PTO Revival Rulings Are Not Subject To Third-Party Collateral Challenge

In Exela Pharma Sciences, LLC v. Lee, No. 13-1206 (Fed. Cir. Mar. 26, 2015), the Federal Circuit affirmed a dismissal of a challenge under the APA on the ground that PTO revivals are not subject to third-party collateral challenge, thereby precluding review regardless of whether the claims were time-barred.

Patentee SCR Pharmatop ("SCR") filed its initial patent application in France and, in conformity with the PCT, filed an international patent application identifying as a designated state the United States, among others. SCR did not timely file the required materials for the U.S. application within the thirty-month statutory deadline, and, consequently, the PTO deemed the application abandoned. SCR filed a petition to revive the application, stating that the delay was "unintentional." Slip op. at 4. The PTO granted the petition, and U.S. Patent No. 6,992,218 ("the '218 patent") issued.

SCR and its exclusive licensee sued Exela Pharma Sciences, LLC, Exela Pharmsci, Inc., and Exela Holdings, Inc. (collectively "Exela"). Exela subsequently petitioned the PTO for infringement of the '218 patent under the Hatch-Waxman Act. Exela then filed the subject petition in the PTO, under the APA and 37 C.F.R. §§ 1.181, 1.182, and 1.183, challenging the PTO's revival of the patent application. The PTO declined to consider Exela's petition, finding that no statute or regulation authorizes a third-party challenge to the PTO's revival of a patent application. Following the PTO's rejection of its petition, Exela filed the present action in the district court under the APA, requesting that the district court compel the PTO to vacate the revival decision. In response, the PTO moved to dismiss the action under Fed. R. Civ. P. 12(b)(1) and (6) on several grounds, including that Exela lacked standing to challenge the PTO's revival ruling, that Exela's APA action was time-barred, and that a PTO revival is not subject to judicial review at the request of a third-party challenger. The district court dismissed Exela's action because its facial challenge to 37 C.F.R. § 1.137 was time-barred by the six-year statute of limitations.

The Patent Act's 'intricate scheme for administrative and judicial review of PTO patentability determinations,' and 'the Patent Act's careful framework for judicial review at the behest of particular persons through particular procedures' demonstrate that third party challenge of PTO revival rulings under the APA is not legislatively...