Abstract

This research delves into the aspect of Compulsory Licensing in pharmaceutical industry by examining its implications on manufacture of generic drugs and access to affordable health care in India. Compulsory Licensing, a concept provided in Section 84 of Indian patent Act 1970, gives the procedure for application and criteria grant of compulsory License. The research begins by delving into the historical evolution and legal framework surrounding compulsory licensing, highlighting its underlying principles and the rationale behind its implementation. It traces the origins of compulsory licensing from international agreements and treaties, such as the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement, which have shaped the global discourse on intellectual property rights in the pharmaceutical domain. Through in-depth analysis, this study provides a comparative analysis of the Compulsory Licensing regimes in Brazil, Europe, and India. This analysis investigates the legal and procedural mechanisms including notable case studies, to understand the context in which compulsory licenses are issued and their impact on the pharmaceutical industry and healthcare affordability. It examines the grounds for granting Compulsory Licenses, the Compulsory Licensing process, the royalties that Compulsory Licensing holders are required to pay, and the promotion of cooperation between pharmaceutical companies and generic manufacturers. This research looks into some areas where India could improve its Compulsory Licensing regime, such as clear interpretation of the grounds on which Compulsory Licensing is to be granted and public health emergencies and making a fixed time period within which Compulsory Licensing is to be granted by Patent Authority. This study concludes by analysing what are the key factors that contribute to successful or unsuccessful outcomes in terms of increased access to medicines and what can be learned from instances of successful and unsuccessful compulsory licensing cases in India and how such problem can be fixed.

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