PTO’s Decision To Revive An Application Is Not Subject To Third Party Challenge Under The APA

Exela Pharma Sciences, LLC v. Michelle K. Lee, Deputy Director, USPTO, No. 2013-1206, 2015 U.S. App. LEXIS 4895 (Fed. Cir. Mar. 26, 2015) (Per curiam). Click Here for a copy of the opinion.

Exela filed an ANDA seeking FDA approval to market a generic version of Ofirmev. The ANDA included a "paragraph IV Certification" against U.S. Pat. No. 6,992,218. In response, Cadence et al. sued Exela for infringing the '218 patent. Exela in turn filed a petition in the PTO, challenging the PTO's grant of a petition to revive the patent application that led to the '218 patent. During prosecution, certain materials were not filed within the 30-month PCT deadline, and the application lapsed. Applicant's petition to revive the application for "unintentional" delay was granted. The application was examined and ultimately led to the '218 patent.

Exela argued that a so-called "unintentional" delay, "was not an available ground for revival of a U.S. patent application claiming priority under the PCT-implementing statute as then in effect." On the other hand, 35 U.S.C. §371(d) allowed revival of such applications only where non-compliance was "unavoidable."

The PTO declined to consider Exela's petition on the basis that "no statute or regulation authorizes third party challenge to a PTO ruling concerning revival of a patent application." Exela then filed this separate action against the USPTO in the district court under the APA. Cadence intervened. The district court interpreted Exela's claims as a facial challenge to the USPTO's regulations and dismissed the case. It found, under the applicable statute of limitations, Exela could not challenge the promulgation of the USPTO's rules more than six years after they were enacted. Exela appealed.

The Federal Circuit affirmed on the merits. It held: "Congress did not intend to permit judicial review for challenges such as the one brought here." The Court reasoned that "[t]he Patent Act's 'intricate scheme for administrative and judicial...