ItemBook Chapter

Regulatory and strategic challenges of patent evergreening in the MedTech industry: An analysis of competition law implications

Title
Regulatory and strategic challenges of patent evergreening in the MedTech industry: An analysis of competition law implications
Creator
Beerannavar, Chaitra Rangappa; Koshi, Sandra Mariya
Description
Patent evergreening is a strategy used by pharmaceutical companies to extend their market exclusivity through minor modifications of existing drugs, often without significant therapeutic advancements. This practice raises concerns about access to affordable medicines, particularly in developing countries like India, where high drug prices impact public health. A comparative analysis with the European Union (EU) reveals that while India relies on patent law restrictions, the EU employs competition law under Article 102 of the Treaty on the Functioning of the European Union (TFEU) to regulate evergreening. Cases such as AstraZeneca v. European Commission demonstrate the EU's effects-based approach to curbing anti-competitive patent strategies. This study highlights the gaps in India's regulatory framework, emphasizing the need for greater coordination between the Indian Patent Office (IPO) and the Competition Commission of India (CCI), and adopting an effects-based approach are crucial to preventing evergreening while ensuring both innovation and consumer welfare. 2025, IGI Global Scientific Publishing. All rights reserved.
Source
Strategic Management, Regulatory Challenges, and Global Governance of MedTech;pp.149-183
Date
01-01-2025
Publisher
IGI Global
Coverage
Beerannavar C.R., Christ University, India; Koshi S.M., Christ University, India
Rights
Restricted Access; Hardcopy may be available in the library
Relation
ISBN: 979-833731207-1; 979-833731205-7;
Format
online
Language
English
Type
Book chapter

Citation

Beerannavar, Chaitra Rangappa; Koshi, Sandra Mariya, “Regulatory and strategic challenges of patent evergreening in the MedTech industry: An analysis of competition law implications,” CHRIST (Deemed To Be University) Institutional Repository, accessed June 19, 2026, https://archives.christuniversity.in/items/show/24609.

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