16 May 2024BiotechnologyLiz Hockley

Fed Circ rejects COVID-19 swabs case

Puritan Medical argued it had immunity under PREP Act in patent suit | Fed Circ said the district court had not conclusively determined any issue.

The US Court of Appeals for the Federal Circuit has said it lacks jurisdiction over an appeal brought by Puritan Medical Products, in a dispute over patents covering swabs for collecting biological samples.

Puritan argued in the patent infringement case brought by Copan Italia that it had acquired immunity under the Public Readiness and Emergency Preparedness Act (PREP Act) when the COVID-19 pandemic hit.

On Tuesday,May 14, CAFC said it lacked jurisdiction over the appeal, finding that the district court had not conclusively determined any issue when it denied Puritan’s partial motion to dismiss—one of the requirements of the collateral order doctrine.

PREP Act immunity

Copan sued Puritan at the US District Court for the District of Maine in 2018, alleging infringement of certain patents related to ‘flocked’ swabs.

In May 2020, after the onset of the COVID-19 pandemic, both parties moved to stay the litigation, telling the court that their resources were best devoted to producing viral testing materials.

That year, Puritan entered into a contract with the US Air Force in which it agreed to expand its facilities for manufacturing flocked swabs, which it said provided it with the funds to construct a new factory called P3.

At the parties’ request, the district court lifted the stay in October 2021, at which point Puritan asserted that it had immunity from some of Copan’s infringement claims due to the PREP Act.

It also filed a partial motion to dismiss Copan’s patent infringement claims to the extent that they were directed at flocked swabs made at its P3 factory, as it said these were required to fulfil the Air Force contract “which expressly recognised Puritan’s PREP Act immunity”.

The district court denied the motion to dismiss, finding that Puritan had not shown that its flocked swabs were “covered countermeasures” under the PREP Act.

No issue ‘conclusively determined’

Addressing Puritan’s appeal against the court’s decision, Copan contended that it must be dismissed for lack of jurisdiction.

In response, Puritan argued that the Federal Circuit had jurisdiction due to the collateral order doctrine, a limited exception to the general requirement that appellate jurisdiction arises only after a district court issues a final order.

For an order to come within this exception, it must satisfy three conditions: it must conclusively determine the disputed question; resolve an important issue completely separate from the merits of the action; and be effectively "unreviewable" on appeal from a final judgment.

Dismissing the appeal, Circuit Judge Leonard Stark said that the district court “held immunity was not shown to be applicable, but it did not hold that immunity cannot be available in the circumstances presented.

“The district court, as we have stressed, did not, therefore ‘conclusively determine’ any issue, so we have no proper collateral order to review.”

In Copan Italia v Puritan Medical Products, Michael Newman of Mintz argued for Copan. James Hulme of ArentFox Schiff argued for Puritan.

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