Federal Circuit IP

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

By Samuel Thacker Published January 10, 2024

CAFC Opinion No. 2022-1482, Decided November 21, 2023

(Dyk, Hughes, Stoll)


Overview: Matter of first impression: PTAB can issue final written decisions after the statutory deadline.

Facts/Procedural Posture:

  • Board institutes PGR of asserted Purdue patent.
  • Roughly six months later, Purdue files for bankruptcy and imposition of an automatic stay. PTAB stays the PGR proceeding.
  • After the one-year and extendable six-month statutory deadlines pass, Purdue files motion to terminate the PGR proceedings, arguing that the Board no longer has authority to issue a FWD.
  • PTAB denies Purdue’s motion and issues FWD finding all claims unpatentable under Sections 112 and 102. Purdue Appeals.

Issues on Appeal: Whether the PTAB had authority to issue a FWD after the statutory deadline and whether the Board’s unpatentability determinations were supported by substantial evidence.

Holdings & Order: (1) PTAB had authority to issue a FWD and (2) PTAB’s Section 112 unpatentability determination supported by substantial evidence[1]. Affirmed.

Fed. Cir. Analysis:

  • PTAB had authority to issue a FWD because: (1) the statute (Section 326(a)) does not impose a consequence for missing the statutory deadline; and (2) the statute and its legislative history give no indication that the PTAB should lose its authority to issue a FWD after the deadline passes.
    • Cir. cases interpreting several S. Ct. decisions have held that, if a statute does not specify a consequence for missing a statutory deadline, courts will not assume that an agency loses its authority to act after a statutory deadline passes. Instead, they look to the language, structure, and legislative history of the statute to determine the impact of the deadline.
    • Nothing in the statute or its legislative history indicates that the Board should not be able to issue a FWD after the statutory deadline.
      • If Congress had meant to impose a consequence for FWD tardiness, they would have included it in Section 326(a), as Congress did in other sections of the patent statute, such as Section 315(b).[2]
      • Preventing the PTAB from issuing a FWD and forcing parties to go through costly D. Ct. litigation runs counter to the very purpose of the AIA: to provide a cheaper, faster alternative to D. Ct. litigation.
    • PTAB’s lack of written description finding supported by substantial evidence because the claims require a polyglycolyzed glyceride (PGG) as a gelling agent, but the specification describes PGG only as a surfactant, not a gelling agent.


  • Don’t assume, or guarantee client, that the FWD will be issued by the statutory deadline; the PTAB can still issue FWDs after the deadline.

[1] Because the Fed. Cir. agreed that the claims were unpatentable under Section 112, it did not reach the issue of anticipation.

[2] Note: Section 315(b) prevents PTAB from acting due to Petitioner’s tardiness (waiting more than one year to file IPR after being served infringement complaint)—not the PTAB’s tardiness.