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The strength and importance of government-funded patents for approved drugs

Nature Biotechnology volume 43, pages 1050–1052 (2025) Cite this article

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Understanding the strength and importance of US government-sponsored patents can help to limit high drug prices as well as constitute a justification to enact reasonable pricing clauses and exercise march-in rights.

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Fig. 1: Composition of primary and secondary patents in government and industry patent portfolios.
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References

  1. Galkina Cleary, E., Jackson, M. J., Zhou, E. W. & Ledley, F. D. JAMA Health Forum 4, e230511 (2023).

    Article  PubMed  PubMed Central  Google Scholar 

  2. Galkina Cleary, E., Beierlein, J. M., Khanuja, N. S., McNamee, L. M. & Ledley, F. D. Proc. Natl Acad. Sci. USA 115, 2329–2334 (2018).

    Article  PubMed  PubMed Central  Google Scholar 

  3. Zhou, E. W., Jackson, M. J. & Ledley, F. D. JAMA Health Forum 4, e231921 (2023).

    Article  PubMed  PubMed Central  Google Scholar 

  4. NIH RePORTER. https://reporter.nih.gov/ (accessed 18 July 2023).

  5. 37 C.F.R. § 401.14(c)(4).

  6. Tu, S. S. & Lemley, M. A. Wash. U. L. Rev. 99, 1673–1731 (2022).

    Google Scholar 

  7. Van de Wiele, V. L., Kesselheim, A. S., Nagar, S. & Tu, S. S. Nat. Biotechnol. 41, 903–906 (2023).

    Article  PubMed  Google Scholar 

  8. Sarpatwari, A., LaPidus, A. K. & Kesselheim, A. S. Ann. Intern. Med. 172, 348–350 (2020).

    Article  PubMed  Google Scholar 

  9. Cohrs, R. In new Regeneron deal for Covid drug, White House imposes price limits for first time. STAT News (13 September 2023).

  10. 35 U.S.C. 203.

  11. Reuters. US declines to force lower price on cancer drug Xtandi. https://www.reuters.com/business/healthcare-pharmaceuticals/us-declines-force-lower-price-cancer-drug-xtandi-2023-03-21/ (22 March 2023).

  12. Ouellette, L. L. & Sampat, B. N. JAMA Health Forum 5, e243775 (2024).

    Article  PubMed  PubMed Central  Google Scholar 

  13. Martin, M. J., Gabriele, S. M. E., Kesselheim, A. S. & Tu, S. S. JAMA 332, 2032–2033 (2024).

    Article  PubMed  PubMed Central  Google Scholar 

  14. Molteni, M. NIH has paused patenting of discoveries, slowing their use in developing treatments. STAT News (7 March 2025).

  15. US Government Accountability Office. Biomedical research: NIH should publicly report more information about the licensing of its intellectual property. https://www.gao.gov/products/gao-21-52 (accessed 28 April 2025).

  16. US National Institutes of Health. NIH Technology Transfer Annual Report Fiscal Year 2022. https://www.techtransfer.nih.gov/sites/default/files/documents/pdfs/FY2022%20Annual%20Report.pdf (2022)

  17. U.S. National Institutes of Health. Direct economic contributions. https://www.nih.gov/about-nih/what-we-do/impact-nih-research/serving-society/direct-economic-contributions (accessed 5 May 2025).

  18. Gersting, J., Wurster, A. & Berigan, G. NIH cuts to indirect costs may stifle IP generation. LAW360 https://www.law360.com/articles/2307043/nih-cuts-to-indirect-costs-may-stifle-ip-generation (10 March 2025).

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Acknowledgements

The authors thank S. Bappanad for help collecting the Google Patents data. He received no compensation. This work was funded by Arnold Ventures and the Commonwealth Fund. The funder had no role in the design or conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review or approval of the manuscript; or decision to submit the manuscript for publication.

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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

    Sarah M. E. Gabriele, Matthew J. Martin & Aaron S. Kesselheim

  2. University of Alabama School of Law, Tuscaloosa, AL, USA

    S. Sean Tu

Authors
  1. Sarah M. E. Gabriele
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  2. Matthew J. Martin
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  3. Aaron S. Kesselheim
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  4. S. Sean Tu
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Contributions

S.S.T. and S.M.E.G. had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. All authors were responsible for the data analysis.

Corresponding author

Correspondence to S. Sean Tu.

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Competing interests

A.S.K. served as an expert witness on behalf of a class of individual plaintiffs in a case against Gilead relating to a new formulation of tenofovir disoproxil and on behalf of a group of payers against Johnson & Johnson related to biosimilar availability and Stelara patents. S.S.T. reports consulting for purchasers of lenalidomide and abiraterone acetate-containing products.

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Gabriele, S.M.E., Martin, M.J., Kesselheim, A.S. et al. The strength and importance of government-funded patents for approved drugs. Nat Biotechnol 43, 1050–1052 (2025). https://doi.org/10.1038/s41587-025-02724-7

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