“A Riddle Wrapped in a Mystery Inside an Enigma”: The Federal Circuit Attempts to Decode the BPCIA

Authors: Sanya Sukduang, William B. Raich Ph.D., Jonathan R. Davies Ph.D., Aaron Gleaton Clay
Editor: Aaron Gleaton Clay

On July 21, 2015, the Federal Circuit issued a divided decision in Amgen Inc. v. Sandoz Inc., No. 15-1499 (Fed. Cir. July 21, 2015), interpreting two provisions of the Biologics Price Competition and Innovation Act (“BPCIA”).  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 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.

For a more detailed summary of this case, check out Finnegan’s recent IP Update.

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