“PATENT BATTLES IN THE PHARMACEUTICAL INDUSTRY: THE CASE OF COVID-19 VACCINE WAIVERS AND BEYOND”

AUTHOR – ADV. NILESH VITTHAL DAKE, ADVOCATE & PROGRESSIVE EDUCATION SOCIETY’S MODERN LAW COLLEGE, PUNE

BEST CITATION – ADV. NILESH VITTHAL DAKE, “PATENT BATTLES IN THE PHARMACEUTICAL INDUSTRY: THE CASE OF COVID-19 VACCINE WAIVERS AND BEYOND”, INDIAN JOURNAL OF LEGAL REVIEW (IJLR), 5 (12) OF 2025, PG. 189-193, APIS – 3920 – 0001 & ISSN – 2583-2344.

Abstract

The COVID-19 pandemic has profoundly intensified global debates surrounding intellectual property (IP) rights and their intersection with public health equity, particularly by bringing into sharp focus proposals to temporarily waive certain provisions of the World Trade Organization’s (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). These waivers were advocated primarily for COVID-19 vaccines, therapeutics, and diagnostics, aiming to facilitate broader manufacturing and distribution amid unprecedented global health demands. This article presents a multifaceted analysis of the legal, economic, and ethical dimensions of the IP landscape during the pandemic, drawing upon pharmaceutical industry case studies, including high-profile disputes involving mRNA vaccine patents and voluntary licensing arrangements, alongside landmark judicial precedents from India and the United States.

The article examines the evolving policy discussions at the WTO, highlighting the negotiations that culminated in the 2022 Ministerial Decision, which provided limited flexibilities but fell short of broader ambitions. It contrasts the perspectives of developed nations—aligned with pharmaceutical innovators emphasizing the need to preserve R&D incentives—and developing nations, which prioritize equitable access in low- and middle-income countries (LMICs). The evaluation also considers compulsory licensing under TRIPS Article 31, assessing its applications and potential limitations in addressing pandemic-scale challenges.

By situating the COVID-19 crisis within a broader history of IP-driven access conflicts, such as those during treatments for Hepatitis C, the paper employs a doctrinal methodology to critically analyze the underlying tensions. Ultimately, it advocates for a balanced IP framework that reconciles the need for pharmaceutical innovation with the universal right to health, proposing targeted reforms such as strengthened TRIPS flexibilities for emergencies, multilateral technology transfer mechanisms, and investments in manufacturing capacities in LMICs to ensure equitable access to life-saving technologies worldwide.