180-Day Advance Notice Of First Commercial Marketing Is Mandatory For All Biosimilar Applicants

Fitzpatrick Case Update
July 7, 2016

On July 5, 2016, the Federal Circuit issued a decision interpreting the 180-day-notice-of-first-commercial-marketing provision of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). Amgen Inc. v. Apotex Inc. (Amgen II), No. 2016-1308 (Fed. Cir. July 5, 2016).  The Court held in an earlier decision that 42 U.S.C. § 262(l)(8)(A) is a standalone provision that is mandatory where the biosimilar applicant fails to participate in the so-called “patent dance,” and the clock starts running on the 180-day-notice only after FDA approval is obtained. Amgen Inc. v. Sandoz Inc. (Amgen I), 794 F.3d 1347 at 1357, 1359, 1360 (Fed. Cir. 2015). In Amgen II, the Court has now held that this provision is obligatory “regardless of whether the applicant” has participated in the patent dance. Amgen II, slip. op. at 25. 

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