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Indian pharmaceutical patent prosecution: The changing role of Section 3(d)

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  • Bhaven N Sampat
  • Kenneth C Shadlen

Abstract

India, like many developing countries, only recently began to grant pharmaceutical product patents. Indian patent law includes a provision, Section 3(d), which tries to limit grant of “secondary” pharmaceutical patents, i.e. patents on new forms of existing molecules and drugs. Previous research suggests the provision was rarely used against secondary applications in the years immediately following its enactment, and where it was, was redundant to other aspects of the patent law, raising concerns that 3(d) was being under-utilized by the Indian Patent Office. This paper uses a novel data source, the patent office’s first examination reports, to examine changes in the use of the provision. We find a sharp increase over time in the use of Section 3(d), including on the main claims of patent applications, though it continues to be used in conjunction with other types of objections to patentability. More surprisingly, see a sharp increase in the use of the provision against primary patent applications, contrary to its intent, raising concerns about potential over-utilization.

Suggested Citation

  • Bhaven N Sampat & Kenneth C Shadlen, 2018. "Indian pharmaceutical patent prosecution: The changing role of Section 3(d)," PLOS ONE, Public Library of Science, vol. 13(4), pages 1-19, April.
  • Handle: RePEc:plo:pone00:0194714
    DOI: 10.1371/journal.pone.0194714
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    References listed on IDEAS

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    1. Mark Duggan & Craig Garthwaite & Aparajita Goyal, 2016. "The Market Impacts of Pharmaceutical Product Patents in Developing Countries: Evidence from India," American Economic Review, American Economic Association, vol. 106(1), pages 99-135, January.
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    5. Michael D. Frakes & Melissa F. Wasserman, 2017. "Is the Time Allocated to Review Patent Applications Inducing Examiners to Grant Invalid Patents? Evidence from Microlevel Application Data," The Review of Economics and Statistics, MIT Press, vol. 99(3), pages 550-563, July.
    6. Yamauchi, Isamu & Nagaoka, Sadao, 2015. "An economic analysis of deferred examination system: Evidence from a policy reform in Japan," International Journal of Industrial Organization, Elsevier, vol. 39(C), pages 19-28.
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    Cited by:

    1. Luis Gil Abinader, 2020. "Pharmaceutical patent examination outcomes in the Dominican Republic," Journal of International Business Policy, Palgrave Macmillan, vol. 3(4), pages 385-407, December.
    2. Omar Ramon Serrano Oswald & Mira Burri, 2021. "India, Brazil, and public health: Rule‐making through south–south diffusion in the intellectual property rights regime?," Regulation & Governance, John Wiley & Sons, vol. 15(3), pages 616-633, July.
    3. Suma Athreye & Lucia Piscitello & Kenneth C. Shadlen, 2020. "Twenty-five years since TRIPS: Patent policy and international business," Journal of International Business Policy, Palgrave Macmillan, vol. 3(4), pages 315-328, December.

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