Patent Law and Bio-Crisis Containment: A Framework for Temporary Patent Freezes in India

Bio-crises create a scenario where pharmaceutical drugs are in great demand. Pharmaceutical patents have a significant impact on public health as they directly affect the price, accessibility and availability of the drugs. The COVID-19 pandemic brought the issue of public health and protecting patents as commercial rights into the limelight, as access to pharmaceutical drugs and equipment was the need of the hour in light of the devastating impact of COVID-19, especially the second wave. The paper seeks to argue and base its premise on the fact that patents create a problem of availability and affordability, especially in a developing, populous country like India. The Indian Patent Act, 1970, enacted in line with the TRIPS Agreement, provides for a mechanism of Compulsory Licensing (CL) where the government can license the patented products to the licensee on an application under Section 84, or Suo motu, under Section 92. While Section 92 of the Act specifically provides for CL during national emergencies, the Covid-19 pandemic served as a strong example in highlighting the practical complexities involved in the issuance of such licenses. To ensure equitable access to COVID-19 vaccines, medicines, and other technologies, India and South Africa proposed a TRIPS waiver at the WTO by temporarily suspending patent rights. However, there was very little consensus on the same, especially among developed countries and the EU, which strongly opposed such a waiver. Many scholars admitted to the fact that CL, though plausible as a mechanism, is practically inadequate and underutilised, while a TRIPS waiver would increase accessibility and ensure equity. However, due to a lack of consensus between nations, an alternative mechanism was considered the need of the hour. This paper proposes an alternative mechanism by providing for a policy of temporary suspension of patent enforcement rights while the crisis subsists, thus allowing for generic manufacturing. The paper also evaluates the legal aspects of such a policy, such as TRIPS Compliance (specifically relying on the Doha Declaration on the TRIPS Agreement and Public Health), and practical workability, including its impact on competition. The paper seeks to address the issue of inequity, inaccessibility, unavailability and unaffordability of pharmaceutical drugs in light of a crisis.