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Recent Orange and Purple Book legislation suggests a need to bridge drug and biologic patent regimes

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Additional changes could make the registries of drug patents published by the FDA, called the Orange and Purple Books, more useful and reduce barriers to effective competition from generic and biosimilar drugs.

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References

  1. US Food and Drug Administration (FDA). Approved Prescription Drug Products with Therapeutic Equivalence Evaluations (Orange Book) (FDA, 2021); https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book

  2. Darrow, J. Health Affairs Blog (July 2019); https://www.healthaffairs.org/do/10.1377/hblog20190718.722161/full/

  3. Lewis, R. A. J. Contemp. Health Law Policy 8, 361–378 (1992).

    CAS  PubMed  Google Scholar 

  4. US FDA. Fed. Regist. 68, 36676–36712 (2003).

  5. 21 CFR § 315.53.

  6. US FDA. Fed. Regist. 57, 17950 (1992).

    Google Scholar 

  7. US Congress. Orange Book Transparency Act of 2019. H. Rept. 116-47 (2019); https://www.congress.gov/congressional-report/116th-congress/house-report/47/1

  8. Carrier, M. A. & Sooy, B. Boston Univ. Law Rev. 97, 1661–1708 (2017).

    Google Scholar 

  9. Cesar Castillo, Inc. v. Sanofi-Aventis U.S., LLC (In re Lantus Direct Purchaser Antitrust Litig.), 950 F.3d 1. F.3d vol. 950 1 (2020).

  10. Hemphill, C. S. & Sampat, B. N. J. Empir. Leg. Stud. 8, 613–649 (2011).

    Article  Google Scholar 

  11. Anonymous. OnPoint Analytics https://onpointanalytics.com/pharma/patent-proliferation/ (September 2016).

  12. Beall, R. F. & Kesselheim, A. S. Nat. Biotechnol. 36, 142–145 (2018).

    Article  CAS  Google Scholar 

  13. 21 U.S.C. § 355(j).

  14. Caraco Pharm. Labs., Ltd. v. Novo Nordisk. U.S. vol. 566, 399 (2012).

  15. US FDA. Fed. Regist. 81, 69580–69658 (2016).

    Google Scholar 

  16. Feldman, R. J. Law Biosci. 5, 590–647 (2018).

    Article  Google Scholar 

  17. 21 CFR § 314.53.

  18. US FDA. Fed. Regist. 59, 50338 (1994).

    Google Scholar 

  19. 21 CFR § 314.108(b).

  20. 21 CFR § 316.34.

  21. US Congress. Orange Book Transparency Act of 2020.

  22. US Congress. Purple Book Continuity Act of 2019. H. Rept. 116-48 (2019); https://www.congress.gov/congressional-report/116th-congress/house-report/48/1

  23. Christl, L. & Lim, S. Biosimilar and interchangeable products in the United States: scientific concepts, clinical use, and practical considerations (December 2018); https://www.fda.gov/about-fda/fda-drug-topics-biosimilar-and-interchangeable-products-us-scientific-concepts-clinical-use-and

  24. US FDA. List of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations (Purple Book) (FDA, 2020).

  25. US Congress. Further Extension of Continuing Appropriations Act, 2021 (2021).

  26. The White House. Executive Order on Promoting Competition in the American Economy (9 July 2021); https://www.whitehouse.gov/briefing-room/presidential-actions/2021/07/09/executive-order-on-promoting-competition-in-the-american-economy/

  27. Teva Pharmaceuticals USA, Inc. Comment from Teva Pharmaceuticals USA, Inc. on Public Docket FDA-2020-N-1127 (2020); https://www.regulations.gov/comment/FDA-2020-N-1127-0010

  28. US Congress. Drug Price Competition and Patent Term Restoration Act of 1984 (1984).

  29. US Congress. Biologics Price Competition and Innovation Act of 2009 (2009).

  30. US FDA. Fed. Regist. 68, 38067 (2003).

    Google Scholar 

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Acknowledgements

Commonwealth Fund. A.S.K. and J.J.D.’s research is also funded by Arnold Ventures, Health Action International’s ACCISS program, the Kaiser Permanent Institute for Health Policy, the National Institutes of Health, West Health and the Collaborative Research Program for Biomedical Innovation Law, which is a scientifically independent collaborative research program supported by the Novo Nordisk Foundation (grant NNF17SA0027784). J.J.D.’s research is also funded by the Greenwall Foundation.

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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

    Bryan S. Walsh, Jonathan J. Darrow & Aaron S. Kesselheim

  2. Department of Law & Taxation, Bentley University, Waltham, MA, USA

    Jonathan J. Darrow

Authors
  1. Bryan S. Walsh
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  2. Jonathan J. Darrow
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  3. Aaron S. Kesselheim
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Correspondence to Aaron S. Kesselheim.

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Competing interests

A.S.K. reports serving as an expert witness in a case on behalf of a class of plaintiffs against Gilead relating to approval of tenofovir-containing drugs.

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Walsh, B.S., Darrow, J.J. & Kesselheim, A.S. Recent Orange and Purple Book legislation suggests a need to bridge drug and biologic patent regimes. Nat Biotechnol 40, 167–169 (2022). https://doi.org/10.1038/s41587-021-01204-y

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