TRIPS, pharmaceutical patents, and generic competition in India

Margaret Kyle, Bhaven Sampat and Kenneth Shadlen
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Margaret Kyle: CEDP i3 - Centre d'Economie et de Décision Publique i3 (anciennement CERNA i3) - Mines Paris - PSL (École nationale supérieure des mines de Paris) - PSL - Université Paris Sciences et Lettres - I3 - Institut interdisciplinaire de l’innovation - CNRS - Centre National de la Recherche Scientifique

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Abstract: Abstract Introduction India introduced pharmaceutical patents in response to the 1995 Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement. Previous studies that focused on older drugs showed limited effects of patents on India's generic market. We examine how a transitional TRIPS provision, which made patents with first global filing (priority) before 1995 ineligible, affected the likelihood of drugs obtaining strong "primary" patents in India, and the subsequent effects on generic competition. Methods We determined the primary patent priority year (PPPYear) for drugs approved in the United States 1995-2017. For each drug, we gathered Indian patent information and recorded the level of generic competition five years from launch. Results Primary patents are much more common after PPPYear 1995. Indian generic competition falls approximately 40% after this cutoff, especially for drugs with Indian primary patents. Conclusion Post-1995 PPPYear drugs are more likely to have primary patents and face less generic competition in India. These drugs now constitute most approvals in India and better reflect the long-run impact of TRIPS than drugs previously examined. The prevalence of drugs in India with primary patents and less competition has important implications for global access to medicines.

Date: 2026-02-04
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Published in Health Affairs Scholar, 2026, 4 (2), ⟨10.1093/haschl/qxaf239⟩

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Persistent link: https://EconPapers.repec.org/RePEc:hal:journl:hal-05762991

DOI: 10.1093/haschl/qxaf239

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