In Copan Italia S.p.A. et al. v. Puritan Medical Products Company LLC et al., the Federal Circuit addressed the issue of whether the Federal Circuit had jurisdiction to handle an appeal based on arguments under the Pandemic Readiness and Emergency Preparedness (“PREP”) Act.

Background

Copan Italia S.p.A. and Copan Diagnostics Inc. (“Copan”) brought a patent infringement case against Puritan Medical Products Company LLC and its affiliates (“Puritan”) in the United States District Court for the District of Maine, asserting infringement of several patents directed to flocked swabs for collecting biological specimens. The case was stayed during the COVID-19 pandemic in 2020, during which Puritan entered into contracts with the United States Air Force to expand manufacturing for Puritan’s accused products in Copan’s case. When the stay lifted in 2021, Puritan filed a partial motion to dismiss, alleging it was immune from liability for a portion of its accused products under a provision of the PREP Act. In particular, Puritan alleged the swabs were being produced to satisfy the Air Force contract, which expressly recognized Puritan’s PREP Act immunity. The district court denied the motion because Puritan had not shown the swabs were “covered countermeasures” under the PREP Act and Puritan had not shown all of its flocked swabs were related to the Air Force contracts. Puritan appealed the district court’s decision and argued the Federal Circuit has jurisdiction under the collateral order doctrine, while Copan argued the Federal Circuit lacked jurisdiction to handle the appeal.

Issues

Does the Federal Circuit have jurisdiction to handle appeals related to arguments asserted under the PREP Act?

Holding

The district court’s denial of Puritan’s partial motion to dismiss did not conclusively determine any issue, and thus the collateral order doctrine was not satisfied, meaning that the Federal Circuit lacked jurisdiction to handle the appeal.

Reasoning

The first requirement of the collateral order doctrine is that the district court’s order must “conclusively determine” the disputed issue. In this case, that required Puritan to show the district court conclusively determined that Puritan lacked immunity from patent infringement

under the PREP Act. The Federal Circuit found the record showed the district court did not conclusively determine any issue. In particular, the district court indicated that further litigation was necessary to determine whether immunity was available for Puritan. The district court did not make any factual or legal determination that Puritan was or was not immune from infringement based on its swabs; rather, the district court held it was not in a position to make these determinations at that point in the case. The Federal Circuit declined to order the district court to address the immunity issue first but noted the district court had discretion to do so. Puritan cited cases in support of its PREP Act argument but the Federal Circuit distinguished these cases on the grounds that none of them addressed the situation where the district court found factual issues precluded summary adjudication. Because the first, conclusive determination factor for the collateral order doctrine was not met, the Federal Circuit held it lacked jurisdiction to handle the appeal.