Indian Govt. Permits Manufacture of Covaxin by Haffkine Institute – But Why Not Others Too?
Praharsh and Swaraj consider the recent Central Government approval of Haffkine Institute for manufacturing Covaxin, on a ‘technology transfer’ basis, for a period of one year to address the vaccine shortage in the country. They highlight that the wording of the current ‘approval’ seems to indicate that the Central Government has the rights to be able to give the permission. However, it leaves several questions as to whether it consists of IP rights or only knowhow, if it constitutes a license – based on what terms and royalties – and why it’s given only to Haffkine Institute. They assert that if the government indeed owns IP rights over Covaxin, it should make the IP available to other entities to ramp up manufacturing nationally and internationally to meet the needs of poorer countries who cannot afford the limited doses available. Perplexingly, Bharat Biotech’s partnership with a US Company to make another version of Covaxin suggests that it owns the IP. Thus, there is an urgent need for clarity on the issue. Pointing towards attempts by Maharashtra and the US State of California, they show that some regional governments have undertaken efforts to become monopoly buyers in the pharmaceutical market to be able to provide for public health. They conclude by emphasizing the need for extending technology transfer to more manufacturing sites, as well as government procurement of vaccine related IP.
The Monopoly Purple – Colours, Shapes and Sizes in the Pharmaceutical World
Swaraj Barooah and Murali Neelakantan highlight the role of trademarks, packaging and visual impressions in extending monopolies over pharmaceutical products. They highlight that patients, particularly busy individuals and the elderly find it easier to take the same coloured, same shaped pills or products like inhalers as part of a routine, than switching to generic versions once they become available. The significant role of medical intermediaries such as doctors, pharmacists, drug regulators and insurance agencies in selection of the drug means that trademarks and visual impressions of the product packaging play a very limited role in purchase decisions. Referring to cases such as Cadila v. Cadila, and Cipla v. MK Pharmaceuticals, they argue that even if a peculiar shape does become distinctive, the public health interest in ensuring patients are aware of generic equivalents by allowing competitors to copy that shape, outweighs the trademark justification for monopoly rights over said shape. They also point to previous efforts by the Indian government to ensure that patients were made aware of generic substitutability of drugs, by mandating that doctors only prescribe medicines by their non-proprietary names. They conclude by calling to attention the need for a policy revaluation, with larger public interest reframing traditional understandings of norms around product design and packaging.
Remdesivir Shortage: Can the Drug be Imported under Patents Act?
Pankhuri explores the question of whether remdesivir can be imported from Bangladesh to meet domestic needs, as its generic version is being manufactured there due to the absence of a product patent regime. She explains that while the Indian patent holder Gilead can prevent imports under Section 48, post the 2005 amendment, the option under Section 107A can be exercised without authorization of the patentee too, so long as it is, ‘duly authorised under the law’. In the absence of clarity regarding this phrase, a plain meaning reading would imply that as long as a person has obtained marketing approval for remdesivir from the drug regulation authority in Bangladesh, it would be considered to be ‘duly authorised under the law.’ This view is supported by a CBEC circular from 2012. However, this risks undermining the very essence of the patentee’s exclusive right to import under Section 48 by permitting import of products whose first sale has also not been authorised. It is also likely to be violative of TRIPS obligations. She then examines whether it may be possible for the government(s) to import remdesivir by invoking Sections 47 or 100. Pankhuri concludes that due to the immediate nature of requirement, importation from Bangladesh would be a better option that providing a compulsory license for manufacture of the drug which would take time.
Decisions from Indian Courts
Delhi High Court in Telefonaktiebolaget Lm v. Gionee Communication Equipment, permitted the second defendant Syntech technology Pvt Ltd to withdraw its application for revocation of subject patent before the IPAB and to prefer a counter-claim for revocation of patent before the Delhi High Court. [April 16, 2021].
- Delhi High Court in M/S Replika Press Private Limited vs Mr. Sanjay Kumar, awarded an ex-parte ad interim injunction in favour of the plaintiff, restraining the defendant from interfering with the plaintiff’s use of MIS software in any manner, which the defendant had created and developed during the course of his employment with the plaintiff company [April 16, 2021].
- Andhra Pradesh High Court in M/S Guaurav Polymers v. M/S Delight Chemicals Private confirmed the injunction granted by the trial court in light of the likelihood of confusion between plaintiff’s ‘Rising Sun’ trade mark used as a device and defendant’s ‘Surya Magical White’ trademark [November 20, 2020].
Other News from around the Country
Central Government has prohibited the export of remdesivir till the Covid-19 infection status in India improves. Companies manufacturing the drug are reportedly undertaking measures to increase its production [Read Pankhuri’s analysis of India’s options to import remdesivir from Bangladesh under the Patent Act].
- Central Government has given approval to Mumbai-based Haffkine Institute for manufacture of Covaxin [Praharsh and Swaraj have discussed the issues surrounding this approval].
- Maharashtra CM Uddhav Thackeray has written to PM Modi requesting smoother supply of medical oxygen and remdesivir as well as suggesting the government to grant a compulsory license for manufacture of remdesivir.
- A piece in The Hindu discusses the issues relating to the now defunct IPAB.
- Lahari Audio company has sued the makers of movie ‘Kirik Party’ for infringement of copyright in their song ‘Madhya Raatrili highway rastheli’, leading to the issuance of a non bailable arrest against the latter.
- Filmmaker Vikramaditya Motwane has accused ALTBalaji for plagiarising the poster of Sudhanshu Saria’s romantic drama, Loev (2015) in the artwork of the poster of their new film, ‘His Story’.
- Recent IMI Report suggests that India’s recorded music industry can rival Europe’s in 10 years.
News from around the World
A group of US Senators including Bernie Sanders and Elizabeth Warren have written to US President Joe Biden urging him to support India and South Africa’s TRIPS Waiver proposal at the WTO.
- The England and Wales High Court has allowed Swatch’s appeal of a ‘bad faith’ opposition filed by Apple against the international trademark application for ‘ONE MORE THING’.
- Germany’s Federal Court of Justice ruled in Solvay’s favor on a patent invalidation case filed by Neo Chemicals & Oxides (Europe) Ltd. against a patent pertaining to ceric oxide products.
- Popular Turkish chef and restaurateur Nusret Gökçe is facing a USD 5 million copyright infringement lawsuit by Brooklyn artist William Hicks for alleged unauthorised use of his artwork on menus, takeout bags, and signs.