Feb 7, 2023 | Indian Patents Act 1970, IPR & Business, Startups
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.
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Feb 1, 2023 | Indian Patents Act 1970, Key Terms of Patents Act
Person interested under Section 2 [Definitions and interpretation] of Indian Patents Act 1970 is a person (legal or natural), who has some concern or interest in the patent/application for the reason of being in the same area of technology. It includes a person engaged in, or in promoting, research in the same field as that to which the invention relates. Person interested includes a person engaged in, or in promoting, research in the same field as that to which the invention relates.
For example, if applicant who filed the patent application is a company, Nokia [legal person or entity] that is in the business of mobile phones, the person interested in its patent may be its competitors involved in the same business of mobile phones such as Motorola or Sony Ericson i.e., person who is engaged in or doing research in the same area, which invention of Nokia relates to.
Person interested has an important role to play in law of patents. Some of the actions that a person interested can perform are:
- File for post-grant opposition for the patent
- Request for examination of patent application on behalf of the applicant.
- File petition for revocation of a patent
- Apply for compulsory license
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Jan 23, 2023 | Patent
United States Patent and Trademark Office (USPTO) is considered to be one of the most lucrative destinations for the applicants to file for a patent for various reasons. Business opportunities in US are better than any other jurisdictions; enforcement of patent rights is effective; time taken for patent grant is less; US market is mature for buying or selling of patents; & US patent is valued more by the investors. For all these reasons, when the applicant wants to file patent application both in India and US, the biggest dilemma he has is where to file for a patent first, in India or US? Problem becomes bigger if the applicant does not want to file for a patent in India at all and directly wants to file in the US without pursing Indian filing.
In this article, we will explore the advantages of filing for a patent in India first, and consequences of filing directly in US first if the applicant is a resident of India.
Filing in India first makes sense (U/S 39)
Before taking a decision on where to file first, it is essential to understand what Indian Patent Laws say about foreign filing of a patent. The issue is sensitive as well as critical and lack of expert legal advice on the same may have fatal consequences.
According to Section 39 (Residents not to apply for patents outside India without prior permission) of the Patents Act 1970, a person who is resident of India may file for a patent in the US or any other foreign country by 2 ways:
- The first option is to file a patent application in India first, wait for 6 weeks and then go for foreign filing or PCT (Patent Cooperation Treaty) application filing, as the case may be. After filing the patent application in India, if the applicant does not get any objections from Indian Patent Office within 6 weeks from the date of filing, this indicates that the Controller does not have any objections with respect to foreign filing and applicant can file application outside India.
- The second option is to take Foreign Filing Permission (FFP) on Form-25 [Request for permission for making patent application outside India] from the Controller of patents, if the applicant does not want to file patent application in India and wishes to go for foreign filing directly. Prescribed fee to be paid along with Form 25 is 1600 INR for natural person/start-up/small entity and 8000 INR for others except natural person/start-up/small entity for e-filing and ten per cent additional respectively in case of filing by physical mode. This permission is usually granted by the Controller within 21 days from the date of request. So, if the applicant wants to file patent application in any foreign country without Indian filing, this Foreign Filing Permission (FFP) or Foreign Filing License (FFL) is required.
If the invention is relevant for defence purpose or atomic energy, the Controller shall not grant permission to file patent in foreign country without the prior consent of the Central Government. This section shall not apply in relation to an invention for which an application for protection has first been filed in a country outside India by a person resident outside India.
Who is “Resident of India”?
The term “Resident of India” has not been defined in the Patents Act, 1970 but according to Income Tax Act, an individual can be termed as a ‘Resident of India’ if he stays for the prescribed period during a fiscal year i.e. 1st April to 31st March, either for:
- 182 days or more; or
- Has been in India in aggregate for 365 days or more in the previous four years.
Any person who does not satisfy these norms is termed as a ‘Non-Resident’. A resident individual is considered to be ‘ordinarily resident’ in any fiscal year if he has been residing in India for nine out of the previous ten years and, in addition, has been in India for a total of 730 days or more in the previous seven years. Residents who do not satisfy these conditions are called individuals ‘not ordinarily resident’.
Rational behind filing in India first
Main rational behind having Section 39 is to safeguard national defence and security. If the invention is relevant for defence purpose or atomic energy, the Controller shall not grant permission for foreign filing without the prior consent of the Central Government. Secrecy Directions may be imposed on such application and the Controller may give direction for prohibiting or restricting the publication of such application if it appears to him that the invention in question falls in one of the classes notified to him by Central Government as relevant for defence purposes or the Controller himself considers it to be so. However, this section shall not apply in relation to an invention for which an application for protection has first been filed in a country outside India by a person resident outside India.
Do you lose anything by filing in India first?
It is a myth that by filing a patent application in India first and US later, one loses on the date and filing and patent filing in the US gets delayed. The fact is that even if you file for a patent in India first, you can file the same application in US (as convention application) immediately after expiry of 6 weeks from the date of Indian filing. Kindly note that patent application may be filed anytime before expiry of 12 months from the date of Indian filing to claim priority from the Indian application. At the time of filing in US, you can claim priority date from your Indian filing as both India and US are convention countries as per the Paris Convention. Effectively, this means that even though you file in India first and US later, the same date of priority can be maintained in USPTO as well. In-fact when priority is claimed from Indian filing, the applicant has to submit to USPTO, the priority document obtained from the Indian Patent Office.
Therefore, it actually does not matter where you filed first, but yes, it certainly is a better and a safe choice to either file for a patent in India first or take permission from the Controller for foreign filing.
Consequences of violating section 39
If a person makes or causes to be made an application for the grant of a patent in contravention of section 39, he shall be punishable with imprisonment for a term which may extend to two years, or with fine, or with both. Hence, it is important to either file application in India first or take FFP from the Controller of Patents.
Conclusion
In the instances where the applicant or inventor is a resident of India, it is important to consider filing for a patent in India or taking permission for foreign filing from the Controller, before filing for a patent in foreign country or PCT for the reason that violation of this provision can lead to fatal consequences.
Dec 20, 2022 | Indian Patents Act 1970, IPR & Business
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.
In December 2005, Celgene received approval from the FDA to market Revlimid.. It is part of a class of drugs called immunomodulatory drugs (IMiDs), which work against cancer cells partly by supporting the function of the immune system. Since then, many generics have filed ANDA (Abbreviated New Drug Application) for Revlimid drug including renowned pharmaceutical companies such as Dr Reddy Laboratories, Cipla Pharmaceutical Company, Natco Pharma and Lotus Pharmaceutical.
Celgene faced its first generic contender in 2010 when Natco Pharma, Arrow Pharmaceuticals and Watson Pharmaceutical Private Limited (collectively as NACTO ) filed an ANDA with FDA seeking approval to make a generic version of Celgene Corporations Lenalidomide Drug under the market name Revlimid, whereas Celgene Corporation proposed that Natco infringes its patents, which on the other hand initiated a Hatch-Waxman Lawsuit (known as Drug Price Competition and Patent Term Restoration Act).
Natco Pharma is an Indian multinational pharmaceutical 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 multinational pharmaceutical 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.
Therefore to conclude, Celgene corporation has settled its patent infringement suit against Sun Pharma in June 2021 and subsequently with companies like Natco Pharma, Dr Reddy Laboratories, Alvogen, Cadila Healthcare, Lotus Pharmaceuticals respectively. These Indian companies are leading pharma Medicare producers in India and are ranked amongst the fastest growing pharmaceutical companies in India.
By: ANUSHKA SEEMENDRA, ICFAI UNIVERSITY, DEHRADUN
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Nov 9, 2022 | General
The Digital Personal Data Protection Act, 2023 (also known as DPDP Act or DPDPA-2023) is an act of the Parliament of India to provide for the processing of digital personal data in a manner that recognises both the right of individuals to protect their personal data and the need to process such personal data for lawful purposes and for matters connected therewith or incidental thereto.
With the entrance of the digital age, and where personal data to become the most wanted currency in the e-universe, India is giving ample consideration to digital privacy rights of the citizens. Visible in the centre of this movement is the so-called Data Protection Bill or DPDP Act shortly (Data Protection and Privacy Bill). Viewed as a complete set of rules which, with the aim of supervising the collection, processing and storage of personal data, the DPDP Act indeed is to bring the new digital era of data protection in India.
Understanding the Need
The soaring of digital technology has overhauled information-processing processes by changing the way people gather, send and use data. The fast expansion of digital world brought us in few words unimaginable ease of use and connection; though, the same evolution is engaging people in an active process of personal data usage discussion since the process is interconnected with safety issues. As an example, data breaches, unauthorized surveillance, and improper use of personal information have caught the data protection attention. People’s data have always been at stake, which made it imperative to implement strong measures regarding data protection legislation.
Awareness of the existing challenges, the Indian government began its journey of mapping a legal structure that not only caters the contemporary scenario’s but also conforms with the globally adopted strategies. When we consider India having the DPDP Act, we realize that this country is resolved to protect the digital privacy rights of its citizens against deterioration in an ever more interconnected global village.
The adoption of the DPDP Bill in the Parliament comes 6 years after Justice K.S. Puttaswamy v Union of India, a landmark case in which the Supreme Court of India recognized a fundamental right to privacy in India, including informational privacy, within the “right to life” provision of India’s Constitution. In this judgment, a nine-judge bench of the Supreme Court urged the Indian Government to put in place “a carefully structured regime” for the protection of personal data. As part of India’s ongoing efforts to create this regime, there have been several rounds of expert consultations and reports, and two previous versions of the bill were introduced in the Parliament in 2019 and 2022.[1]
Key Provisions
For the sake of enacting Personal Data Protection Act (DPDP Act) a set of legal instruments and rules has been put into people’s hands to bring in more responsibility and transparency into the field of personal data management, as well as introduce in the companies and institutions very tight rules and terms of data protection. Here are some key highlights of the bill: Below is some of the monthly bill highlights:
- Consent Mechanism: The act clearly outlines individual’s right to privacy through a consent contract and the introduction of the clear notification system of non-disclosure of sensitive personal information. This consent-based mechanism constitutes the critical principle that the individual should own their data and they should have the will power to decide how the data is used, shared and stopped in case they so desire.
- Data Localization: In the wake of the need to guard the data sovereignty and boost the security of sensitive personal information, the newly proposed Data Protection and Privacy Act (DPDP) compels to locate storage of some sensitive personal data inside the territory of India. This regulation indeed implying the prevention of the unauthorized traffic of confidential information in and putting bearing guidance in communications among nations which is a subject matter of data exchange.
- Data Protection Authority: The Act shall be passed to set up a Data Protection Authority which is the main supervisory body under the authority of DPDP Act and charged with the responsibility of observation of the implementation of the provisions of the legislation. The obvious task of the DPA is to verify the conformity to data protection principles, launch investigations into personal data breaches, and fine persons/organisations if the requirements are not complied with.
- Data Processing Principles: The DPDP Act provides for the codification of some of the fundamental principles that define the collection and processing of data and these comprise data minimization, purpose limitation, transparency, and accountability respectively. The fundamental aspects are a compass, containing the true order of the data which is processed by each of the stakeholders of the data.
- Rights of Individuals: Firstly, the law differentiates in non-transferable nature of the private data of every individual as thus, exceeding individual’s rights are accordingly, the subject of: access to one’s data, rectification, to be forgotten and data portability. Rights to individuals’ personal data and information a user can fully exercise these rights so as to take hold of how data controllers are utilizing them.
Challenges and Opportunities
Alongside the Data Protection Regulation Act of India that unquestionably heralds a great epoch in the Indian information security realm, some difficulties and complexities also prevail. One of the greatest concerns revolves around the question of how to it appears well between encouraging continuous developing and protecting privacy rights. The piece of legislature must successfully pass the challenges associated with regulating an economy centred around data without dissuading innovation or impeding progress with innovations.
Along with this, the efficient implementation of the DPDP Act will be developed based on competent enforcement mechanisms, capacity building classes and public awareness programs. Generating an environment of data privacy awareness needs conjoint efforts from all the actors along the whole field beginning from government agencies to the non-governmental ones, private companies, civil society organizations, and every individual citizen.
Besides these challenges exist incessant possibilities for India to emerge as world class in set data protection norms and regulatory laws. A Country like India which promote a data-driven ecosystem by practicing ethical data management will increase its economic digital attraction for foreign investors and upgrade its economy through innovation. Adding the element of high data protection standards to the norm can certainly serve to increase our standing in the international arena and promote contracting parties the ability to mutual adequacy agreements with others jurisdictions.
Conclusion
Enforcing the Data Protection and Privacy Act kick-starts a new web governance system in India wherein citizens will be provided with protection of their information and data. With the DPDB Act the dream of Indian digital-empowered society and knowledge economy is achieving a new life because for a certain duration data subjects have their data rights to control and the trust and accountability in digital innovation are maintained.
[1] https://fpf.org/blog/the-digital-personal-data-protection-act-of-india-explained/
Author: Rohan Patil, ISBR College
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