Gabriele et al. reply

gabriele-et-al.-reply
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Nature Biotechnology (2025)Cite this article

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Allen argues that the Bayh–Dole Act was never intended to permit the federal government to “march in” on drugs with government-funded patents that are sold at excessively high prices, and that any effort to apply march-in rights or reasonable pricing clauses would undermine US innovation without meaningfully reducing drug costs. We believe that these assertions misrepresent the intent and historical context of the Act, and are belied by substantial empirical evidence on National Institutes of Health (NIH)-funded research and government-sponsored drug discoveries.

Our study showed that although only about 2% of small-molecule drugs have patents directly funded by the NIH1, those patents are often the primary patents covering the drug’s active ingredient and therefore are likely to be the most scientifically and commercially important in the portfolio. Taxpayer-funded drugs also have high clinical impact, including enzalutamide (Xtandi) for prostate cancer, pregabalin (Lyrica) for pain and emtricitabine/tenofovir (Truvada) to reduce HIV-1 infection. For these drugs, for which patents related to taxpayer funding cover the crucial discoveries while the drugs are sold at prices often far exceeding their prices in other comparable countries, the public may reasonably be described as ‘paying twice’. Considering whether to exercise government rights validly held under the Bayh–Dole Act on this narrow set of drugs would not diminish the overall incentives for companies to commercialize the remaining 98% of drugs that lack such patents.

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References

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Acknowledgements

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; and 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
  2. Matthew J. Martin
  3. Aaron S. Kesselheim
  4. S. Sean Tu

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 Sciences 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. Gabriele et al. reply. Nat Biotechnol (2025). https://doi.org/10.1038/s41587-025-02943-y

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