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Patent Claim Scope and Biosimilar Competition in the US and EU

Published online by Cambridge University Press:  22 October 2024

Doni Bloomfield  and
Aaron S. Kesselheim
Doni Bloomfield
Affiliation:
FORDHAM LAW SCHOOL, NEW YORK CITY, NEW YORK, USA
Aaron S. Kesselheim
Affiliation:
HARVARD MEDICAL SCHOOL, BOSTON, MASSACHUSETTS, USA
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Extract

The US has found it hard to establish competition in the market for biologics, which are therapeutics derived from living cells. In the case of small-molecule drugs, the emergence of direct competition from generic drugs at the end of the exclusivity period has provided the impetus for price competition, leading to lower spending. In 2010, to spur competition in the biologics market, Congress created a simplified pathway for the US Food and Drug Administration (FDA) to approve comparable versions of biologic drugs called biosimilars. Biosimilar competition in the US has nonetheless remained weaker than in European peer countries. For example, as of August 2020, there were 52 biosimilars available in Germany, and only 15 in the US.1 An important contributor to this “biosimilar gap” has been the fact that biosimilars to biologic blockbusters such as adalimumab (Humira) and etanercept (Enbrel) were only (or will only become) commercially available in the US several years after receiving FDA approval, while they were available in Europe years earlier.2 Through the end of 2021, it took biosimilars a median of 301 days between receiving FDA approval and becoming available for use.3 In one recent study, the median length of time between when a biologic drug was approved and when its first biosimilar was made available to US patients was 21.5 years.4 This paucity of competition has contributed to high US spending on biologics. According to the Department of Health and Human Services, in 2022 41% of US drug expenditures was spent on biologics, which represented 16% of US prescriptions.5

Keywords

BiologicCompetitionPatentsPatent ScopePatent Thickets
Type
Commentary
Information
Journal of Law, Medicine & Ethics , Volume 52 , Issue 2: Defining Health Law for the Future: A Tribute to Professor Charity Scott , Summer 2024 , pp. 439 - 442
Copyright
© The Author(s), 2024. Published by Cambridge University Press on behalf of American Society of Law, Medicine & Ethics

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References

Carl, D. L. et al., “Comparison of Uptake and Prices of Biosimilars in the US, Germany, and Switzerland,” JAMA Network Open, Dec. 2022, at 2. See also I. Gherghescu and M. Begoña Delgado-Charro, “The Biosimilar Landscape: An Overview of Regulatory Approvals by the EMA and FDA,” Pharmaceutics 13, no. 1 (2021): 48.Google Scholar
Van de Wiele, V. L. et al., “The Characteristics of Patents Impacting Availability of Biosimilars,” Nature Biotechnology 1 (2022); “Etanercept Biosimilars Delayed until 2029 in US,” Generics and Biosimilars Initiative (Jan. 14, 2022), available at <https://www.gabionline.net/biosimilars/news/etanercept-biosimilars-delayed-until-2029-in-us> (last visited June 20, 2024).Google Scholar
Williamson, R. et al., “Are Manufacturing Patents to Blame for Biosimilar Market Launch Delays?” Value Health 27 (2024): at 289.Google ScholarPubMed
Rome, B. N. et al, “Market Exclusivity Length for Drugs with New Generic or Biosimilar Competition, 2012–2018,” Clinical Pharmacology & Therapeutics 109 (2021). Note that because biologics have only recently started facing competition, the sample size in the study was limited, considering four biologic molecules as compared with 264 small molecule therapies.Google Scholar
See Competition In Prescription Drug Markets, 2017-2022, U.S. Department of Health & Human Services 7 (2023), available at <https://aspe.hhs.gov/sites/default/files/documents/1aa9c46b849246ea53f2d69825a32ac8/competition-prescription-drug-markets.pdf> (last visited June 20, 2024) (calculation by authors from figures in Table 2). This disparity could be attributed in part to the fact that newer drugs are more likely to be biologics than small molecules, and hence protected from competition by both regulatory exclusivities and patents. In addition, biologics are more expensive to produce than most small molecule drugs, and so may in part for that reason remain more expensive after their exclusivity expires.+(last+visited+June+20,+2024)+(calculation+by+authors+from+figures+in+Table+2).+This+disparity+could+be+attributed+in+part+to+the+fact+that+newer+drugs+are+more+likely+to+be+biologics+than+small+molecules,+and+hence+protected+from+competition+by+both+regulatory+exclusivities+and+patents.+In+addition,+biologics+are+more+expensive+to+produce+than+most+small+molecule+drugs,+and+so+may+in+part+for+that+reason+remain+more+expensive+after+their+exclusivity+expires.>Google Scholar
Goode, R. and Chao, B., “Biological Patent Thickets and Delayed Access to Biosimilars, an American Problem,” Journal of Law & Biosciences 9 (2022).Google ScholarPubMed
Williamson et al., supra note 3, at 291.Google Scholar
Chao, B., “USPTO’s Lax Policy Leads to Humira Formulation Thicket,” Journal of Law, Medicine & Ethics 52, no. 2 (2024). As Chao notes, whether current exclusivity periods are too long or too short depends in part on whether issued claims are justified (and on what effect patents have on innovation).Google ScholarPubMed
Bloomfield, D. et al., “Improving the Quality of Drug Patents Through International Awareness,” BMJ (2022), available at <https://www.bmj.com/sites/default/files/attachments/bmj-article/pre-pub-history/first_revised_article_1.1.22.pdf> (last visited June 20, 2024); M. D. Frakes and M. F. Wasserman, “Investing in Ex Ante Regulation: Evidence from Pharmaceutical Patent Examination,” American Economic Journal: Economic Policy 15 (2023): 151.Google ScholarPubMed
See Van de Wiele et al., supra note 2.Google Scholar
Goode and Chao, supra note 6.Google Scholar
See generally “Special Theme — An Overview of Patent Litigation Systems Across Jurisdictions,” in World Intellectual Property Indicators 2018, World Intellectual Property Org., available at <https://www.wipo.int/edocs/pubdocs/en/wipo_pub_941_2018-chapter1.pdf> (2018) (last visited June 20, 2024).+(2018)+(last+visited+June+20,+2024).>Google Scholar
Feldman, R., “Dance of the Biologics,” Berkeley Technology Law Journal (forthcoming 2024).Google Scholar
IQVIA estimates that annual real savings from biosimilars in the United States will increase from $13.2 billion in 2022 to $42.9 billion in 2027. See “Biosimilars in The United States 2023-2027: Competition, Savings, And Sustainability,” The IQVIA Institute for Human Data Science 29 (2023). In May 2024, 51 biosimilars had received FDA approval, and 42 were available for use in the United States, according to Cardinal Health. “Biosimilars Landscape, Cardinal Health” (2024), available at <https://www.cardinalhealth.com/content/dam/corp/web/documents/Report/cardinal-health-biosimilar-launches.pdf> (last visited June 20, 2024). In November 2023, 79 biosimilars had received European Medicines Authority approval. Per Troein et al., “The Impact of Biosimilar Competition in Europe, The IQVIA Institute for Human Data Science 39-41 (2023).+(last+visited+June+20,+2024).+In+November+2023,+79+biosimilars+had+received+European+Medicines+Authority+approval.+Per+Troein+et+al.,+“The+Impact+of+Biosimilar+Competition+in+Europe,+The+IQVIA+Institute+for+Human+Data+Science+39-41+(2023).>Google Scholar
Marco, A. C. et al., “Patent Claims and Patent Scope,” Research Policy 48 (2019): 1; J. M. Kuhn and N. C. Thompson, “How to Measure and Draw Casual Inferences with Patent Scope,” Journal of International Business Studies 26 (2019): 5.Google Scholar
See Frakes and Wasserman, supra note 9.Google Scholar
It is true that patents often contain dependent claims to narrow claim scope and avoid the danger of overly broad patent claims. But such dependent claims may not always narrow the claim sufficiently to avoid invalidation on obviousness grounds.Google Scholar
Pairolero, N. A. et al., “Closing the Gender Gap in Patenting: Evidence from a Randomized Control Trial at the USPTO” (USPTO Econ. Working Paper, Paper No. 1, 2022), available at <https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4265093> (last visited June 20, 2024).+(last+visited+June+20,+2024).>Google Scholar
See Bloomfield et al., supra note 9; Ouellette, L. Larrimore, “Patent Experimentalism,” Virginia Law Review 101 (2015): 69. To be clear, we are not asserting that the Humira patents analyzed in Chao’s study are low quality, or that broad claims are of lower quality as a rule.Google Scholar
See Terminal Disclaimer Practice to Obviate Nonstatutory Double Patenting, 89 Fed. Reg. 40,439 (May 10, 2024).Google Scholar