Copan Italia SpA et al. v. Puritan Medical Product Company LLC et al. (D. Me. 18-cv-00218).

In the summer of 2018, Copan Italia and Copan Diagnostics sued Puritan Medical Products and Puritan Diagnostics, accusing Puritan of infringing four patents relating to flocked swabs.  Copan makes swabs for collecting and transporting biological samples for subsequent analysis, and conceived of the inventions in the early 2000’s.  The alleged improvement is that the fibers of the swabs extend outwardly rather than randomly, allowing for sample to be wicked up and more readily released when desired for further testing.  The complaint alleged patent infringement as well as false advertising and violation of the Maine Uniform Deceptive Trade Practices Act.

In May 2020, the case was stayed by joint request of the parties due to the Covid crisis and resultant shutdown of the courts.  The case resumed in the summer of 2021, and in October Puritan moved to dismiss all counts related to swabs made by Puritan at its P3 factory, saying that the Public Readiness and Emergency Preparedness Act (“PREP Act”) provides for immunity from suit.  Puritan also moved to amend its answer.

Judge Levy denied the motion to dismiss.  The PREP Act provides immunity from liability upon the declaration of a public health emergency by the Secretary of Health and Human Services.  Immunity arises under four circumstances, one of which is where the accused product is a “qualified pandemic or epidemic product,” which is further defined (in relevant part) as a device that is made to diagnose or treat a pandemic or epidemic and (importantly) is authorized for emergency use in accordance with provisions of the Federal Food, Drug and Cosmetic Act. 

Puritan alleges that in July 2020, it entered into an agreement with the Air Force to increase production of flocked swabs for Covid testing, in part by opening a new production facility.  The agreement was supplemented in October, including a clause by which the Air Force acknowledged that Puritan would be immune from suit and liability so long as Puritan’s activities fell within the terms of the PREP Act. 

Judge Levy initially determined that PREP Act immunity was an affirmative defense that must be pled in the answer to a complaint.  He noted, however, that when the complaint was initially filed, the Covid pandemic and resultant declaration of a public health emergency had yet to occur.  Accordingly, he granted the request to amend the answer to plead PREP Act immunity.  He denied, however, the motion to dismiss under the PREP Act because it was not clear on the face of the complaint that the allegations with respect to the P3 facility would be barred by the asserted defense.  Puritan’s motion was based in part on the court taking judicial notice of a letter on the FDA website that Puritan characterizes as an emergency use authorization for a COVID-19 diagnostic kit with a nasal swab.  Judge Levy noted, however, that the FDA letter did not mention Puritan, the P3 factory, or even generally flocked swabs, instead referencing emergency use of a PCR test to detect whether covid was present in a swab by a Minnesota laboratory.  Further, Puritan offered no proposed evidence that it actually made flocked swabs for the Air Force at its P3 facility, or that it did not make flocked swabs at the P3 facility that were delivered to an entity other than the Air Force.  Accordingly, he denied the motion to dismiss, allowing discovery to proceed on the Prep Act issue (and on the remainder of the case).