Copan Italia SPA v. Puritan Med. Prods. Co.

101 F.4th 847

COPAN ITALIA SPA, Copan Diagnostics Inc., Plaintiffs-Appellees v. PURITAN MEDICAL PRODUCTS COMPANY LLC, Puritan Diagnostics LLC,Puritan Medical Products Company I LP, Hardwood Products Company LLC, Defendants-Appellants

2022-1943

United States Court of Appeals, Federal Circuit

Decided: May 14, 2024

Appeal from the United States District Court for the District of Maine in No. 1:18-cv-00218-JDL, Chief Judge Jon D. Levy.

Michael Newman, Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., Boston, MA, argued for plaintiffs-appellees. Also represented by Peter Cuomo, Andrew H. DeVoogd, Courtney Patrice Herndon, James M. Wodarski.

James H. Hulme, ArentFox Schiff LLP, Washington, DC, argued for defendants-appellants. Also represented by Taniel E. Anderson, Janine A. Carlan, Kevin R. Pinkney; Michael L. Scarpati, New York, NY.

Before Cunningham, Bryson, and Stark, Circuit Judges.

Stark, Circuit Judge.

Copan Italia S.p.A. and Copan Diagnostics Inc. (collectively, "Copan") brought a patent infringement case against Puritan Medical Products Company LLC and its affiliated companies (collectively, "Puritan") in the United States District Court for the District of Maine. Puritan filed a partial motion to dismiss, alleging that it was immune from liability and suit for a portion of its accused product under a provision of the Pandemic Readiness and Emergency Preparedness Act ("PREP Act"). On June 1, 2022, the district court denied the motion, and Puritan now appeals. We find we lack jurisdiction and, accordingly, dismiss the appeal.

I

Puritan makes "flocked" swabs "for collecting biological specimens." J.A. 129. A flocked swab consists "of a rod [with] a tip covered with fiber with hydrophilic properties" that can absorb biological specimens. Id. The fibers in a flocked swab are deposited by flocking, a process by which the tip of the rod is sprayed with an adhesive so that tiny fibers can attach, creating a fiber layer. Copan holds several patents on flocked swabs and methods of using them.

On June 1, 2018, Copan filed a patent infringement complaint against Puritan in the District of Maine, alleging that Puritan directly and indirectly infringed and infringes several of its swab patents. As relief, Copan sought "damages caused to Plaintiff by Defendant's unlawful acts of patent infringement," as well as a permanent injunction. J.A. 119.¹ The case proceeded normally throughout 2018 and 2019.

Then the COVID-19 pandemic hit. On March 10, 2020, the Secretary of Health and Human Services issued a Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19, which declared the COVID-19 pandemic a public health emergency. See 85 Fed. Reg. 15198, 15201 (Mar. 17, 2020). On May 15, 2020, Copan and Puritan jointly moved to stay this litigation. Both parties requested a stay until after "the crisis passes" because, in part, "all of their resources at this time are best devoted to producing viral testing materials." J.A. 3848. At that time, demand for flocked swabs had skyrocketed, as they were used in many of the new tests for detecting whether an individual was afflicted with COVID-19. Given the spike in sales, the parties further indicated in their stay motion that they expected "the current pandemic could fundamentally change the contours of this case." J.A. 3848. On May 18, 2020, the district court granted the stay.

On July 29, 2020, Puritan entered into a contract with the United States Air Force ("Air Force") in which Puritan agreed to expand its facilities for manufacturing flocked swabs. In a document associated with an amendment to that contract, the Air Force stated:

In accordance with the Public Readiness and Emergency Preparedness Act ("PREP Act"), Pub. L. No. 109-148, Division C, Section 2, as amended (codified at 42 U.S.C. § 247d-6d and 42 U.S.C. 247d-6e), as well as the Secretary of [Health and Human Services'] Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19 (the "PREP Act Declaration"), 85 Fed. Reg. 15198 (Mar. 17. 2020, effective Feb. 4, 2020), (i) this Agreement is being entered into for purposes of production capability expansion for "Covered Countermeasures" for responding to the COVID-19 public health emergency, in accordance with Section VI of the PREP Act Declaration; (ii) Contractor's performance of this Agreement falls within the scope of the "Recommended Activities" for responding to the COVID-19 public health emergency; and (iii) Contractor is a "Covered Person" to the extent it is a person defined in Section V of the PREP Act Declaration. Therefore, in accordance with Sections IV and VII of the PREP Act Declaration as well as the PREP Act (42 U.S.C. § 247d-6d), the Air Force expressly acknowledges and agrees that Contractor shall be immune from suit and liability to the extent and as long as Contractor's activities fall within the terms and conditions of the PREP Act and the PREP Act Declaration.

J.A. 4231-32. Puritan indicates that this contract provided it with the funds necessary to construct a new factory it calls "P3," where Puritan manufactures some of its flocked swabs.

At the parties' request, the district court lifted the stay in October 2021, reopening fact discovery. At that point, Puritan asserted it had immunity from certain of Copan's patent infringement claims by virtue of the PREP Act, 42 U.S.C. § 247d-6d. Puritan sought to amend its answer to include the affirmative defense of PREP Act immunity. Puritan also filed a partial motion to dismiss Copan's patent infringement claims to the extent they were directed at flocked swabs Puritan made at the P3 facility. According to Puritan, the only swabs it was producing at P3 were those required to fulfill the Air Force contract, which expressly recognized Puritan's PREP Act immunity.

Puritan asked the trial court to take judicial notice of the Air Force contract and certain Food and Drug Administration ("FDA") documents. It further requested that the district court find from these materials that Puritan had immunity from "all claims for loss" under the PREP Act, including claims for patent infringement, on the grounds that all flocked swabs made at the P3 factory constituted "covered countermeasures." 42 U.S.C. § 247d-6d(a)(1).

In response, Copan argued that Puritan enjoyed no immunity from liability for patent infringement. In Copan's view, the PREP Act does not apply to claims for patent infringement; instead, the immunity it confers is limited to claims for "loss" due to physical harm (e.g., product liability claims). Alternatively, Copan argued that if the PREP Act's immunity provision reaches patent infringement claims then it is unconstitutional. Finally, Copan insisted that Puritan's "motion to dismiss [was] highly factual" and Copan "should be allowed to explore the factual basis for Puritan's new allegations" of immunity before the district court should consider dismissal. J.A. 4344-45.

The district court denied Puritan's motion to dismiss. It found that Puritan had not shown, as a factual matter, that its flocked swabs were "covered countermeasures" under the PREP Act. The court acknowledged that Puritan had asked that the court take judicial notice of what appeared to be a letter from the FDA regarding an Emergency Use Authorization ("EUA") of a specific antigen test, which Puritan proffered as evidence that its swabs were being used in COVID-19 tests. The trial court found, however, that "the document does not mention Puritan, the P3 factory, or even flocked swabs." J.A. 8. Nor did the letter indicate that any factory had been built, or any swabs manufactured, pursuant to the Air Force contract. Hence, the trial court concluded that the Air Force contract did not support a conclusion that all flocked swabs created at P3 were related to a federal agreement or would be used in COVID-19 tests constituting covered countermeasures. [J.A. 9-10] "In light of the evidentiary gaps" noted, the district court held that "dismissal of the amended complaint is not supported because the limited record . . . does not show that the PREP Act affirmative defense has been proven." J.A. 10. At the same time, the district court did grant Puritan's motion to amend its answer, allowing it to assert PREP Act immunity as a defense, one that would be subject to further argument.

Puritan timely appealed. Before us, Copan not only defends the merits of the district court's decision to deny the motion to dismiss. Copan also contends that the appeal must be dismissed for lack of jurisdiction. In response, Puritan argues that we have jurisdiction by virtue of application of the collateral order doctrine.

We have determined that we lack jurisdiction, for reasons we now explain.

II

The collateral order doctrine is a limited exception to the general requirement that appellate jurisdiction arises only after a district court issues a final order. See Mohawk Indus., Inc. v. Carpenter, 558 U.S. 100, 103, 130 S.Ct. 599, 175 L.Ed.2d 458 (2009) ("Although 'final decisions' typically are ones that trigger the entry of judgment, they also include a small set of prejudgment orders that are 'collateral to' the merits of an action and 'too important' to be denied immediate review."). "Questions of our jurisdiction," such as the determination of whether the collateral order doctrine applies, "are governed by Federal Circuit law." DePuy Synthes Prods., Inc. v. Veterinary Orthopedic Implants, Inc., 990 F.3d 1364, 1368 (Fed. Cir. 2021).

As we have explained, for a district court order to come within the collateral order exception, it must "at a minimum satisfy three conditions: It must [1] 'conclusively determine the disputed question,' [2] 'resolve an important issue completely separate from the merits of the action,' and [3] 'be effectively unreviewable on appeal from a final judgment.' " Apple Inc. v. Samsung Elecs. Co., 727 F.3d 1214, 1220 (Fed. Cir. 201...