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Drug patenting in India: looking back and looking forward

Nature Reviews Drug Discovery volume 14, pages 519–520 (2015)Cite this article

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TRIPS, which entered into effect in 1995, requires countries to grant pharmaceutical product patents. Prior to this time, few developing countries did so. In complying with TRIPS, India took steps that aimed to ameliorate the feared effects of pharmaceutical patenting on access to medicines. One of these steps was the inclusion of Section 3(d), which aims to curb the granting of patents to new forms, compositions and uses of existing substances — so-called 'secondary patents'. Secondary patents are legally more vulnerable, not only in India but globally. For example, in the United States, most secondary patents are overturned when litigated to completion (Science 339, 1386–1387; 2013). Indeed, in the case of Glivec, the secondary patent was the subject of a US patent challenge (Science 337, 414–415; 2012). This challenge resulted in a settlement that allowed generics to enter the market nearly immediately upon expiration of the compound patent, suggesting that Novartis had less than full confidence in the secondary patent in the United States (FiercePharma, 15 May 2014).

While Section 3(d) has attracted considerable attention, another aspect of India's TRIPS implementation was to disallow any patents with a priority year (that is, the year of first global filing) before 1995. During the TRIPS negotiations, pharmaceutical companies lobbied to make patent protection on pre-1995 molecules mandatory, arguing that not doing so would substantially delay the commercial benefits from TRIPS (The Pharma Marketletter, 22 May 1995). These attempts failed.

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Figure 1: Earliest priority year and approval year for patented new molecular entities approved in the United States between 1995 and 2013.

Acknowledgements

This research is funded by a grant (ES/K010999/1) from the UK Economic and Social Research Council (ERSC). The authors wish to thank Scott Hemphill and Duncan Matthews for their comments on earlier drafts.

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Authors and Affiliations

  1. Department of Health Policy and Management, Mailman School of Public Health at Columbia University, 722 West 168th Street, 4th Floor, New York, 10032, New York, USA

    Bhaven N. Sampat

  2. Department of International Development, London School of Economics and Political Science, Houghton Street, London, WC2A 2AE, UK

    Kenneth C. Shadlen

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  1. Bhaven N. Sampat
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Correspondence to Kenneth C. Shadlen.

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Supplementary information

Supplementary information S1 (table)

Priority and approval year of drugs approved 1995–2012 that are among the top 50 selling drugs in 2012 (PDF 96 kb)

Supplementary information S2 (box)

Constructing a list of all new molecular entity (NME) drug approvals between 1995 and 2013 (PDF 128 kb)

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Sampat, B., Shadlen, K. Drug patenting in India: looking back and looking forward. Nat Rev Drug Discov 14, 519–520 (2015). https://doi.org/10.1038/nrd4681

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