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Patent Linkage Systems And Their Impact On Asian Pharmaceutical Markets: A Critical Analysis With Special Focus On India




Ms. Anagha K, Christ (Deemed to be) University


ABSTRACT


Patent linkage systems, which tie pharmaceutical regulatory approval to patent status, have emerged as contentious mechanisms in global pharmaceutical governance. This paper examines divergent approaches to patent linkage across three major Asian pharmaceutical markets India, China, and South Korea analyzing implications for drug access, pricing, and innovation. India has consistently rejected patent linkage through judicial decisions, maintaining separation between patent enforcement and regulatory approval. South Korea implemented linkage in 2015 under Korea- United States Free Trade Agreement (KORUS FTA) pressure, while China adopted a modified system in July 2021. Drawing on legal precedents, empirical data on patent activity, and price comparisons, this paper argues that India’s resistance to patent linkage has preserved affordable medicine access while maintaining innovation incentives. As India faces renewed pressure through trade negotiations, this analysis provides critical assessment of public health and economic implications of potential policy shifts.


Keywords: Patent Linkage; TRIPS-Plus Provisions; Access to Medicines; Intellectual Property Rights; Trade Agreements; India; China; South Korea; Doha Declaration; Section 3(d) of the Patents Act.



Indian Journal of Law and Legal Research

Abbreviation: IJLLR

ISSN: 2582-8878

Website: www.ijllr.com

Accessibility: Open Access

License: Creative Commons 4.0

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All research articles published in The Indian Journal of Law and Legal Research are fully open access. i.e. immediately freely available to read, download and share. Articles are published under the terms of a Creative Commons license which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

 

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The opinions expressed in this publication are those of the authors. They do not purport to reflect the opinions or views of the IJLLR or its members. The designations employed in this publication and the presentation of material therein do not imply the expression of any opinion whatsoever on the part of the IJLLR.

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