IDEAS home Printed from https://ideas.repec.org/a/plo/pone00/0194714.html
   My bibliography  Save this article

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

Author

Listed:
  • 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
    as

    Download full text from publisher

    File URL: https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0194714
    Download Restriction: no

    File URL: https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0194714&type=printable
    Download Restriction: no

    File URL: https://libkey.io/10.1371/journal.pone.0194714?utm_source=ideas
    LibKey link: if access is restricted and if your library uses this service, LibKey will redirect you to where you can use your library subscription to access this item
    ---><---

    References listed on IDEAS

    as
    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.
    2. Sampat, Bhaven N. & Shadlen, Kenneth C., 2017. "Secondary pharmaceutical patenting: A global perspective," Research Policy, Elsevier, vol. 46(3), pages 693-707.
    3. Mark A. Lemley & Bhaven Sampat, 2012. "Examiner Characteristics and Patent Office Outcomes," The Review of Economics and Statistics, MIT Press, vol. 94(3), pages 817-827, August.
    4. Tong, Xuesong & Frame, J. Davidson, 1994. "Measuring national technological performance with patent claims data," Research Policy, Elsevier, vol. 23(2), pages 133-141, March.
    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.
    Full references (including those not matched with items on IDEAS)

    Citations

    Citations are extracted by the CitEc Project, subscribe to its RSS feed for this item.
    as


    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.

    Most related items

    These are the items that most often cite the same works as this one and are cited by the same works as this one.
    1. Drivas, Kyriakos & Kaplanis, Ioannis, 2020. "The role of international collaborations in securing the patent grant," Journal of Informetrics, Elsevier, vol. 14(4).
    2. Nagaoka, Sadao & Yamauchi, Isamu, 2022. "Information constraints and examination quality in patent offices: The effect of initiation lags," International Journal of Industrial Organization, Elsevier, vol. 82(C).
    3. Sampat, Bhaven N. & Shadlen, Kenneth C., 2017. "Secondary pharmaceutical patenting: A global perspective," Research Policy, Elsevier, vol. 46(3), pages 693-707.
    4. Tetsuo Wada, 2018. "The choice of examiner patent citations for refusals: evidence from the trilateral offices," Scientometrics, Springer;Akadémiai Kiadó, vol. 117(2), pages 825-843, November.
    5. Petit, Elise & van Pottelsberghe de la Potterie, Bruno & Gimeno-Fabra, Lluis, 2023. "Are patent offices substitutes?," Research Policy, Elsevier, vol. 52(8).
    6. Bryan, Kevin A. & Ozcan, Yasin & Sampat, Bhaven, 2020. "In-text patent citations: A user's guide," Research Policy, Elsevier, vol. 49(4).
    7. Freilich, Janet & Shahshahani, Sepehr, 2023. "Measuring follow-on innovation," Research Policy, Elsevier, vol. 52(9).
    8. Righi, Cesare & Simcoe, Timothy, 2019. "Patent examiner specialization," Research Policy, Elsevier, vol. 48(1), pages 137-148.
    9. Gaétan De Rassenfosse & Paul H. Jensen & T'Mir Julius & Alfons Palangkaraya & Elizabeth Webster, 2023. "Is the Patent System an Even Playing Field? The Effect of Patent Attorney Firms," Journal of Industrial Economics, Wiley Blackwell, vol. 71(1), pages 124-142, March.
    10. Li Yao & He Ni, 2023. "Prediction of patent grant and interpreting the key determinants: an application of interpretable machine learning approach," Scientometrics, Springer;Akadémiai Kiadó, vol. 128(9), pages 4933-4969, September.
    11. Juranek, Steffen & Otneim, Håkon, 2024. "Predicting patent lawsuits with machine learning," International Review of Law and Economics, Elsevier, vol. 80(C).
    12. Corinne Langinier & Stéphanie Lluis, 2021. "Departure And Promotion Of U.S. Patent Examiners: Do Patent Characteristics Matter?," Contemporary Economic Policy, Western Economic Association International, vol. 39(2), pages 416-434, April.
    13. Cesare Righi & Timothy Simcoe, 2023. "Patenting inventions or inventing patents? Continuation practice at the USPTO," RAND Journal of Economics, RAND Corporation, vol. 54(3), pages 416-442, September.
    14. Kim, Bongsun & Kim, Eonsoo & Miller, Douglas J. & Mahoney, Joseph T., 2016. "The impact of the timing of patents on innovation performance," Research Policy, Elsevier, vol. 45(4), pages 914-928.
    15. 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.
    16. Raffiee, Joseph & Teodoridis, Florenta & Fehder, Daniel, 2023. "Partisan patent examiners? Exploring the link between the political ideology of patent examiners and patent office outcomes," Research Policy, Elsevier, vol. 52(9).
    17. Sun, Zhen & Wright, Brian D., 2022. "Citations backward and forward: Insights into the patent examiner's role," Research Policy, Elsevier, vol. 51(7).
    18. Cesare Righi & Timothy Simcoe, 2022. "Patenting inventions or inventing patents? Continuation practice at the USPTO," Economics Working Papers 1820, Department of Economics and Business, Universitat Pompeu Fabra.
    19. Timothy Simcoe & Cesare Righi, 2022. "Patenting Inventions or Inventing Patents? Continuation Practice at the USPTO," Working Papers 1320, Barcelona School of Economics.
    20. Joan Farre‐Mensa & Deepak Hegde & Alexander Ljungqvist, 2020. "What Is a Patent Worth? Evidence from the U.S. Patent “Lottery”," Journal of Finance, American Finance Association, vol. 75(2), pages 639-682, April.

    More about this item

    Statistics

    Access and download statistics

    Corrections

    All material on this site has been provided by the respective publishers and authors. You can help correct errors and omissions. When requesting a correction, please mention this item's handle: RePEc:plo:pone00:0194714. See general information about how to correct material in RePEc.

    If you have authored this item and are not yet registered with RePEc, we encourage you to do it here. This allows to link your profile to this item. It also allows you to accept potential citations to this item that we are uncertain about.

    If CitEc recognized a bibliographic reference but did not link an item in RePEc to it, you can help with this form .

    If you know of missing items citing this one, you can help us creating those links by adding the relevant references in the same way as above, for each refering item. If you are a registered author of this item, you may also want to check the "citations" tab in your RePEc Author Service profile, as there may be some citations waiting for confirmation.

    For technical questions regarding this item, or to correct its authors, title, abstract, bibliographic or download information, contact: plosone (email available below). General contact details of provider: https://journals.plos.org/plosone/ .

    Please note that corrections may take a couple of weeks to filter through the various RePEc services.

    IDEAS is a RePEc service. RePEc uses bibliographic data supplied by the respective publishers.