Given the surge of Covid-19 cases, every day we come across new vaccines being manufactured, approved and talked on. Some vaccines are approved in a few countries while some are not. Like the Covishield is accepted globally but Covaxin is not. But an issue more important than that is the fact if every vaccine is to be patented, then the production and the amount of people being vaccinated shall be affected. Currently in India, three vaccines are approved i.e. Covishiled, Covaxin and Sputnik-V (the production of which is not very high). If the latest news were to be believed even Moderna is going to be added to the list of approved vaccines. [1]
Patent is becoming an obstacle for countries to produce their own vaccines. Seeing this bad situation around the world, India and South Africa had proposed something in the World Trade Organization, to which now the US have also agreed. The US has said that it is ready to temporarily suspend all patents related to the research and manufacture of the coronavirus vaccine. [2]
Recently, the Government of India happened to file an affidavit in the Supreme Court that if the Patents Act is to be invoked it would have immense consequences on the production of these vaccines.[3]The question raised by the Court is “Why is the government not taking support of Section 92[4] and Section 100[5] of the Patents Act?” , Section 92 and Section 100 of the Patents Act allows the government to use these said technology and adopt a compulsory licensing during a national emergency or urgency.
The provisions under the Patents Act, 1970 that talk about invoking patent rights so as to increase the production:
Voluntary licensing is an arrangement wherein a patent holder voluntarily grants licence to another party to manufacture and enjoy the patented product upon payment of licence fee and royalty to the patent holder. This licence can be for a specific period and can be exclusive or non-exclusive with respect to the other party. A voluntary licence is like any other licence wherein the patent holder i.e. the licensor agrees to part with his exclusive privilege upon payment of some consideration in form of licence fee.[6]
“Compulsory licensing” of the Covid-19 vaccine, which would enable the Central Government to override a patent and grant licence to a local manufacturer to produce a global vaccine for “domestic use” without the authorisation of the patent holder.[7]
The TRIPS agreement to which India is a signatory, states that the provision of compulsory licensing can be invoked during national emergency. Article 31 of the TRIPS Agreement makes an explicit provision for compulsory licensing wherein the member nation can allow the use of the subject-matter of patent without the authorisation of the patent holder.[8]
As previously mentioned the Central Government can invoke Section 92 of the Patents Act, by declaring a national emergency after which any pharmaceutical company interested in producing the vaccine can do so.
Although the pharma companies resisted this waiver of patents as they believed that if patent were to be removed then it would destroy the incentive to the industry. But when the US backed the decision of patent being waived off on the vaccine, as the Biden administration believes that fighting the pandemic is of greater importance than fighting over patents. Patent waiver is an essential step in increasing the production of vaccines and would boost the vaccine drive.
But there are other barriers like for Moderna and Pfizer’s vaccines, for example, are made using mRNA technology; even if the patents for these jabs were waived, vaccine makers would also need to know how to make mRNA, and neither company is under any obligation to share that knowledge.[9] So even if patents were to be waived, the question arises how the other companies would understand the process of producing these vaccines.
Conclusion:
The solution to the issue of shortage of vaccine could not just be waiving off the patents but also making an effort that if such vaccine’s patent is to be waived off, the original pharmaceutical companies producing these vaccines should also be sharing the technology behind these vaccines. Therefore, the only solution to this problem could be backing the patent waiver of vaccines with the information of the technology behind the vaccines being shared with the developing countries and other companies. To increase the vaccine production it is necessary that the patent holder does not keep the monopoly in mind and gives the license of producing vaccines to other willing pharmaceutical companies who have the necessary technology to produce the vaccines.
[1] The Week For Vaccines: Moderna To Hit India In Days And A Three-Dose Shot That Is Easy To Inject, News 18, (July 4,2021 10:56 IST), https://www.news18.com/news/explainers/the-week-for-vaccines-moderna-to-hit-india-in-days-and-a-three-dose-shot-that-is-easy-to-inject-3924098.html
[2] Riddhima Kanetkar, DNA Special: How freedom from patent on vaccine will help in battle against COVID-19, DNA India (May 8, 2021, 06:40 AM IST) https://www.dnaindia.com/india/report-dna-special-how-will-freedom-from-patent-on-vaccine-help-in-battle-against-covid-19-2889349
[3] Bhadra Sinha ,Invoking Patents Act for production of Covid vaccines, drugs can have consequences: Govt to SC, The Print (10 May, 2021 8:04 pm IST), https://theprint.in/judiciary/invoking-patents-act-for-production-of-covid-vaccines-drugs-can-have-consequences-govt-to-sc/655863/
[4] 92. Special provision for compulsory licences on notifications by Central Government
[5] 100. Power of Central Government to use inventions for purposes of Government.
[6] Akber Ahmad and Maria Fatima, Ramping up production of Covid-19 vaccine and its interplay with patent law, SCC Online, (July 03, 2021), http://www.scconline.com/
[7] Supra 5
[8] Supra 5
[9] Darcy Jimenez, Covid-19 vaccine inequity: the debate over patent waivers intensifies, Pharmaceutical Technology (May 17th, 2021 15:13), https://www.pharmaceutical-technology.com/features/covid-19-vaccine-inequity-patent-waivers/
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