Federal Circuit Rules 180-Day Post-Licensure Notice Is Mandatory In Biosimilar Litigation

In Amgen v. Apotex (No. 2016-1308), the US Court of Appeals for the Federal Circuit on July 5, 2016 affirmed a district court's ruling that a biosimilar applicant must provide a reference product sponsor with 180 days' post-licensure notice before commercial marketing of a biosimilar product begins, regardless of whether the applicant provided the § 262(l)(2)(A) notice of USFDA review.

In Amgen v. Apotex, the Federal Circuit rejected Apotex's contention that the 180-day pre-marketing notice requirement does not apply to biosimilar applicants who participated in the "patent dance" procedure of the Biologics Price Competition and Innovation Act ("BPCIA"), expanding on its decision in Amgen v. Sandoz that the 180 days notice provision under § 262(l)(8)(A) is mandatory in all circumstances, whether or not the applicant engages in the patent dance.