Author(s): Dr. Wasif Reza Molla

Abstract: We feel elated by the advancement of Human Rights, particularly when we have already entered into the fourth generation of Human Rights. However, it is disheartening to note that the obligations pertaining to the second generation of Human Rights such as accessibility and affordability of healthcare have yet to be fully realized. There could be a lot of reasons for this, but one of the most pertinent is the product patent of pharmaceuticals. It is a fact that pharmaceutical companies go through a rigorous process of research and development for procuring lifesaving drugs and vaccines, as was evident during the COVID-19 pandemic. These medicines with advanced therapeutic value played important role in improving the quality of human life. However, as it is said, there's no rose without a thorn, so the exorbitant price and inaccessibility of these medicines in developing countries have become a global concern. To mitigate this effect of product patents a number of flexibilities have been incorporated into TRIPS, but compulsory licensing is the most effective of them. In light of the catastrophe brought in by the COVID-19 pandemic, it may be justified to argue that the right to health and the quest for living a dignified life should take precedence over the monopoly right that the patent owner acquires for their inventions. Many experts and researchers have also argued that compulsory licensing of patented medicines is one of the effective measures to ensure accessibility of patented medicines. In many cases, developing countries in Asia and Africa like Brazil, Indonesia, Malaysia, Thailand, and Ecuador have issued compulsory licensing to ensure the accessibility of patented medicine. Even though India has extensive compulsory licensing provisions in the Patents Act, 1970, only in one case has a compulsory license in medicine been granted, and all other attempts for compulsory license in medicine has failed miserably. Like many developing countries in India this issue has emerged as a contentious arena for legal conflicts. In this backdrop this article makes a critical analysis of the complexities of compulsory licensing cases for pharmaceutical patents in India. It then goes on to explore the legal provisions as well as the ethical issues that were taken into consideration in dealing with these cases. It examines whether the provisions regarding compulsory licenses under international treaties and the Indian Patent Act are complied with by the Controller of Patents. It will analyse the impact of the Nato Pharma Limited v. Bayer Corporation ruling in India as well as make a comparison with other unsuccessful attempts in India for compulsory licensing of medicine.

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