Precedential and Key Federal Circuit Opinions
1. PURDUE PHARMA LP v. COLLEGIUM PHARMACEUTICAL, INC. [OPINION] (2022-1482, 11/21/2023) (Dyk, Hughes, and Stoll)
Dyk, J. The Court affirmed the Patent Trial and Appeal Board's decision finding that while "[t]he Board issued its Final Written Decision after the statutory deadline . . . the deadline did not deprive it of authority." Collegium Pharmaceutical, Inc. ("Collegium") instituted post-grant review ("PGR") proceedings against Purdue Pharma LP ("Purdue") on March 13, 2018. "In the PGR, Purdue argued that the [at-issue] patent was not subject to PGR as it claimed priority to an August 6, 2001, application, and applications filed before March 16, 2013, were not subject to PGR." "The Board found the challenged claims eligible for PGR because the pre-America Invents Act ("AIA") application to which Purdue claimed priority did not contain sufficient written description support for the claimed invention, and the effective filing date was therefore after March 16, 2013."
After instituting PGR, the Board had until October 4, 2019—one year after institution—to issue a Final Written Decision, subject to a six-month extension for good cause. "On September 24, 2019, Purdue filed a Notice of Bankruptcy Filing and Imposition of Automatic Stay. The Board subsequently stayed the PGR proceeding." "[O]n October 2, 2019, the Chief Administrative Patent Judge found good cause to grant a six-month extension so the bankruptcy court could assess whether the automatic stay applied to PGRs." While "[n]either party sought guidance from the bankruptcy court," the "April 4, 2020, extended deadline passed." Then, "[o]n July 2, 2020, Purdue moved at the bankruptcy court for the automatic stay to be partially lifted so [a parallel infringement case in] the district court case could proceed." "The bankruptcy court lifted the stay for both the district court and the PGR proceeding on September 1, 2020." "Purdue contend[ed] that if the Board fails to meet the deadline established by 35 U.S.C. § 326(a)(11) and 37 C.F.R. § 42.200(c) (one year plus the six-month extension), the Board no longer has the authority to issue a Final Written Decision."
According to the Court, "[t]his appears to be the only proceeding in which the Board has failed to meet the statutory deadline, and this is accordingly a matter of first impression." The Court explained that "[t]he Supreme Court has established that 'if a statute does not specify a consequence for non-compliance with statutory timing provisions, the federal courts will not in the ordinary course impose their own coercive sanction.'" Thus, the Court explained that "the Board ha[d] authority to issue a Final Written Decision even after the deadline proscribed in the statute has passed absent any contrary indication in the language, structure, or legislative history of the statute."
The Court also "affirmed the Board's determination that claims 1-17 of the [at-issue] patent are unpatentable for lack of written description" because substantial evidence supports the Board's finding that "the claim formulation was not disclosed" because "[t]he disclosure of the application does not reasonably convey to those skilled in the art that the inventor had possession of the claimed drug formula containing PGGs as a gelling agent (aversive agent)."
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.