In Purdue Pharma L.P. v. Collegium Pharmaceutical,
Inc., No. 22-1482 (Fed. Cir. Nov. 21, 2023), the Federal
Circuit held that the Patent Trial and Appeal Board
("Board") has authority to issue a Final Written Decision
("FWD") after the deadline proscribed by 35 U.S.C. §
326(a)(11) and 37 C.F.R. §42.200(c) and affirmed the
Board's finding that claims 1-17 of U.S. Patent No. 9,693,961
are invalid for lack of written description.
The Board took over 37 months from institution to issue its FWD.
Purdue appealed the Board's decision, arguing that the Board
lacked authority to issue a FWD beyond the 18-month deadline after
institution to do so. The Federal Circuit evaluated the
statute's language, structure, and legislative history and
concluded that because §326(a)(11) does not specify any
consequences for non-compliance with the 18-month deadline, the
Board had authority to issue a FWD after the deadline. This holding
was consistent with Supreme Court precedent regarding