Background
In March 2018, Collegium Pharmaceutical, Inc. petitioned the Patent Trial and Appeal Board (PTAB) for post-grant review (PGR) of claims 1-17 of Purdue Pharma’s U.S. Patent No. 9,693,961, which covers an abuse-deterrent extended-release opioid formulation. The PTAB instituted PGR in October 2018, finding sufficient basis to challenge the claims on written description grounds. Under 35 U.S.C. § 326(a)(11), the PTAB had one year to issue a final written decision, with a potential six-month extension — a deadline that fell in October 2019, extended to April 2020.
In September 2019, Purdue Pharma filed for bankruptcy. Both the PGR proceeding and related district court litigation were stayed. The PTAB granted the six-month extension but when the bankruptcy court lifted the stay in July 2020, the extended April 2020 deadline had already passed. The PTAB continued the proceedings and ultimately issued its final written decision in November 2021 — approximately 19 months after the statutory deadline as extended. The decision found the challenged claims unpatentable for lack of written description. Purdue argued that the PTAB lost jurisdiction to issue any decision after the deadline passed, rendering the entire proceeding void. The Federal Circuit disagreed and affirmed.
The Court’s Holding
The Federal Circuit resolved a question of first impression: does the PTAB lose authority to issue a final written decision once the statutory deadline passes? The court held it does not. Applying the Supreme Court’s general rule that statutory deadlines are directory rather than jurisdictional (unless Congress clearly indicates otherwise), the court found no contrary indication in the AIA’s language, structure, or legislative history suggesting that missing the deadline divests the PTAB of authority to act. The deadline is designed to promote efficient resolution of IPR and PGR proceedings — it is not a hard limit that extinguishes the proceeding if missed.
The court emphasized the practical consequences of the alternative rule: if a missed deadline voided the entire proceeding, parties could strategically delay (as Purdue’s bankruptcy effectively did) to escape a proceeding that was not going well. Congress created the IPR/PGR system to provide a faster and more efficient alternative to district court patent validity challenges; allowing parties to escape final decisions through timing maneuvers would undermine that purpose. The court also affirmed the substantive written description invalidity finding against Purdue’s opioid patent claims.
Key Takeaways
- The PTAB does not lose jurisdiction to issue a final written decision in IPR or PGR proceedings merely because the statutory one-year (plus extension) deadline has passed — statutory deadlines in the AIA are directory, not jurisdictional.
- Intervening events like bankruptcy stays that cause delays beyond the statutory deadline do not void PTAB proceedings or strip the Board of authority to reach a final decision.
- Patent owners cannot use delay tactics (including bankruptcy stays) to escape post-grant review proceedings that are moving against them — the Board will continue to have authority to decide the case even after the deadline.
- The decision resolves a significant gap in IPR/PGR practice: practitioners and patentees now know that deadline misses — whether caused by the Board’s own delays or external events — will not automatically nullify a proceeding.
Why It Matters
The PTAB processes hundreds of IPR and PGR petitions annually, and delays are common — whether caused by discovery disputes, stay requests, related litigation coordination, or administrative constraints. Before this ruling, there was genuine uncertainty about what happened if the PTAB issued a final written decision after the statutory deadline. Patent owners facing unfavorable PTAB proceedings had some incentive to argue that late decisions were void, potentially converting a validity loss into a procedural escape.
The Federal Circuit’s ruling closes that loophole. For parties to PTAB proceedings, the decision means that any delay — including stays prompted by external events — will not create a jurisdictional problem for the Board’s eventual decision. This is particularly important in cases involving bankrupt entities, where insolvency proceedings can dramatically extend timelines. The pharmaceutical industry, with its complex intersection of patent validity, bankruptcy, and regulatory approval timelines, will take particular note of the ruling given its opioid patent context.