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 other statutes without any specified consequences for non-compliance with a deadline. The Federal Circuit cautioned, however, that the Board "may not ignore statutory deadlines" and that the "appropriate remedy is mandamus."
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