Patent law over COVID-19 Vaccine and it’s Waiver

Author: Pritika Nagpal (JIMS School of law, Gr. Noida)

Co-Author: Aditi Narula (JIMS School of law, Gr. Noida)


It has been rightly said, that life is like a roller coaster. We see many ups and downs and a part of it was this massive pandemic. Yes, you got it all right trying to acknowledge here about this covid pandemic. The whole world has been going through this widespread whose virus is still not on its death bed yet. Loss of lives, demises but brave warriors too. In the chaos of fight against corona virus many countries have come across an idea of patenting the vaccine of Covid-19 whereas others are trying opposing their idea.

Patent is a property right which is granted to and owned by a sovereign inventor over any product or a process after fulfilling all the dire needs and requirements in order to restrict others from copying, making or even selling the products made by the sole inventor. Patent helps to protect the uniqueness and distinctiveness of the product. On the other hand it helps to create a feeling of competitiveness in the society.[i]


According to the Doctrine of Waiver, it is an intentional or voluntary give up of a known right. It is when a person chooses to give upon or chooses not to exercise his right. Waiving a right means a person with knowledge and intention waiving his or her right to assert. This doctrine is based on a very well-known principle that a person is the best judge of himself. In India, though a person is not allowed to waive off his or her fundamental rights because of the fact that they are made for the society as a whole and are a matter of public policy, not for an individual person that he or she can waive it off for his or her personal benefit. When a fundamental right is granted to the citizens of a country they not only become a sole source of enjoyment but they do cast a duty as well on the citizens towards each other.[ii]


The concept of Patent waiver has become a need in various countries after undergoing through a worst situation. The different views of different countries have been reflected herein below. But before making analysis on the ideas of vaccine patent waiver, we need to grasp the brief understanding of Vaccine patent.

What exactly is Vaccine patent?

Patent is an innovation made by the inventor in the field of drugs, medicines, technology, etc. However the protection of patent is limited to a period of 20 years. Vaccine patent is that innovation which prevents the competitors from making the same variety of product in its own name as this would lead to patent infringement unless compulsory license is granted.[iii]

India and South Africa

It is seen that developing countries like India and South Africa have urged to make proposal to WTO with regard to temporary waiver of patent on the vaccine through TRIPS. Though, TRIPS Agreement which came into force in the year 1995 primarily focused on the issue of IPR related to patent law, copyright, protection of undisclosed information etc.

However according to the statistical data, 8.6 billion doses had been confirmed out of which 6 billion is only for the upper middle income countries leaving behind no scope of availability of vaccines to the poor nations due to which our healthcare systems have been overburdened. On the other hand, in order to ensure speedy recovery of the people at present there is a need to demarcate IPR barriers by sharing the technology in making of vaccine for a large scale production and by allowing poor nation to make usage of doses easily as soon as possible.[iv]

US and Europe

The issue has become a conflict between the powerful pharmaceutical companies and human rights. Although, the two most developed countries i.e. US and Europe opposed the idea of waiver by stating that elimination of patent protection would have no impact on production. Ultimately it would create a negative impact on pharma companies who have made its own innovation through research and development in relation to vaccines.

But now after recognizing many hardships, the discussion that took place between US Trade Representative and various stakeholders on a very debatable issue became a turning point in support of waiver to protect our country. Furthermore the country like US give its support with respect to grant of compulsory license along with TRIPS Agreement by making improvement in supply of vaccines without any hesitation.[v]

However the decision made by US has become wider in scope than the earlier one. The major proposal will be covering different aspects of technologies mainly for the purpose of detection, treatment, prevention but the waiver of patent rights is limited to vaccines only.[vi]


A country like china paved its way to support the proposal made by India and South Africa by working on a large scale with ten other developing countries on transfer of technology and on the production of vaccines. An initiative of 10 million vaccines will be supplied to COVAX, a campaign on global vaccine which is backed by WHO.[vii]


The pharmaceutical companies are of the idea that waiving off patent in no way would help the developing countries. Medicines takes a decade or less to get a drug approval and for that a huge amount of research and development is required. It has been stated that a drug needs $1 billion on its journey from discovery to approval. Moreover, the companies are required to provide jobs and pay their workers marvelously, in addition to this companies have to pay a huge amount to the government as well for their previously patented dugs. They have made their statements very clear that following a drug’s recipe is much easier than finding one.[viii]


In light of the above sited article, on one hand it is crucial to patent the Covid-19 vaccine because the pharmaceutical companies are in a call out for a vast amount of money as they have done a commendable job, researching and developing, putting their workers at force, spending a generous amount for a drug which they now need to cover up with the help of a patent. Not only this, these companies have to protect their inventions as well from being copying, making or selling of their product. We all are aware that a coin always has two side, so on the other hand some of the countries are opposed to the idea of patenting because US alone has about 35% of its population already vaccinated which is nearly 2.3% globally. Whereas Africa has vaccinated under 1% of its population. A huge imbalance has been witnessed. These countries are of a view that rather than focusing on patenting the vaccine, the focus should be on increasing the manufacturing and distribution process round the world. In addition to this each and every country does not have a sound economy that they could pay higher amounts on a drug to get its citizens vaccinated. At this stage when there is an alarming situation in a country like India pharma companies should instead think about the health of people rather than their wealth.