Federal Circuit Lacked Jurisdiction to Address Appeal Based on Arguments Under The PREP Act

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 jurisdict.