Copan Italia SpA v. Puritan Med. Prods. Co. LLC
Authored by: Jeremy J. Gustrowsky
A recent decision from the Federal Circuit highlights the limits of immediate appeals when it comes to claims of immunity under the Public Readiness and Emergency Preparedness (PREP) Act. The case involved Copan Italia S.p.A. and Copan Diagnostics Inc., who accused Puritan Medical Products Company and its affiliates of infringing patents related to “flocked” swabs—specialized swabs used for collecting biological specimens, which became critical during the COVID-19 pandemic.
Puritan argued that it should be immune from the patent infringement claims for swabs made at its new factory, built with funding from a U.S. Air Force contract during the pandemic. Puritan claimed that, under the PREP Act, it was a “covered person” making “covered countermeasures” during a declared public health emergency, and thus should not have to face the lawsuit at all. However, the district court found that there were still factual questions about whether all the swabs made at the new facility actually qualified for this immunity, and denied Puritan’s motion to dismiss the case.
On appeal, Puritan asked the Federal Circuit to step in immediately, arguing that the PREP Act’s immunity from suit should be decided right away to avoid the costs and burdens of litigation. The Federal Circuit, however, dismissed the appeal, explaining that it did not have jurisdiction to review the district court’s decision at this stage. The court emphasized that immediate appeals are only allowed when a lower court has made a conclusive, final decision on an issue like immunity. Here, the district court simply said more facts were needed before making that call.
This decision underscores that claims of immunity under the PREP Act—or similar statutes—will not always be resolved early in litigation, especially when there are unresolved factual questions. Parties seeking to avoid a lawsuit on immunity grounds must be prepared to fully prove their entitlement to that immunity before an appellate court will consider stepping in.