Purdue Pharma L.P. v. Collegium Pharmaceutical, Inc. (United States Patent and Trademark Office intervening), Appeal No. 2022-1482 (Fed. Cir. Nov. 21, 2023)

In the Federal Circuit’s only precedential patent opinion last week, the Court held the Patent Trial and Appeal Board may issue final decisions in post-grant review proceedings even after the statutory deadline has passed.  It was the first time the Court had considered this issue.

Appellant and patent owner Purdue sued Collegium in 2017, alleging infringement of Purdue’s Patent No. 9,693,961.  In 2018, Collegium petitioned the Board for PGR of the ’961 patent.  The district court proceeding continued in parallel to the PGR.  Under 35 U.S.C. § 326(a)(11) and 37 C.F.R. § 42.200(c), the Board had one year—until October 4, 2019—in which to issue a final decision in the PGR, with a six-month extension available for good cause.  On September 24, 2019, Purdue filed a Notice of Bankruptcy Filing and Imposition of Automatic Stay, staying both the PGR and district court proceedings.  On October 2, 2019—two days before the original deadline for the PGR decision—the Board found good cause for a six-month extension so the bankruptcy court could assess whether the automatic stay applied to PGRs.  The parties disagreed as to whether the bankruptcy court’s stay applied to the PGR, but neither party sought guidance from the bankruptcy court or asked the court to lift the stay.  After the extended 18-month deadline passed, Purdue moved the bankruptcy court to lift the stay of the district court proceeding.  Collegium argued the stay should be lifted as to the PGR too, and the bankruptcy court lifted both stays.  With the stay lifted, Purdue moved to terminate the PGR, arguing that the Board no longer had authority to issue a decision after the extended 18-month deadline had passed.  The Board denied Purdue’s motion and issued a decision finding the ’961 patent unpatentable for lack of written description and anticipation.  Purdue appealed both the Board’s ability to issue a decision after the deadline and the unpatentability finding.

Purdue made four arguments as to why the passage of the 18-month deadline should strip the Board of its authority to issue a decision.  First, Purdue argued the presence of “shall” and “requiring” in the statute with respect to issuing decisions before the deadline meant that after the deadline, the Board could not issue decisions.  Second, Purdue argued the “negative words” of “not later than 1 year” and “by not more than 6 months” meant that after these time periods, the Board could not issue decisions.  The Federal Circuit dismissed these first two arguments, pointing to Supreme Court case law where similar obligatory and negative language did not prevent action from being taken outside the prescribed limits.

Third, Purdue argued that because the deadline at 35 USC 326(a)(11) is linked to the jurisdictional grant at Section 6, the Board’s jurisdiction must expire after the deadline has passed.  The Federal Circuit pointed to Supreme Court precedent to the effect that procedural rules such as deadlines should only be treated as limits on jurisdiction where Congress has clearly stated as much, and found that nothing in the relevant statute clearly stated the deadline for PGR decisions should be read as a limit on jurisdiction.  Finally, Purdue argued that because the statute specifies some circumstances when decisions may be issued after the deadline, there are no other circumstances under which the Board could issue decisions after the deadline.  Again, the Federal Circuit turned to Supreme Court precedent, and explained that the existence of express exceptions to a rule does not preclude other exceptions.

To conclude its discussion of the statutory language, the Federal Circuit pointed out that, although the AIA mandates that the Board issue a written decision, it does not expressly prohibit decisions from being made after the deadline.  By contrast, the Court observed that when the AIA sets timelines for instituting inter partes reviews and petitioning for PGR, it expressly prohibits those actions from being made after the applicable deadline.

The Federal Circuit further noted that prohibiting decisions after the deadline would undermine the legislative intent of avoiding costly litigation.  If the Board could not issue decisions after the deadline, more parties would have to pursue district court litigation, and any work done at the Board before the deadline passed would be wasted.  Purdue argued that if the Board could issue decisions after the deadline, then the deadline would be meaningless.  The Federal Circuit pointed out that parties do have recourse if the deadline is missed.  Specifically, the Court held that parties may petition for a writ of mandamus, and (over the intervening PTO’s objections) they may do so as soon as the deadline is missed. 

After affirming the Board’s authority to issue a decision after the deadline, the Federal Circuit found substantial evidence to support the Board’s finding that the ’961 patent was unpatentable, and affirmed that finding as well.

The opinion can be found here.

By Tyler Hall

This article summarizes aspects of the law and does not constitute legal advice. For legal advice for your situation, you should contact an attorney.

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