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Supreme Court decision favours biosimilars

Nature Reviews Drug Discovery volume 16, pages 521–522 (2017)Cite this article

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The BPCIA was enacted in 2010 as part of the Patient Protection and Affordable Care Act to provide an abbreviated process for obtaining approval from the US Food and Drug Administration (FDA) for biosimilar products, based on the prior approval of similar biologic products. The BPCIA permits a biosimilar applicant to rely on the clinical trials conducted to support the original biologic product, significantly reducing the costs and time required for approval. The BPCIA also includes provisions for resolving patent infringement disputes between reference product sponsors and biosimilar applicants. Specifically, the BPCIA lays out a multistep, two-stage process that has come to be known as the 'patent dance'. This dance commences when the biosimilar applicant shares its abbreviated BLA (aBLA), the application used for biosimilars, with the reference product sponsor in accordance with Title 42 of the United States Code (USC), section 262(l)(2)(A) (42 USC §262(l)(2)(A)). It continues with exchanges of lists of patents and validity or infringement contentions, as well as negotiations of the patents to be litigated. During this time, the reference product sponsor must assert the negotiated patents to avoid limitations on remedies. The process culminates with a last-chance opportunity for the reference product sponsor to assert additional patents after the biosimilar applicant provides 180-day pre-marketing notice in accordance with 42 USC §262(l)(8)(A). The two issues before the Supreme Court were whether a biosimilar applicant must share its aBLA with the reference product sponsor in accordance with 42 USC §262(l)(2)(A) — that is, whether that requirement is enforceable by an injunction — and whether a biosimilar applicant can give its 180-day pre-marketing notice before the biosimilar product is approved.

the only consequence for not sharing the aBLA is being subject to an immediate declaratory judgment action

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The views expressed in this article are personal to the author and do not necessarily reflect those of other members of Foley & Lardner LLP or its clients.

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  1. Foley & Lardner LLP, 3000 K Street N.W., Suite 600, Washington, DC 20007-5109, USA, and the editor of Foley & Lardner LLP's PharmaPatentsBlog.com.,

    Courtenay C. Brinckerhoff

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  1. Courtenay C. Brinckerhoff
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Correspondence to Courtenay C. Brinckerhoff.

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Brinckerhoff, C. Supreme Court decision favours biosimilars. Nat Rev Drug Discov 16, 521–522 (2017). https://doi.org/10.1038/nrd.2017.136

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