Purdue Pharma L.P. v. Collegium Pharmaceutical, Inc.

Court: US Court of Appeals for the Federal Circuit

Docket: 22-1482

Opinion Date: November 21, 2023

Judge: Timothy B. Dyk

Areas of Law: Intellectual Property, Patents

Purdue sued Collegium for infringement of its patent, meant to deter the abuse of opioid analgesics by the inclusion of an aversive agent, Collegium petitioned the Patent Trial and Appeal Board for post-grant review (PGR) of claims 1– 17. The Board found the challenged claims eligible for PGR because the pre-America Invents Act (AIA) 2001 application to which Purdue claimed priority did not contain sufficient written description support for the claimed invention. Under 35 U.S.C. 326(a)(11), the Board had one year to issue a Final Written Decision subject to a six-month extension. In September 2019, Purdue filed a Notice of Bankruptcy. The PGR proceeding and court case were stayed. In October 2019, a six-month extension was approved: “Petitioner should seek any relief it deems appropriate from the Bankruptcy Court.” Neither party sought guidance or an order lifting the stay from the bankruptcy court. The April 2020, extended deadline passed. In July 2020, the bankruptcy court lifted the stay for both proceedings.

Rejecting Purdue’s motion to terminate the PGR, the Board concluded that “the AIA’s silence as to a consequence for timely issuing a final written decision does not divest us of our authority” and found claims 1–17 unpatentable for lack of written description and anticipation. The Federal Circuit affirmed. Under Supreme Court precedent, the Board has the authority to issue a Final Written Decision after the deadline proscribed in the statute has passed absent any contrary indication in the language, structure, or legislative history of the statute.