Purdue Pharma L.P., et al. v. Collegium Pharmaceutical, Inc. (USPTO as Intervenor)
Docket No. 2022-1482 (https://cafc.uscourts.gov/opinions-orders/22-1482.OPINION.11-21-2023_2225603.pdf)
DYK, HUGHES, STOLL
November 21, 2023
Brief Summary: PTAB issuance of FWD after one-year deadline allowed; finding of insufficient written description affirmed.
Summary: Purdue appealed PTAB final written decision (FWD) finding claims 1-17 of Purdue’s U.S. Pat. No. 9,693,961 relating to methods for preventing oxycodone abuse using gel formulations invalid for lack of written description and anticipation. Purdue unsuccessfully argued the FWD was issued after the statutory one-year deadline for post grant reviews (PGR), “and that, if the Board did not lose jurisdiction, the Board’s decision was incorrect.” First, the PTAB 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” and a “likely lack of sufficient written description”, making PGR appropriate. The PTAB obtained a six-month extension of time to issue a FWD due to a stay related to Purdue’s bankruptcy proceedings, and that extended deadline passed. The PTAB rejected Purdue’s request to terminate the PGR due to the passed deadline and Purdue appealed. The FC panel rejected Purdue’s arguments because neither “the structure of the statute” or the legislative history supports that position (e.g., “exceptions to the deadline do not strip the Board of authority to issue a Final Written Decision after the deadline passed”, “it is significant that section 328(a) mandates that the Board issue a” FWD, “failure to comply with the statutory deadline does not deprive it of authority thereafter to issue a” FWD). On written description, (“a question of fact reviewed for substantial evidence”), the FC panel explained that “[t]o satisfy the written description requirement, the description must “clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed” (Ariad, FC 2010 (“reasonably conveys…possession”); Novozymes, FC 2013 (“sufficient ‘blaze marks’”)). “The issue here”, it explained, “is whether the ’961 specification adequately discloses the claimed polyglycolyzed glycerides (‘PGGs’) as an aversive agent.” It noted that “[a]lthough the ’961 claims on their face do not require an aversive agent, the specification makes clear that the claims require ‘inclusion of at least one aversive agent’ and the parties agree that the claims require the use of an aversive agent” which the specification states is “a bittering agent, an irritant, a gelling agent [e.g., a surfactant], or combinations thereof.” “[T]he parties agree[d] that not all surfactants are gelling agents” and “[t]he specification does not say that PGGs are gelling agents, as Purdue’s expert witness admitted.” Thus, the FC panel agreed with the PTAB that “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)” (“there are insufficient blaze marks”) and does not satisfy the written description requirements. The Board decision was therefore affirmed.