Glaxo Group Ltd. and Ors. Vs. S.D. Garg and Ors. {CS (OS) 12/2006; Delhi High Court}

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:

1. 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.
2. Garg received the permission from Drug License authority for their medicine “GENTAC” and accordingly they have been selling their medicine under the mark “GENTAC”.
3. 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 

1. 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.
2. 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.
3. 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.
4. 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 

1. 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”.
2. 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.
3. 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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IP waiver & Covid 19 vaccine manufacturing

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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Cipla Ltd. V. Novartis AG & Anr, 2017 (70) PTC 80 (Del)

Oct 22, 2021 | Indian Patents Act 1970, IPR & Business

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:

1. ‘Indacaterol’, a bronchodilator drug approved for the treatment of COPD is protected under a patent (Patent No. IN 222346) held by Novartis.
2. In November 2014, Cipla had launched a cheaper generic version of this drug under the brand name ‘UNIBREZ’.
3. Cipla had priced its drug at Rs 130 per pack as compared to Rs 677 for Onbrez by Novartis (about 1/5^th of the price)
4. 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.
5. On 9 Jan 2015, the Single Judge of Delhi High Court granted temporary injunction restraining Cipla from selling its generic version.
6. However, the said injunction was granted only until a determination of compulsory license application if filed by Cipla.
7. Further if no application is filed the interim injunction would continue until the final disposal of the patent infringement suit.
8. After this, on appeal Cipla approached the Division Bench of the Delhi High Court

Issues

The main issues before the Hon’ble Court were:

1. Whether the interim injunction granted to Cipla was valid?
2. Whether Novartis’s patent ‘Indacaterol’ (Patent No. IN 222346) is valid?
3. Whether Cipla’s manufacture and sale of ‘Indacaterol’ (under brand name ‘Unibrez’) infringe the said patent (Patent No. IN 222346)?

Arguments

1. By Plaintiff i.e., Cipla
2. 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.
3. 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.
4. Cipla contended that the generic version is cheaper and available at 1/5^th price of Onbrez. They further alleged that Novartis was importing Onbrez at a lower quantity and a very high price.
5. 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

2. 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.
3. 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.
4. They contended that there is a huge amount of financial investment in the research and development of the patented drug ‘Indacaterol’.
5. 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. 

By: Runjhun Sharma, School of Law, Mody University

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