide search for a vaccine, the pharmaceutical corporations made it clear that they opposed the proposed transfer of intellectual property rights for the duration of the epidemic. They have issued a warning, stating that using forced licencing to prevent unauthorized copies of their COVID-19 vaccinations “would undermine innovation and raise the risk of unsafe viruses.[7] At first, wealthy nations objected to the idea, particularly the United States. The Joe Biden administration then changed its mind and declared its support for a vaccine IP waiver in May 2021 in response to pressure from activists and Democratic politicians. Later The coalition of poor nations requesting the waiver put forth an updated proposal that same month that was almost identical to the initial one. Vaccines, diagnostics, treatments, and personal protective equipment (PPE) relevant to pandemics were among the “health products and technologies” to which the waiver would be extended. There would be a chance for an extension during the waiver’s minimum three-year term.
Arguments
Advocates claim that the exemption might increase the output of immunizations and other life-saving goods. A basic degree of intellectual property protection, including twenty-year patents and protections for copyrights, trade secrets, and industrial designs, is guaranteed by members of the WTO under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The rules, according to supporters of the waiver, are impeding the production of vital medical items by businesses other than the inventors. The idea that all medications ought to be considered “global public goods,” held by a large number of individuals globally, is at the center of the current trade controversy. Such a notion leaves little opportunity for any intellectual property rights to be taken into account. The right to the best possible standard of health for everyone cannot be compromised by the pursuit of profit, as stated by a group of UN human rights experts. This includes decisions regarding vaccination access, necessary diagnostics and treatments, and all other medical supplies, goods, and services.[8] India and South Africa provided an example of a bottleneck of this kind in their initial proposal: during the early stages of the epidemic, the United States experienced a shortage of N95 respirators, which prompted Kentucky Governor Andy Beshear to request that the manufacturer release its patents. The public should have more access to vaccines, even if it means fewer profits, according to proponents of the waiver, who also cite the large government assistance that pharmaceutical companies got to aid in the development of COVID-19 vaccines. Governments retain the power, in the absence of a waiver, to permit businesses to manufacture a patented product without the rights-holder’s approval in cases of public health emergency — referred to as compulsory licensing. The procedure, according to those who are in favour of a waiver, is overly onerous and fragmented. Furthermore, wealthier nations like the United States have a negative opinion of and frequently put pressure on nations that issue obligatory licenses. This is a narrow-minded perspective. It is one thing to temporarily subordinate IP rights to urgent public requirements in the event of a pandemic or other international health emergency. Another is to completely remove the concept of “profitability” from all policy decisions that concern access to vaccines, essential tests and treatments, and all other medical goods, services and supplies.[9] Unquestionably, this perspective has a surface-level ethical allure. If a “human rights” strategy fails to address the pressing demands of the public, does this moral argument still stand? Opponents view the waiver as a bait and switch that will reduce incentives for research while doing little to boost the distribution of vaccines around the world. Patent firms, medical professionals, and certain governments contend that intellectual property laws—as well as the revenues they permit—help to advance the creation of ground-breaking innovations like the COVID-19 vaccine. Furthermore, it is asserted that the primary obstacle to worldwide vaccination efforts is not patents but rather inadequate production capacity. Some argue that without the technical know-how of the inventors or access to essential chemicals that are currently in short supply, many countries would not be able to create the vaccines even if the patents were repealed. In the meanwhile, a few US politicians Many analysts are wary of giving competing nations like China access to vital intellectual property.
Conclusion:
A new, protracted, passionate international deadlock within the WTO is not the answer. International cooperation in organizations and initiatives outside the World Trade Organization is the answer. Developing nations are requesting a WTO waiver because to the slow progress and unclear outcomes in those other international venues. They ought to intensify their joint efforts to find solutions in those other areas rather than persevering in their demand for an unneeded WTO waiver. And in order to achieve that goal, the United States, the European Union, the United Kingdom, and other developed nations ought to cooperate with them more. When a pandemic is raging over the world and has already claimed over a million lives and is expected to kill millions more, intellectual property rights should never be allowed to stand in the way of everyone’s early access to reasonably priced medications. Moreover, WTO members should never take any actions that would remove the incentives necessary to spur the inventions that enable the development of new medications.
A balance that gives all nations enough latitude to safeguard intellectual property rights and facilitate access to life-saving medications is what makes the WTO trade regulations on intellectual property just right.[10] It is currently not proven that this balance does not exist for COVID-19 medications. In the struggle to stop this pandemic, preserving this equilibrium has to be the WTO’s continued priority as well as the goal of all transnational cooperative efforts.
Author: Nidhi N Anand
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Microorganisms are defined as minute organisms that are invisible to the naked eye. A wide range of organisms come under the umbrella of microorganisms, such as bacteria, fungi, virus etc. While their applications are many, microorganisms are essentially found in nature, for the purposes of patents they are considered products of nature and therefore not patentable. In this article, we will take a look at the path that led to establishment of patentability of genetically modified living organisms. We will be discussing Diamond v Chakrabarty, a landmark case that paved the way for wide interpretation of subject-matter for issuance of a patent and led to patenting of human made living organisms.
Facts of the case
Ananda Mohan Chakrabarty, a genetic engineer working at General Electrics invented a bacterium known as Pseudomonas Putida capable of breaking down crude oil, proposed to aid in treating oil spills.
A patent US4259444A for the same was filed in the United States by General Electric with Chakrabarty as the inventor. The patent was rejected on the basis that bacteria are living organisms that are naturally occurring.
The bacteria in question here was genetically modified to incorporate multiple plasmids, each capable of breaking down different hydrocarbon components of the crude oil, into a single bacterium.
This patent claimed:
how the bacteria was produced i.e the process detailing the combining of two or more plasmids
an inoculum with carrier material and the bacterium
the species of bacteria itself
While the first two claims were granted the third was rejected on the grounds that living organisms are not patentable as given under Title 35 of the USC, on appeal to the Patent Office Board of Appeals this rejection was upheld.
However, the Court of Customs and Patent Appeals reversed the rejection on the grounds that the state of being alive is of no legal significance in the issue of patentability.
The then Commissioner of Patents and Trademarks, Sydney Diamond took this case to the Supreme Court where the decision of the Court was reaffirmed.
The issue before the court
The main issue in this case was whether a living organism like bacteria that is man-made be patented or not.
The arguments advanced by both parties are as follows:
Arguments by the Petitioner – Sydney Diamond
The petitioners had two arguments, firstly that The Plant Patent Act, 1930 and Plant Variety Protection Act, 1970 point toward clear Congressional understanding that “composition of matter” and “manufacture” of Sec 101 are not inclusive of living organisms.
They claimed that the above-mentioned acts would be rendered useless if the section included living organisms in its scope.
Secondly it was argued that protection cannot be granted to microorganisms as genetic technology was not in use when Sec 101 of title 35 of USC was enacted.
Arguments by the Respondent – A.M Chakrabarty
The respondent’s claim to bacteria was not based on any naturally occurring bacteria but a product of ingenuity which could be classified as a manufacture or composition of matter.
The Plant acts listed by the petitioner, were enacted to distinguish between non naturally occurring and products of nature and not between living and nonliving organisms.
The language employed in Patent laws such as the use of expansive terms like ‘manufacture’ and ‘composition of matter’ point towards room for wide interpretation.
Judgement
The Supreme Court of the United States taking note of the arguments and in light of previously decided cases held that:
A live, human-made microorganism is patentable subject matter under Sec 101. Respondent’s micro-organism constitutes a “manufacture” or “composition of matter” within that statute. Pp. 447 U. S. 308-318.
(a) In choosing such expansive terms as “manufacture” and “composition of matter,” modified by the comprehensive “any,” Congress contemplated that the patent laws should be given wide scope, and the relevant legislative history also supports a broad construction. While laws of nature, physical phenomena, and abstract ideas are not patentable, respondent’s claim is not to a hitherto unknown natural phenomenon, but to a non naturally occurring manufacture or composition of matter — a product of human ingenuity “having a distinctive name, character [and] use.” Hartranft v. Wiegmann, 121 U. S. 609, 121 U. S. 615. Pp. 447 U. S. 308-310.
(b) The passage of the 1930 Plant Patent Act, which afforded patent protection to certain asexually reproduced plants, and the 1970 Plant Variety Protection Act, which authorized protection for certain sexually reproduced plants but excluded bacteria from its protection, does not evidence congressional understanding that the terms “manufacture” or “composition of matter” in Sec 101 do not include living things. Pp. 447 U. S. 310-314.
(c) Nor does the fact that genetic technology was unforeseen when Congress enacted Sec 101 require the conclusion that micro-organisms cannot qualify as patentable subject matter until Congress expressly authorizes such protection. The unambiguous language of Sec 101 fairly embraces respondent’s invention. Arguments against patentability under Sec 101, based on potential hazards that may be generated by genetic research, should be addressed to the Congress and the Executive, not to the Judiciary. Pp. 447 U. S. 314-318.”
So, the judgment of the Court of Customs and Patent Appeals was affirmed, and although generally naturally occurring products are not granted patents, growth in genetic technology owing to development of modern science has made way for some interesting exceptions and inclusions as this case of Pseudomonas bacteria aptly illustrates. Thus, General Electric with Ananda Chakrabarty was granted a patent to these claims.
Parle-G is a leading biscuit brand under Parle Products for biscuits and confectionary items. With a worldwide presence, Parle has carved out a place for itself in the biscuit business with value-for-money products, widespread availability, consistent taste and a very long presence in the business.
Foundation
Founded in 1929 by Mohanlal Dayal Chauhan, House of Parle grew and gained popularity as a trusted biscuit and confectionary company in India, eventually gaining worldwide presence. It got its name from the location of the first factory in Vile Parle (then Irla Parla) Bombay, Maharashtra.
The founder, Mr. Mohanlal Dayal, was a part of the Swadeshi movement and Parle Products was started as an attempt to have a homegrown biscuit and confectionary company to serve Indians. At a time when biscuits were considered to be luxury goods and were imported from Britain, only the rich could afford it. Parle Products started with the aim of making confectioneries and biscuits available to all classes of the Indian society, rich and poor alike. Parle-G or then known as Parle Gluco was born in 1938 and thrived on being affordable to all and was marketed as healthy biscuits available to all.
As the years passed, Parle Products introduced various products for Indian markets, understanding the demands and psyche of their consumers. This included a variety of biscuits, candies and other snacks. In 1947, when India gained independence, there was a shortage of wheat supply. However, this did not stop Parle from producing India’s very own biscuits. There was a temporary shift to Barley biscuits and their ad campaign focused on encouraging people to buy barley biscuits instead.
Market Success
Parle-G has created its brand value and brand trust among consumers over the past 90 odd years. Many factors have played important roles in achieving the success the brand enjoys today, with a worldwide consumer base and being the top-selling biscuit brand in India and the World. Some of these include the following:
Advertising
Starting from printed advertisements in the pre-independence era to having an active social media presence today, Parle-G’s advertising has been one long journey transforming a local confectionery product to the biscuit brand that India loves. But in all these years, while Parle Gluco went on to become Parle-G, the company’s positioning is the one thing that still holds true to the brand even today. Right from its packaging to its pricing, Parle-G has always appealed to the masses of India. Sometimes by harping on the emotion of nostalgia and most times constantly evolving in their advertising insights to stay relevant to their audience. Parle-G’s 2018 campaign – ‘Aaj ke digital geniuses ke liye’ is the perfect example of that.
Pricing
Low and affordable prices was the principle behind the inception of Parle Products during pre-Independence India and has since been carried forward as the distinguishing factor for Parle-G. Not only is the brand popular among the more affluent, it is also the most popular biscuit brand amongst the impoverished because of its affordable pricing. According to Kamal Kapadia, who worked at Parle for 32 years and left as CEO, Bengaluru project, this has been possible because “it had everything in-house, from packaging to procurement. And, the owners were hands-on.”[1]
Packaging
Over the long period of time that Parle-G has existed, it has maintained a simplistic yet differentiating packaging, with the photo of a young girl on all Parle-G packaging. This has helped the brand create a unique identity and a visual association of the brand with the product. This in turn helps the brand stand out and have a loyal consumer base.
Product
Parle Products have maintained their quality, including Parle-G, with consistency in taste and by marketing the product as a healthy glucose biscuit. Even though it is manufactured on a very large scale and in different factories across the country, Parle-G has maintained its taste over the years. The brand boasted of having created the country’s largest oven between 1946-50.[2]
From Parle Gluco to Parle-G
During its inception in 1939, Parle-G was called Parle Gluco because the brand sold very popular glucose biscuits. For a very long time, Parle Products sold these biscuits under the name of Parle Gluco and enjoyed exclusivity of this name. However, “Gluco”, which stood for “Glucose” was of such a nature that it belonged to the public at large for common use and could not be registered as a trademark. Hence, it was a “publici juris trademark” and the competition for Parle Gluco increased since many other companies started using “Gluco” to sell their brand of glucose biscuits.
In 1982, a rebranding and reimaging of Parle Gluco biscuits by Everest Brand Solutions gave birth to the very popular “Parle-G” biscuits, which was a trademark of the glucose biscuits sold by Parle Products. This helped secure the consumer base and develop consumer loyalty towards Parle Products by discarding the use of a word which could not be used exclusively by the company.
Breaking Sales Records during the Covid-19 Pandemic
Although Parle-G has been the favourite biscuit brand of the country for a very long time, the market has seen the growth of many other brands in the last few years. However, the onset of the Coronavirus Pandemic and the subsequent lockdowns brought about an interesting spike in the sales of the biscuits. At a time when packaged food has emerged as the go-to grocery option and people have found themselves indoors for a solid few months, snack consumption has increased considerably. Other than this, those financially weaker have also resorted to these cheaper yet healthy biscuits during these unprecedented times.
For the brand, March, April & May have been their best months in over eight decades. “We’ve grown our overall market share by nearly 5%… And 80– 90% of this growth has come from the Parle-G sales. This is unprecedented,” said Mayank Shah, category head at Parle Products.[3]
Therefore, by catering to a variety of needs during a pandemic and by maintaining steady production of Parle-G biscuits, it has seen the highest ever sales during the country-wide lockdown.
By Ria Mishra
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Recently in June 2021, Sun Pharmaceutical Industries Ltd, Indian multinational pharmaceutical company headquartered in Mumbai, Maharashtra, settled a patent litigation with Celgene Corp, a subsidiary of Bristol Myers Squibb. This litigation was regarding submission of an Abbreviated New Drug Application (ANDA) for a generic version of Revlimid (lenalidomide capsules) in the US by Sun Pharma.
Revlimid (lenalidomide) in combination with dexamethasone is indicated for the treatment of patients with multiple myeloma and is a single agent which is also indicated as a maintenance therapy in patients with multiple myeloma following autologous hematopoietic stem cell transplant. It is approved in the U.S. for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. Lenalidomide is on the World Health Organization’s List of Essential Medicines.
Abbreviated New Drug Application (ANDA) is an application that is filed at FDA to get approval for generic drug where the innovator drug is already approved. Typically, generic drug is equivalent to an innovator drug product in terms of dosage, form, strength, route of administration, quality, performance, characteristics and intended use. All approved products, both innovator and generic are listed in FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).
ANDA application passes through 4 levels of certifications where paragraph IV certification is very critical. It requires applicant to establish that the generic drug for which ANDA is filed does not infringe any existing patent rights of the third parties. To understand patent infringement, it is important to know rights of a patent holder. In a given jurisdiction where patent is granted, a patent holder has right to prevent third parties from making, using, selling, offering for sale and even importing the patented product. Violation of any of the rights of the patent holder or patentee is called as infringement.
In this case, Celgene had a patent on Revlimid and upon ANDA filing by Sun Pharma, Celgene filed a lawsuit for patent infringement against Sun Pharma. Licensing is one of the popular ways, the companies adopt to settle the patent litigation in exchange of royalty payment. The word “license” means “permission”, which may be granted by the patent holder on certain terms and condition for a specific period of time by executing an exclusive or non-exclusive license agreement. In this case, Celgene agreed to grant license to Sun Pharma, for a specific amount of money to be paid by Sun Pharma as royalty, to manufacture and sell the drug, subject to the U.S. Food and Drug Administration approval. By providing license, Celgene would allow Sun Pharma to manufacture and sell an unlimited quantity of generic lenalidomide capsules in the U.S. from Jan. 31, 2026.
Before this case between Celgene and Sun Pharma, other Indian companies, Cipla Ltd., Natco Pharma Ltd., Cadila Healthcare Limited and Dr. Reddy’s Laboratories Ltd. and the U.S.-based Alvogen had settled patent litigations for Revlimid with Celgene. Celgene granted patent license to all these companies, required to manufacture and sell an unlimited quantity of generic lenalidomide in the United States beginning after January 31, 2026. However, these company’s ability to market lenalidomide in the U.S. will be contingent on its obtaining approval of an Abbreviated New Drug Application.
After working hard on the new idea, investing money, resources, it’s time to fulfil the dreams, set-up new business, bring new product in the market. IP protection is an important step to secure innovation to prevent others from copying it. Is there anything else that is required to be done much before it? Following are the most crucial issues to be considered by an inventor to help him in enhancing quality of research and file the patent application in a cost-effective manner:
Prior art search: Get a thorough prior art search done right in the beginning when you conceive a new idea. The scope of the search should not be limited to the granted patents, but the published patent applications and paper publication should also be searched. The search shall be done globally using various paid or unpaid databases to identify the closest and the most relevant patents/patent application that would help you to assess the novelty of the invention. Prior art search also is helpful in drafting of the patent specification. Prior art search is an essential and crucial step to give shape to your idea and hence it’s a good idea to take professional help to get the search done.
Maintain confidentiality: Inventors often are extremely passionate and enthusiastic about their invention. Having invented something feels great and one feels like disclosing it to the world. But stop! It is strictly essential to maintain strict confidentiality of the invention till the patent application is filed. One of the critical requirements of getting a patent is that invention shall be novel on the date of filing. Hence, never disclose, publish or make your invention available to public till you file a patent application for the same. Additionally, do have an NDA (Non-Disclosure Agreement) with your attorney as well for the same before initiating discussion on filing patent application. A classic example is when Archimedes solved the problem of checking the purity of a gold crown without damaging the crown. While taking a bath, he noticed that the level of the water in the tub rose as he got in and realized that this effect could be used to determine the volume of the crown. Archimedes then ran in the street naked, so excited by his discovery that he had forgotten to dress, crying “Eureka!”.
Documentation: Documentation of an invention is extremely critical. Stepwise documentations shall be done and the novel features of the invention, existing technical problem which your invention overcomes, how your invention works shall be highlighted. Explain the process or the product with drawing and\or flow diagrams. Thorough understanding of the invention by your attorney is necessary. Don’t get lazy to fill the invention disclosure form if given by your attorney in order to describe the invention systematically. Consider the cost: Understand why and in which county (ies) or jurisdiction (s) you want to file a patent application. Choosing to file provisional or complete application, PCT application or convention application or filing in India based on your requirements can really help you to manage your finances and to identify the timelines. Spend some time with your attorney to understand the procedure to work on the most cost-effective package.
Explore options other than patent: Depending upon kind of product, it is advisable to explore other option for protection of the innovation in the form of copyrights, design or trademark. Being an inventor requires tremendous amount of effort and taking invention in right direction, in right manner is imperative to protect it appropriately and to reap the benefits.
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An over- simplification of licensing is monetizing the intellectual property of your invention by allowing third parties such as companies to license the intellectual property for various purposes that involve manufacturing, marketing and selling. A patent, trademark, copyright, trade secret, a tech algorithm, or techniques or procedures or know-how are all examples of intellectual property. Subject to the provisions of the licensing agreement, when an invention is given for licensing to a licensee, the organization is empowered with the ability to manufacture; market and sell the invention. The process of Licensing of the technology is completed upon execution of Technology License Agreement (TLA) between the Licensor and licensee whilst the inventor is given royalties by the licensee as a consideration for the said agreement.
It is of paramount importance that the terms and conditions of License Agreement are explicitly agreed by both parties and is in a written form.
Why license an innovation to a company?
The fundamental reason that inventors license their patents for royalties is so that they can focus exclusively on attempting to create rather than managing to manufacture, monetize, or distribute each of their inventions. Inventors can create intellectual property and then license the rights to another company to bring the product to market through a patent license agreement. For many innovators who may not have the resources to bring their invention to market on their own, this serves as a viable option.
Licensing inventions for royalties can also help inventors access new markets and expand the reach of the invented product. If an inventor intends to expand into a market where he has limited experience or in an industry across the borders or want to endorse a licensee who has similar products in the market and where the invention could be optimally used in, the inventors decide to license their patent.
Structure of a License Agreement
Licensee: Selecting an appropriate licensee to meet the requirements is one of the first crucial steps in licensing an intellectual property for royalties.
Scope: The scope of the license is determined by the licensor (inventor) which clarifies specifications of the intellectual property. The questions involved are whether the licensee is allowed to access the IP rights as a whole, or will the licensee only be allowed to use the patent for a precise task, for instance, manufacturing or distribution worldwide or in specific jurisdiction. The valid duration of such intellectual property license along with restrictions on geographical locations and various markets is important to be negotiated.
There are no specific requirements of the license to either be exclusive or non-exclusive. It solely depends upon choice of the parties. The license may contain a prohibition on the parties competing in the jurisdictions in which they operate; the contents of the contract will factor in the determination.
In order to receive protection against similar inventions or otherwise, a patent must be compulsorily registered or filed for priority protection, and the patent license must be in writing and registered under section 68 of the Patents Act 1970.
Validity of License Agreements
A license agreement, as previously said, should be in writing with all pertinent terms fully outlined. Would just a term-sheet, to the contrary, suffice as a legitimate license agreement? PVR Pictures Limited vs. Studio 18[1], the Delhi High Court delved at this issue. The parties had agreed in this matter to enter into a term-sheet agreement (TSA) under which PVR would be the exclusive licensee for distribution rights in respect of selected cinematic pictures for which written agreements would be executed. PVR accused Studio 18 for infringement, claiming that by refusing to enter into an agreement with PVR on the film, Studio 18 was infringing on PVR’s rights. PVR asked for ad interim relief against the defendant. The issue was whether PVR is Studio 18’s licensee for the film Short Kut, and if so, whether it is entitled to an ad-interim injunction. The courts held that the TSA does not signify a license agreement because the parties did not intend for the TSA to become a binding contract and a license as defined by the Copyright Act; and because PVR failed to develop any legal right or copyright for the grounds of suit, PVR cannot seek specific performance or an ad interim injunction.
Hence, the license terms must not only be in writing but should also be in the form of a binding definitive document for a valid License Agreement.
Terms of a License Agreement
A license agreement must be extensively drafted to provide for specific details of the rights and the limitations imposed on the licensee in the exercise of such right. The definition of licensed property, the geographical features for which licenses are granted, the right given to the licensee to further sublicense the property, clauses regarding revocation of the license, royalty or consideration for the grant of license, dispute resolution, cessation, all of which are inherent areas of the agreement.
To ensure that the licensee cannot claim that the IP has been transferred to it, the license agreement must be carefully drafted, and certain license constraints must be included. There have been certain cases where the licensor has executed an exclusive license and the licensee claims that the IP has been assigned. Indian courts have looked at the essence of the contract, notably the royalty payment clauses, to assess whether a transfer should be interpreted as an assignment or an exclusive license in a number of cases.
In Deshmukh and Co. (Publishers) Pvt. Ltd. vs. Avinash Vishnu Khandekar and Ors[2], the Court looked at the difference between assignment and licensing of Copyright. It was iterated that the essence of a document, not the manner of words used, must be considered when determining whether it is an assignment or just provides a license. The question usually arises in the context of whether the right in question has been partially assigned or licensed exclusively; the distinction is subtle but significant.
The copyright is not conveyed if the consideration is in the form of royalties or a portion of profits rather than a direct payment. It would be a publishing and selling license. In this situation, the payment of royalty rather than substantial money intended to be a sale, stands against partial assignment.
Consequently, the licensing provisions must unambiguously declare that it is a license (whether exclusive or non-exclusive) and clarify the contractual terms. More significantly, the royalty payment clause should be formulated carefully that it does not imply that any direct payment is made in exchange for Intellectual property assignment.
Improvements, enhancements, and revisions to IP are the responsibility of the IP owner.
Licensee can design and develop an enhancement to an existing technology or a component that improves the technology’s use or functionality. The new innovation could be the result of modifying the licensed IP to make any improvements, or it could be the outcome of an innovation related to the use of the licensed IP. These improvements signify advancement in the licensed technological field that improves the initial IP’s usage, functionality, efficiency, productivity, or other attributes. A license agreement must indicate what designates an improvement, and the ownership of such improvement and all property created as a result of it.
Mandated registration of License Agreement
When a license agreement is intended to be performed, the issue of whether the registration of the agreement is mandatory arises. If required by law, what are the consequences of non-registration? The Patents Act, the Trademarks Act, and the Designs Act all require license agreements to be registered, although the Copyright Act does not. The Indian Stamp Act, 1899 (the “Indian Stamp Act”) governs the transfer of intellectual property rights in the form of licenses, assignments, and sales, among other things.
Quantification of Royalty
As previously mentioned, when an inventor licenses his invention to a third party, the two parties engage into a license agreement in which the licensee acquires the patent rights and the licensor receives a fixed sum of money each time the product is sold.
The royalty is a fixed sum paid to the licensor or inventor as consideration, and the licensing royalty rate is a percentage of the net or gross profit selected to constitute the royalty. The quantification of royalties may heavily depend on the negotiations between the parties and merchantability of the invention. The Licensor may be in violation of The Competition Act, 2002 (the “Competition Act”) if it attempts to set extortionate prices as a result of its dominating market position. The test of accuracy of the royalty is reasonability.
The accuracy of the royalty base would determine the reasonableness of a royalty. The royalties is calculated on an individual basis. The Competition Commission of India (“CCI”) has adjudged on numerous cases regarding royalty rates assessment. It has been iterated that offering different licensing prices to different users for the same technology is in violation of FRAND requirements. Further, the CCI determined that Ericsson imposed unjustified royalties because no alternative technology for its patents 2G, 3G, and 4G standards was available.[3]
Even-though, licensing an invention comes with certain limitations and risks, the license agreement allows parties to expand the inventions to various jurisdictions and markets which aligns with the primary visions of licensor and reach larger targeted audience.
A major chunk of a progressive company’s assets today is in the form of Intellectual property (IP) such as trademarks, patents, copyrights, trade secrets, designs and so on. Sharing of confidential information becomes unavoidable when two entities are transacting business. A non-disclosure agreement (NDA) is also known as a confidentiality agreement and is an agreement where two or more parties agree to keep certain information confidential. In most situations, NDAs serve as the first move towards subsequent business agreements and contracts that include additional provisions covering the complexity of business transactions between the parties. This can either be one-sided (only one party shares confidential information) or mutual (expecting exchange of confidential information from both the parties) but the outcome of it is to protect the information or the businesses’ trade secret.
Parties
It is very important to list out the party names correctly on an NDA as a relatively minor error such as forgetting to include the word “Limited” can have disastrous consequences. Some companies have different legal names and trade names when they begin their operations. A legal name is the name used by an entity when registering as a business, when signing official legal documents, and when dealing with governmental processes. A business name or a trading name however is the name a company uses for ads and sales and under which it performs its business with the public. A party may have the same legal and trading name, but it is also entirely possible that they may not be the same.
Further, there is no legal protection to halt the use of a trade name by other companies unless the entity trademarks its name. It is therefore important to list both the legal and trade name of the businesses involved when drafting an NDA.
Define what is deemed to be confidential information
Confidential information should be defined specifically for both parties. The parties involved must be precise when identifying the type of confidential information exchanged and whether it is the same or different for all parties. For example, the type of information to be shared by each party may not be the same in the case of a discussion involving the mutual exchange of confidential information between the two parties. Therefore in such cases, it makes sense to provide an exact definition of confidential information for each party.
Classifying all the information disclosed to a receiving party as confidential can be tempting. However, using catch-all clauses must be avoided and instead, the agreement should only include information that is truly necessary to keep a secret.
For example, in Trailer Leasing Co. v. Associates Commercial Corp, a federal court in Illinois declined to enforce an NDA where the concept of ‘confidential’ was deemed too vague, over and above a lack of specified geographical limitations.
The law treats confidential information differently than trade secrets and hence care must be taken to appropriately label the information as confidential information or a trade secret. A differentiator between the two is that trade secrets are known to last for a longer period of time across generations.
Term of the agreement
The term of the NDA may or may not be the same as the term of contractual obligations and therefore it requires a specific definition of the term. Perpetual clauses should be avoided unless the same is in the context of the parties’ discussions.
Clearly define non-disclosure and non-use
The agreement should include separate provisions on non-disclosure and non-use in both types of NDA (mutual and one-sided).
NDA clauses should be drafted so as to not create undesirable delays in discussions and negotiations. The business goal should always be given priority to the lawyers involved in drafting and negotiating NDAs and excessive clauses should be avoided while standard clauses in NDA should be given utmost importance. In the case of any problems, it is often best to adhere to the primary purpose of signing NDA, i.e. confidentiality and limiting the use of sensitive information, whereas additional agreements can be enforced to include relevant provisions (Non-compete, Non-solicited, IP Assignment, IP Licensing, etc.)
By Damini Mohan
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In this case, Medley Laboratories (P) Ltd. (hereinafter referred to as Medley) filed a suit of trademark infringement against Alkem Laboratories for usage of mark “SUPAXIN” which is deceptively similar to registered trademark of Medley, “SPOXIN”. Brief facts of the case are as follows:
Medley is registered proprietor of the trademark “SPOXIN” in respect of Pharmaceutical and Medicinal Preparations in Class 5 vide Registration number 420835. They applied for registration in year 1984 and have been using the mark since 1999, for medicinal preparations containing the generic drug SPARFLOXACIN.
Alkem, India’s 10th largest Pharmaceutical Company (at the time of suit), started using the mark “SUPAXIN” and for the same registration application had been sent to Registrar of Trademark as ‘proposed to be used’.
Suit for infringement and notice of motion was taken out by plaintiff to restrain Alkem from using infringing mark, initially an ex-parte injunction was passed in favour of Medley, but on another notice of motion by Alkem, parties were heard afresh and it was held by a single judge that the marks in question are not similar and therefore injunction is bound to be said aside. On such order by the Single Judge, appeal was preferred by Medley, which was the subject matter of present case.
Arguments
By Medley i.e., Appellant
That medley is the registered proprietor of the trademark “SPOXIN” vide registration number 420835 and by virtue of registration they are entitled to exclusively use the mark and protect it.
That Single judge has committed error of law by not granting injunction in favour of Medley, decision of Hon’ble Supreme Court in case of Cadila Healthcare Ltd. v. Cadila Pharmaceuticals Ltd.; {[2001]2SCR743}, was relied upon, wherein Supreme Court decided upon similar question with respect to marks being used in medical preparation. Medley contented that Apex Court held that in medical products and drugs public interest should be considered and a stricter approach has to be adopted because confusion as to medicinal product can have disastrous effect on health and in some cases on life as well.
That balance of convenience was in favour of Medley as their mark “SPOXIN” is a registered mark and irreparable loss and injury would also be caused to them if injunction is refused, as the suit will take a long time and in spite of registered trade mark, the defendant will continue to use ‘deceptively similar’ mark SUPAXIN.
By Alkem i.e., Defendant
That Alkem is honest user of the mark “SUPAXIN”, it has coined the term by taking into consideration two words i.e., “SUPA” which means superior and “XIN” which is a common suffix for antibiotics. That prior to applying for registration, they made an application to Registrar under rule 24 of Trade and Merchandise Marks Rules, 1959, requesting him to conduct a search and issue a search for similar marks and on basis of such search report they started using the mark “SUPAXIN”.
That there was no dishonest intention in applying the mark and the mark is neither deceptively similar nor it would create any confusion to customers.
That a discretionary order has been passed by Single Judge and under ordinary circumstances such orders are not interfered with by Appellate Court.
That balance of convenience was not in favour of Medley because as per the findings of Trial Court Medley and Alkem started using the mark at around same time. That Alkem has established its bona fide usage by making search request to Registrar.
That no evidence is produced before the court of Medley regarding the confusion, on the contrary affidavits were produced by Alkem to support that there was no likelihood of deception or confusion to doctors, or to chemists, or to patients.
Issue
The primary issue before the court was, whether the mark of Medley i.e., “SPOXIN” is deceptively similar to mark of Alkem i.e., “SPUAXIN”.
Judgement
Hon’ble Delhi High court observed that by virtue of registration Medley got the right to exclusively use the mark “SPOXIN” and the right to prevent others from using deceptively similar mark. Further court observed that the marks “SPOXIN” and “SPUAXIN” are deceptively similar and that once the mark is proved “to be identical or deceptively similar, the other factors, viz., the packing being different, number of tablets contained in the competing package is not the same, prices are not identical and/or the goods being sold on doctor’s prescription are altogether irrelevant and immaterial.”
Decision of Single Judge was overruled, as he failed to promptly apply the principles laid out of Apex Court in the case of Cadila Health Care (supra). It was held by court that:
“In our opinion, however, when the test is ”possibility’ of confusion in medicinal preparations, as held by the Supreme Court in Cadila Health Care Ltd., and the Courts have been asked by the Apex Court to take special care, in such cases, since confusion may harm and result in unpleasant consequences, if not disastrous results, the learned Single Judge ought to have granted injunction as prayed by the plaintiffs (Medley).”
As to the issue of discretionary matter it was held that when an adjudication has been made, may be prima facie, and in doing so, correct test has not been applied, it is open to the Appellate Court to interfere with the discretionary order made by the trial Court.
Thus, the appeals were allowed and Alkem’s mark was found to be deceptively similar with the mark of Medley.
Bayer Corporation, a US based corporation had a patented drug in India under the brand name Nexavar. This landmark judgement became the first case where a compulsory license was issued after India became a signatory to Trade Related Aspects of Intellectual Property Rights [TRIPS] and also to the Doha Declaration in 2001. The Intellectual Property Appellate Board [IPAB] elaborated the grounds and conditions for compulsory licenses. Brief facts of the case are as follows:
Bayer Corporation, a US based corporation which developed “Sorafenib Tosylate” sold under the patented drug “Nexavar” [Patent Number IN 215758] for curing kidney cancer. The drug relieves the pain and slows down the spread of cancer.
Compulsory license for Nexavar was granted to Natco Pharmaceuticals Ltd. (hereinafter referred as Natco Pharma).
On 3rd Mar, 2008, Bayer Corporation was granted a patent in India for “Nexavar”
On 6th Dec, 2010, Natco Pharma approached Bayer Corporation for grant of voluntary license of the patented drug.
Bayer Corporation was selling the drugs at Rs 2, 80,428 per month for 30 tablets. Natco Pharma proposed to sell the same drug at Rs 10,000/- per month to make it available at an affordable price in India. Later Bayer Corporation rejected this offer.
On the other hand, CIPLA Ltd (hereinafter referred as CIPLA), another Indian Pharmaceutical, was already selling the drugs as “Soranib” at Rs 30,000/- for a month later it sold at Rs. 5,400/-. CIPLA didn’t take prior permission or license from Bayer Corporation and hence was undergoing litigation in Delhi High Court for infringement of Bayer Corporation’s Patent.
The controller drafted the terms and conditions of the compulsory license and awarded a 6% royalty from profits to Bayer. Then Bayer appealed the Controller’s decision before IPAB.
Issues
The main issues before the Hon’ble Court were:
Whether the requirements for the grant of compulsory licensing are fulfilled?
Whether the decision of the controller to grant compulsory license to Natco Pharma with a royalty at 6% of its net sales to Bayer Corporation was valid?
Whether the supplies by Natco Pharma & CIPLA of the disputed drug have to be taken into account to determine the satisfaction of reasonable requirement test?
Arguments by the parties
By Plaintiff i.e., Bayer Corporation
Bayer Corporation alleged that if the Sorafenib Tosylate drug was already available in the market at affordable prices, then section 84(1) (b) of the Patents Act, 1970 cannot be one of the issues.
The cost of inventing the drug is high and the corporation has invested a huge amount on research and development.
Furthermore, they argued that the controller has ignored the mandatory nature of Section 90(1) (i) [7] of the Patent’s Act, 1970, as it has not taken into account the cost of invention incurred while fixing the royalties.
Bayer contended that the utilization of “sale” along with “import” excluded the term “export” from the meaning of the expression “sale”. Section 84 and Section 92A has used the term “export” expressly. Therefore, the court should not accept Natco Pharma’s contention that an export transaction is covered by sale.
By Respondent i.e., Natco Pharma
The price charged by Bayer Corporation was not an affordable price when compared to purchasing power of the public or to meet the requirements in the market and hence Bayer Corporation contravened the Patent Act.
They argued that the charitable program i.e., Patient Assistance Program [PAP] of Bayer Corporation is discretionary and conditional. Therefore, cannot be applied for public.
Furthermore they stated that the IPAB has complied with Section 90 of the Patents Act, 1970 as they enhanced the royalty from 6% to 7%.
Judgement
Court relying on various judgments held that:
“The Hon’ble Supreme Court dismissed the SLP filed by the Bayer Corporation and upheld the decision of Bombay High Court providing compulsory licensing for a life-saving drug named ‘Nexavar’.The High Court judgement relied on the fact that even after taking Cipla’s supplies into consideration, the public prerequisite would not be met and commitment to meet the reasonable requirement of the general public must be of the patent holder alone, either by patentee himself or through his licensees. The charitable program by Bayer Corporation was unaccepted as a defense for Section 84 (1) (b) of the Patent Act, which insists on the fact that the patented drug should be made available to the public at a fairly affordable price i.e. to any portion of the public tendering the price. It was also held that the term “exports” is employed in different contexts in Sections 84, 90 and 92A all of which deal with compulsory licensing. The court observed that when it comes to drugs the sufficient extent test has to be 100% i.e. to the fullest extent. Under Doha declaration the concept of compulsory licensing empowers the government to provide an organization to use the patent technology and the use of patented product even without the real owner’s consent. In the present case, Natco Pharma fulfilled all the conditions for compulsory licensing.”
The judgement strikes a balance between the issues pertaining to public interest and also those made in regard to patentee’s rights. It demonstrates the focus of Indian Pharmaceutical patent law, which indeed pushes towards affordable access to the larger public and the Court’s primary concern is that of public interest.
Hence, the High Court then dismissed the petition of Bayer Corporation.
Copyright is a type of Intellectual Property (IP) that gives its owner the exclusive right to make copies of a creative work, usually for a limited time. In India, Copyright Act, 1957 and Copyright Rules 2013 cooperatively deal with the subject of Copyright.
Artistic work including photographs, sculptures, architectural work, painting, drawing, engravings or any such work of artistic craftsmanship;
Cinematograph films
Sound recordings
Software, Computer programs and allied compilations (as part of literary work)
Registration of copyright is not mandatory as copyright is inherent and automatic right. When any of the abovementioned works takes birth, along with it comes copyright into the picture. Therefore, it isn’t mandatory to register copyright. However, registering copyright gives an extra layer of protection to such works. By having an existing record, the evidence of such an existing work is created. This makes legally proving the existence of copyright in a court of law, very easy. Matters of assignment, transfer of ownership, creating an authorized agent etc. is generally made easier when you have a registered copyright. With a registered copyright, the risks involved are less.
Authors have prima facie copyright protection. Section 2(d) of the Act lays down authors of works:
Literary work
Author of the work
Dramatic work
Author of the script
Musical work
Composer
Artistic work other than photographs
Artist
Photograph
Photographer
Computer-generated literary, musical, dramatic work, artistic work
Person causing the creation of the work
Cinematograph films
Producer
Sound recording
Producer
Other than authors, owners or any authorized agent of the author, or any person/organization with exclusive rights over the work, obtained through a contract, can also enforce the copyright.
Copyright registration process
Chapter X of the Copyright Act, 1957 and Chapter XII of Copyright Rules, 2013 elucidate upon Copyright Registration. Registration involves the procedure of entering the particulars of a work in the Register of Copyrights. Copyright Register has 6 parts to it, each part pertaining to each type of work. The Register is arranged alphabetically, following Indexes and each part is maintained both physically and electronically. The work seeking copyright will be entered into the appropriate part of the Register, if it is deemed worthy of copyright protection.
To register a Copyright, the Registrar of Copyrights should receive an application for the same with prescribed fees. Form-XIV should be used for the Copyright registration application. If changes are to be made to an already existing copyright, then Form XV should be used. After receiving an application, the Registrar of Copyrights will then conduct an inquiry and decide accordingly.
The Application is to be signed either by the author or the owner of the work. In case of owners, a NOC duly signed by the author shall be attached along with the application.
The Application should be filed in the Copyright Office in person, by post or using the online filing facility available on the official website of the Copyright Office. The link for the same is provided here. https://copyright.gov.in/Default.aspx
The Applicant has a duty to give notice (including such statements, particulars or enclosures used for the application) of making such an application to every person claiming or having an interest in the subject-matter of the copyright or contesting the applicant’s rights over such work.
An inquiry will be conducted in case any objection is received by the Registrar within a period of 1 month, or if the Registrar is not convinced about the correctness of that application and/or details attached with it.
An opportunity for a hearing will be given to the Applicant before rejecting the application.
In case no objection is received within 30 days from the date of receipt of the application and if the Registrar is satisfied with the application and the particulars in it, the same will be entered in the Register.
The Registration process comes to an end only when the work entered in the Register of Copyrights and the copy of such entry is made, signed and issued by the Registrar, Deputy Registrar or such authorised person. Such a copy will be sent to the concerned parties within a reasonable time.
Application to register unpublished work shall be accompanied by 2 copies of the work
Object code and source to be included in case of Computer programs
In case of registering an artistic work capable of being used as a good, a statement indicating the same, along with a Certificate from the Registrar of Trade Marks proving that there is no registered Trade Mark that is identical or deceptively similar to such artistic work, or that no Trade Mark application for registration has been made by any person other than the applicant.
For artistic works capable of being a registered Design, applications for copyright registration shall be accompanied by affidavits stating if such an item has been registered under the Designs Act, 2000, if there has been an application of the work to any article under industrial process and if it has been reproduced more than 50 times.
Statement of particulars to be attached with Application form shall include the following details:
Name, Address and Nationality of the Applicant
Name, address and nationality of the Author. In case the author is deceased, the date of his demise
Names, address and nationalities of the owners of the various rights comprising the copyright in the work and the extent of rights held by each, together with particulars of assignment and licenses, if any
Names, addresses and nationalities of other persons, if any, authorized to assign or license the rights comprising the copyright
Nature of the applicant’s interest in the copyright
Class, description, title of the work
Language of the work
Whether work is Published or Unpublished
In case of a published work, Year and country of first publication with name, address and nationality of the publishers. Additionally, Years and countries of subsequent publications with details of publishers.
In case of an “artistic work”, the location of the original work, including name, address and nationality of the person in possession of the work. (Year of completion to be included in the case of an architectural work)
Certificate from Registrar of Trade Marks for artistic work capable of being used as goods
For an artistic work that could potentially be registered as a Design, details showing if it has been registered under Designs Act, if it has been applied to any article by an industrial process, and the number of times it has been reproduced.
Other remarks
Registration number (entered by Copyright Office).
SoFP is to be included with the application for registering literary (including computer programs and software), dramatic, musical and artistic works only. It contains details such as:
If the work is original / If work is the translation of a work is available in the public domain, or translation of a copyrighted work / If it is an adaptation of a work in the public domain or of a work in which copyright subsists
In case the work is a translation or adaptation of a copyrighted work-
(a)Title, Language of the work, (b) Name, address, nationality of the author of the original work and date of death in case of a deceased author (c) Name, address, nationality of the publisher, if any, of the original work (d) Documents proving authorization for a translation or adaptation including the name, address and nationality of the party authorizing.
Literary or Artistic work, capable of being used in relation to any goods
Rs. 2000
Rs. 1000
Cinematograph Film
Rs. 5000
Rs. 2000
Sound Recording
Rs. 2000
Rs. 1000
Payment of such prescribed fee can be done in various ways. By postal orders or bank drafts issued by a Scheduled Bank under Reserve bank of India Act, 1934, as a deposit into a Government Treasury, through payment gateway provided with the online-filing facility of the Copyright Office Website etc. are some of the ways prescribed under Rule 83.
Few examples of registered copyrights
Title of the work
Type of Work
Issued on
Applicant
To hell with Corona
Literary/ Dramatic
5/1/2021
Bhanu Arora
Andy
Artistic
9/12/2020
Aum international Studios Pvt. Ltd.
Lead Management Distribution Methodology
Computer Software
8/6/2019
R Varadarajan
Bachpan Theher Jaa
Sound Recording
6/9/2018
Vrinda Parwal
Tere Ishq ki Aadat
Cinematograph film
30/10/2017
Mohd. Farman
Author: Bhavana B, School of Law, CHRIST (Deemed to be) UNIVERSITY, Bangalore
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In this technologically progressive era, huge amount of knowledge gets generated and added in the prior art every day. Where on one hand keeping pace with technical progress in present times is a challenge, on the other hand, innovation has to happen to ensure sustainable growth. Till the time, you foresee the innovation in a given area of technology, it is impossible to create significantly creative and valuable products. Another issue in technologies such as electronics or software is that innovation cycle is too short, meaning that in no time after you market or commercialize the product, you may see next versions of the product floating around. Considering the high cost of R&D and resources, output often is not that meaningful and sustainable.
In most of the companies, before designing R&D in a given area of technology, one important parameter is often missed out, i.e. assessment of “state of the art”. Even though by means of product surveys, competitors’ products or otherwise, the products available in the market are often watched carefully but the wealth of technical information lying in the form of patents is largely ignored. It is important to note that few of the patented technologies actually come in the market, meaning that, there is a huge amount of knowledge, in the form of patents, which is not seen in the market. However, assessment of this wealth may help in various ways, such as:
It helps you to assess quality of your product and after knowing state of the art, you may further fine tune your product or add more value to it.
‘State-of-the-Art’ may reveal many interesting ways of performing a process or a method or manufacturing a product, which you would have never thought about and this actually can add lots of value to the existing product/process.
Assessment of patentability of the invention compared to state of the art becomes clear and easy.
The best thing about a patent is that the best mode of performing an invention known to the inventor is disclosed. In most of the countries, patent law expects inventor to disclose the best mode of working the inventions. Thus, most of the times the patent documents provide complete technical working of the inventions with illustrations, drawings and examples.
Based upon State-of-the-Art, if you feel that your invention is significantly better than existing patents, you might consider filing for a patent for your invention.
Infringement of patent happens when one makes, sells, offers to sale, import patented product or a product made from a patented process without permission of a patent holder. As a result of state-of-the-art search, you might come across a few patents or patent application (not been granted), that are very close to your invention. In such a case, it is worth looking at such patents in detail and check for their validity (whether they are legally enforceable or not) or to see if they have been filed or granted in the country (ies), where you intend to market your product. If there are any such patents, you need to be careful as there are chances that you might be infringing such patents.
State of art data can be represented in various forms and interpretation of such data into various graphs can provide you valuable information in terms of key players, active areas of technology, patent filing, publication and grant trends, favorable jurisdictions, international classification etc. This data may play a vital role in formulating patent strategies for the organization.
State-of-the-art is a wealth of knowledge, in fact a powerful tool that is important not only to prepare a strong base to formulate your R&D strategies but also assists in multiple ways. It is worth investing time to unfold state-of-art to create innovative, commercially viable and meaningful products to obtain a competitive edge in the market.
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In simple words, patent infringement is the violation of patent rights of a patentee in the country or jurisdiction where the patent has been granted. This violation happens when any third party, makes, uses, sells, offer for sale, a product or process claimed in the patent, granted to the patentee without his/her authorization or license. When a patent is granted, the patentee gets the right to prevent third party (ies) from making, using, selling, offering for sale or importing the patented product in the country where there is patent protection.
A business owner may violate rights of a patent with or without knowledge and therefore, it is highly recommended for business owners to examine existing patents before launching their new products to ensure that no patent rights are violated in the territory where their product is going to be launched. This investigation to assess patent infringement risk is called as Freedom to Operate (FTO) analysis or clearance search.
How is FTO performed?
Purpose of FTO search is to assess the likelihood of patent infringement upon launch of new product in a specific market. The best time to perform FTO search is at the time of designing the new product because its is easier to make changes in the product specifications and the infringement risk can be minimised or nullified easily at early stage of product development. FTO is a very specialised investigation and analysis of patent documents, done by a skilled attorney, who possesses a good working knowledge of technology as well as law. The final opinion on infringement shall always be rendered by an advocate according to the laws of the jurisdiction. Generally, following steps are taken up to perform FTO analysis:
Identification of components of the product to be launched and listing out nomenclature of the components, as generally used in the industry.
Performing a patent search with all possible synonyms of the product component names and other search techniques to pull all relevant patents. Patent search here may be global or country-specific depending on the countries in which the product is going to be launched or sold. The business owner must be very focussed and specific with respect to patent search strategies to ensure that the appropriate data is extracted.
Depending on the requirements, a history dating 20 to 22 years prior to the date of performing the search may be set as the scope of patent search because the term of a patent is 20 years and only “in-force” or live patents get infringed. Therefore, considering very old and expired patents may not be of much use for FTO search. However, expired patents may be extremely helpful to find out technologies or products for which patents have expired. Even though expired patents may not impose any infringement risk but they can certainly provide valuable information otherwise.
After the relevant patent documents are extracted, it is important to segregate them into “expired”, “abandoned” or “in-force” patents. Further, there may be a need to separate out patent applications and granted patents. If there are any risky patent applications, it is highly recommended to monitor them periodically to find out the kind of objections that the examiner raises during prosecution and to know if patent application gets granted as a patent or not.
Further, during performing FTO search, if there are any “lapsed patents”, there may be chance of restoring such lapsed patent. Therefore, the legal status of lapsed patent shall be checked periodically and the risk it imposed shall be completely ruled out only after the timeline to restore has lapsed and its legal status reflects as “Expired”.
Patents so extracted shall be studied in detail by comparing claims of the patents with product features. Generally, patent practitioners prepare claim maps where the portions of the claims with match or overlap with product components are highlighted. Based on the extend of overlap between patent claims and the product components, the patent documents may further be considered as low, moderate or high-risk patents.
How to handle high-risk patents?
In case the FTO analysis reveals high risk patents, using such patents may be detrimental for the business. Following points may be taken into consideration before using such patents:
Check expiry date of the patent. If the patent is going to expire soon, it is worth to wait for the patent to expire before using it.
Carefully read and analyse patent claims and try to understand what is claimed. Often the language used in the claims is very complex and expert advice must be sought.
Perform invalidation search to understand how strong the patent is. This search is performed to identify the grounds on the basis of which a patent may be invalidated. Generally patent search is performed to reveal closest prior art and novelty/inventive step is assessed.
Based on the outcome of invalidation search, opposition to the grant of patent, if patent is not yet granted; or post-grant opposition or even revocation may be filed. The opposition petition shall have all possible statutory grounds of opposition, which help the Controller of Patents to give decision on invalidating or revoking the patent.
In case there is no other way out, obtaining license to use the patent may be obtained from the patentee. This option may not be feasible in most of the cases as granting license is at sole discretion of the patentee.
Above listed are few ways to handle a situation where there is a high risk of patent infringement. If none of the steps work, it is advisable not to use the patent because if patentee takes a legal action, it may be detrimental for the reputation and good will of the business. In Merck vs. Glenmark case, the Delhi High Court passed an injunction against Glenmark for manufacturing the generic drug Sitagliptin and using patented product of Merck as there was prima facie infringement of patent rights of Merck. Delhi High court passed injunction order against Glenmark from manufacturing and selling of Zita and Zitamet. Thereby, patent rights of Merck were protected and enforced.
Patent infringement risk assessment and mitigation shall be integral part of steps to be followed before new product launch. FTO search can be extremely helpful to understand extent of infringement risk and to take right measure to minimise it.
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Patents are recognized as a valuable source of technology and competitive information due to the disclosure of technical and scientific information in it. Study and analysis of patent literature provides good understanding of current technological and competitive environment of any technology domain. A better insight of the patenting activity reveals a more objective approach in determining how to prioritize research and development. Research-based firms continuously seek to discover new ideas and new technologies and to translate these into unique products that can be protected from competition by patents or other intellectual property rights such as design or copyright.
In order to convert ideas into unique product one should possess solid knowledge of the market and trends in the market, also a better understanding of the competitors in the relevant field of technology. This is possible through patent mapping or patent landscaping. Patent landscaping, also known as “patent mapping” or “patent analytics” is a comprehensive state of art search, which gives past and present patent and non-patent activities of the competitors in the given area of technology. It also provides a graphical representation allowing for comprehensive analysis with an ability to link more detailed text when needed. This search is a deeper analysis of a State of Art Search, where State of Art Search is the broadest and most general of all patent searches. It is essentially a market survey that should ideally finds out what technology already exists and then build on it.
The Patent Landscape Search can identify potential patent portfolios for acquisition, existing or potential infringers to be pursued, and potential technology to be exploited. The typical Patent Landscape Analysis, Patent Mapping or Patent Analytics are customized to the client’s needs and are useful for:
Identifying the key players operating in a technology domain. This is critical for any business to know so that activity of competitors can be monitored and based on this own IP strategies can be devised.
Identifying the R&D focus of key industry players by identifying the patents and analyzing the technologies they are working in. Based on this, own R&D can be planned in a better manner.
Identifying the technology curve & trends
Identifying seed patents in a technology domain
Identifying licensing opportunities based on the identification and knowledge of technologies patented by others in particular jurisdiction. The thorough review of the valid patents can also help to minimize patent infringement risk.
Monitoring market interest
Identifying opportunistic technology gaps for licensing, development, or in a geographic area
Visualizing the most densely patented and most sparsely patented technology area
Determining the most prolific inventors
Identification of possible collaboration and acquisition and merger opportunities
Therefore, patent analytics or patent landscape can be useful for to formulate business strategists, market analyst, scientists who make key decisions in new product development, R & D planning and strategic business development in order to gain a competitive edge.
Origiin, with a skilled team of patent agents is one of the best patent companies in India offering patent services such as, patent searching and patent filing, in India and abroad.
Deliverables: Landscape report in PDF and backend data in excel sheet is provided
Timeline: 15 business days
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In this case, Medical Technologies (hereinafter referred to as MT) filed a suit for passing off against Neon Laboratories (hereinafter referred to as NL), for the use of the Trade Mark “ROFOL”, which they pleaded is deceptively similar and identical to their trademark “PROFOL”. Brief facts of the case are as follows:
MT herein had pleaded that they are engaged in business and manufacture of pharmaceutical products and medical preparation, and have acquired high reputation and goodwill in the market. That their predecessor-in-title, introduced a molecule preparation and generic drug ‘propofol’ for which the product permission was obtained from Commissioner of Food and Drugs Control Administration on 02.05.1998. That their predecessor also coined the trademark “PROFOL” in April 1998 and since then the said mark has been used for the product. In 2000 after amalgamating with the predecessor, MT became owner of the mark “PROFOL” and subsequently filed for trademark registration.
On coming to knowledge that NL introduced in the market similar product with the mark “ROFOL”, the present suit was filed by MT claiming that the mark “ROFOL” is deceptively similar and identical to their mark “PROFOL” and that the NL has been passing off its products as that of MT. The Trial Court restrained NL from using the “ROFOL” on the basis of its similarity to MT’s mark “PROFOL”, which was affirmed by the High Court on an appeal. And an appeal was preferred by NL against the decision of High Court.
Arguments
By Appellants i.e., NL
That they had obtained registration of the trademark “ROFOL” in class 5 of fourth schedule Trade Mark Rules on 14th September 2001 relating back to date of application viz. 19th October 1992.
That the date of application is relevant to present dispute as MT was not present in the market in the year 1992.
By Respondents i.e., MT
The primary contention of MT was that they were honest concurrent user of the mark “PROFOL” and that the mark had been in use since 1998 by their predecessor-in-title which was passed upon them in the year 2000 whereupon they filed for registration of the said mark. That they have acquired high reputation and goodwill and that the mark used by NL was deceptively similar and identical to that of MT’s and hence injunction was sought by them to restrain NL from passing off their product as that of MT’s.
Issues
The core issue before Hon’ble Supreme Court was that whether the prior registration will obliterate the goodwill and reputation earned by the parties? Would a deeming provision i.e., relating registration retrospectively prevail on prior user?
Judgement
The Hon’ble Supreme Court observed that to claim exclusivity trademark should not be descriptive and should normally be partake of new creation, but in pharmaceutical industry it is common for a product to be named after the molecule or salt from which it is constituted which form a favourable determinant in passing-off action.
Further, Hon’ble Supreme Court elucidated upon the rule of “first-user” and observed that this rule is seminal part of the Trade Marks Act. The court reiterated Section 34 of the Trade Marks Act, 1999 and observed that:
“This Section palpably holds that a proprietor of a trade mark does not have the right to prevent the use by another party of an identical or similar mark where that user commenced prior to the user or date of registration of the proprietor. This “first user” rule is a seminal part of the Act. While the case of the Plaintiff-Respondents is furthered by the fact that their user commenced prior to that of the Defendant-Appellant, the entirety of the Section needs to be taken into consideration, in that it gives rights to a subsequent user when its user is prior to the user of the proprietor and prior to the date of registration of the proprietor, whichever is earlier. In the facts of the case at hand, the Defendant-Appellant filed for registration in 1992, six years prior to the commencement of user by the Plaintiff-Respondents. The Defendant-Appellant was, thus, not prevented from restraining the Plaintiff-Respondents’ use of the similar mark PROFOL, but the intention of the Section, which is to protect the prior user from the proprietor who is not exercising the user of its mark prima facie appears to be in favour of the Plaintiff- Respondents.”
And thus, it was held by court that reluctance on part of NL to use the mark and to restrain MT from using similar mark could be interpreted as an indication of abandonment of the mark. And, that the MT had been using the mark well before any attempted use by NL. The Court affirmed with the observation of lower courts and subsequently injunction was grated in favour of MT.
The most significant aspect of a patent specification is unquestionably the patent claim. A patent claim concisely defines what the invention claims and what is to be protected. In other words, patent claims specify the scope of the invention. Every patent application must have carefully phrased claims, as claims are very important in litigation. Notably, a claim is typically phrased as a codified statement of technical facts indicating the extent of the invention claimed to be protected. A patent claim specifies the novel characteristics in the patent application that the inventor wishes to protect.
Anatomy of a Patent Claim
A patent claim comprises three essential parts: the preamble, transitional phrases, and the body of the claim.
Preamble: This section specifies the type of invention for which the patent is being applied, such as a method, process, apparatus etc. The preamble should always be consistent with the title of the invention. For example, if the applicant wishes to patent a method/assembly/system, the preamble will begin like, “A method for…”
Transitional Phrases: The transitional phrases indicates whether the claim is restricted to the elements stated or whether it may apply to products or processes that have other elements. In other words, they are typically the statements that convey the idea that the claim is either limited to the items specified or encompasses more procedures with additional attributes. Some examples of transitional phrase are, comprising of, wherein, consisting of etc.
Body: This section of the claim includes all constraints and aspects of the claim and illustrates their relationship.
Preamble Transitional Phrase Body of the Claim
A bed sheet tensioning device comprising [a resilient strap with releasable fasteners at each end thereof, each of the releasable fasteners being adapted to fasten the strap to the cloth material of a bed sheet by gripping the cloth material without any part of the fasteners being included on the cloth material]
Different types of patent claims
Types of claims based on drafting
Independent Claims: Due to their ability to precisely define the distinguishing quality, they are also referred to as “primary claims.”. Independent claims are “stand-alone” claims that do not refer to any other claim. Independent claim includes a preamble and all the details required to describe the invention. The first claim, generally stands alone, establishes the level of protection that the invention is claiming. To prevent possible infringers from evading the independent claim in any way, independent claims are often more expansive than dependent claims.
Dependent claims: These claims are so called because they relate back to a prior independent or dependent claim, thereby limiting the applicability of the earlier claims. The scope of dependent claims is generally less than that of the claim upon which they are based such as independent claim. It occasionally might include well-known characteristics, even minor details and optional innovative elements of the invention.
Types of claims based on invention field
Jepson claims: The preamble of a Jepson claim describes a prior art statement, which is followed by claims that represent an improvement over the prior art. In an overview, it elaborates on the point of the invention’s uniqueness in comparison to previous art in a specific domain. Jepson claims are the most common in US patent law.
Markush claims: A Markush claim is a type of claim that is used to prevent the creation of new claims. A Markush claim allows a patent drafter to select a specific element of the invention from a group of features that all share some common characteristics.
Swiss-type claim: This type of claim is used when a previously unknown compound or substance is to be patented for a new medicinal use. In other words, this is a resurrected claim format intended to include the first, second, or subsequent medical utilisation of a well-known composition or substance.
Types of claims based on invention
Product claim: A product or apparatus claim addresses an invention’s structure or functionality. A product claim, for example, can define the components of a new device, the structure of an electrical device, or the functional components of an equipment.
Process claim: A process or method claim describes how you do something, such as perform a task, develop a product, or process the data. For example, the manner you process specific materials to form a product, encode and decode data within a particular context, or perform image recognition using an imaging system are all examples of processes which may be described with a process claim. Software and corporate approaches also fall into the process claim category.
Types of Claims based on structure
Composition claims: These claims are frequently made when an innovation relates to the elemental composition of any component or material.
Mean-plus-function claims: These claims make no reference to the precise design of the invention. Further, the mean plus function claims provides instructions on how to carry out the desired function. In a mean-plus-function claim, the element in the claim can be expressed in terms of the steps necessary to carry out a function. Additionally, the scope of these claims is broad enough to encompass all the components or structures described in the application.
Patent claims are perhaps the most significant aspect of any patent application. As a matter of fact, when drafting a patent claim, the patent drafter should always consider taking extra care and attention. The more precisely the patent claim is documented, the easier it is to defend the invention against potential infringers. The technical aspects of the invention should be stated as thoroughly as possible in the claims. Drafting a patent is a challenging task, and failure to do so properly can arise in a delay in grant, or even rejection. To avoid such disruptions, one should seek the advice/assistance of patent experts to attain a thorough understanding of preparing claims that provide better protection.
By: Dr. Paridhi Malhotra
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A limited liability partnership (LLP) is a partnership company in which the partners have limited liabilities, and each partner is not responsible or liable for another partner’s misconduct or negligence.
Steps to register a LLP in India are as below:
Step 1: Getting Digital Signature Certificate (DSC)
The first step towards registering LLP is to acquire the digital signatures of all the designated partners of the LLP since the LLP’s documents are filed online. Digital signatures can be obtained from certified government agencies, such as National Informatics Centre, IDRBT Certifying Authority, E-MUDHRA, CDAC and NSDL. The cost of acquiring a DSC depends upon the certifying agency that the applicant has applied for.
Step 2: Reserving the Name of LLP
To register a LLP, the applicant needs to get a Limited Liability Partnership-Reserve Unique Name (LLP-RUN) that can be processed at the Central Registration Centre. However, before citing or quoting the name, it is always advisable to check from the Ministry of Corporate Affairs (MCA) portal for a free name. This will provide a list of companies with the same or similar names to a proposed LLP. Once the name has been chosen, the registrar will approve the name that is not very similar to any existing LLP. The LLP-RUN will need to be submitted along with a fee that will then proceed for the approval of the registrar.
Step 3: Incorporation of LLP
Form for incorporation of Limited Liability Partnership (FiLLiP) is required to be filled and submitted with the registrar for incorporation of LLP. Prescribed fees have to be paid as per Annexure ‘A’. Application for allotment shall be permitted to be made by 2 individuals only.
This agreement governs the mutual rights and duties amongst the partners. The agreement can be filed in form 3 online on MCA Portal. From the date of incorporation, Form 3 for LLP agreement has to be filed within 30 days. LLP Agreement has to be printed on Stamp Paper, wherein every state has their different stamp paper.
It takes approximately 15 days to get DSC and Form 3, subject to availability of all the documents.
Documents Required for LLP Registration
The documents required to register your LLP are roughly the same as required for most business set-ups. However, there are two sets of documents that will need to be submitted for the LLP registration i.e. documents required of partners and the LLP documents.
Documents of Partners
All partners in the LLP will be required to submit the following documents:
Identity proofs and PAN cards of all partners.
Address Proofs of partners that includes Voter ID, passport or driving license.
A passport size photograph against a white background.
Passports of NRIs and foreign nationals who wish to become partners in an LLP.
Documents to be submitted
Documents related to the LLP entity that need to be compulsorily submitted are:
A proof of the registered office of address needs to be submitted at the time of registration or within a time span of 30 days of the incorporation of the LLP. In case, the registered office is a rented facility, an NOC from the landlord is necessary. Additionally, at least one proof of residence will need to submit such as utility bills that are no older than 2 months.
A Digital Signature Certificate (DSC)
Cost of LLP registration
Find below the cost involved in the registration process:
DSC – Around Rs. 1500-2000 for 2 partners Name Reservation – Rs. 200 Incorporation – Depends on capital contribution
Contribution up to Rs. 1 lakh – Rs. 500 & Contribution between Rs. 1 and 5 lakh – Rs. 2000 LLP Agreement -Depends on capital contribution.
Contribution up to Rs 1 lakh – Rs 50 for filing Form 3 and stamp duty based on the state where LLP is formed
Limited Liability Partnerships in India
Limited Liability Partnerships in India are based on the Limited Liability Partnership Act of 2008. The Limited Liabilities Partnership Act 2008 was officially published on the 9th of January, 2009 in the official Gazette of India and has been effective since 31st March, 2009. The rules constitutive of this act were later published on the 1st of April, 2009 and amended in 2017. The official incorporation of the LLP happened on the 2nd of April, 2009. An LLP is attractive for many new entrepreneurs since the cost of forming an LLP is little; there is no minimum capital contribution and very few compliance regulations as compared to other kinds of business enterprises. Like many entrepreneurs seeking to become part of an LLP or set it up, you can avail of a range of business loans that will help you in starting a new business or for business expansion purposes.
The total time for registering an LLP is approximately 15 days. The minimum members should be 2 whereas there is no upper limit of members in LLP.
A patent is one of the most important forms of Intellectual Property Rights (IPR) and can be defined as a set of exclusive rights granted by the Government or a sovereign state to an inventor or assignee for a limited period in exchange for detailed public disclosure of an invention. Patents are granted to the inventions that are novel, inventive and industrially useful. Additionally, the subject matter shall not fall under category of “Inventions not patentable” and the patent specifications shall fulfil the statutory requirements that describe contents of the specifications and manner, in which a patent application is to be submitted. In order to get a patent, the inventor or applicant has to describe the invention in a prescribed format and submit to respective patent office, and upon thorough due diligence and scrutiny, the patent is granted, provided it fulfils statutory requirements. Once the patent is granted, patent holder or patentee gets right to exclude everyone else from making, using, selling, offering for sale and even importing the product or process that uses patented invention.
Now, when the patent is granted, though, patent holder gets a set of rights to prevent other from using the patented invention, grant of patent comes with a set of duties and obligations. After getting a patent, it becomes duty of the patent holder to work the invention, himself or by means of granting a license to third party (ies) because the sole purpose of having a system of patents is to ensure that the inventions are worked in India on a commercial scale and to the fullest extent without any undue delay and patented product is available to the public. In fact, Section 146 of the Indian Patents Act 1970 requires every patentee to disclose every year, the extent to which he/she has commercially “worked” his/her patent. Additionally, having set of rights in the form of patents should also ensure that patentee is not abusing the rights, especially in case of pharmaceutical patents, where the subject matter claimed a patent, may pertain to a lifesaving drug, it becomes critical to ensure that drug is available at affordable price and sufficient quantity to cater market needs.
The history of compulsory license goes back to the time when Africa was in the grip of HIV/AIDS epidemic and the patents for Anti-Retroviral (ARV) drug combination were in hands of few leading pharmaceutical companies such as Glaxo, Merck and SmithKline etc. ARV is one of the most effective drug combinations to not only suppress the HIV virus and but also stop the progression of HIV disease. As these companies had patents on the drugs, they also had right to prevent all other companies from making, selling, offering for same and importing the drug in the territory of Africa. This kind of exclusivity extended by the patent sometimes results in complete monopoly and abuse of patent rights by the patentee. In this case, these multinational companies were exclusively marketing the drugs at exorbitant prices of $10,000 per patient per year, which was unaffordable for majority of patients.
In the meantime, looking at the opportunity to cater needs of patients, Cipla, an Indian Pharma company offered to manufacture and sell a generic version of the drug at about 3 % of the price. The African Government started to procure the drugs from Cipla mainly because of low price and quality, for which it was sued by drug multinationals for violating their patent rights. One important point to be noted here is that Africa is a country with little or no drug manufacturing capacity and therefore, it had to solely depend upon importing the drug from outside. However, the multinationals in this case were forced to withdraw the suit due to an outrage by the international community.
This incident became an issue in international forums like WHO, UN, UNCAD and WTO Ministerial conference at Doha, Qatar on 14th November 2001. In the fourth Ministerial conference at Doha, the issue of pharmaceutical patent and public interest was taken up and a declaration was made on “TRIPS Agreement and Public Health”. Its purpose was to respond to the concerns that have been expressed that the TRIPS Agreement might make some drugs difficult to obtain for patients in poor countries.
Doha Declaration constituted a milestone in the TRIPS Agreement for two reasons because:
It ensures balance between public health and patent rights, and
Sets forth a clear preventive standard
According to Section 83 (General principles applicable to working of patented inventions) of Indian Patents Act 1970, there has been emphasis on “Working of the patents” which means that the patented invention shall be commercialized in order to meet reasonable requirements of the public and patented products are available at reasonable price to the public. Patents are granted to the inventors for the purpose of encouraging inventions as well as to enhance industrial development and, therefore, should be worked in its fullest extent within the territory of India. The patents are not granted merely to enable patentees to enjoy a monopoly for the importation of the patented article, but the invention shall be worked commercially to meet demands of the public. The patents granted shall not delay protection of public health and nutrition and should act as instrument to promote public interest, especially in sectors of vital importance for socio-economic and technological development of India. The patent rights should not be abused by the patentee and the patentee shall not resort to practices, which unreasonably restrain trade or adversely affect the international transfer of technology. The patents are granted to make the benefit of the patented invention available at reasonably affordable prices to the public.
if the patentee is not commercializing the invention and because of that, the reasonable requirements of the public are not met or the patented product is not available to public at reasonable price, the compulsory license is available as a remedy against abuse of patent right. The provisions for compulsory licenses are made to prevent the abuse of patent as a monopoly and to make the way for commercial exploitation of the patented invention by an interested person. Compulsory licensing is granted by the Government to produce the patented product or process without the consent of the patent owner. With respect to the pharmaceutical industry, the compulsory license attempts to strike a balance between promoting access to existing drugs and promoting research and development into new drugs.
If the invention is not commercialized for 3 years or in case of national emergency or urgency, the compulsory license may be granted to the person who requests the controller for the same. After thorough assessment of entire situation such as necessity and demand of commercializing the invention, capacity of the applicant to manufacture the patented product or process, the Controller may grant compulsory license. The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) also sets out specific provisions that shall be followed if a compulsory license is issued. All significant patent systems comply with the requirements of TRIPs.
Section 84, 92 and 92A are the three main provisions that talk about compulsory license. According to section 84 (Compulsory License) of Indian Patents Act 1970, if patentee doesn’t commercialize the invention for 3 years, any person interested can request the Controller to grant him a compulsory license in order to manufacture and commercialize the patented invention so that reasonable requirements of the public are met and the product is available to the public at reasonable cost. The application for compulsory license under Section-84 can be filed only after expiry of 3 years from the date of grant of the patent.
According to Section 92 (Special provision for compulsory licenses on notifications by Central Government), if the Central Government is satisfied that it is necessary that compulsory licenses should be granted at any time after the sealing of patent to work the invention, it may make a declaration to that effect, by notification in the Official Gazette. The compulsory license under this section is granted under following circumstances:
National emergency; or
In circumstances of extreme urgency; or
In case of public non-commercial use.
The Controller shall grant to the applicant a license under such circumstances on the terms and conditions as he thinks fit. He shall settle the terms and conditions of a license and try to secure that the articles manufactured under the patent shall be available to the public at the lowest prices consistent with the patentees deriving a reasonable advantage from their patent rights. The public health crises may be related to Acquired Immuno Deficiency Syndrome (AIDS), Human Immuno Deficiency Virus (HIV), tuberculosis, malaria or other epidemics.
Section-92A (Compulsory license for export of patented pharmaceutical products in certain exceptional circumstances) was introduced by The Patents (Amendment) Ordinance, 2004 which came into force on 1st January 2005, to provide for grant of compulsory license by the Controller for export of patented pharmaceutical product in certain exceptional circumstances, where compulsory license has been granted by the country to which the export is intended. This provision is introduced to address the public health concerns of the countries having insufficient or no manufacturing capacity in the pharmaceutical sector to implement the decision of the TRIPS council on Para 6 of the Doha Declaration on TRIPS Agreement and Public Health. This section lays down the conditions that are required to be fulfilled, when the compulsory licenses for export purposes will be available. The compulsory license is available only for:
(a) The patented pharmaceutical product;
(b) Manufacture and export to any country having insufficient or no manufacturing capacity in the pharmaceutical sector and
(c) The product addressing the public health problems in such country.
Compulsory license is available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems. Such country shall permit importation of the patented pharmaceutical products from India by notification or otherwise. On receipt of an application in the prescribed manner, the Controller shall grant a compulsory license solely for manufacture and export of the concerned pharmaceutical product to such country under such terms and conditions as may be specified and published by him.
The term ‘pharmaceutical products’ used in this section means any patented product, or product manufactured through a patented process, of the pharmaceutical sector needed to address public health problems and shall be inclusive of ingredients necessary for their manufacture and diagnostic kits required for their use.
Compulsory license once granted under certain circumstances such as national emergency or extreme urgency expires when the circumstances under which it was granted do not exist anymore. While considering an application for termination of compulsory license, the Controller shall take into account that the interest of the person who had been granted the license is not unduly prejudiced.
March 2012 , Indian Patent Office granted its first compulsory license to a domestic generic drug-maker, Natco for anti-cancer drug called Nexavar. German pharmaceutical company Bayer AG had monopoly over an anti-cancer drug, and it authorized the production of a low-cost version for the Indian market. Under Section 84 (1) of the Indian Patent Act 1970, any person may request a compulsory license if, after three years from the date of the grant of a patent, the needs of the public to be covered by the invention have not been satisfied; the invention is not available to the public at an affordable price; or the patented invention is not “worked in,” or manufactured in the country, to the fullest extent possible.
Bayer acquired an importing license for the drug Nexavar (sorafenib tosylate) in 2007 but, according to the Indian Patent Office‘s decision, the Bayer did not begin importing the drug to India in 2008 and only small quantities were available during the following two years. Bayer “took no adequate or reasonable steps to start the working of the invention in the territory of India on a commercial scale and to an adequate extent,” the decision notes. The drug was found to be exorbitantly priced and out of reach of most of the people. ” the patent authority wrote in its 62-page decision. “The product in question is not a luxury item but a lifesaving drug and it is highly important that a substantial part of the demand be met strictly. In the present case, even 1 percent of the public doesn’t derive benefit of the patented drug.[1]”
In its compulsory license request, Indian generic manufacturer Natco proposed selling sorafenib tosylate at Rs. 8,800 per patient per month, approximately US $175, resulting in a 97 percent price cut compared to Nexavar. The Indian Patent Office also said that Natco must pay royalties to Bayer on a quarterly basis at the rate of 6 percent of the net sales of the medicine.
Compulsory license is a kind of permission or license granted by controller of patents with respect to the working of the invention. This is one of the effective remedies to keep drug price under control and ensure that the drug is available to public at affordable price in the territory of India and balance between patent rights and public health is maintained well.
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Amritdhara Pharmacy Vs. Satya Deo Gupta (AIR 1963 SC 449)
Satya Deo Gupta (hereinafter referred to as Respondents), in this case, had filed application for registration of the mark “Lakshmandhara” in 1950 under class 5 of fourth schedule of Trademark Rules, 1942. Averments were made that they were honest user of the mark since 1923 and that their products were sold not only in India but in foreign market as well. Amritdhara Pharmacy (hereinafter referred to as Appelant) objected the application on the grounds that they were user of the mark “Amritdhara” since 1901, the name “Amritdhara” has acquired commendable reputation throughout India and the composite word “Lakhmandhara” was used to denote the same medical preparation as that of “Amritdhara”. The registration of mark “Lakshmandhara” by respondent is likely to deceive and cause confusion and thus the registration of the mark should be refused. In response to this a counter affidavit was filed by the Respondents claiming that they were honest user of the mark and that their mark does not deceptively resembles with that of appellant’s mark. The Respondent further alleged that the single word ‘dhara’ had no particular significance in relation to the medicine, nor did that word mean or convey any special or exclusive meaning or effect in relation to the medicine.
Proceedings
Primarily there were two issues involved in this case which were disputed before Registrar of Trade Marks, High Court and Supreme Court which are:
Whether the mark “Lakshmandhara” closely resembles with the mark “Amritdhara” and is likely to deceive public.
Whether there was any acquiescence on behalf of Amritdhara Pharmacy for the use of mark “Lakshmandhara” as contended by the Respondents.
Before Registrar of Trade Marks
As to the first issue, on the basis of evidence produced before it, Registrar held that there is sufficient similarity between the mark of Appellant and mark of Respondent so as to deceive and cause confusion among public. Had it been only the matter of trademark infringement, Registrar would have no hesitation in allowing opposition.
As to the acquiescence registrar found in the favour of Respondent as the advertisement for both the marks were made through same media and it cannot be said that the Appellant did not had knowledge of use of mark by the Respondent. And on the basis of circumstances Registrar allowed for registration of the mark “Lakshmandhara” for sale in the State of Uttar Pradesh only.
On such decision of Registrar two appeal were sought by Appellant and Respondent respectively before High Court.
Before Allahabad High Court
As to the honest concurrent use, the Court held in the favour of Respondent, but on the issue of acquiescence they held in favour of Appellant. They observed that from the fact that both the medicines were being advertised in the same journals or periodicals it did not follow that the attention of the appellant was drawn to the use of the word ‘Lakshmandhara’ by the respondent. Hon’ble High Court allowed for registration of mark “Lakshmandhara” throughout India and observed that:
“There is no possibility of any Indian confusing the two ideas. Even phonetical differences are wide enough not to confuse anybody. The claim of the Amritdhara pharmacy that both the words ‘Amrit and dhara’ have become so associated with their goods that the use of each part separately or in any combination is likely to mislead is an untenable claim. The whole phrase ‘Amritdhara’ had been registered and the monopoly has to be confined only to the use of the whole word. The words of common language like ‘Amrit’ and ‘dhara’ cannot be made the monopoly of any individual. We, therefore, see no reason to disallow registration of the trademark “Lakshmandhara”.”
Before Supreme Court
Hon’ble Supreme Court devised the test of imperfect recollection and overall impression in the appeal filed before them. As to the issue of similarity the court framed two questions i.e., (1) who the persons are whom the resemblance must be likely to deceive or confuse, and (2) what rules of comparison are to be adopted in judging whether such resemblance exists. The Court observed that the medical preparation in question is likely to be purchased by people with or without doctor’s prescription and an ordinary unwary consumer having imperfect recollection would not split the terms or even look for the etymological meaning of the two marks as observed by High Court, he would go for the overall structure and similarity. The court observed:
“A critical comparison of the two names may disclose some points of difference, but an unwary purchaser of average intelligence and imperfect recollection would be deceived by the overall similarity of the two names having regard to the nature of the medicine he is looking for with a somewhat vague recollection that he had purchased a similar medicine on a previous occasion with a similar name.”
And thus, the Court held that their exists overall similarity between two Trade Marks and High Court was erred in their observation.
On the question of acquiescence, the Hon’ble Supreme Court agreed with the observation and decision of the Registrar and thus upheld the decision of Registrar.
By Dhruv Dangayach
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There is a myriad of factors to consider when it comes to licensing. For instance, the licensor should first recognize that simply creating IP does not result in revenue. Before it can be monetized, successfully generated intellectual property must be properly secured and managed. Accordingly, the licensor must ensure that the IP is registered, renewed, and protected against infringers incessantly. IP that is well-protected reflects with a high market value. For efficient and maximum revenue of its IP, the licensor should be extremely clear on provisions of exclusivity, royalties, whether sub-licensing is allowed, cost of maintaining the IP portfolio, provisions about quality inspections, and so on, when entering into the agreement.
The licensee, on the other hand, should be aware of a few requirements seeing as it will be the entity responsible for paying royalties and licensing fees to the licensor. The licensee is responsible for conducting due diligence on the intellectual property involved in the agreement. The agreement’s success hinges on the IP’s upkeep and maintenance. To avoid conflicts, it is imperative to document all of the purposes for which the IP will be used. To avoid additional expenditures or who would have the right to develop the IP, the licensee should insist on a clear demarcation of cost sharing. For better drafting of the terms and conditions, it is necessary to understand and articulate what is anticipated from the agreement.
Besides the fundamental aspects listed above, there are legal requirements that further protect the Intellectual Property which is mandated by law.
Is registration of a licensing agreement mandatory?
The laws governing various types of IP include caveats mandating the registration of a license agreement. When a statute requires the registration of a licensing agreement, both the licensor and the licensee must corroborate enforcing that it is executed within the specified period.
Patents
A license agreement must be registered, according to the Patents Act of 1970, and a licensee must apply in writing to the Controller of Patents for registration of his title. The Patents Act of 1970, Section 68, explicitly states that a patent assignment is not legitimate unless it is in written and duly executed. It additionally reiterates that an assignment of a patent or a share in a patent, a mortgage, a license, or the creation of any other interest in a patent is not valid unless it is in writing and the agreement between the parties is reduced to the form of a document comprising all of the terms and conditions governing their rights and obligations and duly executed.
The terms of a patent license are thus obvious, and they can be summarized as follows:
It must be written down.
It must be properly executed.
Document embodying all terms and conditions regulating the parties’ rights and duties.
The provisions for registration of assignments, transmissions, and other similar acts are set forth in Section 69 of the Patents Act of 1970.
The Patent Rules, 2003, were also issued by the government, and they include the procedural aspects of patent license agreement registration. Here mentioned is a brief overview of the rule:
The application for registration of title and interest in patents must be made in Form 16 according to Rule 90 of the Patent Rules, 2003. The following documents must be presented with Form 16:
The document presenting evidence of a patent transfer, or
The document affecting proprietorship, or document producing interest, and
Two copies of the assignment or other instrument certified to be true copies by the applicant or his agent,
The Controller may also request additional confirmation of title or written consent.
The form in which the Controller shall record the details in the register is prescribed by Rule 92 of the Patent Rules, 2003.
The courts in Sergi Transformer Explosion Prevention Technologies Pvt Ltd. vs. Kumar Pratap Anil and Ors[1], entertained the issue of legality of the license or assignment agreement as evidence will be recognized only when the document has been registered with the Controller, according to Section 69(5) of the Patents Act, 1970.
The agreement will only be considered if the Controller or Court permits or directs it with grounds stated in writing.
The judgment goes on to say that if the relevant sections are read together, there is no obstacle to the licensee filing a complaint for infringement even if the licensing agreement is not registered. The admission of an unregistered agreement, on the other hand, is only at the Controller’s or the Court’s discretion. Since, the Controller’s or Court’s instructions were missing in this case, hence the Delhi
The agreement will not be considered unless it is registered, ruled by the High Court.
Trademark
The Trade Marks Act of 1999 does not require the registration of a license agreement, but it does introduce the concept of a “registered user.” Provisions have been made to allow someone other than the registered proprietor to register as a registered user for the purposes of utilising the mark in commerce. A registered user can file infringement proceedings in his or her own name under the statute.
It is recommended that the Registered User Agreement/ License Agreement be registered with the Registrar of Trade Marks, even though recording of approved usage is optional. Only registered trademarks can be used to file an application for recordal of a License Agreement/Registered User Agreement with the Trade Marks Registry, and the application must be filed within six months of the date of the license agreement. When the Registrar is convinced with the application and the required particulars, he registers the intended registered user/licensee for the goods or services with which he is satisfied. The date on which the application for registration of a registered user was made must be recorded in the register. This is when agreement becomes effective and enforceable against third parties. Within two months of the registration date, the records will be published in the Trade Marks Journal. The Registrar is also required to notify other registered users/licensees of the concerned trade mark, if any, in the prescribed manner of such licensee’s registration. The Registrar, on the applicant’s request, will take steps to ensure that information provided for the purposes of an application under this section (other than facts put in the register) is not divulged to competitors in trade.
Copyright
The License Agreement is not mandatorily required to be registered under the Copyright Act of 1957.
Design
Under the Designs Act of 2000, an application for registration of title under a license agreement must be filed with the Controller within six months of the license agreement’s execution. Unless the court orders contrarily, a license agreement for which no entry has been made in the register cannot be entered in evidence in any court as proof of title to copyright in a design or any interest therein.
Are license agreements subject to stamp duty?
Stamp duty is a tax paid to the government on a transaction, and it is charged on the instrument that records the transaction. On license agreements, stamp duty is due, and the rate of stamp duty is different in each state. Prior to executing a license agreement, it is critical to determine whether there is a merit to executing the license agreement in a specific state and obtaining reduced stamp duty rates.
Consequences of not paying stamp duty
If sufficient stamp duty has not been paid on a document, the said agreement cannot be entered in evidence for any purpose, nor can it be acted upon, registered, or authenticated, according to the Indian Stamp Act of 1899.
Considering the intellectual property licensing attract the monetizing culture, here are certain mandatory provisions required by law regarding the registration and the stamp duty applicable on the same.
Merck Sharp & Dohme (hereinafter referred as MSD), an American pharmaceutical company and subsidiary of the German company Merck. MSD filed a suit against Glenmark Pharmaceutical Ltd. (hereinafter referred as Glenmark), an Indian Pharmaceutical company for permanent injunction in regards to salts of any form of SITAGLIPTIN, an anti-diabetic drug. Delhi High Court granted the first ever permanent injunction in a patent infringement suit and upheld the validity of the MSD’s patent. This judgement was first-of-its-kind order since the enactment of the Patents Act, 1970.
MSD along with its licensee, Sun Pharmaceutical Industries Ltd., (hereinafter referred as Sun Pharma) filed a patent infringement suit against Glenmark in April 2013 for making and marketing generic versions of MSD’s anti-diabetic drug ‘Januvia’(Sitagliptin) and ‘Janumet’ (combination of Sitagliptin and metformin)
The molecule ‘Sitagliptin’ was invented by Merck. It claims the base molecule ‘Sitagliptin’ in free base form and also its pharmaceutically accepted salts thereof.
On 28thMarch, 2008 the drug was approved for marketing in India. MSD also granted a license in India to Sun Pharma which sells the drug under the brand name Istavel & Istamet.
Glenmark was restrained from manufacturing, selling, or dealing in “Sitagliptin Phosphate Monohydrate” or any salt of ‘Sitalgliptin’. They had launched the generic versions of “Januvia” and “Janumet” under the brand name “Zita” and “Zitamet” respectively.
MSD launched “Sitagliptin” in India with a reduced price equivalent to 1/5 price of that was being charged in USA in accordance with the public interest at large.
Initially the Single Judge of Delhi High Court disposed of MSD’s application seeking an interim injunction.
On appeal, the Division Bench of Delhi High Court reversed this decision and held MSD’s patent to be prima-facie valid and infringed by Glenmark’s products.
After that, Glenmark challenged this order before the Supreme Court.
Issues
The main issues before the Hon’ble Court were:
Whether Glenmark’s manufacture and sale of Sitagliptin Phosphate Monohydrate infringe the said patent (Patent No. IN 209816)?
Whether MSD’s patent ‘Sitagliptin’ (Patent No. IN 209816) is valid?
Arguments
By Plaintiff i.e., MSD
MSD alleged that Glenmark’s products infringe its patent i.e., the Sitagliptin molecule. The sitagliptin phosphate monohydrate salt is sold under the trademarks Januvia, by MSD and Istavel, by its licensee Sun Pharma. Similarly, combination of metformin and Sitagliptin is sold under Janumet and Instamet respectively.
Sitagliptin and its pharmaceutically acceptable salts are specifically claimed by Claim No. 19 of the suit. They further stated that ‘Januvia’ was launched at a very low price, roughly 1/5th of its price in the US paying special regards to public interest.
They further contested that Section 48 of the Indian Patents Act, 1970 extends exclusive rights to exclude others from making, using or offering for sale of products which fall within the scope of a suit claim.
They stated that Glenmark is selling Sitagliptin Phosphate Monohydrate under the brand name “ZITA” which cannot be prepared without the active ingredient Sitagliptin molecule. Hence, infringes the patent in question. (Patent No. IN 209816).
They argued that Sitagliptin was the invention and Sitagliptin Phosphate was merely a derivative of the invention and therefore wasn’t eligible for patent protection under Section 3(d) of the Patents Act, 1970. Hence, MSD abandoned the phosphate salt application.
By defendant i.e., Glenmark
They contended that the products sold by them are not covered by the said patent (Patent No. IN 209816). They claimed Sitagliptin Phosphate Monohydrate is a different chemical entity with different physical and chemical properties.
MSD did not pursue the application in respect of Sitagliptin Phosphate Monohydrate in India and voluntarily abandoned the same, thus resulting in Sitagliptin Phosphate Monohydrate being in the public domain.
They argued that the invention lacked an inventive step under Section 64(1) (f) of the Patents Act, 1970 and there was insufficient disclosure regarding the preparation of Sitagliptin base within the meaning of Section 64(1) (h).
They contended that the drugs “Zita” and “Zitamet” are beneficial to the public at large because of their low price. They alleged MSD for overcharging the customers by charging same for “Janumet” and “Istamet” regardless of potential of tablets.
Judgement
Court relying on various judgements held that:
“On 7th Oct, 2015, the Hon’ble Supreme Court upheld the decision of Delhi High Court and also took cognizance of the “commercial” nature of the matter. An expedited trial ordered by Delhi HC resulted in disposal of the law suit within 5 months from the date of order. The whole case was decided within 2 years. The Delhi High Court judgement smothered Glenmark by a decree of permanent injunction from making, selling, distributing or using, etc. and any dealings in Sitagliptin Phosphate Monohydrate, infringing the patent in question. The Court held that since the patent relates to an invention of a chemical molecule/compound in the medical filed it must be analyzed by technical experts as well. The court conceded with MSD’s argument that the conversion of salt to a free base and then to another salt is a very basic chemical transformation and hence the patent claims Sitagliptin and all its pharmaceutically acceptable salts. It also observed that the disclosure in the suit patent is not for a lay person but is addressed to a person of ordinary skill. Further, the provisions under Section 64 of the Patents Act, 1970 make it clear that the court may or may not revoke the patent in the given facts and circumstances of the case. The court gave a lot of weightage to expert testimony in this highly technical matter. On the question of lack of industrial applicability the court holds that Sitagliptin free base is the moiety that possesses the therapeutic effects claimed. The court also stated that in Glenmark’s drug there is no material effect. The Delhi High Court conclusively held that all the three ingredients i.e., prima facie, irreparable injury and balance of convenience for passing the order of injunction were established by MSD and hence injuncted Glenmark from manufacturing and selling of Zita and Zitamet.”
One-of-its-kind order was passed by the Hon’ble Supreme Court, which involved cross-examination of seven witnesses. This decision indicates that the Indian judiciary enacted Commercial courts; Commercial division- is cognizant of the urgent need for a proper, effective and efficient system to safeguard all intellectual property.
A patent landscapeis an analysis of patent data for a particular technology, product company (ies) in specific countries within a given time frame that reveals valuable business, competitor, scientific and technological trends. Landscape reports generally focusses on a product, industry, competitors, technology, specific time period or geographic region.
Based on the output required, parameters are fixed for Patent Landscape and Patent Landscape Report (PLR) is prepared with pictorial and graphical representation of the data obtained. Patent landscape Report provides a comprehensive snapshot of the patent trends and hence useful for the businesses, especially when new markets are to be explored for the business or research in new areas is to be planned.
State of the art (SOA) or Patent Landscape Search are the terms which are used inter-changeably in the industry, however the main difference is that patent landscape report is more detailed and deeper. State of the art is the broadest among the other types of patent search, wherein a state-of-the-art search is essentially a market survey which is performed to identify the existence of similar technologies in the market. This search also provides findings regarding the competitors and indicates the trend of technology in the domain of interest.
Patent Landscape is specifically useful at the time of:
Starting research in new areas of technology and companies need to understand the trends, active research areas and status of patents available.
Exploring new markets for business, with respect to specific product (s). The patents so obtained to perform prepare patent landscape report may also help to give idea about potential patent infringement risk.
Getting to know patent filing activities of the competitors because after filing patent application, it gets published on official website of patent office of given country. Compilation of published patent applications and granted patents helps companies to understand the patent filing trends and active research areas of their competitors.
Innovations that are happening in a specific area of technology. This can be understood well with respect the a given period of time or based on specific country (ies).
Assess the research happening in a given area of technology which also sometimes opens up opportunities in terms of IP licensing as well as Merging & Acquisition.
Depending upon findings of technology landscape analysis, an appropriate IP & business strategy which is compliant with the company’s business strategy may be devised and implemented. Technology landscape is performed in following steps:
Step 1: Before starting patent landscape it is important to define scope of landscape and the output expected. There is so much data available that if scope is not defined well, volume of the patents extracted becomes difficult to manage.
The timeline shall be fixed carefully depending upon how old patents are required to be analysed
List out the parameters required, such as, top patent filing companies, country wise trend for a product
Step 2: Formulate appropriate key words and search strategies to extract right and appropriate patents
Step 3: Categorize the extracted patents based on parameters and output expected.
Step 4: Compile the data obtained into graphical representation for easy understanding
Step 5: Write description of each parameter taken into consideration and prepare the final report
Origiin, with a skilled team of patent agents is one of the best patent companies in India offering patent services like, patent searching and patent filingin India and foreign countries.
Deliverables: Patent Landscape report in PDF along with all prior art search data in excel sheet
Timeline: 3 business days
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Patent valuation can be defined as a method to determine the real market value of patents. It is important as it plays a crucial role during many transactions such as negotiating deals, procuring investments, identifying strengths and weaknesses of the enterprise, technology transfers etc.
Important elements used to determine the value of a patent are –
NPV (Net Present Value);
Forecast of future value (growth options);
Financial model to estimate cash flows from the patent.
The market today provides for three main approaches to value patents as provided in the table above. However, it has been acknowledged that factors such as the nature of the transaction (whether by assignment or licensing), desired result, realistic growth opportunities and the expenditure on research and development of the patent must be kept in mind while selecting which approach is most suitable.
The two broad classifications of valuing patents are through the quantitative and qualitative approach where one uses numeric and economic data. The other analyses the opportunities and the risks associated with the patent. A mixture of the two, or popularly known as the hybrid model of patent valuation, is in much demand. It provides for a holistic approach to understand all the aspects of income generation from a patent. The same will be discussed towards the end of this article.
The popular methods to assess value of the patent are as below:
Market ApproachMethod
As the name suggests, this approach takes into consideration the amount of money that a buyer is willing to pay for a similar patent in an already existing market. This method is also known as the comparable transaction approach. The assumption that this approach is based upon which the value of the patent is equal to the amount that a buyer is willing pay to a seller of a similar patented product. The shortcomings of this approach are finding a comparable patent in the market and the ability of such a comparable patent in income generation would not be the same as the patent being valued.
The following components are required to use this approach of patent valuation –
An active marketplace with available price information;
An identical or a group of identical patents in the market;
A method to control the variables or differences.
2. Income ApproachMethod
The income approach is also known as the Discounted Cash Flow (DCF) approach. It estimates the overall profit that a patent can generate. Most commonly, the value of the patent is based on company-specific profit projections and the use of a risk premium. The projected revenue inflow of the patented technology is discounted by variables such as the risk premium to ascertain the present value of the patent. The value attainted is considered to be the market value of the patent. The drawback of this approach is that the values used in the first place to derive at final market value can be clouded by subjective bias and manipulation.
The following components are essential to this approach:
An estimate of the revenue inflows generated by the patent during its useful life;
Measuring direct costs relating to the patent which are to be deducted against the revenue inflows;
The amount of risk associated with the patent must be discounted or deducted from the present-day value of the patent.
3. Cost ApproachMethod
In this approach a patent is valued based on the amount of cost incurred to develop a similar patent either internally or externally. The historical rates trending in the market or the estimate of the cost of creation (based on current market conditions) serve as a basis to come up with the required cost estimate. It seeks to determine the value of a patent at a particular point in time by summing up the direct expenditures and opportunity costs involved in the development of the patent and considering its obsolescence. The most obvious shortcoming of this approach is that it does not consider the income-generating nature of a patent, which can and in most cases, is the primary reason to create a patent.
The following are the components required to carry out this approach:
An estimate valuation of the cost of development of a patent;
Value of expenditures, opportunity costs, inflation etc. at a particular point of time;
Costs related to obsolescence of patent over a period of time.
4. Hybrid Model
A hybrid model would consist of factors envisaged in all of the above approaches. It included features of both qualitative and quantitative nature. This model aims to customize the patent valuation to the exact nature of the transaction that it aims to participate in. This approach has also been known to have the most practical use and has become an upcoming in the current market.
The following elements are essential to this model:
The size of the market and the share of the technology concerned;
The annual turnover that is generated by the patented technology;
The profit derived after applying tax and other duties;
The risk value that should be discounted;
If the patent is a part of a product, then the value of how essential it is to the product.
Conclusion
No method of valuation can predict the value of a patent with 100% accuracy but valuing patents have become crucial to companies due to their ability to generate capital, attract profitable partners, enabling licensing and franchising business models and their relevance in solving disputes. Thus whichever mode of valuation that a company uses should have a nexus with the ultimate objective that the company has for the patent. Many companies often use two approaches together such as the income approach and the cost approach to obtain a more holistic view; further customization is possible and should be incorporated for such valuations in the future.
Technology transfer in simple words means a process wherein owner of the technology transfers its skills, knowledge, and know-how to another party. In return owner of the technology often gets royalty which is determined based on various parameters, such as, market value of the technology, the effort needed to implement technology and initial investment etc. However one of the extremely important parameter that is to be taken into consideration is whether the technology has legal protection in the form of patent or not, though there might be possibility of protection in the form of trademark, copyright, design as well.
If worked out well, technology transfer is an extremely effective way to commercialize the patented invention. It plays an important role as a catalyst for the further development of technology and patents play a very vital role in case of technology transfer because patent is one of the best ways to protect a technology. Technology transferred without even filed for a patent is a very risky affair. At least a patent application for the technology should have been filed before negotiating on technology transfer for the reason that after grant of the patent, the certificate obtained from the patent office serves as a proof of ownership. A Patent also confers certain statutory rights to the patent holder that the technology transfer process.
Technology transfer happens by means of executing an agreement between owner of technology or Patentee and the buyer. Practically speaking, taking a patent to the level of technology transfer is a very big challenge where strength and value of the patent shall be assessed vigilantly and at the same time it is important for the patent holder to examine capacity of the buyer to manufacture, market and sell his patented invention. Technology transfer is beneficial to the patentee because he gets a channel to commercialize his invention and still have ownership of the patent with him. For the buyer, getting access to patented technology can give him cutting edge over his competitors.
Though the process of technology transfer is not as simple as it sounds, there are various success stories. As reported by The Chronicle of Higher Education, in academic research in the 2011 fiscal year, Northwestern University earned the most of any institution reporting, with more than $191-million in licensing income. The revenue mainly came from the invention related to new breeds of wheat, a new drug for the treatment of HIV, and from longstanding arrangements over enduring products like Gatorade.
Having a patent is one of the essential pre-requisites before transfer of technology though there are several other factors that determine fate of the invention to be commercialized by means of technology transfer. Well negotiated agreement between patentee and buyer can lead to a real profitable and symbiotic relationship.
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The word corona represents crown. The term coronavirus was coined in 1968 for the virus which resembled a solar corona, the bright crown-like ring of gasses surrounding the sun that is visible during a solar eclipse.
Corona Virus are a group of RNA virus which affects the mammals and birds. In mammals, the attack and effect the respiratory tract causing infections, that can be mild to severe to lethal. Mild illnesses in humans include some cases of the common cold (which is also caused by other viruses, predominantly rhinoviruses), while more lethal varieties can cause SARS, MERS, and COVID-19. In cows and pigs, they cause diarrhea, while in mice they cause hepatitis and encephalomyelitis. Corona viruses constitute the family of Coronaviridae, order Nidovirales and realm riboviria. Corona Virus have been said to have existed for around 8000 BCE. The Human Corona Virus have their origin in Bats. Coronavirus can have cold with major symptoms, such as fever, cough and sore throat.
In total six species of corona viruses are known till date, in which one strain is divided into two different strains making it a number of seven. Three human coronaviruses produce potentially severe symptoms:
Severe acute respiratory syndrome coronavirus (SARS-CoV), β-CoV (identified in 2003)
Middle East respiratory syndrome-related coronavirus (MERS-CoV), β-CoV (identified in 2012)
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), β-CoV (identified in 2019)
These cause the diseases commonly called SARS, MERS, and COVID-19 respectively.
Leading Manufacturers of Corona Virus or Covid-19 vaccines
Vaccine and vaccination are derived from Variolae vaccinae (smallpox of the cow), the term devised by Edward Jenner (who both developed the concept of vaccines and created the first vaccine) to denote cowpox.
Abstract of patent: The present invention provides recombinant adenoviral vectors, immunogenic compositions thereof and their use in medicine, and methods for generating recombinant adenoviral vectors. In particular, the present invention provides an adenovirus vector comprising a capsid derived from chimpanzee adenovirus AdY25, wherein said capsid encapsidates a nucleic acid molecule comprising an exogeneous nucleotide sequence of interest.
Contact Information: University of Oxford, University Offices, Wellington Square, Oxford, OX1 2JD, United Kingdom, Telephone: +44 1865 270000, Fax: +44 1865 270708
Kind of vaccine: A VIRAL VECTOR VACCINE, adenovirus vectors rAd26 and rAd5, which promote the delivery of antigens to the human body, to promote the immune response.
Patent Number: The Russian patent RU2720614C1 has already been internationalized through application WO2021002776A1 and in the future patent protection in other countries should be requested.
Abstract of the patent: FIELD: Biotechnology, immunology, virology. SUBSTANCE: The invention relates to the field of biotechnology, immunology and virology, in particular to an immunobiological agent for the prevention of diseases caused by the severe respiratory syndrome virus SARS-CoV-2. Also, a method is disclosed for inducing specific immunity to the SARS-CoV-2 virus, comprising administering one or more immunobiological agents to the mammalian body for the prevention of diseases caused by the severe respiratory syndrome virus SARS-CoV-2. The invention allows to effectively induce an immune response against SARS-CoV-2 virus. EFFECT: the invention allows to effectively induce an immune response against SARS-CoV-2 virus.
Contact Information: The Russian Direct Investment Fund (RDIF) Capital City, South Tower, 7th 8th floor 8 bid. 1 Prsenenskaya nab, Moscow, Russian 123112, T- +7 495 644 3414, F- +7 495 644 3413
Abstract of the patent: The disclosure relates to respiratory virus ribonucleic acid (RNA) vaccines and combination vaccines, as well as methods of using the vaccines and compositions comprising the vaccines.
Contact Information: Global Headquarters 200 Technology Square Cambridge, MA 02139, T- 617- 714-6500
Name of the vaccine: Janssen COVID-19 Vaccine, JNJ-78436735
Patent’s abstract: The invention relates to the production of coronaviruses. In particular, the invention relates to methods for producing SARS-CoV by using cells expressing a functional SARS-CoV receptor.
Patent Number: The Sputnik Light vaccine is the first component (recombinant human adenovirus 26 serotype (rAd26) of the Sputnik V vaccine. Therefore, has the same characteristics as of Sputnik V.
Contact Information: The Russian Direct Investment Fund (RDIF) Capital City, South Tower, 7th 8th floor 8 bid. 1 Prsenenskaya nab, Moscow, Russian 123112, T- +7 495 644 3414, F- +7 495 644 3413
Patent’s abstract: The invention provides a novel coronavirus vaccine taking human type 5 replication-defective adenovirus as a vector. The vaccine takes replication-defective human type 5 adenovirus with combined deletion of E1 and E3 as a vector, HEK293 cells integrating adenovirus E1 genes as a packaging cell line and carried protective antigen genes are 2019 novel coronavirus (SARS-CoV-2) S protein genes (Ad5-nCoV) which are subjected to optimization design. After the S protein gene is optimized, the expression level in the transfected cells is obviously increased. The vaccine has good immunogenicity on mouse and guinea pig models and can induce organisms to generate strong cellular and humoral immune responses in a short time. The protection effect research on the hACE2 transgenic mouse shows that the virus load in lung tissues can be obviously reduced after a single immunization of Ad5-nCoV14 days, and the vaccine has a good immune protection effect on 2019 novel coronavirus. In addition, the vaccine is fast and simple to prepare, and can be produced in a large scale in a short time to cope with sudden epidemic situations.
Patent’s abstract: The invention discloses a kind of coronavirus vaccine of the receptor binding domain subunit based on dimerization, belong to pharmaceutical technology field.The present invention expresses RBD (E367 Y606) regions of MERS CoV albumen and the RBD (R294 F515) of ARS CoV by baculoviral body in insect cell, so that RBD by the cysteine residues of S protein itself 603 can form dimer or form dimer by the cysteine residues of S protein itself 512, Balb/c mouse are immunized using the RBD albumen dimer and monomer of purifying respectively. The RBD of dimerization of the invention overcomes the not enough shortcoming of RBD monomeric immunogenics, and the neutralizing antibody for substantially increasing mouse for MERS CoV is produced.
Patent number: NO DATA AVAILABLE IN THE PUBLIC DOMAIN
Contact Information:108819, Russian Federation, city of Moscow, settlement Moskovsky, settlement of the Institute of Poliomyelitis, household 8, building 1, T- +7(495) 841-90-02, +7(495) 531-01-70
The concept of Drug Exclusivity can be perceived as a period or duration of time when a drug of a particular brand is protected from other generic drugs competition in the market. The conceptualization of Exclusivity was majorly evolved to induce and bring about a balance between new drug production and competition of generic drugs.
Initially, the concept of “exclusivity” was attributed to the protection of undisclosed data, and information that have highly commercialised value that needs to be protected in accordance with the TRIPS Agreement. Under the common law, these types of date have been protected as Trade Secrets.
Therefore, Data Exclusivity can be perceived as a transformational notion of protecting data by not disclosing the data to the general public which essentially is the protection of data in the form of trade secrets and the basis of principles such as equity and good faith. In addition, the invention whose information is kept protected must confine itself to the essentialities of a patent that is- the invention must be new, should be an inventive step and must be capable of being industrially applied.
Therefore, in specific pertinence to drugs, there arises a need to gauge and assess the existing conditions in the developing countries wherein a generic drug manufacturer might develop drugs at prices that are cheaper by manufacturing a biologically equivalent drug that is similar to the innovator company.
The concept of exclusivity acts as a conflict between the inventing company that has already availed protection under the existing patent laws and that of the public interest.
Extension of Data Exclusivity to Drugs
In India, the Indian Pharmaceutical Alliance was brought notice about a rule change that was proposed by the Central Government to provide a longer duration of protection to drugs that are newly manufactured which would bring about an impact of generic and low cost medicines for the public in India.
This change was suggested in lieu of the United States Trade Representative (USTR), which falls under the United States government that is responsible for the enforcement of intellectual property from the US around the world. The proposed change by the central government was to increase the exclusivity period from the existing four years to that of ten years.
Data Exclusivity in essence includes the exclusion of registration data, and can be established as the period of not disclosing the chemical compositions, pharmaceutical compositions and any other form of agrochemical registration or test data. This is an individual intellectual property right and cannot be included under the protection that is provided by the other rights like the patents.
For Drugs, there are many clinical trials and tests that are conducted, the results of which cannot be disclosed as it is a resultant scientific discovery and the innovating company has invested expenses as well as time. A simple molecular discovery and development generally takes about a decade and is seen to be expending millions of dollars. Within this, the generation of test results takes 50% of the cost. Therefore, the data when publically disclosed might be taken advantage of by third parties.
Data and Drug exclusivity provide the innovating company with the right to secrecy and prevents third parties from utilising the data to obtain any marketing authorization for duration of time. But this right does not prevent any third parties from producing their own data.
Subsequent manufacturers could apply for their formulations and discoveries, but they have to get it sanctioned by the innovating company and prove the equivalence of the product with that of international standards. Otherwise, by simply making reference to the originator’s submitted information, they get an unnecessary benefit, as they have not played out any of the costly and tedious tests or presented any information to show the security and viability of their item. Therefore this process helps in securing and making sure that-
The innovating company obtains exclusivity of the drugs for a specified period which would enable the company to recover the costs that would be incurred while obtaining approvals.
The regulatory authority is not supposed to check the innovating company’s data, without the consent, while reviewing applications put forth by the subsequent manufacturers.
The subsequent generic manufacturers could apply for marketing sanctions if they are in a position to generate their own test results.
Without a drug data exclusivity period, subsequent registrants can bring identical items into the market solely based on bioequivalence tests without leading tedious and costly preliminary tests that are needed to show the effectiveness of the discovery. This would bring about extreme detriment to the innovating company, having made significant speculation and investments to their discoveries.
An Anatomization of Drug Data Exclusivity: A Global Frame of Reference
Data protection of drugs came into effect and gathered international limelight when the issue of unfair competition was undertaken in the Paris Convention and importance was attributed to undisclosed information. The Agreement on Trade-Related Aspects of Intellectual Property Rights, 1994 also advocates the exclusivity of information under Article 39(3).
Accordingly, the concept of drug exclusivity provides that there exists a predefined period where no subsequent manufacturer could demonstrate bioequivalence and stay away from a tests for adequacy, safety and different properties. A trade off is struck where the innovating company is permitted a specific timeframe to recover the costs engaged with the testing in; and the public premium objective of benefiting protected and proficient items in the commercial center, while empowering subsequent participant items to enter the market yet after a characterized period. The subsequent participant may not be permitted during this period to be absolutely or to some extent excluded from recording unique testing information by demonstrating bio-equality. This is a commitment of non-dependence, both by the authorities and that of the third parties.
A Reference to Indian Legal Framework
There has been immense tension on India from the nations like the US and the EU, as international embargoes on the issue of drug data exclusivity, obviously on the grounds that the vast majority of the drug monsters have a place with these nations.
As per The Official Secrets Act, 1923- has been enacted that binds the public servants and government official from using any information that is deemed to be confidential in an unauthorised manner which would ultimately affect the security, integrity and sovereignty of the country. An oppressed party might sue the Government in a Civil Court. Nonetheless, the extent of this enactment is exceptionally restricted as it doesn’t guarantee data protection, however is restricted to security against divulgence of the information which is just one of the components of information protection. There is no arrangement to address against unfair competition brought about by outsider to unlawfully depend on the innovative company’s exclusive information. Albeit, this resolution accurately concedes an oppressed party the option to guarantee harms in a common suit and get damages, it doesn’t proactively guarantee insurance against out of line business utilization of the information. Consequently, the Official Secrets Act, 1923 doesn’t guarantee information security according to TRIPS Article 39.3 principles.
Trade secret protection is a solution to forestall the revelation of information, yet it is a private cure that is untested against administrative experts in India. Moreover, regardless of whether such an apparatus might be utilized to limit the abuse of test information, it again doesn’t keep the regulatory authorities from depending on it themselves to allow endorsements to subsequent manufacturers.
The Indian Patents Act, 1970 is another significant enactment. In any case, the Patent Act is appropriate just to patentable developments and doesn’t secure new utilization of a known substance or definitions by blends. Further, patent security stretches out just to the creation yet not to the information produced by the originator.
Conclusion
The methodology suggested for drugs and pharmaceuticals includes a momentary period for which initial steps will be taken to carry out the process of minimum data protection for example to work on the protection information the board in the Drug Regulatory Authorities and to forestall unapproved revelation of information. This period will can be trailed by a post transition period which will involve a duration of 5 years in which the Drug Regulatory Authority would not depend on the information put together by the innovating company while giving second and ensuing marketing approvals.
In 1877, Dr. Kellogg created a mixture of flour, oats, and cornmeal, which he baked twice and broke into small pieces to serve after a patient broke her tooth on a biscuit version of the mix. In his opinion, baking whole grains at high temperatures would produce the simple sugar dextrose, which would make them more easily digestible. John Kellogg baked a wheat dough for the first time at extremely high temperatures to break down the starch in the grain into the simple sugar dextrose. He called this process dextrinization. For years, Dr. Kellogg and Will worked together to create dextrinized flaked cereals – first with wheat, then with corn. At first, the cereals were ready to eat without sugar or milk. While W. K. Kellogg was a pioneer in the mass marketing of the cereal to the public, he also noticed the potential benefits of mixing the cereal with milk.
SUPER GLUE
The first cyanoacrylates were discovered in 1942 when a team of scientists at the B.F. Goodrich Company, led by Harry Coover Jr, were making clear plastic gun sights during World War II. They developed a formulation for cyanoacrylates but rejected it for use in gun sights because it was too sticky.
At Eastman Kodak, Coover and a colleague (Fred Joyner) discovered that cyanoacrylate had commercial potential in 1951. After testing hundreds of compounds, Dr. Coover and his colleague Fred Joyner found that the lenses were not detachable when they spread the 910th compound, cyanoacrylate, between two lenses. They developed the formula for sale as an adhesive, which was first sold as “Eastman #910” in 1958.
MICROWAVE OVEN
Percy Spencer was an engineer at Raytheon in 1945, when he noticed that a candy bar in his pocket began to melt while he was working near the magnetrons that created microwaves. Spencer later patented the invention together with Raytheon. Spencer built the first microwave after two years and launched it for commercial use after two years. He was inducted into the National Inventors Hall of Fame in 1999.
THE PACEMAKER
Wilson Greatbatch designed the first practical implantable pacemaker working as an assistant professor of electrical engineering at the University of Buffalo. While constructing a heart rhythm recording device, he used the wrong-sized resistor and created the first practical implantable pacemaker. The oscillator required a 10 KΩ resistor, but Greatbatch misread the color coding and got a 1 MΩ resistor instead. The new circuit produced intermittent electrical pulses, rather than continuous pulses, and Greatbatch immediately realized the device could drive a human heart. Veterans Administration hospital doctors demonstrated that this two cubic inch device could control a dog’s heartbeat on May 7, 1958.
PENICILLIN
Sir Alexander Fleming, a Scottish bacteriologist at St. Mary’s Hospital, introduced penicillin to cure bacterial infections. According to a legend, Dr. Fleming noticed that a mould called “Penicillium notatum” had contaminated his Petri dishes after returning from a summer vacation on September 3, 1928. The story is only partly true, however.
Fleming did notice a mould growing in a petri dish that prevented the growth of bacteria, however, it was not immediately apparent to him that the mould was useful. This is because he didn’t know precisely why bacteria weren’t growing. It took around 14 years – and the effort of many researchers – to isolate the active agent that prevented bacteria from growing – penicillium – and to make enough to use.
Albert Alexander was a policeman with an uncontrollable bacterial infection after being scratched by a rose. He was the first person treated with penicillin in 1941. Despite a dramatic response to penicillin, he relapsed ten days later.
DYNAMITE
Alfred Nobel, a Swedish chemist and engineer, dedicated his life to the study of explosives. He attempted to stabilize nitroglycerin, a highly unstable and explosive chemical. To make nitroglycerine easier to handle, Nobel realized it must be absorbed by some kind of porous material. A type of porous, absorbent sand or diatomaceous earth was found nearby the place he was staying in Germany. In the “Kieselguhr”, nitroglycerine forms a stable paste that can be safely kneaded, shaped, transported and even ignited without triggering an explosion.
In 1867, he patented his product. Dynamite was soon used in blasting tunnels, cutting canals, building railways and roads, and also in warfare. Nobel established the Nobel Prize in his will in November 1895 to promote world peace.
THE X-RAY
Undoubtedly, the discovery of the X-ray was a breakthrough in medicine. Wilhelm Conrad Röntgen deserves credit for the discovery. He noticed a glow coming from a nearby chemically coated screen while testing whether cathode rays could pass through glass.
He discovered that the mysterious light would pass through most substances, but leave shadows of solid objects. Since he did not know what the rays were, he called them “X-rays”.
The discovery of X-rays by Roentgen enabled him to see the bones and tissues beneath human tissue. In 1897, doctors used X-rays to detect bullets and broken bones inside patients during the Balkan war.
TEFLON
Chemist Roy J. Plunkett was involved in the research of Freon refrigerants. Tetrafluoroethylene gas (TFE) was produced by Plunkett and stored in small cylinders at dry-ice temperatures before being chlorinated. He discovered that a frozen canister had spontaneously polymerized into a white, waxy solid to form polytetrafluoroethylene (PTFE).
Plunkett was fascinated by the mysterious chemical and began categorizing its properties. He realized the TFE had polymerized to produce this substance – later named Teflon. DuPont assigned other teams to investigate the substance, and Plunkett was transferred to DuPont’s tetraethyl lead division, which made the additive which was used to increase gasoline octane for many years.
THE POPSICLE
Frank Epperson, a 11 year-old boy, mixed soda powder and water with a wooden stirrer one night in 1905. The California native left the glass outside in the cold overnight. In the morning, he noticed that the soda mixture was frozen solid.
He removed the ice pop from the class by running the glass under hot water and using the stick as a handle. When Frank came up with this great idea, he named the treats “Epsicles” and started selling them around town.
“Popsicle” is actually a brand name, but frozen juice on a stick is known by different names around the world. It’s called a popsicle in the USA, but an ice lolly in England, icy poles in New Zealand and freeze pop in Ireland.
STAINLESS STEEL
Arms manufacture increased dramatically in the UK in the years immediately before the First World War, but practical difficulties were encountered due to erosion (excessive wear) of the inner surfaces of gun barrels. Brearley began researching new steels that could better resist erosion (rather than corrosion which was a common misconception) caused by high temperatures. As chromium was known to raise steel’s melting point, he began to examine what would happen if chromium was added to steel.
A 20th-century arms manufacturer hired metallurgist Harry Bearly to create rust-resistant gun barrels. On the side, he conducted a few experiments of his own. After the metal held up against corrosives such as lemon juice, he saw the potential for food-grade silverware and the elimination of the nightly routine of washing, polishing and putting away silverware. However, stainless steel appliances were still a bit out of his league.
RADIOACTIVITY
Henri Becquerel and Mother Nature are both to be commended for this success. In 1896, the chemist was trying to make fluorescent materials produce X-rays through sunlight. There was a week of clouds and overcast, so he left the supplies in his drawer. He opened the drawer and found the uranium rock he was using imprinted on a nearby photographic plate- all without any exposure to light.
Cathode ray fluorescence was the focus of Becquerel’s research. There were some uranium salts next to the photographic plates by chance. Despite being protected from sunlight, the plates appeared to be exposed later on. A photographic plate marked by uranium salts was found emitting a ‘penetrating radiation’. This radiation was proved to be new and not X-ray radiation as per further studies.
POTATO CHIPS AND FRENCH FRIES
During the summer of 1853, a customer at Moon’s Lake House in Saratoga Springs, New York, ordered French fries. As a chef at that hotel, Crum served his standard thick-cut French fries to his customers with a fork. However, the customer complained that they were extremely thick and soggy. The ‘Gordon Ramsay’ of his day, George Crum was easily angered but resourceful. He made another batch of thinner French Fries to satisfy the customer, but he again complained that they were too thick and refused them. After becoming frustrated with his annoying customer, this time he decided to teach him a lesson and made another batch, cutting the potatoes thin so that they were difficult to eat with a fork and heavily salting them. He was surprised when the customer loved them and asked for more, as did other diners. As a result of a complaint from an annoying customer and an act of mischief by George Crum, the invention “Potato Chip” was born. Moon’s Lake House served potato chips called “Saratoga Chips”.
ARTIFICIAL SWEETENERS
Even though you should always wash your hands before eating, there are instances where a bathroom break would change history. If chemist Constantin Fahlberg had washed his hands before dinner in 1879, it would have removed all the coal tar from his skin. He would not have tasted how sweet his food was due to the saccharin in the tar. (This is the exception, though- please exercise good health and grooming habits.)
Sugar substitutes – such as high-intensity sweeteners – have many times the sweetness of sucrose, common table sugar.Therefore, much less sweetener is required, and the energy contribution is often negligible. These compounds cause a different sweet sensation than sucrose (the sweetness profile), so they are often used in complex mixtures to achieve the most intense sweetness.
A bulking agent may be needed if sucrose (or other sugar) has contributed to the texture of the product. Soft drinks or sweet teas labelled as “diet” or “light” often contain artificial sweeteners and often have an unusual “mouthfeel”, or table sugar replacements containing maltodextrins and an intense sweetener to achieve a pleasing texture.
SLINKY
Richard James, a naval mechanical engineer stationed at the William Cramp & Sons shipyards in Philadelphia, developed springs that could stabilize sensitive instruments aboard ships during rough seas in 1946. During World War II, Richard James tried using springs to keep sensitive instruments steady. But when he dropped one of the springs, it landed upright and recoiled on its own – much to James’ amusement. During the next year or so, James experimented with different types of steel wire, and eventually discovered one that would “walk” on its own. His wife, Betty, was hesitant to admit its potential, but after the toy was fine-tuned and neighbourhood children expressed excitement about it, she changed her mind. The toy was dubbed Slinky (meaning “sleek and graceful”) after she found the word in a dictionary and decided that it aptly described the sound of a metal spring expanding and collapsing.
COCA COLA
Pemberton, a Civil War veteran who achieved the rank of Lieutenant Colonel, suffered a sabre wound to his chest at the Battle of Columbus in April 1865 and soon became addicted to morphine. Chemist Pemberton tried several opium-free alternative painkillers and experimented with coca and cola wines until he discovered a recipe containing extracts of cola nuts and damiana that had a taste which was not heard of before.
Using flowery rhetoric, he described his new invention as a “valuable brain tonic” that would cure headaches, relieve exhaustion and calm nerves. As a medicine, he called it “delicious, refreshing, pure joy, exhilarating and invigorating”. He named his accidental product “Pemberton’s French Wine Coca”.
Pemberton’s product became an instant success, but due to growing public concern over an alcohol addiction, he changed the recipe to make it non-alcoholic and blended the base syrup with carbonated water, which was also an accident.
Incorporating the names Coca and Cola into the composition of this new beverage, he called it “Coca-Cola”. Another factor for its global success was the fact that General Eisenhower ordered millions of Coca-Cola bottles for American soldiers fighting the Germans in North Africa during the 2nd World War. 200 years after Coca-Cola had last been marketed as a medicinal product, there is some empirical evidence from researchers and doctors that it has some inherent health benefits.
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Contracts are used to regulate and legitimize essentially all business transactions. They are, of course, appropriate instruments in contexts other than standard buy-sell and employment agreements. Any situation involving a reciprocal exchange of promises will almost always need the use of a formal, written contract. This is certainly relevant when significant intellectual property (IP) is under consideration. Contracts must be employed by companies with valuable IP to ensure that their internal employees and any external vendors or consultants who have access to their IP information act responsibly, regardless of the timing or duration of that access. Furthermore, corporations must clearly indicate who possesses the proprietary rights over the IPs to employees who are involved in or responsible for IP development.
The symbiotic link between copyright and contract law is examined in this article. The intellectual property bargain, or the delicate balance that purportedly exists in present IP laws, cannot simply be viewed as a matter of property laws stating a balance. A major characteristic of IP dispersed in the open market has always been the connection between IP and contract norms, and that interaction is central to whatever balance has been established. It is pointless to focus exclusively on the statutory provisions of copyright, patent, or trademark laws when discussing a current balance in the property rights sector. IP contracts deal with a wide variety of rights that can be assigned, or licensed to any other person or organization. It is necessary to grasp and incorporate the fact that the policy approach has always assumed that property rights are frequently transferred, waived, or released. The clauses adopted in such contracts, on the other hand, must be designed with extreme prudence and care.
Finally, firms can impose IP protection through a variety of contracts, including confidentiality and non-disclosure agreements, non-compete agreements, and property or assignment agreements, among others. Regardless of which contract is best for the situation, any IP-related contract must include the following provisions:
These are important factors in an IP contract that should be considered while drafting these agreements:
Confidentiality
To safeguard the owner, a confidentiality clause is required. Because there has been a significant increase in technological knowledge, further security measures must be taken to secure the work, and hence a secrecy provision prohibits and binds the other party from disclosing the creation’s integrity. Patents, copyright, and trademarks are instances of intellectual property that have been published and are thus publicly accessible. They are, however, frequently used in conjunction with other confidential know-how to generate commercial outcomes – and such sensitive know-how must be kept confidential.
Contractually requiring tight confidentiality is perhaps the most important part of any IP arrangement. Companies must be exceedingly proactive, take extraordinary security precautions, and remain watchful to potential intrusions or data misappropriation as technological innovation thrives and competition grows. Undoubtedly, despite a company’s investment in the most advanced security measures, essential IP can be exposed purposefully or inadvertently owing to human frailties.
As a result, a robust contract that explicitly imposes an obligation to maintain secrecy, as well as serious repercussions for failure to comply, will dissuade irresponsible and/or malevolent action. Employees who are aware of the potential consequences of disclosing a company’s information are significantly more likely to take the necessary safeguards and follow any IP-related security policy.
Confidential Information Access
Conditions for access to know-how and confidential information by parties’ employees, consultants, or representatives must be stated in order to safeguard confidentiality in a realistic manner. Standards for guaranteeing the security of secret information might also be stated.
Ownership of Intellectual Property Used or Created Over the Duration of the Relationship
The contract must state clearly who will be the owner of the intellectual property that is being used or constantly developed throughout the duration of relationship. Even if the connection is later terminated, the ownership status of the IP should be clearly stated. This is a common dispute in which an employee chooses to leave his job after the creation of the IP and wishes to take the creation with him on the assumption that it was developed by him. However, the fact that it was made while he was employed does not give him the right to own it, which must be expressly stated in every contract.
Disputes over IP often emerge when an individual resigns from the employment at the organization severs a relationship with external associates. Employees and consultants who contribute to the creation and development of IP may believe they have the right to take it with them when they depart. Even if this is acceptable to a corporation, it must be determined from the beginning to avoid costly misconceptions. In most circumstances, a business expects to keep ownership of whatever IP it develops. To avoid misunderstanding, this proprietary intent must be made abundantly explicit in any relevant contract.
Access
A contract must unambiguously indicate which individuals are authorized to access the IP, when they may access it, and for how long they will have access, in addition to declaring explicitly which party will retain property rights over the IP. In some situations, a non-compete agreement may prevent an employee from working in a related area for a period of time after leaving a company. However, the extent and length of any such agreement are limited, and a former employee may presume that he or she can still refer to IP information that was created with their participation. Even if a corporation grants such access to current or former employees, the manner in which such access is granted must be specified in a contract. Companies may, for instance, aim to make sure that information is accessed through a secure server or a tightly managed data repository. The requirements for access to IP within a corporation must be clearly specified.
Indemnification
IP indemnification on IP representations and warranties, can be used to hold a seller liable for violations of IP representations and warranties. These aren’t the only types of breaches that might trigger indemnity in a contract, but in contracts where IP may not be the main emphasis, the IP-related indemnification clauses can get neglected during negotiations, which can lead to dispute later if a claim occurs.
In discussions about IP indemnity, the scope and duration of indemnification should be addressed. The seller will aim to reduce the amount of time it can be held liable for indemnification, while the purchaser will seek a longer survival period. The seller will also wish to try to limit its indemnity liability, though this can be challenging. If there are restrictions in place for breaches of general representations, the seller may seek comparable caps for IP breaches, but the acquirer is more likely to push for a larger cap. Acquirers may also try to have specific matters exempted from the cap (i.e., fraud claims, and intentional breach). Control of claim defense is another area where IP indemnification is being negotiated. The seller may want to demand control considering he or she will be more compelled to resolve the claim if the acquirer has control and simply forwards the invoices to the seller.
In the event of an IP license, which may be a stand-alone agreement or a component of a larger agreement, indemnification terms may oblige the licensor to extend its IP protection to the licensee if and when a third-party IP dispute arises. It is critical for the indemnifier to understand what he is committing to indemnify, regardless of the type of IP matters that may be indemnified.
Recourse
A contract must clearly point out the consequences of any breach of the agreement in order to have the bite it requires. It will not be adequate to utilize vague descriptions like “such fines or litigation”. It must be apparent to the person who will be signing the agreement that the company takes the security of its IP very seriously and will aggressively pursue any and all legal remedies available. In the unfortunate event where valuable IP is misappropriated, there should be no ambiguity regarding the next course of action.
Intellectual Property Documentation and Records
Sophisticated contracts may include a system for recording and documenting the IP developed throughout the course of the relationship (e.g., by creating specialized lists) so that it can be identified. This allows for improved future valuation of IP and enhances the potential to monetize such property through full or partial assignment, depending on the interests of the parties.
Termination/ Breach of Contract
Contracts must explicitly specify the consequences of breaching the contract. Because a vague definition of such termination/cancellation/penalty clauses might lead to years-long tedious legal battles, an ironclad contract with respect to penalty clauses is required. There should be no ambiguity or vagueness in a contract.
Purple Book, brought out on September 9, 2014, by the FDA consolidates list of licensed biological products including biosimilar and their interchangeable biological products. This compendium guides pharmacists in implementing pharmacovigilance in biological products and its biosimilars. Biological products and biosimilars are FDA approved that are primarily governed under Public Health Services Act. For the FDA approval, a Biologics License Application (BLA) can be filed under sub-sections of Section 351(a) and 351(k) of PHSA. An application filed under Section 351(a) for biologics and innovator biologics should submit all requisite information supporting its safety and effectiveness. This section 351(a) application is also referred as a standalone application for its non-reliance placed on other biologic products. A BLA filed under Section 351(k) for biologics license should submit information that confirms the manufacturer’s claim that the biosimilarity of the product is based on data to animal studies, clinical studies and analytical studies. Thus, the primary purpose of the Purple Book is to enable cross-checking as to whether a licensed biological product under Section 351(k) is biosimilar to or interchangeable with the reference product and to provide information pertaining the exclusivity of such reference product. Thus, the Purple Book lists all the biological products licensed under Section 351(a) and lists correspondingly, all the licensed biosimilar and interchangeable products of the reference product.
Purple Book originally accommodated two separate lists:
Biologics approved by FDA’s Centre for Drug Evaluation and Research
Biologics approved by FDA’s Centre of Biologic Evaluation and Research
The aforementioned lists have been replaced and discontinued after FDA releasing a single, searchable, online database, Purple Book Database, storing all the information about FDA approved / licensed biological products. This planned transitioning to online database is a step forward for ensuring improved transparency and accessibility for patients, industry users and other stakeholders. The information of the biologic product listed in Purple Book include:
BLA tracking number
Product Name
Biologic product’s non-proprietary name
If a biological product is a biosimilar or interchangeable one
Application number
Approval date
Biosimilar information
Date of licensure
Date of first licensure- this indicates whether the biological product qualifies for reference product exclusivity and the expiration date to such exclusivity if applicable.
Expiration date of Reference product exclusivity (12 yrs)- This exclusivity period disallows FDA from approving a 351(k) application until the exclusivity period of reference product is expired in 12 years from its first licensure.
Biologics Price Competition and Innovation Act, 2009
BPCI Act of 2009 amended the PHSA Act to create an abbreviated approval pathway for biosimilars or interchangeable biological products, which is comparable to the one created through Hatch-Waxman Amendments for ANDA applications under FD&C Act for the Orange Book. BPCI Act requires the BLA applicant to submit evidences supporting the claim that the biological drug is biosimilar to reference product. Evidences should show that the drug has same dosage, same route of administration and same strength as the reference biological product, and additionally, exhibits no clinically meaningful differences in terms of its purity, safety and potency from the reference product. Now for the designation of interchangeability, the BLA applicant must provide requisite information to demonstrate bisoimilarity as well as to show that the biological product has same clinical result as its correspondent reference drug when administered to the patient. Moreover, it is essential to demonstrate that a biological product when administered to a patient more than once, the risks associated in terms of its safety and diminished efficacy upon alternating or switching the reference product with the biological product, should not be greater than the risks associated when administering the reference product alone.[1] Section 351(i)(3) of the PHS Act implicates that once a biological product has received the designation of interchangeability, it can be in official capacity be substituted for the reference product with no intervention from the public health care provider. [2]
PURPLE BOOK CONTINUITY ACT, 2020
Patent Listing in Purple Book
Since its time of outset, Purple Book limited itself in providing information on a biological product’s labeling of being a biosimilar or its interchangeability to a reference biological product, and accommodated no listing of patents for such biological products. However, with the recent enactment of Purple Book Continuity Act (PBCA), FDA has for the first time imposed the requirement of patent listing of approved biological products as well as FDA regulatory exclusivity information. This transparency of patent information facilitates the biosimilar developers in getting hold of the patent information before the patent dance itself. Patent dance is a procedural concept formulated under the legislation of Biologics Price Competition and Innovation Act, intended to create an opportunistic space for patent dispute resolution between biosimilar applicant and biologic license holder, thus facilitating for a less elaborative approval route for biosimilar applicants. The preliminary step that needed to be furthered for the patent dance is the disclosure of such patent information that could otherwise possibly result in infringement by the biosimilar applicant, as per Section 1(3)(a) of the BPCI Act. As per the new law, a window period of 30 days is provided for the biologic license holders to share the disclosed patent information and its expiry dates to FDA which would later be incorporated in Purple Book.
Section 325 of the Consolidation Appropriations Act has specifically recognized for biological product patent transparency which upon preliminary concordance with the Public Health Service Act, has given FDA a period of 180 days from the date of enactment of the Purple Book Database. Moreover, FDA is required to update the list within 30 days after its first publication to include newly licensed products. In regards to the patent information that has been already subjected to the disclosure during the patent dance, requires the reference product sponsor to submit such list of patents and its corresponding expiry dates before FDA, within 30 days after such disclosure to the biosimilar applicant. [3]When the exclusivity of the biologic product has been duly determined or established by the Secretary of FDA, the product would be accordingly fitted into the Purple Book.
Implications of the Patent Information Requirement in Purple Book
With the new law creating an attic for the incorporation of patent information alongside with other details of the biologic product, it is essential to understand its implications on a biosmilar applicant. As mentioned before, patent information gets incorporated in the Purple Book database only upon following a standardized disclosure of the same by the biologic license holder to the section 351 (k) applicant during patent dance. This implies that only subsequent applicants can have an effective perusal of the patent information mentioned in the Purple Book and little impact on the first applicant. It is imperative to understand that this patent information provided and updated in Purple Book is not holistic at its preliminary view since it is totally dependent on the extent of disclosure engaged in by the license holder during the patent dance. hence, when a subsequent applicant peruse through the provided patent information in Purple Book, the possibility of the applicant getting ambushed by the license holder with its unidentified patent information still lies ahead.
Exclusivity Information
Under the new legislation, FDA is required to codify all the regulatory exclusivities for biological products including any attached pediatric exclusivities.[4] Initially the list did not identify periods of orphan exclusivities of the biological products and their expiration dates, which are usually listed in Orphan Designated and/or Approved Products.[5] However, the revised Purple Book database has listed information on orphan exclusivities as well. [6]
CONCLUSION
Though biosimilar and interchangeable products are not as dominant in market place as the generic drugs in pharmaceutical sector, it is prospectively expected that the marketing of biological products will potentially increase. Even the enactment of Purple Continuity act can be viewed as a step taken towards this potential shift in pharmaceutical market. The confidentiality shield that once protected the patent information of the products are partially lifted with the new listing requirement under the Act. Essentially, this compendium is facilitated for the pharmacists in comprehending the nature of the biological product and its administration in patients, and to implement pharamacovigilance on the biological products.
Paytm is an Indian e-commerce platform primarily dealing with digital payments. In 2016, PayPal, an US-based international digital payment company accused Paytm of trademark infringement. PayPal issued a Notice of Opposition in Paytm’s trademark registration application under Class 38. With its presence in over 190 countries and having the competency to transact in over 100 currencies, PayPal has become one of the world’s largest online payment services.
After demonetization was implemented in India, there was a massive amount of increase in subscribers of Paytm. Paytm had 300 million registered users by August 2018. This figure compares with 520 million Alipay users and 237 million PayPal users around the same time. On average, one in five Indians had already started useing Paytm.
Paytm filed its application for trademark in 2012. However, it was advertised in the Trademark Journal (No. 1754) on July 18, 2016 only. Section 21 of the Trademark Act, 1999, enables any person to oppose a trademark by filing Form TM-5 within 3 months of the advertisement of such mark in the TM Journal, with a maximum extension of another month. PayPal filed its Notice of Opposition on November 18, 2016, with the Indian trademark office.
Contentions of PayPal (Plaintiff)
PayPal alleged that Paytm’s logo was “deceptively and confusingly similar” to its own. PayPal alleged that Paytm had “adopted the two-tone blue colour scheme” of its registered trademark logo. Also, the two brands start with the word “Pay” and has same nature of business existing in the same market, thus confusing consumers at a glance.
According to PayPal, Paytm has violated the following provisions:
Section 9(2)(a) of the Trademarks Act, 1999, provides deception or confusion as an absolute ground for refusal of a trademark registration,
Section 11 of the Act provides for similarity with an ‘earlier trademark’ as relative ground for refusal of a trademark registration,
Section 11(2) states that usage of the similar trademark would be inimical to the distinctive character of its trademark, and
Section 11(3) as it would amount to passing off.
Paytm is precluded from relying on Section 11(4) of the Act which allows the applicant to seek the consent of the earlier trademark holder.
Section 11(10) as there is an element of bad faith involved.
Section 18 as it disallows the registrar from registering trademarks where there is no honesty involved, with the original proprietor being the owner of the trademark.
On the contrary, Paytm has declined to comment on the allegations.
Analysis
It is not appropriate for PayPal to claim exclusivity over a generic word like “Pay”. Delhi Hing Court has decided in a case that generic word like “Today” cannot be claimed to be exclusive by any of the news company groups.[1]
In India, the trademark law protects colors to the extent the colors or combination of colors confer a distinctive characteristic upon a product or service. Schedule 10 of the Trademarks Act deals with use of colors:
A trademark may be limited wholly or in part to any combination of colors and any such limitation shall be taken into consideration by the tribunal having to decide on the distinctive character of the trademark.
As far as a trademark is registered without limitation of color, it shall be deemed to be registered for all colors.
Here, the two-tone blue color in question, is not identical but they are similar.
Then, it has to be considered whether the whole package – name, font, and colors – used by Paytm and PayPal are similar enough for consumers, with average mind in India, to be misled into buying or choosing the other product.
As a matter of fact, ordinary consumers like fruit or vegetable vendors, taxi drivers, regular workers, small hotel owners, use and hear the word “Paytm” every day of their life, and they may not even know about the existence of PayPal. PayPal’s existence in the Indian market is limited generally to eBay shoppers, freelancers and IT software developers that are exposed to global economy much more than the ordinary consumers, which implies that if PayPal and/or Paytm were to conduct a survey, it would likely result strongly in favor of Paytm.
Order of the TM Registrar
The opponent, i.e., PayPal has withdrawn their opposition to the registration of Paytm’s trademark via a letter dated 25.06.2021. The order of the TM Registrar dated 12.07.2022, states that since PayPal withdrew their opposition, Paytm was successful in registering its trademark under class 38 in India.
Arvind Panagariya, “Digital Revolution, Financial Infrastructure and Entrepreneurship: The Case of India” (November 18, 2019), SIPA’s Entrepreneurship & Policy Initiative Working Paper Series, 2019 available at http://dx.doi.org/10.2139/ssrn.3493341
Please contact us at info@origiin.com to know more about our services (Patent, Trademark, Copyright, Contract, IP Licensing, M&A of companies)
Trademark as a term, refers to name of the product, services or business and comprises name, logo and tagline. Trademark is a valuable business asset and shall be registered in the countries where such trademark is to be used.
In the Trade Marks Act of 1999, section 2(m) defines a “mark” as a device, brand, heading, label, ticket, name, signature, word, letter, numeral, shape of goods, packaging or combination of colours. It is important to choose the trademark for a business carefully so that the customers can distinguish the services or goods from others. Distinct trademarks not only help companies to build a strong trademark but also makes the process of trademark registration smooth because there are less objections during the process of registration. Further, a distinct trademark is less likely to get into any legal disputes. Thus, coining the right mark and protecting it in the initial phase helps in multiple ways.
According to the report of Forbes, the top 10 most valuable trademarks are as below:
Section 2(1)(zg) of the Trademarks Act defines well-known trademark as, “a mark which has become so to the substantial segment of the public which uses such goods or receives such services that the use of such mark in relation to other goods or services would be likely to be taken as indicating a connection in the course of trade or rendering of services between those goods or services and a person using the mark in relation to the first mentioned goods or services.” Some of the well-known trademarks include, Amul, Coca-Cola, Pepsi, McDonald and Dominos etc.
Steps for trademark registration
Trademark search
The purpose of trademark search is to identify the similar trademarks that are already filed for or registered and assess strength of the trademark. Trademark search is required to be done before trademark application is filed. Trademark search is performed in specific class (s) of goods and services, as specified in the Trademarks Act.
Filing application for trademark registration:
Application for trademark registration in the desired class(s) along with the prescribed forms and fee may be filed online. As soon as application is filed, the application number is generated. Any person, including, an individual, company, proprietor, or legal entity claiming to be the owner of the trademark can apply for Trademark Registration.
Documents required for filing a Trade Mark Application in India are as below:
Trademark or logo in .jpg format
Applicant details like name, address, nationality, phone number and email ID
Goods or services to register
Date of first use of the trademark in India, if used prior to filing the application.
Power of attorney, to be signed by the applicant
Examination report
After a trademark application is filed, the examiner reviews it and sends examination report on certain grounds to be replied by the applicant. In the report, there may be objections to be complied if the mark is similar to any of the existing trademarks. However, in case there is no objection raised by the Trademark Registry, the mark shall advertise it in the Trade Marks Journal. Within four months of such publication, any third party(ies) may raise opposition to the grant of registration of the trademark. In case no opposition is raised by any third party (ies) within the stipulated timeline, the trademark shall proceed for registration.
Registration & renewal
Once registered, a trademark is valid for 10 years from the date of filing, which can be renewed from time to time for another period 10 years.
Conclusion
Trademark is a valuable business asset. It is important to choose right trademark and register it so that you can claim ownership on it and use it effectively for your business.
Please contact us at info@origiin.com to know more about our services (Patent, Trademark, Copyright, Contract, IP Licensing, M&A of companies)
A patent assignment is an act by the patent owner in which the patent owner permanently transfers the patent’s exclusive rights to third party (Assignee). This transfer of rights is documented in the official patent record. In a patent assignment, the assignee must pay the assignor a consolidated amount and can collect profits from the patented invention subsequently. This qualifies as a consideration.
Patent licensing allows for the creation of value from innovation as well as the advancement of certain other strategic corporate objectives. Bilateral licensing transactions are the hallmark of the ‘traditional’ patent-licensing industry. It is moreover characterized by consequential transaction costs borne by the parties and information asymmetries that threaten to shrink the market over time. An exclusive license encompasses all of the patent’s rights licensee receives except the title. In this instance, the licensee enjoys the same rights as the patent owner, with the exception of the ability to transfer the patent to another individual or company. This restriction exists simply because even though the agreement allows the rights to be transferred; the patent owner retains ownership of the title.
The rights in lieu of the license agreement are predominately granted to the licensee and in accordance to the terms of the said agreement cannot be transferred further. Ergo, patent licensing is only for a limited term, when the license period ends, the owner reclaims his exclusive rights to his invention.
Professor David Teece asserted in an unconventional paper[1] that the ability to construct value from invention was dependent on interrelate assets like marketing, production, and after-sales assistance. Innovators frequently lack direct ownership or control over these assets, forcing them to license out the commercialization process.[2] Licensing can also be used to impact market demand and competitiveness. Patents are licensed out to restrict competitors from further conducting research and development.
This article states the various practices involving the re-assignment clarifying the ownership of the Patent Agreements.
Infringement Litigation
The patentee (licensor) has the sole right to sue for infringement under the Indian patent system.[3] The only statutory exceptions are the exclusive license and the licensee to whom a compulsory license has been granted.[4] A non-exclusive licensee is not allowed to sue for infringement in his or her own name.[5]
Preventing a third party from infringing on the patent, on the other hand, serves the interests of both the licensor and the licensee. Unlicensed usage by a third party will result in ULR fees being charged to the licensor. Similarly, the licensee will be concerned about an infringing competitor who has not been subjected to ULR payments, the expressions of the mutual interest. It may be however become problematic as the expenses of contesting the infringement are more than the patentee’s personal returns, (s)he may not be motivated to file the claim.
Patent buyouts
At least two instances during the early nineteenth century, when both patents and prizes were employed to encourage discovery, Governments integrated the patent and prize systems by purchasing patents. Patent buyouts are appealing because they provide the chance to eliminate monopolistic pricing distortions and duplicate research incentives while increasing rewards for innovative research. It’s crucial to investigate how they implemented the patent buyouts in practice.
Patents scarcely incentivize original research owing to the fact that potential inventors will not consider consumer surplus while deciding whether or not to pursue it. By purchasing the patent for Daguerreotype photography and releasing the technique in the public domain in 1839, the French government blended aspects of the patent system and direct government sponsorship of research. Daguerreotype photography was quickly embraced over the world after the patent was bought out, and it underwent significant technical advances. Patent buyouts like these have the capacity to eradicate monopolistic price distortions and inefficient reverse engineering incentives while further stimulating original research. Determining the price is a major difficulty for any patent buyout mechanism.
The government would propose to buy out patents at this private value times a fixed markup that would roughly cover the gap between the social and private value of inventions. Inventors could have the option of selling or preserving their patents. Government-purchased patents are usually released into the public domain.
However, in order to encourage auction participants to be honest about their appraisals, the government would select a few patents at random and sell them to the highest bidder. Encouragement of invention through such a process would necessitate greater discretion from government officials than the current patent system, but somewhat less discretion than that exercised by the National Institutes of Health.
Patents also restrict research by generating excessive motivation to produce alternatives for patented assets while providing too little incentive to develop complements. Firms can steal rents from existing patent holders by producing replacement inventions. The minimal information available implies that this issue could be intense. Mansfield, Schwartz, and Wagner (1981) discovered that 60 percent of patented discoveries were reproduced within four years, with the average imitation cost being two-thirds of the original cost of development. Potential complementary invention developers, conversely, will have insufficient incentive to create these inventions if they must first invest in developing supplementary inventions before negotiating license arrangements with original patent owners [Green and Scotchmer 1982]. Sometimes, due to asymmetric information, agreements between owners of complementary patents are not achieved, and inventions go underutilized.[6]
Grant Back
Many patent license agreements fail to address licensee improvements, allowing the licensee to file improvement patents of their own, potentially rendering the licensor’s technology obsolete or even preventing the licensor from commercializing its own product with the enhancements. By including “grant back” provisions in license agreements, a licensor can ensure that when licensing out patents covering its technology, any improvements by the licensee are granted back to the licensor. A licensor can ensure that when licensing out patents covering its technology, any enhancements made by the licensee are granted back to the licensor by incorporating “grant back” terms in license agreements.
Literature in relation to Employee-Employer Patent Ownership
By omitting to add a “deemed ownership” provision in the Patents Act of 1970, Indian policymakers missed the mark. Section 39 of the UK Patent Act, Section 132 of the Israeli Patent Act, and Section 6 of the Chinese Patent Act have all codified similar provisions. This deeming theory is founded on the “duty to invent” principle, which states that a person who has a duty to invent cannot have a patent registered in his name. This premise is based on the idea that if an employee has exploited the company’s facilities, technological know-how, or resources, the employer should not be barred from the benefits.
As a corollary, an employee who created the invention during his or her “course and scope of employment” is unable to get a patent in his or her own name. In Darius Rutton Kavasmanek v. Gharda Chemicals, the Bombay High Court was introduced this argument of “duty to invent.” The court, however, refused to evaluate the issue since it was an injunction appeal, and it could not opine on the merits of the case. In addition to the “duty to invent” argument, the “shop-right” principle, which originated in the United States, can be used to address the ownership problem. Regrettably, it has yet to be implemented in India. Even if there is no agreement for royalties, shop-right is a non-exclusive and non-transferable license with the employer to use the innovation without paying royalties. Even if the employee, who is the patent owner, sells his interest in the patent, the employer retains his shop-right in the patent under this doctrine.
When global firms are involved in Research and development activities and their inventors are Indian employees, the above-mentioned flaw in Indian patent law is very troublesome. According to Section 39 of the Patents Act, any resident of India who applies for a patent or causes an application for a patent to be filed in a country outside of India must first obtain authorization from the Controller of Patents.
For instance, a US corporation wishes to submit a patent in the US, but the inventors are Indian employees who live in the country. It might now be argued that the Indian employees, by their patent assignment agreement, have ‘caused’ the patent application to be filed in the United States, necessitating clearance from the Indian Controller of Patents. This is a significant impediment to the employer-company receiving a patent in a timely manner. Such unnecessary delay in an area as dynamic as intellectual property is likely to have an influence on the utilization of resident Indian personnel for invention. Incorporating such a provision that assigns patent ownership to the employer/company, on the other hand, will go a long way toward resolving such issues.
It’s worth noting that the United States Patent Act makes no mention of patent ownership between employers and employees. However, the courts have established a number of precedents that benefit employers“It is feared that if a corporation is denied the advantages of its success, it would cease to subsidize and experiments will go,” the court held in Goodyear Tyres and Rubber Company v. Miller in the United States. In future judgements, Indian courts could take cognizance of this and set better precedents to potentially enable occlude loopholes in the patent law.
With India’s existing patent ownership framework, the employer bears the threat of not owning the invention despite making significant investments. Employers may be hesitant to invest in research possibilities as a result of this. An equivalent approach in India, as in the United States, the United Kingdom, and other nations, would undoubtedly aid in the resolution of patent ownership disputes between employers and employees. If the invention was developed using the employer’s resources and during the course of employment, the employer should be given a say in the patent, even if there is no pre-assignment / assignment agreement for the same involving the abovementioned principles.
There clearly is a dilemma revolving the true ownership of the Patents developed under employment and the legal literature of various countries reflect the very same. The question of ownership, however, in India remains with the employer (with the assignment of intellectual property in the course of employment) development during an employment.
There is a certain exception which that outruns the private benefit and focuses on public good.
Compulsory License
Compulsory license occurs when the government grants authorization to any individual or organization to use, sell, or manufacture a patented design or product for the public good, regardless of the patent owner’s wishes. Compulsory licenses are commonly given in the pharmaceutical industry and in products that meet the standards set forth in Section 84 of the Patent Act 1970. On March 9, 2012, Natco Pharma Ltd. received the first compulsory license in India for making a generic version of Nexavar, a patented Bayer Corporation drug.
Compulsory licensing is provided under Chapter XVI of the Patents Act of 1970 as an essential precaution for defending the public interest. Any interested party can request compulsory license after three years if the invention is not fairly available to the general public. The central government has the authority to file an application with the controller, requesting that the controller endorse a patent with the ‘license of right’.
The provision of the central government was repealed by the amendment. Furthermore, required adjustments were made with regard to whether the public requirements were fulfilled, if the innovation is not manufactured in India or if the patentee refuses to accord a license, by removing a presumption that the public’s requirements are fulfilled based on local manufacture. The amendment also granted the controller the authority to issue a forced license in the event of a national emergency. There is also a provision that allows a third party to apply for a compulsory license even though the invention is not manufactured in India. This shift also allows the controller to revoke the compulsory license if the circumstances that led to it cease to exist.
In simple terms, the choice to assign or license is based on the most profitable commercialization route available to the patent holder. And, while making a decision, the advantages of receiving royalties or alternatively receiving a lump sum price, giving away title, or simply surrendering the rights to commercialize the invention in a certain location for a set length of time must always be evaluated against one another. Assignment may occasionally seem more beneficial than licensing.
Regardless of the fact that the law safeguards a patentee’s interests, the patent holder must prepare an appropriate assignment or license agreement to avoid any potential disputes regarding the ownership. Intellectual property rights have only recently come to the attention of the general public. Where industrial property is adequately protected, which in turn raises the country’s economy, a comprehensive understanding of intellectual property rights is vital. The entire legal infrastructure was furnished by the Government of India. Software, traditional knowledge, plant varieties, and geographical indications have all been accorded specific legal provisions. Among these provisions, certain remedies are only available to the owner of the intellectual property; hence the determination of ownership and proper re-assignment becomes vital.
[1] David J. Teece, “Profiting from Technological Innovation : Implications for Integration, Collaboration, Licensing and Public Policy”, 15 Research Policy 285 (1986).
[5] Pravin Anand, T. Saukshamaya & Aditya Gupta, India, in Patent Litigation : Jurisdictional Comparisons 201, 203 [Massimo Sterpi et al. (eds.), 2011]; Suchita Saigal, Parul Kumar & Aditya Verma, Licensing Intellectual Property Rights’ Use, in The Law of Business Contracts in India 92, 96 (Sairam Bhat edn., 2009).
[6] The Quarterly Journal of Economics , Nov., 1998, Vol. 113, No. 4 (Nov., 1998), pp. 1137-1167
Income from technology transfer could be a great source of income to the innovators and may add fuel to economy of a country. Thus, to promote more of such ventures, willing countries pledge to follow international treaties such as the Trade-Related Aspects of Intellectual Property Rights (TRIPS), which contain several provisions to govern trade-related matters between countries in respect of IPR. Certain tax exemptions and deductions are also provided to native companies in other member states to provide an incentive to enhance their business income. In the Indian context, it has been observed that an efficient IP taxation regime and royalty policy would persuade creators to produce more original and artistic work and expand the number of technology or know-how transfers into the country.
The following article provides a basic understanding of how income derived from IPR transactions are taxed under the Income Tax regime in India.
Taxation Policy in India w.r.t. Intellectual Property Rights
The taxation structure in India provides that income from intellectual property rights (IPR) shall be segregated according to the nature of the transaction. If an individual authors a book, creates music or is the sole inventor of a medicinal cure, then in those situations, the Income Tax Act of 1956 (the ‘Act’) provides for certain tax deductions which will promote tax planning. Once the nature of the transaction is determined, it is easy to identify whether the amount paid is taxable or would be allowed as a deduction. The categories under which IP can be taxed are:
Deductions – In the pre-existing stage of an IP, the cost which is incurred on analysis, manufacturing, i.e., capital spent on research and development is treated as an expense and is to be deducted from the gross income received for the calculation of income tax.
Income – Income from an IPR either by assignment or licensing is treated as Capital gains or income received from royalties under the Income Tax Act, 1961.
Goods and Sales Tax – Tax on the sale of IP, transfer of IP, licensing of IP and assignment of IP are covered under the GST Act.
What is intellectual property according to tax law
As per the definition of ‘capital asset’ in Section 2(14)[1], a capital asset has an all-embracing connotation except if it expressly excludes a certain item. It includes ‘property of any kind,’ which undoubtedly incorporates intellectual property. The Act does not define intellectual property as such but the difference between tangible and intangible assets is examined in Section 2(11)[2]. Intangible assets, as per the definition, include ‘know-how, patents, copyrights, trademarks, licenses, franchises or any other business or commercial rights of a similar nature.
Royalty
Section 9(1)(vi)[3] of the Income Tax Act elaborates the definition of royalty. Royalties are taxable as income or as a business expense. It is to be noted that regardless of the conditions mentioned in Section 9(1)(vi)[4], if the IP is located in India, then the consideration for its use or disposal will arise in India and will be taxed according to Section 5(2)[5] of the Income Tax Act. Income by way of royalty is taxable under the Income Tax Act for a resident except in respect of:
any right, property or information used or services utilized outside India or
To make or earn any income from any source outside India.
Royalty income is taxable for a non-resident in respect of –
any right, property or information used or services utilized in India or
To make or earn any income from any source in India.
If such income is payable due to an agreement made before the 1st day of April 1976, and the agreement is approved by the Central Government, such income cannot be taxed.
In CIT Vs. Koyo Seiko Co. Ltd[1999 233 ITR 421 AP] it was held that royalty excludes any consideration which would be chargeable under the head of ‘Capital Gains’ and is assessable to capital gains tax at the rates applicable. Thus, royalty is any consideration, including lump-sum amounts but excluding those which would be the income of the recipient chargeable under the head capital gains, for:
The transfer of all or any rights (including the granting of a licence) in respect of an invention, patent, secret formula or process, model, design, trademark or similar property;
The imparting of any information concerning the working of or the use of an invention, patent, secret formula or process, model, design, trademark or similar property;
The use of any invention, patent, secret formula or process, model, design, trademark or similar property;
The imparting of any information or the use or right to use concerning technical industrial, commercial or scientific knowledge, experience or skill; (but not including the amount referred to in Section 44BB[6].)
The transfer of all or any rights (including the granting of licence) in respect of any copyright, scientific, artistic or literary work including films or videotapes for use in connection with television or tapes for use in connection with radio broadcasting, but consideration for the sale, distribution or exhibition of cinematographer films.
The render in of any other service about the activities mentioned above.
Expenditure and Deductions
While determining tax liability, the aim and object of the expenditure should be kept in mind to decided whether it is a capital expenditure or revenue expenditure. A revenue expense is deductable from the chargeable income of a business, while the expenditure incurred on capital is not. The Supreme Court in the case of Assam Bengal Cement Companies Ltd. v. CIT [1955 SCR (1) 876], observed that if the expenditure is made for acquiring or bringing into existence an asset or advantage for the benefit of the business it is attributable to capital expenditure. On the other hand, if it is made for running the business or using it to produce profits, it is a revenue expenditure.
Section 32 (1)(ii) – Depreciation of an intellectual property asset as an expenditure [7].
Depreciation of an asset is considered to be a business expense and the section accounts for such depreciation of IP to be an expenditure for computation of Income Tax.
Section 35A – Expenditure on the acquisition of patents and copyrights [8]
When the consideration is paid in a lump sum, the depreciation over the acquired patent and copyrights shall be claimed over a period;
When the consideration is paid periodically, the depreciation can be claimed as an expenditure fully incurred for business.
Any expense undergone after 28th February 1966 but before 1st April 1998 on the acquisition of patent rights or copyright for a business committed actions will be allowed for each of the previous years on an amount equal to the appropriate fraction of the amount spread over fourteen years.
Section 35AB – An assessee who has paid any lump sum consideration to acquire any know-how for the use of his business, the expenditure for the same shall be deductable in six equal instalments for six years in the following manner [9]–
1/6th of the amount paid shall be deducted while calculating the profits and gains of the business for the previous year;
the balance amount shall be deducted in equal portions for each immediately succeeding the previous five years.
Section 80 GGA – deduction in respect of certain donations for scientific research or rural development [10].
The research work for the development of intellectual property such as a patent comes under the category of scientific research. Under present laws, expensed deductions and additional weighted deductions are permitted to everyone for research and developmental expenditure. For the tax years 2017-2018 to 2019-2020, the weighted deduction is limited to 150% after which it will be reduced to 100% of the expenditure.
Section 80 O – no deduction in respect of royalties from certain foreign enterprises [11]
40% for the assessment year beginning on the 1st April 2001,
30% for the assessment year beginning on the 1st April 2002,
20% for the assessment year beginning on the 1st April 2003,
10% for the assessment year beginning on the 1st April 2004,
No deduction from 1st April 2005 onwards.
Section 80 QQA – Specific provision for copyright products [12]
A deduction of 25% shall be allowed from any income obtained by an author in the exercise of his profession on account of any lump sum consideration for the assignment or grant of right in the copyright of any of his works, except for the following –
Dictionary
Thesaurus
Encyclopedia,
Any book that has been added as a textbook in the curriculum by any university for the degree of graduate or postgraduate course of the university, or
Book which is written in any language specified in the 8th schedule of the constitution or any other language as the Central Government by notification in the official gazette specifies for the promotional need of the language.
Section 80QQB – deductions made in respect of royalty income of authors of certain books other than text-books [13]
Section 88 RRB – Specific provision for patented goods and services [14]
In some cases, the total income earned on a patent can be divided into royalty and additional income other than royalty. The income received as royalty is only eligible for tax deductions. When income is received as a royalty, the whole income or Rs. 3 lakhs (the lesser amount) shall be deducted. If a compulsory license is being granted for a patent, the terms and conditions of the license agreement shall decide the status of the income to allow deduction under this section which shall not exceed the amount of royalty.
Basic qualification criteria for an inventor under this section-
The individual must be an Indian resident.
Original patent holders are only eligible to tax benefits.
The patent under this section should be registered under the Patent Act of 1970, either on or after April 1, 2003.
Section 115BBF – concessional tax rate on the exploitation of patents [15]
10% concessional rate of taxation is applicable on royalty income from the exploitation of patents granted under the Patents Act, 1970. The following criteria must be satisfied –
The patentee should be an eligible Indian taxpayer,
The total income of the patentee must include income by way of royalty in respect of the patent developed and registered in India,
At least 75% of the expenditure is incurred in India for the invention, and
No other expenditure is allowed under the tax provisions if the concessional tax rate under this section is availed.
The benefit of Section 115BBF can be used in any year but the patentee is required to continue to avail of the benefit for the next 5 years. If the option is not exercised in any of the next 5 years, the benefit under the section for the next 5 years following such year in which option is not exercised, shall cease the exist.
Startups and SME’s
A Startup is an industry that has been in existence for not more than seven years and has a turnover not exceeding twenty-five crores whereas an SME is an enterprise with an investment of up to one crore in Plant and Machinery. A startup primarily focuses on the innovation and development of products and processes. Startup-India is an initiative of the government which intends to catalyze the startup culture in India to build a strong and inclusive ecosystem for innovation and entrepreneurship in the country and to provide IPR facilitation, better tax benefits and easier compliance procedures. The special tax exemptions to promote such startups are –
Section 80 IAC: Income tax exemption for recognized startups [16]
After getting recognition as a startup, this section provides that for any three consecutive years out of a block of 7 years (10 years for startups from the Bio-Technology Sector) from the date of its incorporation, tax exemptions can be availed. The eligibility criteria for the same is –
The entity should be a recognized startup,
Only private limited companies or limited liability partnerships are eligible,
The startup should have been incorporated after the 1st of April 2016.
After getting recognition, a startup may apply for Angel Tax Exemption. Eligibility Criteria for this section is –
The entity should be a DPIIT recognized startup
The aggregate amount of paid-up share capital and share premium of the startup after the proposed issue of shares, if any, does not exceed INR 25 Crore.
Other Benefits for Startups regarding IPR:
Patent applications and facilitation helpline will be speedily available.
The entire fees of the facilitators for any number of patents, trademarks or designs that a startup may file shall be taken up by the Central government and the cost of the statutory fees shall be paid by the startup.
Startups shall be provided with an 80% rebate in the filing of patents.
Government Scheme for MSMEs– Support for International Patent Protection in E&IT (SIP-EIT) Scheme
This scheme of the Government of India provides financial support to MSMEs and technology startups for international patent filing. The reimbursement limit provided in it has been set to a maximum of INR 15 lakhs per invention or 50% of the total charges incurred in filing and processing a patent application, (the lesser of the two). This scheme can be availed at any stage of international patent filing by the applicant. The reimbursement, however, will only apply to expenditures incurred from the date of acceptance of a complete application by DeiTY which has to be approved by a competent authority.
Conclusion
Today, several entities derive most of their income from their IP assets and thus enforce the importance of IP and the need for a more enabling taxing regimen. In India, the current economy is witnessing rapid growth in micro and small sector enterprises with great abilities to compete at a global level. Most of these enterprises do not protect their intellectual property due to several reasons such as lack of awareness, lack of funds, exhaustive procedures etc. and are not well equipped to take their businesses to the next level. Awareness of tax planning and a supplementing taxing regimen is the way forward to make a win-win situation for both the Government and the competing parties.
The process of obtaining the grant of a patent begins with drafting of the patent specification and filing in appropriate branch of patent office. After filing, application is published and take up for examination. Examiner performs a patent search or prior art search to assess novelty of the invention before granting a patent. Once examination has taken place and the applicant has replied to all objections raised by the examiner, patent is granted. Even though patent is granted by the patent office, there may be some additional grounds based on which it may be possible to invalidate a patent. In India, if the patent has to be invalidated, it can be done at 3 levels, i.e., pre-grant opposition (before a patent is granted), post-grant opposition (within 12 months from the date of grant) or revocation (after 12 months’ time has expired from the date of the grant).
When in invalidation or validation search done?
Though the steps to perform validation or Invalidation search are same, purpose and outcome may be different. Invalidation search is performed to identify the grounds on the basis of which a patent can be opposed or revoked whereas validation search is primarily performed to find out how strong the patent is compared to prior art and how strong is it to sustain a litigation. In simple words, we can say that when a search is conducted to validate the claims of a given patent, it is called Patent Validity search and when it is used to invalidate the claims of a given patent then it is called Patent Invalidity Search. Other that prior art in the form of patents, this search also includes the non-patent literature.
Some of the scenarios where invalidation or validation search is performed are:
In case of patent infringement, when defendant wants to oppose or revoke a patent, he performs invalidation search to identify statutory grounds on the basis of which patent can be invalidated. Therefore, invalidation report’s finding form part of opposition or revocation petition and helps the defendant to gauge the substance of patent infringement.
In case of Technology Transfer process or at the time of valuating a patent, the patent to be licensed, often needs to be validated to find how strong the patent is. Here, the invention claimed in the patent specification is usually analysed in comparison with the prior art to understand how strong the patent is and this may be a great impact over the royalty fixed between the parties to license the patent.
Sometimes the companies launch their products in the market without performing infringement analysis or FTO (Freedom to operate) search or don’t have knowledge about existing patents which they might be infringing. After they get to know about some existing patents that they might be infringing, it may be too late for them to stop manufacturing the product. In this situation, if there is no other option left and they are willing to take some risk, they usually get invalidation search done to understand the kind of risk they are taking by using third party’s patent (s).
The statutory grounds to invalidate a patent will differ according to the national patent laws of different countries. However, most national laws recognize grounds such as novelty, inventiveness of the invention as grounds to oppose a patent application or a patent. Therefore, an exhaustive prior art search will be directed at each of these separate sources of prior art to identify the prior publication to invalidate the patent.
Steps to perform an invalidation search
The broad steps to perform invalidation search are as below:
Check legal status of the patent and the country wherein it is granted.
Perform a global prior art search, restricted by priority date of the patent to be invalidated. Prior art available, before data of priory of the patent to be invalidated shall be taken into consideration. While performing search, it is highly recommended to perform a search in research papers too.
Claims of all prior art and patent to be invalidated may be mapped to understand clearly the extent of overlap. It helps to understand novelty and inventiveness of the patent to be invalidated.
Further, file wrapper history of the patent to be invalidated shall be checked thoroughly to find out if there is any official requirement which the patent holder has skipped. And this may be a useful piece of information to be added in the report.
Finally, all findings shall be compiled to an Invalidation Report.
We at Origiin have expert team to perform Invalidation/Validation search for Patents. Our deliverables include:
Invalidation report
Claim mapping
All prior arts in PDF format
Please contact us at info@origiin.com to know more about our services (Patent, Trademark, Copyright, Contract, IP Licensing, M&A of companies)
Contracts are used to regulate and legitimize essentially all business transactions. They are, of course, appropriate instruments in contexts other than standard buy-sell and employment agreements. Any situation involving a reciprocal exchange of promises will almost always need the use of a formal, written contract. This is certainly relevant when significant intellectual property (IP) is under consideration. Contracts must be employed by companies with valuable IP to ensure that their internal employees and any external vendors or consultants who have access to their IP information act responsibly, regardless of the timing or duration of that access. Furthermore, corporations must clearly indicate to employees who are involved in or responsible for IP development who possesses the proprietary rights.
The symbiotic link between IP and contract law is examined in this article. The intellectual property bargain, or the delicate balance that purportedly exists in present intellectual property law, cannot simply be viewed as a matter of property law laws stating a balance. A major characteristic of intellectual property dispersed in the open market has always been the connection between intellectual property and contract norms, and that interaction is central to whatever balance has been established. It is pointless to focus exclusively on the statutory provisions of copyright, patent, or trademark laws when discussing a current balance in the property rights sector. Intellectual property contracts deal with a wide variety of rights that can be assigned, licensed to any other person or organization. It is necessary to grasp and incorporate the fact that the policy approach has always assumed that property rights are frequently transferred, waived, or released. The clauses adopted in such contracts, on the other hand, must be designed with extreme prudence and care.
Finally, firms can impose IP protection through a variety of contracts, including confidentiality and non-disclosure agreements, non-compete agreements, and property or assignment agreements, among others. Regardless matter which contract is best for the situation, any IP-related contract must include the following provisions:
These are important factors in an intellectual property contract that should be considered while designing these agreements:
Confidentiality
To safeguard the owner, a confidentiality clause is required. Because there has been a significant increase in technological knowledge, further security measures must be taken to secure the work, and hence a secrecy provision prohibits the binds from disclosing the creation’s integrity. Patents, copyright, and trademarks are instances of intellectual property that have been published and are thus publicly accessible. They are, however, frequently used in conjunction with other confidential know-how to generate commercial outcomes – and such sensitive know-how must be kept confidential.
Contractually requiring tight confidentiality is perhaps the most important part of any IP arrangement. Companies must be exceedingly proactive, take extraordinary security precautions, and remain watchful to potential intrusions or data misappropriation as technological innovation thrives and competition grows. Undoubtedly, despite a company’s investment in the most advanced security measures, essential IP can be exposed purposefully or inadvertently owing to human frailties.
As a result, a robust contract that explicitly imposes an obligation to maintain secrecy, as well as serious repercussions for failure to comply, will dissuade irresponsible and/or malevolent action. Employees who are aware of the potential consequences of disclosing a company’s information are significantly more likely to take the necessary safeguards and follow any IP-related security policy.
Confidential Information Access
Conditions for access to know-how and confidential information by parties’ employees, consultants, or representatives must be stated in order to safeguard confidentiality in a realistic manner. Standards for guaranteeing the security of secret information might also be stated.
Ownership of Intellectual Property Used or Created Over the Duration of the Relationship
The contract must state clearly who will be the owner of the intellectual property that is being used or constantly developed throughout the duration of relationship. Even if the connection is later terminated, the ownership status of the intellectual property should be clearly stated. This is a common dispute in which an employee chooses to leave his job after the creation is completed and wishes to take the creation with him on the assumption that it was developed by him. However, the fact that it was made while he was employed does not give him the right to own it, which must be expressly stated in every contract.
Disputes over Intellectual Property often emerge when an individual resigns from the employment at the organization severs a relationship with external associates. Employees and consultants who contribute to the creation and development of IP may believe they have the right to take it with them when they depart. Even if this is acceptable to a corporation, it must be determined from the beginning to avoid costly misconceptions. In most circumstances, a business expects to keep ownership of whatever IP it develops. To avoid misunderstanding, this proprietary intent must be made abundantly explicit in any relevant contract.
Access
A contract must unambiguously indicate who individuals are authorized to access the IP, when they may access it, and for how long they will have access, in addition to declaring explicitly which party will retain property rights over the IP. In some situations, a non-compete agreement may prevent an employee from working in a related area for a period of time after leaving a company. However, the extent and length of any such agreement are limited, and a former employee may presume that he or she can still refer to IP information that was created with their participation. Even if a corporation grants such access to current or former employees, the manner in which such access is granted must be specified in a contract. Companies may, for instance, aim to make sure that information is accessed through a secure server or a tightly managed data repository. The requirements for access to IP within a corporation must be clearly specified.
Indemnification
IP indemnification on IP representations and warranties, can be used to hold a seller liable for violations of IP representations and warranties. These aren’t the only types of breaches that might trigger indemnity in a contract, but in contracts where IP may not be the main emphasis, the IP-related indemnification clauses can get neglected during negotiations, which can lead to dispute later if a claim occurs.
In discussions about IP indemnity, the scope and duration of indemnification should be addressed. The seller will aim to reduce the amount of time it can be held liable for indemnification, while the purchaser will seek a longer survival period. The seller will also wish to try to limit its indemnity liability, though this can be challenging. If there are restrictions in place for breaches of general representations, the seller may seek comparable caps for IP breaches, but the acquirer is more likely to push for a larger cap. Acquirers may also try to have specific matters exempted from the cap (i.e., fraud claims, intentional breach). Control of claim defense is another area where IP indemnification is being negotiated. The seller may want to demand control considering he or she will be more compelled to resolve the claim if the acquirer has control and simply forwards the invoices to the seller.
In the event of an IP license, which may be a stand-alone agreement or a component of a larger agreement, indemnification terms may oblige the licensor to extend its IP protection to the licensee if and when a third-party IP dispute arises. It is critical for the indemnitor to understand what it is committing to indemnify, regardless of the type of IP matters that may be indemnified.
Recourse
A contract must clearly out the consequences of any breach of the agreement in order to have the bite it requires. It will not adequate to utilize vague descriptions including such fines or litigation. It must be apparent to the person who will be signing the agreement that the company takes the security of its intellectual property very critically and will aggressively pursue any and all legal remedies available. In the unfortunate event where valuable IP is misappropriated, there should be no ambiguity regarding the next course of action.
Intellectual Property Documentation and Records
Sophisticated contracts may include a system for recording and documenting the intellectual property developed throughout the course of the relationship (e.g., by creating specialized lists) so that it can be identified. This allows for improved future valuation of intellectual property and enhances the potential to monetize such property through full or partial assignment, depending on the interests of the parties.
Termination/ Breach of Contract
Contracts must explicitly specify the consequences of breaching the contract. Because a vague definition of such termination/cancellation/penalty clauses might lead to years-long tedious legal battles, an ironclad contract with respect to penalty clauses is required. There should be no ambiguity.
An over- simplification of licensing is monetizing the intellectual property of your invention by allowing third parties such as companies to in-license the intellectual property for various purposes that involve manufacturing, marketing and selling. A patent, trademark, copyright, trade secret, a tech algorithm, or techniques or procedures or know-how are all examples of intellectual property. Subject to the provisions of the licensing agreement, when an invention is given for licensing to a licensee, the organization is empowered with the ability to manufacture; market and sell the invention. The process of Licensing of the technology is completed upon execution of Technology License Agreement (TLA) between the Licensor and licensee whilst the inventor is given royalties by the licensee as a consideration for the said agreement.
It is of paramount importance that the terms and conditions of License Agreement are explicitly agreed by both parties and is in a written form.
Why license an innovation to a company?
The fundamental reason that inventors license their patents for royalties is so that they can focus exclusively on attempting to create rather than managing to manufacture, monetize, or distribute each of their inventions. Inventors can create intellectual property and then license the rights to another company to bring the product to market through a patent license agreement. For many innovators who may not have the resources to bring their invention to market on their own, this serves as a viable option.
Licensing inventions for royalties can also help inventors access new markets and expand the reach of the invented product. If an inventor intends to expand into a market where he has limited experience or in an industry across the borders or want to endorse a licensee who has similar products in the market and where the invention could be optimally used in, the inventors decide to license their patent.
Structure of a License Agreement
Licensee: Selecting an appropriate licensee to meet the requirements is one of the first crucial steps in licensing an intellectual property for royalties.
Scope: The scope of the license is determined by the licensor (inventor) which clarifies specifications of the intellectual property. The questions involved are whether the licensee is allowed to access the IP rights as a whole, or will the licensee only be allowed to use the patent for a precise task, for instance, manufacturing or distribution worldwide or in specific jurisdiction. The valid duration of such intellectual property license along with restrictions on geographical locations and various markets is important to be negotiated.
There are no specific requirements of the license to either be exclusive or non-exclusive. It solely depends upon choice of the parties. The license may contain a prohibition on the parties competing in the jurisdictions in which they operate; the contents of the contract will factor in the determination.
In order to receive protection against similar inventions or otherwise, a patent must be compulsorily registered or filed for priority protection, and the patent license must be in writing and registered under section 68 of the Patents Act 1970.
Validity of License Agreements
A license agreement, as previously said, should be in writing with all pertinent terms fully outlined. Would just a term-sheet, to the contrary, suffice as a legitimate license agreement? PVR Pictures Limited vs. Studio 18[1], the Delhi High Court delved at this issue. The parties had agreed in this matter to enter into a term-sheet agreement (TSA) under which PVR would be the exclusive licensee for distribution rights in respect of selected cinematic pictures for which written agreements would be executed. PVR accused Studio 18 for infringement, claiming that by refusing to enter into an agreement with PVR on the film, Studio 18 was infringing on PVR’s rights. PVR asked for ad interim relief against the defendant. The issue was whether PVR is Studio 18’s licensee for the film Short Kut, and if so, whether it is entitled to an ad-interim injunction. The courts held that the TSA does not signify a license agreement because the parties did not intend for the TSA to become a binding contract and a license as defined by the Copyright Act; and because PVR failed to develop any legal right or copyright for the grounds of suit, PVR cannot seek specific performance or an ad interim injunction.
Hence, the license terms must not only be in writing but should also be in the form of a binding definitive document for a valid License Agreement.
Terms of a License Agreement
A license agreement must be extensively drafted to provide for specific details of the rights and the limitations imposed on the licensee in the exercise of such right. The definition of licensed property, the geographical features for which licenses are granted, the right given to the licensee to further sublicense the property, clauses regarding revocation of the license, royalty or consideration for the grant of license, dispute resolution, cessation, all of which are inherent areas of the agreement.
To ensure that the licensee cannot claim that the IP has been transferred to it, the license agreement must be carefully drafted, and certain license constraints must be included. There have been certain cases where the licensor has executed an exclusive license and the licensee claims that the IP has been assigned. Indian courts have looked at the essence of the contract, notably the royalty payment clauses, to assess whether a transfer should be interpreted as an assignment or an exclusive license in a number of cases.
In Deshmukh and Co. (Publishers) Pvt. Ltd. vs. Avinash Vishnu Khandekar and Ors[2], the Court looked at the difference between assignment and licensing of Copyright. It was iterated that the essence of a document, not the manner of words used, must be considered when determining whether it is an assignment or just provides a license. The question usually arises in the context of whether the right in question has been partially assigned or licensed exclusively; the distinction is subtle but significant.
The copyright is not conveyed if the consideration is in the form of royalties or a portion of profits rather than a direct payment. It would be a publishing and selling license. In this situation, the payment of royalty rather than substantial money intended to be a sale, stands against partial assignment.
Consequently, the licensing provisions must unambiguously declare that it is a license (whether exclusive or non-exclusive) and clarify the contractual terms. More significantly, the royalty payment clause should be formulated carefully that it does not imply that any direct payment is made in exchange for Intellectual property assignment.
Improvements, enhancements, and revisions to IP are the responsibility of the IP owner.
Licensee can design and develop an enhancement to an existing technology or a component that improves the technology’s use or functionality. The new innovation could be the result of modifying the licensed IP to make any improvements, or it could be the outcome of an innovation related to the use of the licensed IP. These improvements signify advancement in the licensed technological field that improves the initial IP’s usage, functionality, efficiency, productivity, or other attributes. A license agreement must indicate what designates an improvement, and the ownership of such improvement and all property created as a result of it.
Mandated registration of License Agreement
When a license agreement is intended to be performed, the issue of whether the registration of the agreement is mandatory arises. If required by law, what are the consequences of non-registration? The Patents Act, the Trademarks Act, and the Designs Act all require license agreements to be registered, although the Copyright Act does not. The Indian Stamp Act, 1899 (the “Indian Stamp Act”) governs the transfer of intellectual property rights in the form of licenses, assignments, and sales, among other things.
Quantification of Royalty
As previously mentioned, when an inventor licenses his invention to a third party, the two parties engage into a license agreement in which the licensee acquires the patent rights and the licensor receives a fixed sum of money each time the product is sold.
The royalty is a fixed sum paid to the licensor or inventor as consideration, and the licensing royalty rate is a percentage of the net or gross profit selected to constitute the royalty. The quantification of royalties may heavily depend on the negotiations between the parties and merchantability of the invention. The Licensor may be in violation of The Competition Act, 2002 (the “Competition Act”) if it attempts to set extortionate prices as a result of its dominating market position. The test of accuracy of the royalty is reasonability.
The accuracy of the royalty base would determine the reasonableness of a royalty. The royalties is calculated on an individual basis. The Competition Commission of India (“CCI”) has adjudged on numerous cases regarding royalty rates assessment. It has been iterated that offering different licensing prices to different users for the same technology is in violation of FRAND requirements. Further, the CCI determined that Ericsson imposed unjustified royalties because no alternative technology for its patents 2G, 3G, and 4G standards was available.[3]
Even-though, licensing an invention comes with certain limitations and risks, the license agreement allows parties to expand the inventions to various jurisdictions and markets which aligns with the primary visions of licensor and reach larger targeted audience.
Biosimilars can be perceived as a category of biological product that have been sanctioned and approved by due regulatory authorities in consonance with the fact that these products are highly alike and akin to a biological product that has been approved on a prior basis. This previously approved biological product is known as the biological reference product.
In distinct contrast to the chemically synthesised generic versions of drugs, biosimilars are sanctioned in accordance with the standards of the pharmaceutical standards, effectiveness, efficacy and safety that are in common parlance applied to all biological medicines.
Biosimilars and Generic Medicines- An underlying dissimilarity
A Biosimilar cannot be perceived as a generic biological medicine, in due accordance with the process of manufacture of a Biosimilar. This means that the variability that occurs naturally and the complex process of manufacturing biological medicines does not facilitate the process of exact replication of molecular microheterogeneity.
Biosimilars are seen to be very similar to the reference product that they are manufactured in comparison to, but have certain minute differences in terms of the purity and potency.
An Anatomization of Biosimilars- Legal and Regulatory Framework in India
India refers to Biosimilars as “similar biologics” and has paved its way into the biosimilar industry with the first launch of “similar biologic” for the disease hepatitis B. India has about 95 biosimilars that are duly approved by the regulatory authority.
In India, the Central Drugs Standard Control Organization is the national authority and the regulatory body that has introduced new guidelines for biosimilars that became effective from the 15th of August, 2016. The previous guidelines that were in existence with regards to biosimilars were the “Draft Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India” which was effective from 2012.[i]
The 2012 guidelines seek to address the pre and post-marketing regulatory requirements body which is also known as the comparability exercise. These guidelines direct and address the requirements related to the manufacturing process and quality control.[ii]
India follows the pattern of “sequential approach” with regards to biosimilar products. The guidelines that were released in 2016 focus on the aspect of Post Marketing. The major vital difference underlined between the 2012 and 2016 guidelines is the Reference product. If the reference product cannot be marketed in India, it could be licensed and marketed in any ICH Country (International Council for Harmonization).
Apart from the guidelines as enforced by the Central Drugs Standard Control Organization, biosimilars are also synchronised and balanced by the Drugs and Cosmetics Act, 1940, the Drugs and Cosmetics Rules, 1945, Recombinant DNA Safety, 1990 and the Guidelines and Handbook for Institutional Biosafety Committee, 2011.
Market Authorization for the sale of these biosimilars in India is authorised by the Department of Biotechnology via the Review Committee on Genetic Manipulation. There are three stages that act as a precursor to the marketing authorization of these biosimilars- pre-clinical, clinical and post-clinical trials.
The Pre-Clinical Trial process includes information on the biological reference product, and the corresponding information on the biosimilar. This trial phase also includes the submission of details with regards to the downstream process development like that of fermentation, considerations of molecular biology and other quality based considerations.
The Clinical Phase consists of information in consonance to the pharmacokinetic, pharmacodynamics, immunogenicity and other efficacy studies.
The Post- Clinical Trial process includes the studies carried out on the marketing of the biosimilar, drug safety and reporting of any adverse reactions to the drug.
These trial phases and processes are exhibited in the strict and stringent manner in India. In the case of Roche Products (India) Private Limited v. Drugs Controller General of India[iii], Roche had filed a case against two other pharmaceutical companies in lieu of non-adherence to the guidelines applicable and grossly misrepresenting the generic drugs as biosimilars. The court enforced a restraining order on the pharmaceutical companies.
PatentProtection of Biosimilars in India
It is of immense necessity to conform to the regulations set out for the production and trial process to duly attain the right of marketing the biosimilar in India. The process of patenting biosimilars is subject to the criteria that are applicable to patentable items like that of novelty, involving an inventive step and industrial application of the biosimilar. The nature of biosimilars mandates it to be close in efficacy and nature to the biological reference product.
Therefore, these biologic medicines and biosimilars are subject to and governed by Section 3 of the Patents Act. Any biological product that are not naturally occurring and are synthetically developed by human beings could be patented, but if it contains a living organism that occurs in nature then it would fall under Section 3(c)[iv] which rules out the patentability of a scientific discovery or conception of abstract theories.
Section 3(d)[v] of the Patents Act, lays down the following for which patent protection is prohibited-
The sole discovery of any new forms of a known substance if it does not increase the effectiveness and efficacy of the substance at hand.
The discovery of any new property of a substance that has already been discovered.
Albeit, a few boundaries for deciphering improved viability for drugs have risen up out of court choices, as far as biopharmaceuticals (especially biosimilar innovations) the subtleties stay obscure.
Trends Observable
Albeit Indian organizations are known for delivering conventional and generic biological drugs, many organizations are presently moving into the worldwide biosimilars market. As per the Associated Chambers of Commerce of India’s 2017 Report, biosimilars sum to $2.2 billion of the $32 billion Indian market – and is required to accomplish a development pace of around 30% build yearly development. A phenomenal illustration of the organization of worldwide drug firms in concurrence with an Indian drug organization can be discovered when Swiss-based Roche went into a concurrence with Emcure for Herceptin, a biosimilar utilized for human epidermal development factor and in instances of positive metastatic bosom and gastric disease. The medication was subsequently promoted by Emcure in India under the brand name ‘Biceltis’. In another model, Mylan, a worldwide monster with an enormous generics portfolio, gone into association with Bangalore-based biopharmaceutical organization, Biocon. Trastuzumab, a biosimilar made by the joint endeavors of both the organizations to lessen febrile neutropenia during chemotherapy, was supported by the US Food and Drug Administration in 2018 and was the first biosimilar created by an Indian organization to be endorsed in the United States.
In spite of the fruitful turn of events and showcasing of some biosimilars by Indian companies, innovative work in this space will face difficulties with regards to the improvement biologics and biosimilars. As opposed to generics – which are comparative instead of indistinguishable from the marked medication – biosimilars are substantially more mind boggling and costly to produce. In furtherance, as opposed to the generics business, biosimilars are likewise dependent upon rigid clinical courses of events obviously characterizing administrative methodology for enormous scope, complete clinical projects setting up the security and viability for treatment of demonstrated problems. The oddity of the biologic and biosimilar improvement measure makes it hard for new organizations to enter this space. Considering an illustration of other drug organizations in India, Dr Reddy’s Laboratories, Cipla, Lupin and Aurobindo are additionally producing biosimilars, some of which are endorsed for promoting. It is normal that more Indian drug organizations will have the capacities and assets to create biosimilar items. As need be, steady and clear administrative and authoritative rules are at present expected by the business.
Conclusion and Way Ahead
In layman’s context, pharmaceutical products and biosimilars are a combination of effort and time from the conception of idea to the process of commercialisation and require rigorous endeavours with regards to research and development. There has been a rampant and a pronounced switch in the pharmaceutical industry of India to that of biopharmaceutical products. It has been seen that regardless of the extra time and exertion needed for advancement and foundation for research work, just as the patching up of consolidations and extensions, it is expanding to address the issues of the biologics.
[i] Government of India, Department of Biotechnology, Central Drugs Standard Control Organization. Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India; 2012.
[ii] Government of India, Department of Biotechnology, Central Drugs Standard Control Organization. Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India; 2016.
[iii] Roche Products (India) Pvt. Ltd. and Others v. Drugs Controller General of India and Others, 2014 SCC OnLine Del 7682.
In 2005, the Madras Patent Office considered and later (in 2006) rejected the product patent application filed by Novartis AG for Glivec on the basis that it was not novel, that is obvious to a person skilled in the art and was anticipated by the prior publication of Zimmermann patent; Novartis AG had also wrongly claimed date of filing of the application in Switzerland as the priority date in India. Further, Section 3(d)
In our journey forward, we aim to forge partnerships with NBFCs, Banks, and other deposit-taking entities. This collaborative effort will provide our investors with a comprehensive retail investment perspective. Additionally, we are committed to assisting new-to-credit users in initiating their credit journey. Through secured credit cards and loans offered by us, we empower users to build their credit scores, subsequently opening doors to further credit opportunities.
The Reimbursement limit has been set to the maximum of Rs. 15 Lakhs per invention or 50% of the total charges incurred in filing and processing of a patent application, whichever is lesser.
Patent licensing is the process by means of which patent owner grants permission to other party or licensee to use the patented invention for a specific period of time in a particular jurisdiction in lieu of royalty. By granting license to use the patent, the patent owner is able to introduce his patented invention into the new markets through the licensee, who, in most of the cases, is a well-established company. By obtaining a license, the licensee gets to exploit the patented invention in terms of building, marketing and selling innovative products.
Invalidation or validation search is a kind of search wherein prior art is compared with the patent to assess the ease or difficulty involved in invalidating the patent. The term ‘Invalidation’ is often used when patent office declares a patent to be invalid as a result of pre/post-grant opposition or revocation of the patent. Before patent is granted and after its publication, there is a chance for third parties to oppose a patent application to prevent it from getting granted on the basis of statutory grounds listed under Section 25 (1) of the Indian patents Act 1970. Likewise, there are statutory grounds for post-grant opposition and revocation of patents also listed under section 25 (2) and Section 64 of the Act, respectively. It is important to note here that the Controller of Patents invalidates the patent only when opposition or revocation petition is filed by the third party (ies). Decision to invalidate the patent is taken by the Controller after reviewing arguments and evidence submitted by both the parties (i.e., opponent and patent owner). The steps and process involved to perform invalidation and validation search are the same but the outcome or opinion may be different. An invalidation search is performed to identify the grounds on the basis of which a patent can be 
Every business possesses one or the other form of Intellectual Property and most of the times, such IP is either under-utilised or un-identified. Though it may not be required to register all IP assets, it is pertinent or rather crucial to identify it to take decision on whether it is worth registration or not.
Today, most businesses are facing the threat of IP theft or leakage by the their members such as employees and even consultants. Intellectual Property (IP) is a valuable asset for any organization not just due to its market value, but also the amount of money and effort which goes in to create it. Due to its intangible nature, IP is easy to misappropriate & leakage of IP may happen due to inappropriate disclosure by employees, lack of safety measures or weak policies and agreements.
Intellectual property (IP), which includes trademarks, patents, copyrights, and other forms of creative assets, plays a crucial role in establishing authority, quality, and distinctiveness in the dynamic and competitive business environment, where companies strive to set themselves apart and achieve uniqueness. Certain types of IP, such as trade secrets, are considered confidential due to the potential harm that their disclosure to competitors can cause. Therefore, companies are highly concerned about protecting their IP and employ various measures, including registration and the use of NDA. NDAs are particularly significant when sharing sensitive information with investors or venture capitalists, as they provide a legal framework to prevent unauthorized use or replication of ideas by individuals who have access to confidential data. By implementing a NDA, companies can effectively safeguard their IP, maintain their competitive advantage, and ensure the preservation of their innovative ideas.
In an era of technological advancements, innovations are on a verge of representing the qualitative approach of a changing society. On one hand, innovations have the potential of ameliorating the quality of life by significantly contributing to labor and production. On the other hand, such transitions also demand ground-breaking competitive advancements that can square up to the needs of changing dynamics of developments. The ideology of managing the adoption and flow of knowledge has become a crucial parameter for every country. Therefore, it’s of utmost importance to focus on scientific and technological research methods for fruitful exchange to maintain the aura of competition.
Parle Products introduced Parle-G way back in 1938. The biscuits themselves have had a long journey attaining global recognition, with the brand undergoing reimaging in 1982. One may wonder why an exceedingly popular and successful brand had to undergo reimaging after so many years of being introduced to the market and becoming a hit among consumers. The answer lies in an understanding of trademarks.
This landmark judgement is the first “process patent” case in India that actually demonstrates the difficulties and uncertainties that arise in establishing that products are identical. It highlights the significance of 
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In this landmark judgement the Division Bench of the 
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This is a landmark case in the history of Indian patent system. On April 2013, the Supreme Court of India confirmed the rejection by the Indian Patent Office of a patent application (Patent number: 1602/MAS/1998) filed by 
The landmark case took place between 
In this case of trademark infringement, an exemplary amount of Rs. 1.5 crore was awarded by the Hon’ble Bombay High Court in favour of 
Apex laboratories
Parle-G is a leading biscuit brand under Parle Products for biscuits and confectionary items. With a worldwide presence, Parle has carved out a place for itself in the biscuit business with value-for-money products, widespread availability, consistent taste and a very long presence in the business.
Bayer Corporation, a US based corporation had a patented drug in India under the brand name 
In this case, Medical Technologies (hereinafter referred to as MT) filed a suit for passing off against 
Merck Sharp & Dohme
If worked out well, technology transfer is an extremely effective way to commercialize the patented invention. It plays an important role as a catalyst for the further development of technology and patents play a very vital role in case of technology transfer because patent is one of the best ways to protect a technology. Technology transferred without even filed for a patent is a very risky affair. At least a patent application for the technology should have been filed before negotiating on technology transfer for the reason that after grant of the patent, the certificate obtained from the patent office serves as a proof of ownership. A Patent also confers certain statutory rights to the patent holder that the technology transfer process.
Corona Virus are a group of RNA virus which affects the mammals and birds. In mammals, the attack and effect the respiratory tract causing infections, that can be mild to severe to lethal. Mild illnesses in humans include some cases of the common cold (which is also caused by other viruses, predominantly rhinoviruses), while more lethal varieties can cause SARS, MERS, and COVID-19. In cows and pigs, they cause diarrhea, while in mice they cause hepatitis and encephalomyelitis. Corona viruses constitute the family of Coronaviridae, order Nidovirales and realm riboviria. Corona Virus have been said to have existed for around 8000 BCE. The Human Corona Virus have their origin in Bats. Coronavirus can have cold with major symptoms, such as fever, cough and sore throat.
Therefore, Data Exclusivity can be perceived as a transformational notion of protecting data by not disclosing the data to the general public which essentially is the protection of data in the form of trade secrets and the basis of principles such as equity and good faith. In addition, the invention whose information is kept protected must confine itself to the essentialities of a patent that is- the invention must be new, should be an inventive step and must be capable of being industrially applied.
The symbiotic link between copyright and contract law is examined in this article. The intellectual property bargain, or the delicate balance that purportedly exists in present IP laws, cannot simply be viewed as a matter of property laws stating a balance. A major characteristic of IP dispersed in the open market has always been the connection between IP and contract norms, and that interaction is central to whatever balance has been established. It is pointless to focus exclusively on the statutory provisions of copyright, patent, or trademark laws when discussing a current balance in the property rights sector. IP contracts deal with a wide variety of rights that can be assigned, or licensed to any other person or organization. It is necessary to grasp and incorporate the fact that the policy approach has always assumed that property rights are frequently transferred, waived, or released. The clauses adopted in such contracts, on the other hand, must be designed with extreme prudence and care.
Purple Book, brought out on September 9, 2014, by the FDA consolidates list of licensed biological products including biosimilar and their interchangeable biological products. This compendium guides pharmacists in implementing pharmacovigilance in biological products and its biosimilars. Biological products and biosimilars are FDA approved that are primarily governed under Public Health Services Act. For the FDA approval, a Biologics License Application (BLA) can be filed under sub-sections of Section 351(a) and 351(k) of PHSA. An application filed under Section 351(a) for biologics and innovator biologics should submit all requisite information supporting its safety and effectiveness. This section 351(a) application is also referred as a standalone application for its non-reliance placed on other biologic products. A BLA filed under Section 351(k) for biologics license should submit information that confirms the manufacturer’s claim that the biosimilarity of the product is based on data to animal studies, clinical studies and analytical studies. Thus, the primary purpose of the Purple Book is to enable cross-checking as to whether a licensed biological product under Section 351(k) is biosimilar to or interchangeable with the reference product and to provide information pertaining the exclusivity of such reference product. Thus, the Purple Book lists all the biological products licensed under Section 351(a) and lists correspondingly, all the licensed biosimilar and interchangeable products of the reference product.
After demonetization was implemented in India, there was a massive amount of increase in subscribers of Paytm. Paytm had 300 million registered users by August 2018. This figure compares with 520 million Alipay users and 237 million PayPal users around the same time. On average, one in five Indians had already started useing Paytm.
In the Trade Marks Act of 1999, 
Patent licensing allows for the creation of value from innovation as well as the advancement of certain other strategic corporate objectives. Bilateral licensing transactions are the hallmark of the ‘traditional’ patent-licensing industry. It is moreover characterized by consequential transaction costs borne by the parties and information asymmetries that threaten to shrink the market over time. An exclusive license encompasses all of the patent’s rights licensee receives except the title. In this instance, the licensee enjoys the same rights as the patent owner, with the exception of the ability to transfer the patent to another individual or company. This restriction exists simply because even though the agreement allows the rights to be transferred; the patent owner retains ownership of the title.
The taxation structure in India provides that income from intellectual property rights (IPR) shall be segregated according to the nature of the transaction. If an individual authors a book, creates music or is the sole inventor of a medicinal cure, then in those situations, the Income Tax Act of 1956 (the ‘Act’) provides for certain tax deductions which will promote tax planning. Once the nature of the transaction is determined, it is easy to identify whether the amount paid is taxable or would be allowed as a deduction. The categories under which IP can be taxed are:
The process of obtaining the grant of a patent begins with drafting of the patent specification and filing in appropriate branch of patent office. After filing, application is published and take up for examination. Examiner performs a patent search or prior art search to assess novelty of the invention before granting a patent. Once examination has taken place and the applicant has replied to all objections raised by the examiner, patent is granted. Even though patent is granted by the patent office, there may be some additional grounds based on which it may be possible to invalidate a patent. In India, if the patent has to be invalidated, it can be done at 3 levels, i.e., 
The symbiotic link between IP and contract law is examined in this article. The intellectual property bargain, or the delicate balance that purportedly exists in present intellectual property law, cannot simply be viewed as a matter of property law laws stating a balance. A major characteristic of intellectual property dispersed in the open market has always been the connection between intellectual property and contract norms, and that interaction is central to whatever balance has been established. It is pointless to focus exclusively on the statutory provisions of copyright, patent, or trademark laws when discussing a current balance in the property rights sector. Intellectual property contracts deal with a wide variety of rights that can be assigned, licensed to any other person or organization. It is necessary to grasp and incorporate the fact that the policy approach has always assumed that property rights are frequently transferred, waived, or released. The clauses adopted in such contracts, on the other hand, must be designed with extreme prudence and care.
The fundamental reason that inventors license their patents for royalties is so that they can focus exclusively on attempting to create rather than managing to manufacture, monetize, or distribute each of their inventions. Inventors can create intellectual property and then license the rights to another company to bring the product to market through a patent license agreement. For many innovators who may not have the resources to bring their invention to market on their own, this serves as a viable option.
A Biosimilar cannot be perceived as a generic biological medicine, in due accordance with the process of manufacture of a Biosimilar. This means that the variability that occurs naturally and the complex process of manufacturing biological medicines does not facilitate the process of exact replication of molecular microheterogeneity.
