Last week, the U.S. Court of Appeals for the Federal Circuit issued an opinion in Purdue Pharma L.P. v. Collegium Pharmaceutical, Inc., No. 2022-1482 (Nov. 21, 2023), affirming a Patent Trial and Appeal Board Post Grant Review decision that found claims 1–17 of U.S. Patent No. 9,693,961 unpatentable for lack of written description and anticipation. The court further rejected Purdue’s argument that the PTAB’s failure to meet its statutory deadline deprived the Board of authority to issue a Final Written Decision on the matter.
Purdue’s primary contention was that the use of “shall” and “requiring” in section 326(a)(11) of Title 35 deprived the Board of authority to issue a Final Written Decision after the statutory deadline. The Court, however, cited Supreme Court precedent from Brock v. Pierce County, which emphasized that the use of “shall” alone does not divest an agency of jurisdiction. Purdue’s argument relying on the “negative words” of “not later than 1 year” and “by not more than 6 months” and the link to the Board’s jurisdictional grant in section 6 of 35 U.S.C. was also rejected.
The Court highlighted that the statute lacked explicit consequences for non-compliance and, therefore, under the Supreme Court’s rule the Board retained authority after the deadline. Purdue’s argument that exceptions for “good cause” and “joinder” were the only circumstances allowing action after the deadline was rejected, with the Court stating that exceptions do not strip the Board of authority.
The Court emphasized that the structure and legislative history of the statute supported the conclusion that the Board retained authority after the deadline. Specifically, the Court stated that Congress intended to create an expeditious alternative to district court litigation, and denying authority after the deadline would contradict this purpose.
On the substantive patent issue, the Court considered whether the patent claims had sufficient written description support for the aversive agent, specifically polyglycolyzed glycerides (PGGs). The Court found that the specification failed to adequately convey to skilled artisans that PGGs were gelling agents, a requirement for the claimed drug formula. As a result, the Court affirmed the Board’s determination of unpatentability based on lack of written description, making it unnecessary to address the issue of anticipation.
