Skip to main content

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

  • Patents
  • Published:

Patents

The prevalence of drug patent term extensions in the United States, 2000–2018

Nature Biotechnology volume 41, pages 903–906 (2023)Cite this article

Subjects

Drug patents that are given patent term extension are important bellwether indicators for generic drug market entry.

This is a preview of subscription content, access via your institution

Access options

Buy this article

  • Purchase on Springer Link
  • Instant access to full article PDF
Buy now

Prices may be subject to local taxes which are calculated during checkout

Fig. 1: New drug approvals with patent term extension, 2000–2018.
Fig. 2: Small-molecule vs. biologic drugs with patent term extension.

References

  1. Beall, R. F., Darrow, J. J. & Kesselheim, A. S. Value Health 21, 1382–1389 (2018).

    Article  PubMed  Google Scholar 

  2. Rome, B. N., Lee, C. C. & Kesselheim, A. S. Clin. Pharmacol. Ther. 109, 367–371 (2021).

    Article  PubMed  Google Scholar 

  3. Dunn, M. K. Nat. Rev. Drug Discov. 10, 487–488 (2011).

    Article  CAS  PubMed  Google Scholar 

  4. US Food and Drug Administration. Small Business Assistance: Frequently Asked Questions on the Patent Term Restoration Program (2020). https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/small-business-assistance-frequently-asked-questions-patent-term-restoration-program

  5. Van de Wiele, V. L., Beall, R. F., Kesselheim, A. S. & Sarpatwari, A. Nat. Biotechnol. 40, 22–25 (2022).

    Article  PubMed  Google Scholar 

  6. Van de Wiele, V. L., Torrance, A. W. & Kesselheim, A. S. Health Aff. (Millwood) 41, 1117–1124 (2022).

    Article  PubMed  Google Scholar 

  7. Tu, S. S. & Lemley, M. A. Wash. Univ. Law Rev. 99, 1673–1731 (2022).

    Google Scholar 

  8. Beall, R. F., Darrow, J. J. & Kesselheim, A. S. Drug Discov. Today 24, 20–25 (2019).

    Article  PubMed  Google Scholar 

  9. US Food and Drug Administration. Center for Drug Evaluation and Research, Manual of Policies and Procedures (2022); https://www.fda.gov/media/94381/download

  10. US Food and Drug Administration. Drugs@FDA: FDA-Approved Drugs (accessed 7 June 2023); https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm

  11. US Patent and Trademark Office. Applications for patent term extension and patent terms extended under 35 U.S.C. §156 (as of February 2023); https://www.uspto.gov/patents/laws/patent-term-extension/patent-terms-extended-under-35-usc-156

  12. Heled, Y. Michigan Telecomm. Tech. Law Rev. 18, 419–479 (2012).

    Google Scholar 

  13. US Food and Drug Administration. Approved Drug Products with Therapeutic Equivalence Evaluations | Orange Book (2022).

  14. Amin, T. & Kesselheim, A. S. Health Aff. (Millwood) 31, 2286–2294 (2012).

    Article  PubMed  Google Scholar 

  15. Van de Wiele, V. L., Kesselheim, A. S. & Sarpatwari, A. Health Aff. (Millwood) 40, 1198–1205 (2021).

    Article  PubMed  Google Scholar 

  16. Beall, R. F., Darrow, J. J. & Kesselheim, A. S. J. Law Med. Ethics 47, 177–182 (2019).

    Article  PubMed  Google Scholar 

Download references

Acknowledgements

Results presented at the US Patent and Trademark Office–US Food and Drug Administration listening session at the USPTO on 29 January 2023. Funding: Commonwealth Fund. V.L.V.d.W., A.S.K. and S.S.T. also receive support from a grant from Arnold Ventures. The funders had no role in the preparation, review or approval of the manuscript or the decision to submit the manuscript for publication.

Author information

Authors and Affiliations

  1. Program On Regulation, Therapeutics And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA, USA

    Victor L. Van de Wiele, Aaron S. Kesselheim & Sarosh Nagar

  2. West Virginia University College of Law, Morgantown, WV, USA

    S. Sean Tu

Authors
  1. Victor L. Van de Wiele
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Aaron S. Kesselheim
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Sarosh Nagar
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. S. Sean Tu
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to S. Sean Tu.

Ethics declarations

Competing interests

The authors declare no competing interests.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Van de Wiele, V.L., Kesselheim, A.S., Nagar, S. et al. The prevalence of drug patent term extensions in the United States, 2000–2018. Nat Biotechnol 41, 903–906 (2023). https://doi.org/10.1038/s41587-023-01847-z

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1038/s41587-023-01847-z

Search

Advanced search

Quick links

Nature Briefing

Sign up for the Nature Briefing newsletter — what matters in science, free to your inbox daily.

Get the most important science stories of the day, free in your inbox. Sign up for Nature Briefing