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
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
Darrow, J. Health Affairs Blog (July 2019); https://www.healthaffairs.org/do/10.1377/hblog20190718.722161/full/
Lewis, R. A. J. Contemp. Health Law Policy 8, 361–378 (1992).
US FDA. Fed. Regist. 68, 36676–36712 (2003).
21 CFR § 315.53.
US FDA. Fed. Regist. 57, 17950 (1992).
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
Carrier, M. A. & Sooy, B. Boston Univ. Law Rev. 97, 1661–1708 (2017).
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).
Hemphill, C. S. & Sampat, B. N. J. Empir. Leg. Stud. 8, 613–649 (2011).
Anonymous. OnPoint Analytics https://onpointanalytics.com/pharma/patent-proliferation/ (September 2016).
Beall, R. F. & Kesselheim, A. S. Nat. Biotechnol. 36, 142–145 (2018).
21 U.S.C. § 355(j).
Caraco Pharm. Labs., Ltd. v. Novo Nordisk. U.S. vol. 566, 399 (2012).
US FDA. Fed. Regist. 81, 69580–69658 (2016).
Feldman, R. J. Law Biosci. 5, 590–647 (2018).
21 CFR § 314.53.
US FDA. Fed. Regist. 59, 50338 (1994).
21 CFR § 314.108(b).
21 CFR § 316.34.
US Congress. Orange Book Transparency Act of 2020.
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
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
US FDA. List of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations (Purple Book) (FDA, 2020).
US Congress. Further Extension of Continuing Appropriations Act, 2021 (2021).
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/
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
US Congress. Drug Price Competition and Patent Term Restoration Act of 1984 (1984).
US Congress. Biologics Price Competition and Innovation Act of 2009 (2009).
US FDA. Fed. Regist. 68, 38067 (2003).
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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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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DOI: https://doi.org/10.1038/s41587-021-01204-y
