Recently, in Purdue Pharma L.P. v. Collegium Pharmaceutical, Inc., the Federal Circuit held for the first time that the Patent Trial and Appeal Board (“the Board”) has the authority to issue a Final Written Decision even after the statutory deadline has passed.
Congress introduced post grant review (“PGR”) and inter partes review (“IPR”) in 2011 as part of the America Invents Act (AIA). Parties can use these processes to ask the Board to review the patentability of a patent’s claims. Under the AIA, the Board must provide a Final Written Decision within one year of instituting the PGR or IPR; this can be extended for good cause for an additional six months.
In March 2018, Collegium petitioned the Board for PGR, challenging a Purdue Pharma patent directed toward “an abuse deterrent controlled release dosage form” of oxycodone. The Board instituted review in October 2018. However, in September 2019, Purdue Pharma filed for bankruptcy. This triggered a stay of the PGR proceeding, less than two weeks before the one-year deadline. The Board extended its deadline by six months, but neither party asked the bankruptcy court to lift the stay until several months after the extended deadline had passed. The Board finally issued its decision in November 2021, finding the challenged claims unpatentable. Purdue appealed, arguing that the Board lacked authority to issue a Final Written Decision after the deadline.
The Federal Circuit panel first considered the language and structure of 35 U.S.C. § 326(a)(11), which states that “The Director shall prescribe regulations . . . requiring that the final determination in any post-grant review be issued not later than 1 year” after institution, unless, “for good cause shown,” the deadline is extended “by not more than 6 months.” According to the court, nothing in this statute divests the Board of its authority to issue a Final Written Decision if it does not meet this deadline.
Citing Supreme Court decisions in Brock v. Pierce County and Barnhart v. Peabody Coal Co., the court found that neither the use of mandatory language like “shall,” nor negative phrases like “not later than 1 year,” were sufficient to bar the Board from issuing a decision after its deadline. The court noted that other portions of the AIA require the Board “shall” issue a Final Written Decision for every PGR that is instituted but not dismissed. Similarly, the existence of the six-month extension did not imply that no other exceptions exist—had Congress wished to bar the Board from issuing decisions after the deadline, it could have expressly stated that the Board “may not” issue a decision once the deadline has lapsed. And while Purdue argued that the Board loses jurisdiction if it fails to comply with any part of § 326, the court disagreed, finding that nothing in the AIA clearly states that § 326(a)(11) is jurisdictional.
The court then considered the legislative history and Congressional intent. According to the court, Congress created the PGR and IPR processes to provide a faster, less expensive alternative to litigation. The one-year deadline reflected this goal. However, if the Board were to lose its authority to issue a decision once it missed its deadline, then parties would be forced to rely on litigation—“the exact opposite of the purpose of the AIA.” Therefore, the court denied Purdue’s appeal and held that the Board did not lose its authority to issue a decision once the deadline had passed.
However, parties wishing to hold the Board to its deadline are not without relief. The court explained that had Purdue wished to compel a faster decision, it could have sought mandamus relief from the Federal Circuit as soon as the deadline lapsed. The court could then have compelled the Board to issue a decision.