High prices of biological drugs have placed substantial strain on the US healthcare system. To help address this problem, Congress passed the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) as part of the Affordable Care Act, which created an abbreviated approval pathway for biosimilars – versions of ‘originator’ biological drugs made by different manufacturers. To resolve disputes over whether a biosimilar manufacturer would infringe patents on the originator biological by entering the market, the BPCI Act included a multi-step litigation process, which starts when the biosimilar manufacturer submits its abbreviated biological license application to the US Food and Drug Administration (FDA). However, a decade after its passage, the BPCI Act has spurred only limited competition .
Van de Wiele et al. examined the role that patent litigation has played in this muted success, reviewing all 21 lawsuits related to the BPCI Act filed between its enactment and 1 August 2020 . The review identified two key problems. First, claims of biosimilar manufacturer non-compliance with the BPCI Act litigation process were present in 19 (90%) complaints. These claims included ‘failure to share an [abbreviated biological license application]’ [3, 4], ‘failure to exchange patent lists’  and ‘failure to engage in good faith negotiations’ [6, 7]. Potential reasons for this high proportion include a 2016 Supreme Court decision in Sandoz v Amgen, which limited the consequences of non-compliance  and biosimilar manufacturer concerns about sharing sensitive information found in the abbreviated biological license application. Second, a wide range of patents were alleged to be infringed across the 21 cases, with nine cases involving 20 or more patents. Combined, non-compliance with the litigation process and large numbers of litigated patents have contributed to frequent confidential settlements between originator and biosimilar manufacturers, which has delayed the availability of biosimilars.
To facilitate more timely biosimilar entry, Van de Wiele et al. argue that policymakers should consider:
• Re-evaluating the litigation process to become more in line with the litigation process for small-molecule drugs
• Addressing excess patenting by giving patent examiners more time
• Limiting biological patent enforceability, possibly by capping the number of patents that can be obtained or litigated
• Mandating public patent listing for biologicals
• Enhancing anti-trust enforcement of patent settlement agreements
Conflict of interest
The authors of the research paper  have declared their funding and conflict of interest in the paper. For full details of the authors’ conflict of interest, see the research paper .
Abstracted by Victor L Van de Wiele, LLB, LLM, Research Fellow, Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, USA.
Readers interested to learn more about biosimilar patent litigation are invited to visit www.gabi-journal.net to view the following manuscripts published in GaBI Journal:
Biosimilars patent litigation in the EU and the US: a comparative strategic overview
Biosimilars patent litigation in Canada and Japan: a comparative strategic overview and EU and US update
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1. Sarpatwari A, Barenie R, Curfman G, et al. The US biosimilar market: stunted growth and possible reforms. Clin Pharmacol Ther. 2019;105(1):92-100.
2. Van de Wiele VL, Kesselheim AS, Sarpatwari A. Barriers to US biosimilar market growth: lessons from biosimilar patent litigation. Health Aff. 2021;40(8):1198-205.
3. Amgen v. Sandoz, No. 3:14-cv-04741 (N.D.Cal.) (2015).
4. GaBI Online - Generics and Biosimilars Initiative. US Supreme Court to review 180-day notice for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Oct 29]. Available from: www.gabionline.net/policies-legislation/US-Supreme-Court-to-review-180-day-notice-for-biosimilars
5. Genentech Inc. v. Celltrion Inc. No. 1-18-cv-00095 (D.Del.) (2018).
6. Genentech Inc. v. Celltrion Inc. No. 1:18-cv- 11553-RMB-KMW (D.N.J.) (2018).
7. GaBI Online - Generics and Biosimilars Initiative. Biosimilar patent litigation trends in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Oct 29]. Available from: www.gabionline.net/biosimilars/general/Biosimilar-patent-litigation-trends-in-the-US
8. Sarpatwari A, Gluck AR, Curfman G. The Supreme Court ruling in Sandoz v Amgen: a victory for follow-on biologics. JAMA Intern Med. 2018;178(1):5-6.
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