Compulsory Licensing for Vaccines amidst COVID-19



In the modern world, majorly patent rights are acknowledged to be ethical rights as they advance innovation and incentivise the rendering of data. The necessity to balance patent rights with access to information and essentials is the preferred discussion in today’s time. Generally, this dispute arises in the field of biotechnology and becomes a political issue. Arguments against granting patents contend that there are inventions like gene-splicing, which are so beneficial to humankind that they must be available to all. The aforementioned has given rise to concerns regarding the moral implementation of patenting practice within the discipline of biotechnology. This article will discuss one of the flexibilities granted within the patenting laws about compulsory licenses regarding the assembly of COVID-19 vaccines in India while critically analysing the government’s reception of an equivalent.


Meaning of Patent

WIPO defines a patent as "an exclusive right granted for an invention, which is a product or a process that provides, in general, a new way of doing something, or offers a new technical solution to a problem." A patentee shall have exclusive rights over his invention for 20 years, and he can exclude others from making any use of his patented product. However, under certain circumstances, a compulsory license to form use of a licensed product is likely to be given to a third party. This opinion of compulsory licensing is mentioned in Chapter XVI of the Indian Patents Act, 1970.


What is Compulsory Licensing?

A compulsory license is a license or authorisation issued by the government to an applicant for manufacturing, using, and selling a patented product or employing a patented process without the consent of the patentee. In other words, the compulsory license is the authorisation given to a third party by the Controller General to create, use, or sell a specific product that has been patented without the necessity of the permission of the patent owner. This idea is acknowledged at both, national and international levels with a mention in both (Indian) Patent Act, 1970 and TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement. One of the flexibilities granted by this TRIPS Agreement is the policy of compulsory licenses. Article 31 of this agreement discusses the provisions that are required to be met before granting compulsory licenses. It lists out three requirements for the same:

➔ National Emergency,

➔ Extreme Urgency, and

➔ for public non-commercial use

However, this doesn't imply that the patentee has lost all rights over their product or process completely. They will still get compensation for the profits made through the utilization of the compulsory license within the sort of the licensing fee.


In India, the equal provisions for this are mentioned in Chapter XVI of the Indian Patent Act of 1970. Section 84(1) gives three conditions under which an individual can request a compulsory license from the Controller. Firstly, the reasonable requirements of the general public are not satisfied by the patented products. Second, the product is not affordable for people, and third that the product is not working in India. Licenses must be given after the terms and conditions under Section 90 are complied with.


India’s first-ever compulsory license was granted by the Patent Office on March 9, 2012, to Hyderabad-based Natco Pharma for allowing them to locally manufacture Nexavar, a patented product of the German pharmaceutical firm Bayer, for treating kidney cancer patients. [1]


Compulsory Licensing of COVID-19 Vaccines

Vaccines are required by the world, as are drugs like Remdesivir and Tocilizumab, and medical equipment like ventilators and oxygen concentrators. Global business practices have to be compelled to back down from insisting on patent obligations. This does not indicate that vaccine and drug production becomes a charitable exercise. The present global health crisis and high demand for drugs and vaccines mean their producers have enough countries and customers to provide to. The massive volumes would make sure that they're ready to recover the prices of their scientific investments. But what drug developers must avoid is that the inclination to earn profits by exploiting the incapability of nations.


One of the effective ways by which global trade rules can contribute to higher access to vaccines and medicines is by permitting compulsory licensing. The WTO’s rules allow countries to issue compulsory licenses to domestic producers for manufacturing patented drugs and other products. This can be allowed under situations of significant public health concern.


At the domestic level, one of the Indian COVID-19 vaccines is sold under the brand name “Covaxin”. Since Covaxin is created by Bharat Biotech with the support of the Indian Council of Medical Research (ICMR) and the National Institute of Virology, Pune, it should be easy for the government to grant a license to anyone who can produce the vaccines. They can issue a compulsory time-bound license in favour of other things which have the manufacturing capacity to manufacture these vaccines. This does not mean that Bharat Biotech will have absolutely no rights and benefits for the product. They will still have a particular percentage of profits as their licensing fee plus the brand name will still be theirs to use.


Interestingly, the stand taken by India on the international platform is different from its domestic standpoint. In October 2020, India and South Africa had put forth a proposal to waive off the property protections to create medicines, vaccines, and testing available to any or all. This proposal has gotten the support of quite 120 countries, including the United States. Implementation, however, would require a worldwide consensus on the matter, but the European Union remains and may pose an enormous hurdle in its way.


In the current scenario, India is in urgent need of vaccines at a five times larger rate. The present production capacity does not seem to form up for the rising demands for vaccines. For India, there is little option apart from authorising compulsory licenses. Such licenses should not be limited to only the local production of patented medicines.


Compulsory licensing provisions under the Patents Act, 1970, are WTO-compliant. There must not be any hesitation in using these provisions. At the same time, the country needs to cooperate with the US, the UK, and other countries, which had opposed India’s proposal at the WTO, to urge the worldwide trade body to succeed in a consensus on allowing the flexibilities in trade rules that India and South Africa had demanded. Still, if patents still determine global access to vaccines and medicines, then fighting Covid-19 will remain a foreign dream for many countries.



Endnote:

1. Bayer Corporation V. Union of India & Others 2014(5)ABR242, AIR2014Bom178, MIPR2014(3)53, 2014(60)PTC277(BOM)

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