Errors in the US Patent and Trademark Office’s automated program to calculate patent expiration dates could result in hundreds of millions of dollars in added costs to drug prices.
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References
Beall, R. F., Darrow, J. J. & Kesselheim, A. S. J. Law Med. Ethics 47, 177–182 (2019).
35 U.S.C. §154.
Cheian, D. Fordham Intell. Prop. Media & Ent. L. J. 33, 1–33 (2022).
US Patent & Trademark Office. Applications for patent term extension and patent terms extended under 35 U.S.C. §156. https://www.uspto.gov/patents/laws/patent-term-extension/patent-terms-extended-under-35-usc-156 (accessed 29 December 2023).
US Patent & Trademark Office. 2732 Reduction of period of adjustment of patent term [R-07.2022] (accessed 14 January 2024).
Feldman, W. B., Tu, S. S., Alhiary, R., Kesselheim, A. S. & Wouters, O. J. J. Am. Med. Assoc. 329, 87–89 (2023).
Manual of patent examining procedure §2733. https://www.uspto.gov/web/offices/pac/mpep/s2733.html (accessed 6 June 2024).
Acknowledgements
This research was funded by Arnold Ventures. A.S.K.’s work was also supported by a grant from Commonwealth Fund, and B.N.R. and A.S.K. are supported by grants from the Elevance Health Public Policy Institute and the National Academy for State Health Policy. The funders 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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S.S.T. reports consulting for purchasers of lenalidomide-containing products. A.S.K. reports serving as an expert witness on behalf of a class of plaintiffs against Gilead relating to its tenofovir-containing products.
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Tu, S.S., Cheian, D., Gabriele, S. et al. The cost of drug patent expiration date errors. Nat Biotechnol 42, 1024–1025 (2024). https://doi.org/10.1038/s41587-024-02298-w
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DOI: https://doi.org/10.1038/s41587-024-02298-w
