IP Law Daily, PATENT—D. Me.: PREP Act immunity not applicable to patent infringement claims, (Jul 28, 2025)

By Kevin M. Finson, J.D.

Patent infringement claims for the manufacture of flocked swabs such as those used in COVID-19 tests were not barred by immunity under the PREP Act because the immunity was intended to cover injuries arising from administration or use of countermeasures by an individual, not the manufacture of an infringing product.

A manufacturer of swabs used to collect samples for COVID-19 tests was not immune to patent infringement claims under the PREP Act, the U.S. District Court in Portland, Maine, has held. The Act covered physical, tortious injury to individuals, not patent infringement by a product manufacturer (Copan Italia S.P.A. v. Puritan Medical Products Co., LLC, No. 1:18-cv-00218-SDN (D. Me. July 25, 2025)).

Copan Italia S.P.A. and Copan Diagnostics, Inc. (collectively, Copan) were the owners of patents relating to flocked cotton swabs used in collecting biological specimens. Copan brought suit for infringement against Puritan Medical Products Company, LLC and affiliated companies (collectively, Puritan), alleging that Puritan infringed Copan’s flocked swab technology and methods for use. Puritan moved for partial summary judgment, alleging that flocked swabs it produced after the start of the COVID-19 pandemic were immunized from patent infringement claims under the Pandemic Readiness and Emergency Preparedness Act (PREP Act).

Definition of “individual.” The PREP Act specifically immunized a “covered person... with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or the use by an individual of a covered countermeasure...” It was undisputed that Puritan was a “covered person” and that the flocked swabs were a “covered countermeasure.” Copan argued that Puritan was not an individual person, and therefore Puritan’s production of flocked swabs fell outside the statutory immunity. Puritan argued that its production was an immunized “use” of the covered countermeasure. Neither the statute nor the Secretary of Health and Human Services’ declaration activating the statute for the COVID-19 pandemic defined the term “individual.”

Reviewing the specific language of the statute and dictionary definitions, the court held that “individual” meant a natural person, and would not include an entity such as Puritan. This was supported by the statute’s inclusion of a definition for the term “covered person” which expressly included business entities. Therefore, the manufacture of flocked swabs by Puritan was not covered by the statutory immunity.

Definition of “loss.” Puritan argued that the alleged infringement was a “loss” covered by the PREP Act, while Copan argued that “loss” should be read more narrowly to require a physical injury. Reviewing the inclusive list following the grant of immunity for “any type of loss,” which included death, physical, mental, or emotional injury, and disability, including loss to property such as business interruption, the court found that the losses Congress had in mind were those which involved some tortious physical injury, which did not extend to patent infringement claims.

Fifth Amendment taking. Finally, the court held that if the PREP Act were read to abrogate patent rights it would amount to an unconstitutional taking of private property without due process or just compensation. There was no authorization or consent by the government to Puritan’s alleged infringement; in fact, a contract to provide flocked swabs to the Air Force contained a provision requiring Puritan to indemnify the federal government in the event of any patent infringement.

The court denied the motion for partial summary judgment.

The Case is No. 1:18-cv-00218-SDN.

Judge: Neumann, S.

Attorneys: Courtney Herndon (Mintz Levin Cohn Ferris Glovsky & Popeo PC) for Copan Italia S.p.a. and Copan Diagnostics, Inc. Michael Scarpati (Arent Fox Schiff LLP) for Puritan Medical Products Co. LLC.

Companies: Copan Italia S.p.a.; Copan Diagnostics, Inc.; Puritan Medical Products Co. LLC

Cases: Patent Covid19 MaineNews