Dec 22, 2021 | Indian Patents Act 1970, IPR & Business
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.
By: Runjhun Sharma, School of Law, Mody University
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Dec 15, 2021 | General
Recently, an app’s advertisement read “Speak English as fluently as Shashi Tharoor,” regarding which, the Kerala MP was forced to clarify that he is not endorsing the app and that legal action would be taken against the makers of the app for misusing his name and picture for promotion[i]. We come across many such instances in the contemporary world due to the advent of various social media platforms, and in such cases, the personality rights of a person are violated.
G.W.F. Hegel, a German philosopher, viewed property as an extension of personality[ii]. Based on this, many modern theorists argue that property rights are linked to human rights such as liberty, privacy, identity, etc. Personality is a means through which a person is identified in the society and therefore, the protection of personality in the form of a right essentially protects private property which are of the form of intellectual property. Each person has a right to control the commercial use of their name, image, or any matter that forms a part of their identity. These rights are called personality rights. In India, there are no codified laws enacted to protect personality rights, but it is protected under fundamental rights, Copyright Act, Trademark Act, and through various judicial pronouncements. An overview of the protection guaranteed under the law is presented in this article.
Common Law and Constitutional Protection of Personality Rights
One of the earliest case laws that we can find on the violation of personality rights is that of Tolley v. JS Fry & Sons Ltd[iii], although the case was about defamation under tort. The defendant’s advertised their product, ‘Fry’s Chocolate Creams’, using a caricature representing the claimant, who was a well-known amateur golfer, without his consent. The court held that the defendants are guilty of libel because they had exploited a person’s image without his consent, thereby amounting to an ‘appropriation of personality’. The offence of passing off under tort, which prevents a trader from misappropriating another trader’s goods or services, is also an example of protection guaranteed to personality rights under tort.
Personality rights as such do not find a place in the Indian Constitution but in the case of Justice K.S.Puttaswamy(Retd) vs. Union Of India[iv], privacy was recognized as a fundamental right under Article 21 of the Constitution. Privacy, as an extension of liberty, is a ‘right to be let alone’[v], and any person misappropriating the identity of a person without their consent is said to have violated the fundamental right to privacy and thereby, the personality right.
Personality Rights and The Indian Copyright Act, 1957
Section 13 (1) of the Act defines the scope of the Act and states that it is applicable to:
- original literary, dramatic, musical and artistic works;
- cinematographic films;
- sound recordings.
Further, Section 14 of the Act provides exclusive right to do or authorize reproduction of their artistic work. Copyrights are not provided to identity as such, and the copyrights of the image of a person is vested with the photographer and not the said person. Therefore, the misuse of any such image violates the copyrights of the photographer and fails to protect the personality right. However, Section 38 of the Act provides right over performances to the performer and the performer has exclusive rights over the recording and reproducing of the performance. Even after the performer has consented to the incorporation of the performance in other forms, the moral rights of the performer are protected from distortion or mutilation of the performance which could harm his reputation. Right to paternity and right to integrity is protected under Section 57 of the Act, thereby protecting the personality rights of the artists. In the case of Amar Nath Sehgal vs. Union of India[vi], Amar Nath Sehgal created a bronze mural for International Convention Hall in Delhi as per the request of the government of India in 1959, which was placed on a wall in Vigyan Bhavan. Later it was pulled down and consigned to the storeroom of the Union of India in the year 1979 without his permission. The Delhi High Court upheld the moral right of the artist, holding that the act of the government amounted to distortion of the artist’s work which is detrimental to his reputation.
Personality Rights and The Indian Trade Marks Act, 1999
Section 2(1) of the Indian Trade Marks Act, 1999, allows registration of any “sign capable of distinguishing goods and services of one person from another” and Section 2(1)(m), which provides the definition of ‘mark’ to include name as well. Section 14 of the Act states that when an application is made for registration of a mark which dishonestly suggests an association with a living person or a person whose death took place within 20 years of the date of application, the Registrar may seek consent from the living person or the legal representatives of the deceased person before granting the registration. Through Section 2 and Section 14, the Indian Trade Marks Act, 1999, protects the identity of an individual from being misused.
Judicial Recognition
One of the most important cases where personality rights were recognized, was in the case of ICC Development (International) Ltd. vs. Arvee Enterprises[vii], in which the Delhi High Court held that: “The right of publicity has evolved from the right of privacy and can inhere only in an individual or in any indicia of an individual’s personality like his name, personality trait, signature, voice. etc. An individual may acquire the right of publicity by virtue of his association with an event, sport, movie, etc”
In the case of TITAN Industries vs. M/s Ramkumar Jewelers[viii], the Delhi High Court granted a permanent injunction against the hoarding of the defendant’s advertisement which was similar to the plaintiff’s and featured Mr. Amitabh Bachchan and Mrs. Jaya Bachchan. The court stated that: “When the identity of a famous personality is used in advertising without their permission, the complaint is not that no one should not commercialize their identity but that the right to control when, where and how their identity is used should vest with the famous personality. The right to control the commercial use of human identity is the right to publicity”.
Conclusion
Shakespeare in his celebrated play, Romeo and Juliet, writes:
“What’s in a name? that which we call a rose
By any other name would smell as sweet”
Although the lines suit the context of the play, they can hardly be generalized. The identity of a person is of vital importance as there is an increase in the commercialization of the personality. Any person imitating a celebrity, even if the person’s imitation is accurate, is still not the same as a celebrity. The ‘name’ or the ‘image’ of the personality is what drives the commercialization rather than their art, which has taken the form of an intangible property over the years. The Copyright Act and Trade Marks Act protect personality rights to a certain extent, but there is a need for enacting a law that protects personality rights more effectively.
Author: Rachel Thomas
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Nov 23, 2021 | Indian Patents Act 1970, IPR & Business
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.
By: Dhruv Dangayach, Ramaiah College of Law
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Nov 20, 2021 | Indian Patents Act 1970, IPR & Business
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.
BY: Nikhil Verma, Kirit P. Mehta School of Law, NMIMS, Mumbai
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Nov 18, 2021 | Indian Patents Act 1970, IPR & Business, Patent, Startups
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.
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