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The puzzle of biologics manufacturing platform patents

Nature Biotechnology volume 43, pages 295–299 (2025)Cite this article

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The predominance of manufacturing process patents asserted in litigation by originator biologics companies against would-be biosimilar entrants has resulted in a number of Congressional and administrative agency proposals that could increase scrutiny and limit enforceability.

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Fig. 1: AbbVie annual count of platform patents by priority year.
Fig. 2: Genentech annual count of platform patents by priority year.

Data availability

Data underlying this work are publicly available: https://www.lens.org/lens/report/view/Therapeutic-protein-biologics-and-their-manufacturing-process-patents/24706/page/24707.

Change history

  • 21 August 2025

    In the version of the article initially published, a Data availability statement was not included and now appears in the HTML and PDF versions of the article.

References

  1. Goode, R. & Chao, B. J. Law Biosci. 9, lsac022 (2022).

    Article  PubMed  PubMed Central  Google Scholar 

  2. Horrow, C., Gabriele, S. M. E., Tu, S. S., Sarpatwari, A. & Kesselheim, A. S. JAMA Intern. Med. 184, 810–817 (2024).

    Article  PubMed  PubMed Central  Google Scholar 

  3. Rai, A. K. & Price, W. N. II Nat. Biotechnol. 39, 20–22 (2021).

    Article  CAS  PubMed  Google Scholar 

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

    Article  PubMed  Google Scholar 

  5. Williamson, R., Munro, T., Ascher, D., Robertson, A. & Pregelj, L. Value Health 27, 287–293 (2024).

    Article  PubMed  Google Scholar 

  6. Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., 586 US 123 (2019).

  7. Celanese International Corp. et al. v. International Trade Commission, 22-1827 (Fed. Cir. 2024).

  8. Prevent Pandemics Act of 2022, PL 117-308, Division FF, Title II.

  9. White House. Executive Order 14036, Promoting Competition in the American Economy https://www.federalregister.gov/documents/2021/07/14/2021-15069/promoting-competition-in-the-american-economy (9 July 2021).

  10. US Patent and Trademark Office. Duties of Disclosure and Reasonable Inquiry, 87 Fed. Reg. 45764 (29 July, 2022).

  11. Belcher Pharmaceuticals, LLC v. Hospira, Inc., 11 F.4th 1345 (Fed. Cir. 2011).

  12. Feldman, R. PLoS Med. 21, e1004381 (2024).

    Article  PubMed  PubMed Central  Google Scholar 

  13. Song, C. How non-product-specific manufacturing patents block biosimilars. Duke Law J. 71, 1923–1973 (2022).

    Google Scholar 

  14. US Food and Drug Administration. Platform Technology Designation Program for Drug Development Guidance for Industry https://www.fda.gov/regulatory-information/search-fda-guidance-documents/platform-technology-designation-program-drug-development (2024).

  15. Lerner, J. & Tirole, J. J. Polit. Econ. 123, 547–586 (2015).

    Article  Google Scholar 

  16. Tu, S. S., Goode, R. & Feldman, W. B. J. Am. Med. Assoc. 331, 355–357 (2024).

    Article  Google Scholar 

  17. Canter, B. et al. J. Law Biosci. 11, lsae015 (2024).

    Article  PubMed  PubMed Central  Google Scholar 

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Author information

Authors and Affiliations

  1. Duke University School of Law, Durham, NC, USA

    Osmat Azzam Jefferson & Arti K. Rai

  2. University of Michigan Law School, Ann Arbor, MI, USA

    W. Nicholson Price II

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

    S. Sean Tu

  4. Cardozo School of Law, New York, NY, USA

    Saurabh Vishnubhakat

Authors
  1. Osmat Azzam Jefferson
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  2. W. Nicholson Price II
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  3. S. Sean Tu
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  4. Saurabh Vishnubhakat
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  5. Arti K. Rai
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Corresponding author

Correspondence to Arti K. Rai.

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The authors declare no competing interests.

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Supplementary Information

Supplementary Data — Appendices A–E

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Jefferson, O.A., Price, W.N., Tu, S.S. et al. The puzzle of biologics manufacturing platform patents. Nat Biotechnol 43, 295–299 (2025). https://doi.org/10.1038/s41587-025-02579-y

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