Amgen v. Sandoz Federal Circuit Decision

On July 21, 2015, the Federal Circuit issued a divided decision in Amgen Inc. v. Sandoz Inc.,1 interpreting two provisions of the Biologics Price Competition and Innovation Act (BPCIA).2 The Federal Circuit decided two issues: 1) whether, as Amgen contends, the BPCIA requires Sandoz, and other biosimilar applicants, to provide a complete copy of their biosimilar application and manufacturing information within twenty days after the U.S. Food and Drug Administration (FDA) accepts the application, and 2) whether Sandoz's 180-day notice of commercial marketing was premature, as it was provided before the FDA approved and licensed Zarxio® (filgrastim-sndz), Sandoz's biosimilar to Amgen's Neupogen® product (filgrastim). These issues provided the Federal Circuit with its first real opportunity to substantively interpret the provisions of the BPCIA.

The majority opinion was authored by Judge Lourie and joined in parts by Judges Chen and Newman. The majority (Judges Lourie and Chen) affirmed the district court's interpretation of the "information exchange" provision of the BPCIA, finding that biosimilar applicants are not required to provide their biosimilar applications to the Reference Product Sponsor (RPS). However, the majority (Judges Lourie and Newman) partially reversed the district court's decision by holding that the 180-day notice of commercial marketing provision of the BPCIA is ineffective unless it is provided after a biosimilar applicant receives FDA licensure. The Court's decision therefore blunts Sandoz's earlier victory at the district court.

Quoting Winston Churchill and echoing statements made during oral argument, the majority opinion described the BPCIA as "a riddle wrapped in a mystery inside an enigma,"3 and noted that the Court did their "best to unravel the riddle, solve the mystery, and comprehend the enigma." Judge Chen, in his separate opinion, similarly noted that "[t]o fulfill our judicial obligation 'to say what the law is,' we must choose from a series of imperfect choices."4 In contrast, Judge Newman wrote that the "BPCIA as enacted leaves no uncertainty as to which of its provisions are mandatory and which are permissive."5

1. The "information exchange" provision does not require biosimilar applicants to give their application to RPSs.

   Paragraph (l)(2)(A) (the "information exchange" provision) of the BPCIA provides that:

   Not later than twenty days after the Secretary notifies the subsection (k) applicant that the application has been accepted for review, the subsection (k) applicant shall provide to the reference product sponsor a copy of the application submitted to the Secretary under subsection (k), and such other information that...