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Regulatory and Strategic Challenges of Patent Evergreening in the MedTech Industry: An Analysis of Competition Law Implications
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Author(s): Chaitra Rangappa Beerannavar (Christ University, India)and Sandra Mariya Koshi (Christ University, India)
Copyright: 2025
Pages: 36
Source title:
Strategic Management, Regulatory Challenges, and Global Governance of MedTech
Source Author(s)/Editor(s): Ricardo Marcão (ISLA Santarem, Polytechnic University, Portugal & NECE, University of Beira Interior, Portugal
), Vasco Ribeiro Santos (Instituto Politécnico de Tomar, Portugal)and Stéphanie Monteiro (Institute for Systems and Robotics, Portugal)
DOI: 10.4018/979-8-3373-1205-7.ch007
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Abstract
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.
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