Amgen Inc. v. Sandoz Inc., Fed. Cir. Cas No. 2015-1499, decided July 21, 2015.

http://www.cafc.uscourts.gov/sites/default/files/s15-1499.pdf

On July 21, 2015 in a fracture opinion, the Federal Circuit ruled on two provisions of the Biologics Price Competition and Innovation Act (“BPCIA”). This is the first appellate decision addressing provisions of the BPCIA.

Sandoz had filed an abbreviated biologic license application with the FDA regarding their Zarxio product, which is a biosimilar version of Amgen’s Neupogen product. The appeal stems from the district courts holdings regarding the two provisions of the BPCIA.

First, Judges Lourie and Chen affirmed the district court and held that the patent exchange provisions of the BPCIA were not mandatory. Rather, the Federal Circuit held that either party could opt out of the disclosures provisions and then be subjected to the remedies provided under 42 U.S.C. § 262(l)(9)(C) and 35 U.S.C. § 271(e) for failing to meet the disclosure requirement.

Second, Judges Lourie and Newman reversed the district court and held that the notice of commercial marketing provisions of the BPCIA, paragraph (l)(8)(A), require that the 180-day pre-launch notice be given upon FDA’s approval of the biosimilar product for licensure rather than upon acceptance of the biosimilar application. That is, the biosimilar applicant may not provide the 180-day marketing notice until the FDA approves their biosimilar application.

While this may be the first appellate decision regarding the BPCIA, there certainly will be more decision to follow. We will continue to follow these proceeding as well as other biosimilar product cases and provide updates to this complicate law.