Supreme Court to Consider BPCIA Requirements for Biosimilars

McDermott Will & Emery

McDermott Will & Emery

The Supreme Court of the United States has granted certiorari in a case involving the Biologics Price Competition and Innovation Act of 2009 (BPCIA) in the context of a biosimilars dispute. Sandoz, Inc. v. Amgen Inc. and Amgen Inc. v. Sandoz, Inc., Case No. 15-1195 (Supr. Ct., Jan 13, 2017) (cert. granted). The Supreme Court is expected to decide whether notice of sale of biosimilars must be given after approval of the biosimilars (essentially extending the period of exclusivity), and whether the parties are obligated to disclose approval applications and intellectual-property-related information.

Each party had filed its own petition for Supreme Court review of the US Court of Appeals for the Federal Circuit’s 2015 interpretation of the BPCIA (IP Update, Vol. 18, No. 8). In its decision, the Federal Circuit concluded that the 180-day notice of sales under the BPCIA can only be given after a biosimilar is approved. That finding may effectively grant an innovator of a biologic an extra six months of exclusivity.

The questions presented are as follows:

Amgen v. Sandoz

(1) Is a biosimilar applicant required by 42 USC § 262(l)(2)(A) to provide the reference product sponsor with a copy of its biologics license application and related manufacturing information, which the statute says the applicant “shall provide”?

(2) Where an applicant fails to provide that required information, is the sponsor’s sole recourse to commence a declaratory judgment under 42 USC § 262(l)(9)(C) and/or a patent-infringement action under 35 USC § 271(e)(2)(C)(ii)?

Sandoz v. Amgen

(1) Can notice of commercial marketing given before Food and Drug Administration approval be effective?

(2) In any event, is it improper to treat § 262(l)(8)(A)—the BPCIA’s “notice of commercial marketing” provision, which states that a biosimilar applicant shall provide notice to the incumbent seller of the biological product “not later than 180 days before the date of the first commercial marketing of the biological product licensed under” an abbreviated pathway for biosimilars—as a stand-alone requirement and as creating an injunctive remedy that delays all biosimilars by 180 days after approval?

The acting US solicitor general recently urged the Supreme Court to take the case and sided with Sandoz. The ruling may decide how quickly lower cost biosimilars get to market in competition with relatively higher cost pioneer biosimilars.

Although the underlying dispute case involves Zarxio, the first biosimilar approved under the BPCIA, the case is relevant only for future biosimilars, as Zarxio has been on the market for more than a year.

Based on the question presented in the Amgen petition, the Supreme Court is also expected to review the Federal Circuit’s finding that biosimilar makers don’t have to participate in exchange of intellectual property information that starts with disclosure of an approval application.


DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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