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Pharmaceutical Patents V Right To Health – Legal Remedies To Combat Evergreening In India




Sarferaaz Khaan, Master of Laws (Intellectual Property & Technology Law), National University of Singapore


ABSTRACT


Patents are vital for encouraging innovation, while their misuse through "evergreening"—a practice of extending patent monopolies by making minor modifications to existing drugs—poses a significant barrier to affordable healthcare. This paper examines the concept and methods of patent evergreening, particularly in the pharmaceutical sector, and its adverse impact on market competition and access to essential medicines in a developing country like India.


Focusing on Section 3(d) of the Indian Patent Act, 1970, which serves as a statutory safeguard against evergreening, the paper critically analyses its interpretation, implementation, and compatibility with the TRIPS Agreement. Through a doctrinal and case-based analysis, especially the landmark Novartis AG v. Union of India case, the study identifies key legislative and procedural gaps that enable pharmaceutical companies to circumvent the anti-evergreening provision. The paper also discusses the inadequacies in the Indian Patent Office's examination process and highlights the high error rate in granting secondary patents.


In response, the research proposes concrete legislative reforms including the need for clearer definitions of "efficacy," a declaration mechanism for patent applicants, improved disclosure standards, and adoption of a standard checklist for identifying secondary patents. Additionally, the paper calls for updated examination guidelines that explicitly incorporate judicial principles established in the Novartis decision.


By strengthening India’s anti-evergreening framework, the study advocates for a balanced approach that protects both pharmaceutical innovation and public health. It concludes that India, by refining its legal stance, has the potential to set a global benchmark in ensuring that the right to health is not compromised by unchecked patent practices.


Keywords: Patent evergreening, section 3(d), right to health, pharmaceutical patents, India



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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Licensing: 

 

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.

 

Disclaimer:

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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