Addressing appellate jurisdiction in view of the collateral order doctrine, the US Court of Appeals for the Federal Circuit dismissed an appeal of a district court’s ruling denying a motion to dismiss because the district court’s order did “not conclusively determine any issue.” Copan Italia S.p.A. v. Puritan Med. Prod. Co. LLC, Case No. 22-1943 (Fed. Cir. May 14, 2024) (Cunningham, Bryson, Stark, JJ.)

Copan and Puritan are competing medical supplies companies. Copan filed suit against Puritan alleging infringement of Copan’s patents for “flocked” swabs, which are used “for collecting biological specimens.” While the lawsuit was filed in 2018, the circumstances surrounding the case changed significantly in March 2020 when the COVID-19 pandemic caused the demand for flocked swabs to skyrocket. In May 2020, the parties agreed to stay the proceedings until the COVID-19 crisis passed.

During the stay, Puritan entered into a contract with the US Air Force, causing Puritan to expand its manufacturing facilities and capabilities. The Air Force stated in a document associated with the contract that, under the Public Readiness and Emergency Preparedness Act (PREP Act), (1) the contract was being entered into for the purpose of covered countermeasures for responding to a public health emergency, (2) Puritan’s performance under the agreement was for recommended activities in responding to the public health emergency and (3) Puritan was a covered person under the PREP Act. Further, the Air Force “expressly acknowledge[d]” that Puritan “shall be immune from suit and liability to the extent and as long as [Puritan’s] activities fall withing the terms and conditions of the PREP Act and the PREP Act declaration.”

Puritan asserted it had immunity under the PREP Act from certain claims in Copan’s infringement suit. Puritan sought leave to amend its answer to include this affirmative defense and filed a partial motion to dismiss the claims directed to Puritan’s performance under the Air Force contract. Copan opposed the motion, arguing the PREP Act does not apply to claims for patent infringement and immunity only applies to claims for losses relating to physical harm, like products liability.

The district court denied Puritan’s motion, finding “that Puritan had not shown, as a factual matter, that its flocked swabs were ‘covered countermeasures’ under the PREP Act.” The district court pointed to “evidentiary gaps,” which prevented Puritan – at the current stage of litigation – from proving the PREP Act affirmative defense. Puritan appealed.

The Federal Circuit determined it lacked jurisdiction and dismissed the appeal. Because the denial of Puritan’s partial motion to dismiss was not a final order, appellate jurisdiction would only arise in limited circumstances under the collateral order doctrine. The collateral order doctrine allows appellate jurisdiction on rulings that (1) conclusively determine a disputed question, (2) resolve an issue completely separate (collateral) to the merits of the action and (3) are effectively unreviewable on appeal from a final judgment.

The Federal Circuit found that the district court order did not conclusively determine any issue and therefore the Federal Circuit lacked jurisdiction under the [...]

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