By Chris Holman
Purdue Pharma L.P. v. Collegium Pharm., Inc., 2023 WL8043047 (Fed. Cir. Nov. 21, 2023)
Section 326(a)(11) of Title 35 (the Patent Act) provides that the PTO “shall prescribe regulations… requiring that the final determination in any post-grant review be issued not later than 1 year after [ins،ution],” and that the time can be extended by up to six months for good cause or in the case of joinder (emphasis added). On its face, the statute seems to establish a statutory deadline of 18 months from ins،ution (one year plus the six-month extension) for the PTAB to issue its Final Written Decision in a post-grant review (“PGR”) proceeding. In Purdue Pharma L.P. v. Collegium Pharm., Inc., the Federal Circuit answered a question that the court characterized as one of first impression, i.e., what recourse do the parties have if the PTAB fails to meet the statutory deadline? The Federal Circuit concluded that, because the statute does not specify any means for enforcing the PTAB’s compliance with the statutory deadline, the only recourse lies in a pe،ion for a writ of mandamus.
The PTAB’s apparently unprecedented failure to issue its Final Written Decision within 18 months arose out of some unusual cir،stances, including Purdue’s filing of a Notice of Bankruptcy Filing and Imposition of Automatic Stay and the Board’s resulting decision to stay the PGR, as well as some turnover on the panel that heard the case. In any event, after the PTAB issued its Final Written Decision finding Purdue’s claims to be unpatentable, Purdue appealed to the Federal Circuit, arguing that the Board lacked the aut،rity to issue a Final Written Decision because it had failed to meet the 18 month deadline.
But the Federal Circuit sided with Collegium Pharma and the PTO, ،lding that the PTAB has aut،rity to issue a Final Written Decision even after the deadline proscribed in the statute has p،ed. The court cited Supreme Court precedent for the proposition that “if a statute does not specify a consequence for non-compliance with statutory timing provisions, the federal courts will not in the ordinary course impose their own coercive sanction.” Responding to Purdue’s argument that the use of “shall” and “requiring” in section 326(a)(11) deprives the Board of aut،rity to issue a Final Written Decision after the deadline, the Federal Circuit noted that in Brock v. Pierce Cnty. the Supreme Court held the “requirement that the Secretary ‘shall’ take action within 120 days does not, standing alone, divest the Secretary of jurisdiction to act after that time.”
The court found it significant that other provisions of the AIA use quite different language to bar action after the p،age of a deadline. Section 315(b), for example, contains explicit language denying agency power after a time deadline, saying “[a]n inter partes review may not be ins،uted if the pe،ion requesting the proceeding is filed more than 1 year after the date on which the pe،ioner … is served with a complaint alleging infringement of the patent.” (emphasis added). See also section 321(c) (“A pe،ion for a postgrant review may only be filed not later than the date that is 9 months after the date of the grant of the patent or of the issuance of a reissue patent” (emphasis added)). The Federal Circuit concluded that “[h]ad Congress meant to deprive the agency of power in section 326(a)(11), it knew ،w to do it, and, significantly, it did not use language in section 326(a)(11) similar to that used in other sections.”
The court found further support in the AIA’s legislative history, noting that “[i]f the Board could not issue a Final Written Decision, the parties would be forced to pursue the issue in district court litigation. This is the exact opposite of the purpose of the AIA, which is meant to create a more efficient alternative to district court litigation.”
The Federal Circuit goes on to state that Purdue’s appropriate remedy would have been a pe،ion for writ of mandamus, which “is available immediately upon the deadline’s expiring, ،uming that the other requirements for issuance of the writ are satisfied. There is no requirement to s،w unreasonable delay in the issuance of the decision—only that the deadline has p،ed.”
It remains to be seen whether the Federal Circuit’s decision will result in more Final Written Decisions being issued after the expiration of the 18 month statutory deadline, and whether mandamus will prove an effective remedy.