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Columns & DepartmentsThe Intellectual Property StrategistIntellectual PropertyPatent Litigation

IP News

BY Sarah Brand
January 01, 2024

Federal Circuit: PTAB Did Not Err In Finding That It Retained Authority to Issue Final Written Decision After Deadline Passed

On Nov. 21, 2023, a Federal Circuit panel of Judges Dyk, Hughes, and Stoll issued a unanimous opinion, authored by Judge Dyk, in Purdue Pharma L.P. v. Collegium Pharmaceutical, Inc., Case No. 2022-1482. The panel affirmed the Patent Trial and Appeal Board's (the Board) decision denying Purdue Pharma L.P. and Purdue Pharmaceuticals L.P.'s (collectively Purdue) motion to terminate Post Grant Review (PGR) proceedings and finding that claims 1–17 of Purdue's U.S. Patent No. 9,693,961 ('961 patent) are invalid for lack of written description and anticipation. Slip Op. at 1.

The '961 patent is directed to a method for preparing an abuse deterrent for use with opioid analgesics. Id. at 2–3. Purdue sued Collegium Pharmaceutical, Inc. (Collegium) for infringement of the '961 patent in September 2017, and Collegium thereafter petitioned the Board for PGR of claims 1–17 on grounds that they lacked a sufficient written description. Id. at 3. The district court infringement case proceeded in parallel to the PGR. Id. The Board had one year to issue a Final Written Decision (FWD), subject to a six-month extension by the Chief Administrative Patent Judge for good cause. Id at 4.

In September 2019, Purdue filed a Notice of Bankruptcy Filing and Imposition of Automatic Stay, after which the Board stayed the PGR proceeding, and the district court similarly stayed the infringement case. Id. Before the one-year deadline had passed for the Board to issue a Final Written Decision (FWD) in the PGR proceeding, the Chief Administrative Patent Judge granted a six-month extension for the Board to issue a FWD so that the bankruptcy court could determine whether the automatic stay applied to the PGR proceeding. Id. The Board advised both parties to seek a determination from the bankruptcy court on the issue, but neither did so, and the deadline passed. Id. The bankruptcy court, on motions by both parties, eventually lifted the stay. Id. Purdue, however, filed a motion with the Board to terminate the PGR proceeding on grounds that the Board no longer had the authority to issue a FWD after the 18-month deadline had passed. Id. at 4–5. The Board denied the motion and issued a decision that claims 1–17 are unpatentable for lack of written description and anticipation. Id. at 5.

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