Abstract

The catastrophic impact of the COVID-19 pandemic on every facet of human life has made the requirement of a pharmaceutical breakthrough in the form of a vaccine more urgent than ever. The urgency has led to a hundred plus researches being underway, with tremendous amounts of capital and intellect invested. The vaccine being an invention, invites patent regulations and the rights of the patent holder associated with the invention. However, given the urgency of the situation, countries need to ensure hassle free access to the vaccine. Here, Compulsory Licensing regulations would play an important role. Beginning with a historical background of Compulsory Licensing under TRIPS, the authors analyse its subsequent amendment keeping in view the right of countries to give primacy to public health over intellectual property protection. The authors then highlight the diverse legislative positions of Compulsory Licensing in South Asia through the lens of the TRIPS position. The authors also comment upon Patent Pools, a comparatively new concept in the area of public health which is gaining spotlight. Further emphasis has been laid on keeping administrative impediments minimal with regards to the working of the intellectual property. This is important since firstly, the majority of the attempts underway are a collaborative innovation involving multiple stakeholders and secondly, multiple patent applications could be filed for different parts of a single invention leading to complexities while licensing. Finally, suggestions have been given as to how the patent regulations could be worked so as to maintain a balance between the rights of the patent holder and public health.

Highlights

  • The COVID-19 pandemic has wreaked havoc by disrupting normal life, putting immense strain on the healthcare systems, and by bringing the economies of even the most developed countries in the world to a standstill

  • Beginning with a historical background of Compulsory Licensing under TRIPS, the authors analyse its subsequent amendment keeping in view the right of countries to give primacy to public health over intellectual property protection

  • Further emphasis has been laid on keeping administrative impediments minimal with regards to the working of the intellectual property

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Summary

Historical Background of Compulsory Licensing for Public Health

Compulsory Licensing has a history which dates back to the 1830s and which gained popularity during the British anti-patent movement of 1850s and 1860s.11 It received international recognition for the first time at the Paris Convention of 1883.12 Article 5A (2) of the Convention reads the following:. The United States had a strict Compulsory Licensing regime in place and it considered the TRIPS Agreement to be nothing more than “a minimum standard of protection.”[19] Due to the monopolization, a year’s treatment of HIV/AIDS cost anything between $10,000 and $15,000 This led to the loss of millions of lives in the poor sub-Saharan countries for 10 years. 21 Bob Aroture, ‘10 examples of the use of Compulsory Licenses for AIDS-Related Pharmaceuticals in Africa’, Nigerian Law Intellectual Property Watch Inc., 02 August 2013, available athttps://nlipw.com/10examples-of-the-use-of-compulsory-licenses-in-africa-2/, accessed on 12 July 2020 As it has already been highlighted, the potential costs of a COVID-19 vaccine could be way too high for the poor and developing countries. All 10 candidate vaccines which are in phase 1 and 2 of human trials are being developed in the world’s most powerful economies[29] who might not choose to take a humanitarian approach

Compulsory Licensing Under the TRIPS Agreement
Conditions for grant of compulsory license
38 Council Discussion on Access to Medicines
Prevailing Legislative Position
Findings
Patent Pools
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