ROLE OF JUDICIARY IN COMPULSORY LICENSING REGIME

AUTHOR – SWATI GUPTA, LLM SCHOLAR AT AMITY UNIVERSITY NOIDA

BEST CITATION – SWATI GUPTA, ROLE OF JUDICIARY IN COMPULSORY LICENSING REGIME, INDIAN JOURNAL OF LEGAL REVIEW (IJLR), 5 (4) OF 2025, PG. 774-787, APIS – 3920 – 0001 & ISSN – 2583-2344.

Abstract

  This chapter delves into the critical role of the Indian judiciary in shaping the compulsory licensing regime for pharmaceutical patents under the Indian Patents Act, 1970 (as amended), within the context of international obligations and public health imperatives. Employing a doctrinal and case law analysis, the chapter examines key judicial pronouncements, including the landmark cases of Natco Pharma Ltd. v. Bayer Corporation, BDR Pharmaceuticals International Pvt Ltd v. Bristol-Myers Squibb Co, Lee Pharma v. AstraZeneca, and Novartis Ag v. Union of India and Others. The analysis highlights the judiciary’s general inclination towards a public health-oriented interpretation of compulsory licensing, demonstrated by the granting of the first compulsory license in Natco v. Bayer based on unmet public needs and unaffordable pricing. Conversely, the rejections in BDR Pharma and Lee Pharma underscore the significance of fulfilling statutory prerequisites and demonstrating genuine efforts to secure voluntary licenses. Furthermore, the chapter analyzes the pivotal role of the judiciary in upholding Section 3(d) of the Patents Act, as seen in the Novartis case, in preventing patent evergreening and safeguarding the accessibility of generic medicines. The chapter critically reflects on the complexities and potential obsolescence of the current compulsory licensing process and argues for its streamlining. It underscores the significance of India’s judicial approach as a potential model for developing nations seeking to utilize TRIPS flexibilities to address public health crises and ensure access to affordable pharmaceuticals.