COPAN ITALIA SPA v. PURITAN MEDICAL PRODUCTS COMPANY LLC

UNITED STATES DISTRICT COURT

DISTRICT OF MAINE

COPAN ITALIA S.P.A., et al., )

)

Plaintiffs, )

)

v. ) Case No. 1:18-cv-00218-SDN

)

PURITAN MEDICAL PRODUCTS )

COMPANY, LLC, et al., )

)

Defendants.

ORDER ON DEFENDANTS’ MOTION FOR PARTIAL SUMMARY

JUDGMENT

Plaintiffs Copan Italia S.P.A. and Copan Diagnostics Inc. (collectively, “Copan”)

initiated this patent infringement suit against Defendants Puritan Medical Products

Company, LLC, and its affiliated companies (collectively, “Puritan”), alleging Puritan

infringed upon Copan’s flocked swab technology and methods for use. Puritan now

moves for partial summary judgment, alleging that any flocked swabs it produced past

the start of the COVID-19 pandemic are immunized from patent infringement claims

pursuant to the Pandemic Readiness and Emergency Preparedness Act (“PREP Act”).

For the reasons below, Defendants’ motion for partial summary judgment is denied.

PROCEDURAL HISTORY AND BACKGROUND1

The facts of this suit between Copan and Puritan have developed over nearly

seven years of litigation before this Court. See Pls.’ Compl. (ECF No. 1). Essentially,

Copan claims Puritan infringed upon its flocked swab technology and methods of using

the flocked swabs. Puritan filed a motion for partial dismissal of this matter, claiming

the flocked swabs Puritan produced in response to the COVID-19 pandemic are

immunized by the PREP Act (ECF No. 212). Puritan’s motion was unsuccessful (ECF

No. 230). Puritan filed an interlocutory appeal to the United States Court of Appeals for

the Federal Circuit challenging this Court’s decision (ECF No. 237). Since this Court

refrained from deciding whether PREP Act immunity applied to patent infringement

claims, the Federal Circuit dismissed the case for lack of jurisdiction pursuant to the

collateral order doctrine and remanded the matter back to this Court (ECF Nos. 269,

270). The Federal Circuit also advised this Court to structure the issues in a manner that

warranted a determination on Puritan’s PREP Act immunity defense (ECF No. 270 at

14).

As a result, Puritan is now moving for partial summary judgment, alleging the

record reveals PREP Act immunity shields the portion of flocked swabs Puritan

produced after the PREP Act came into effect (ECF No. 288). Following Local Rule

56(h), the parties have submitted their respective versions of factual allegations, as well

1 The summary judgment facts are drawn from the parties’ stipulations, if any, and from their statements

of material facts submitted in accordance with Local Rule 56. The Court will adopt a statement of fact if it

is admitted by the opposing party and is material to the dispute. If a statement is denied or qualified by

the opposing party, or if an evidentiary objection is raised concerning the record evidence cited in support

of a statement, the Court will review those portions of the summary judgment record cited by the parties,

and will accept, for summary judgment purposes, the factual assertion that is most favorable to the party

opposing the entry of summary judgment, provided that the record material cited in support of the

assertion is of evidentiary quality and is capable of supporting the party’s assertion, either directly or

through reasonable inference. D. Me. Loc. R. 56; Boudreau v. Lussier, 901 F.3d 65, 69 (1st Cir. 2018).

as responded to one another’s factual allegations (ECF Nos. 289, 296, 298). Since the

issue before me is limited to determining whether PREP Act immunity is intended to

protect entities from claims of patent infringement, I relay only the facts that contribute

to interpreting the PREP Act and whether it covers Puritan’s production of flocked

swabs during the COVID-19 pandemic.

I. The PREP Act and COVID-19 Declaration

Congress passed the PREP Act in 2005 “to encourage the expeditious

development and deployment of medical countermeasures during a public health

emergency by allowing” the Secretary of Health and Human Services (“HHS Secretary”)

“to limit legal liability for losses relating to the administration of medical

countermeasures such as diagnostics, treatments, and vaccines.” Cannon v. Watermark

Ret. Communities, Inc., 45 F.4th 137, 139 (D.C. Cir. 2022) (quotation modified); see 42

U.S.C. § 247d-6d. The PREP Act offers immunity from suit and liability to “covered

persons” for claims of loss “caused by, arising out of, relating to, or resulting from the

administration to or the use by an individual of a covered countermeasure.” 42 U.S.C.

§ 247d-6d(a)(1).

The PREP Act provides the types of entities who may be considered “covered

persons” and the types of products that may be considered “covered countermeasures.”

Id. § 247d-6d(i)(1)–(2). However, Congress delegated authority to the HHS Secretary to

make recommendations and state the boundaries of PREP Act immunity with respect to

the public health emergency at hand, such as which countermeasures are immunized

and how they should be administered, the time periods that immunity is in effect for

each countermeasure, and the populations that can be immunized:

[I]f the Secretary makes a determination that a disease or other health

condition or other threat to health constitutes a public health emergency,

or that there is a credible risk that the disease, condition, or threat may in

the future constitute such an emergency, the Secretary may make a

declaration, through publication in the Federal Register, recommending,

under conditions as the Secretary may specify, the manufacture, testing,

development, distribution, administration, or use of one or more covered

countermeasures, and stating that subsection (a) [the immunity

provision] is in effect with respect to the activities so recommended.

Id. (emphasis added).

Accordingly, immunity only takes effect upon the HHS Secretary issuing a

declaration of a public health emergency and delineating the particular covered

countermeasures immunized. Id. § 247d-6d(b)(1). Therefore, PREP Act immunity is not

without limitation. See Cannon, 45 F.4th at 139 (“A court should deny the immunity if,

for example, the defendant is not a covered person, the measure administered is not

covered, or the claim otherwise falls beyond the scope of the Secretary’s declaration.”).

In light of the COVID-19 pandemic, on March 17, 2020, the HHS Secretary issued

a PREP Act Declaration of a public health emergency (the “Declaration”). Statement of

Material Facts (“SMF”) ¶ 18 (ECF No. 296)2; Declaration Under the Public Readiness

and Emergency Preparedness Act for Medical Countermeasures Against COVID-19, 85

Fed. Reg. 15198 (Mar. 17, 2020). Pursuant to 42 U.S.C. § 247d-6d(b)(1), in Section VI of

the Declaration, the HHS Secretary identified the covered countermeasures immunized

by the PREP Act as “any antiviral, any other drug, any biologic, any diagnostic, any

other device, or any vaccine, used to treat, diagnose, cure, prevent, or mitigate COVID-

19.” 85 Fed. Reg. at 15202. Section V of the Declaration reincorporates the PREP Act’s

definition of “Covered Person,” which includes a “manufacturer,” that is “a supplier or

2 In their Statement of Material Fact, Defendants inscribe March 10, 2020, as the date the HHS Secretary

issued the Declaration. However, the correct date is March 17, 2020. See 85 Fed. Reg. 15198.

licenser of . . . intellectual property . . . used in the design, development, clinical testing,

investigation or manufacturing of a covered countermeasure.” Id. at 15201–02; 42

U.S.C. § 247-6d(i)(4)(A)–(B).

The HHS Secretary is authorized to limit immunity to covered countermeasures

obtained through a particular means of distribution. See id. § 247d-6d(b)(2)(E) (“The

Secretary shall identify, for each covered countermeasure specified in the

declaration . . . whether [immunity] is effective only to a particular means of distribution

as provided in subsection (a)(5) for obtaining the countermeasure, and if so, the

particular means to which such subsection is effective.”); see also id. § 247d-6d(a)(5)

(“The provisions of this section apply to a covered countermeasure . . . obtained by

donation, commercial sale, or any other means of distribution, except to the extent

that . . . the declaration under [subsection (b)] provides that [immunity] applies only to

covered countermeasures obtained through a particular means of distribution.”). Here,

the HHS Secretary did just that. In the Declaration, the HHS Secretary limited

immunity to covered countermeasures obtained through

(a) Present or future federal contracts, cooperative agreements, grants,

other transactions, interagency agreements, memoranda of

understanding, or other federal agreements; or (b) Activities authorized in

accordance with the public health and medical response of the Authority

Having Jurisdiction to prescribe, administer, deliver, distribute or

dispense the Covered Countermeasures following a Declaration of an

emergency.

85 Fed. Reg. at 15202.

The PREP Act also authorizes the HHS Secretary to “amend any portion of a

declaration.” 42 U.S.C. § 247d-6d(b)(4). On December 9, 2020, the HHS Secretary

issued its “Fourth Amendment to the Declaration” to add a new means of distribution

for covered countermeasures that are:

Licensed, approved, cleared, or authorized by the [Food and Drug

Administration] (or that are permitted to be used under an Investigational

New Drug Application or an Investigational Device Exemption) under the

FD&C Act or PHS Act to treat, diagnose, cure, prevent, mitigate, or limit

the harm from COVID-19, or the transmission of SARS-CoV-2 or a virus

mutating therefrom . . . .

Fourth Amendment to the Declaration Under the Public Readiness and Emergency

Preparedness Act for Medical Countermeasures Against COVID-19 and Republication of

the Declaration, 85 Fed. Reg. 79190, 79196 (Dec. 9, 2020); SMF ¶ 21. The Fourth

Amendment also provided that immunity for the covered countermeasures newly

identified in the amendment began on the date the HHS Secretary issued the

amendment and expired either on the final day that the Declaration was in effect or

October 1, 2024, whichever came first. 85 Fed. Reg. at 79198; SMF ¶ 22.3

II. The Air Force Contract with Puritan

The federal government by way of the U.S. Air Force sent Puritan an offer,

through an “Undefinitized Contract Action” (“UCA”), to “expand the domestic

production of flock tipped swabs required by medical professionals for COVID-19

testing.” SMF ¶¶ 1–3; ECF No. 289-2 at 66. Puritan signed and accepted the offer on

July 29, 2020, thereby forming a contract between the Air Force and Puritan (the “P3

Contract”). ECF No. 289-3. In the “Contract Terms and Conditions” section, the P3

Contract contained an indemnification clause which stated:

The Contractor shall indemnify the Government and its officers,

employees and agents against liability, including costs, for actual or

alleged direct or contributory infringement of, or inducement to infringe,

any United States or foreign patent, trademark or copyright, arising out of

3 In the Eleventh Amendment to the Declaration, the HHS Secretary extended the October 1, 2024,

deadline to December 31, 2024. See 88 Fed. Reg. 30769, 30775 (May 12, 2023); SMF ¶ 23. The Eleventh

Amendment also provided manufacturers with an additional 12 months of liability protection after

expiration of the prescribed immunity period. SMF ¶ 24.

the performance of this contract, provided the Contractor is reasonably

notified of such claims and proceedings.

ECF No. 289-2 at 16; Plaintiff’s Statement of Additional Facts (“PSAF”) ¶¶ 22–21 (ECF

No. 300-1). In the “Background” section, the P3 Contract stated that “[i]n order to meet

domestic demand of 50 million flock tip swabs per month, [Puritan] will have to install

and run an additional 20 Ultra Flock Tipping machines and 6 Automated Packaging

Machines.” ECF No. 289-2 at 66. The Background section also stated the Air Force

would “fund [Puritan’s] required upgrades of the facility and the balance of the

machines.” Id. Puritan planned to procure a new facility and five Ultra Flock Tipping

machines on its own, through capital investments, to fulfill the requirements of the P3

Contract. SMF ¶ 5; ECF No. 289-2 at 66. The P3 Contract required Puritan to perform

“Installation Qualification (IQ), Operational Qualification (OQ) and Performance

Qualification (PQ) testing and equipment performance testing” to “ensure that ultra

flock tipped swabs produced in the upgraded facility [were] in compliance with

requirements.” ECF No. 289-2 at 67–68. The P3 Contract contained a condition that the

government would issue a written acceptance and verification that Puritan’s new facility

was capable of producing “45 million flock tipped swabs per month” to fulfill the P3

Contract requirements. SMF ¶ 10; ECF No. 289-2 at 68.

During the negotiation stage, Puritan questioned the Air Force about the

inclusion of language on PREP Act immunity into the P3 Contract, PSAF ¶ 26; ECF No.

294-6, and Puritan drafted and proposed the specific language to the Air Force, id. The

Air Force clarified to Puritan that:

PSAF ¶¶ 25–26; ECF No. 294-7.

On October 2, 2020, the Air Force sent Puritan a modification of the UCA that

served as the definitized version of the P3 Contract. SMF ¶ 15; ECF No. 289-5. The

definitized version of the P3 Contract stated, “In accordance with the . . . PREP Act” the

“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” and that Puritan’s

“performance of this Agreement falls within the scope of the ‘Recommended Activities’

for responding to the COVID-19 public health emergency.” ECF No. 289-5 at 6–7. The

definitized version of the P3 Contract identified Puritan as a “‘Covered Person’ to the

extent it is a person defined in Section V of the PREP Act Declaration,” and stated that

“the Air Force expressly acknowledges and agrees that [Puritan] shall be immune from

suit and liability to the extent and as long as [Puritan’s] activities fall within the terms

and conditions of the PREP Act and the PREP Act Declaration.” Id. at 7.

In accordance with the P3 Contract, Puritan built a new facility in Maine (the “P3

Facility”). SMF ¶ 6. The Air Force visited the P3 Facility on June 20, 2021, and shortly

after confirmed in writing that Puritan met the P3 Contract acceptance criteria. Id.

¶¶ 12–13; ECF No. 289-4. Puritan began producing flocked swabs at the P3 Facility in

2021. SMF ¶ 16.

III. Food and Drug Administration’s Emergency Use Authorization

On March 27, 2020, the FDA issued an Emergency Use Authorization (“EUA”)

for the ID NOW COVID-19 device (“ID NOW device”). SMF ¶ 38; ECF No. 289-17. The

EUA letter explained the FDA issued its authorization so the ID NOW device could be

used “for the qualitative detection of nucleic acid from the SARS-CoV-2 virus in direct

nasal, nasopharyngeal or throat swabs from individuals who are suspected of COVID-

19.” SMF ¶ 38; ECF No. 289-17 at 1. In the “Scope of Authorization”, the EUA letter

stated:

Testing of direct nasal, nasopharyngeal or throat swabs from individuals

using your product run on the ID NOW Instrument, as outlined in the “ID

NOW COVID-19” Package Insert and “ID NOW COVID-19 Quick

Reference Guide,” is authorized to be used in laboratories certified under

[the Clinical Laboratory Improvement Amendments of 1988 (“CLIA”)]

that meet the requirements to perform high, moderate, or waived

complexity tests. This test is authorized for use at the POC, i.e., in patient

care settings operating under a CLIA Certificate of Waiver, Certificate of

Compliance, or Certificate of Accreditation using the ID NOW Instrument

outside of the clinical laboratory environment.

ECF No. 289-17 at 3–4; SMF, ¶ 39. The EUA letter also stated that, when accompanied

with the Package Insert, the ID Now device “is authorized to be distributed to and used

by authorized laboratories.” ECF No. 289-17 at 4; SMF ¶¶ 40–41. The Package Insert

stated, “[f]or optimal test performance [regarding throat swabs], use the swabs provided

in the test kit. Alternatively, foam, polyester, HydraFlock® and nylon flocked throat

swabs can be used to collect throat swab samples.” ECF No. 289-18 at 4; SMF ¶ 43. The

Package Insert also stated that “rayon, foam, HydraFlock® Flocked swab (standard tip),

HydraFlock® Flocked swab (mini tip), Copan Mini Tip Flocked Swab, or Copan

Standard Flocked swabs can be used to collect nasal swab samples” as an alternative to

the swab provided in the test kit. ECF No. 289-18 at 5; SMF ¶ 44.

On June 23, 2020, the FDA issued an EUA for the HealthQuest Esoterics

TaqPath SARS-CoV-2 Assay (“TaqPath Assay”). SMF ¶ 34; ECF No. 289-13. The FDA’s

EUA letter explained the TaqPath Assay is for the “[q]ualitative detection of nucleic acid

from SARS-CoV-2 in nasopharyngeal, oropharyngeal, anterior nasal, and mid-turbinate

nasal swabs . . . .” ECF No. 289-13 at 1. The FDA’s EUA Summary for the TaqPath Assay

stated that “[t]he swabs that were used for assay validation include Puritan PurFlock

Ultra Collection swabs . . . . Other flocked swabs with plastic shafts . . . are also

acceptable for testing with the [TaqPath Assay].” ECF No. 289-14 at 2; SMF ¶ 35.

On February 13, 2021, the FDA issued an EUA for the Assurance SARS-CoV-2

Panel DTC (“Assurance Panel”). SMF ¶ 36; ECF No. 289-15. The FDA’s EUA letter

explained the Assurance Panel was used “as a direct to consumer product for testing of

anterior nasal swab specimens self-collected at home using either: (1) the Simplicity

COVID-19 Home Collection Kit or (2) the Everlywell COVID-19 Test Home Collection

Kit DTC . . . .” ECF No. 289-15 at 1; SMF ¶ 36. The FDA’s EUA Summary for the

Assurance Panel listed “Miraclean or Puritan” as the Material Suppliers of flocked nasal

swabs. ECF No. 289-16 at 6; SMF ¶ 37.

On March 25, 2021, the FDA issued an EUA for the Amazon Real-Time RT-PCR

Test for Detecting SARS-CoV-2 (“RT-PCR Test”). SMF ¶ 31; ECF No. 289-11. The letter

specified that the FDA authorized the RT-PCR Test “for the qualitative detection of

nucleic acid from SARS-CoV-2 in anterior nasal swab specimens that are self-collected

by any individuals . . . .” SMF ¶ 32; ECF No. 289-11 at 2 n.2. The FDA’s EUA Summary

identified Puritan as the supplier for nasal swabs used in the RT-PCR Test. SMF ¶ 33;

ECF No. 289-12 at 10. The EUA Summary described the nasal swabs as “[i]ndividually

wrapped sterile flocked nylon swab for anterior nasal specimen collection.” SMF ¶ 33;

ECF No. 289-12 at 10.

LEGAL STANDARD

Summary judgment is appropriate “if the movant shows that there is no genuine

dispute as to any material fact and the movant is entitled to judgment as a matter of

law.” Fed. R. Civ. P. 56(a). As cautioned by the Supreme Court, “the mere existence of

some alleged factual dispute between the parties will not defeat an otherwise properly

supported motion for summary judgment; the requirement is that there be no genuine

issue of material fact.” Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247–48 (1986). A

material fact is one that has the potential to determine the outcome of the litigation. Id.

at 248; Oahn Nguyen Chung v. StudentCity.com, Inc., 854 F.3d 97, 101 (1st Cir. 2017).

To raise a genuine issue of material fact, the party opposing the summary judgment

motion must demonstrate that the record contains evidence that would permit the

finder of fact to resolve the material issues in its favor. See Triangle Trading Co. v.

Robroy Indus., Inc., 200 F.3d 1, 2 (1st Cir. 1999) (“Unless the party opposing a motion

for summary judgment can identify a genuine issue as to a material fact, the motion may

end the case.”).

DISCUSSION

Puritan argues the PREP Act immunizes it from Copan’s patent infringement

claims with respect to any flocked swabs Puritan produced after the HHS Secretary

issued the Declaration in response to the COVID-19 pandemic. Puritan further asserts

that PREP Act immunity applies to its production of flocked swabs because they

constitute a covered countermeasure, Puritan is a covered person, and Puritan satisfied

two means of distribution outlined in the Declaration. Copan asserts that PREP Act

immunity does not apply to Copan’s claims against Puritan because Puritan’s

production of flocked swabs does not count as an individual’s administration or use of a

countermeasure under the statute, and because applying PREP Act immunity to patent

infringement claims would result in an unconstitutional taking in violation of the Fifth

Amendment. The parties do not dispute that flocked swabs are a covered

countermeasure or that Puritan is a covered person under the PREP Act.

In the PREP Act, Congress authorizes the HHS Secretary to determine the

guidelines of immunity. 42 U.S.C. § 247d-6d(b)(1) (providing that the HHS Secretary

must state in the declaration that PREP Act immunity “is in effect with respect to the

activities so recommended,” such as “the manufacture, testing, development,

distribution, administration, or use of one or more covered countermeasures”); see

Loper Bright Enters. v. Raimondo, 603 U.S. 369, 395 (2024) (“When the best reading

of a statute is that it delegates discretionary authority to an agency, the role of the

reviewing court under the [Administrative Procedure Act] is, as always, to

independently interpret the statute and effectuate the will of Congress subject to

constitutional limits.”). Additional provisions in the PREP Act detail the HHS

Secretary’s authority to limit immunity “to covered countermeasures obtained through a

particular means of distribution,” 42 U.S.C. § 247d-6d(a)(5), identify in the declaration

“(A) the category or categories of diseases, health conditions, or threats to health for

which the Secretary recommends the administration or use of the countermeasure;”

(B) the time period for which immunity is in effect; (C) the population of individuals for

which immunity is in effect with respect to the administration or use of the

countermeasure; and (D) the geographic areas for which immunity is in effect with

respect to the administration or use of the countermeasure, id. § 247d-6d(b)(2), and

limit the effective time period of immunity with respect to the manufacture of certain

countermeasures, id. § 247-6d(b)(3)(A)–(B). Thus, I will draw on the Declaration to

interpret the terms at issue here where permissible and relevant. See, e.g., Sutherland v.

Peterson’s Oil Serv., Inc., 126 F.4th 728, 739 n.5 (1st Cir. 2025) (finding a statute that

authorizes agency “to issue regulations implementing the definitions of

disability . . . including rules of construction” is a “quintessential example” of a

permissible delegation under Loper Bright).

I. The PREP Act immunizes only claims involving an individual person’s

administration or use of a covered countermeasure.

The PREP Act provides immunity to 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 if a declaration under

subsection (b) has been issued with respect to such countermeasure.” 42 U.S.C. § 247d-

6d(a)(1). According to Copan, since Puritan is not an individual person, Puritan’s

production of flocked swabs falls outside of the meaning of the phrase “administration

to or the use by an individual” in the PREP Act immunity provision. In other words,

Copan asserts the meaning of the phrase “administration to or the use by an individual”

encompasses only the physical application of a covered countermeasure to a recipient.

Puritan, focusing more on the phrase “use by” an individual, argues for a more

expansive meaning that would render its production of flocked swabs pursuant to the P3

Contract as an immunized “use” of a covered countermeasure.

The PREP Act authorizes the HHS Secretary to give meaning to the terms

“administration” and “use.” 42 U.S.C. § 247d-6d(b)(1) (“[T]he Secretary may make a

declaration . . . recommending, under conditions as the Secretary may specify,

the . . . administration, or use of one or more covered countermeasures, and stating that

[immunity] is in effect with respect to the activities so recommended.” (emphasis

added)). Here, in the Declaration, the HHS Secretary defined “administration” to mean

the “physical provision of the countermeasures to recipients, or activities and decisions

directly relating to public and private delivery, distribution and dispensing of the

countermeasures to recipients . . . .” 85 Fed. Reg. at 15202. The Description of the

Declaration explains further that the phrase “physical provision” includes activities

“such as vaccination or handing drugs to patients, and to activities related to

management and operation of programs and locations for providing countermeasures to

recipients, such as decisions and actions involving security and queuing, but only

insofar as those activities directly relate to the countermeasure activities.” Id. at 15200.

The HHS Secretary did not define the term “use” in the Declaration. Relatedly,

the PREP Act also does not define the term “individual,” and it does not authorize the

HHS secretary to do so. Thus, with respect to interpreting “use” and “individual,” I turn

to the traditional principles of statutory interpretation. See In re Fin. Oversight &

Mgmt. Bd. for P.R., 919 F.3d 121, 128 (1st Cir. 2019) (“It is elementary that in resolving

a dispute over the meaning of a statute [courts] begin with the language of the statute

itself.” (citing Landreth Timber Co. v. Landreth, 471 U.S. 681, 685 (1985))); see also

Loper Bright, 603 U.S. at 400 (“[W]hen faced with a statutory ambiguity in such a case

[where congressional delegation is not applicable], the ambiguity is not a delegation to

anybody, and a court is not somehow relieved of its obligation to independently

interpret the statute.”).

Accordingly, I begin with the plain language of the PREP Act. My first inquiry is

whether the statutory provision “at issue has a plain and unambiguous meaning with

regard to the particular dispute in the case.” Fin. Oversight, 919 F.3d at 128 (quoting

Robinson v. Shell Oil Co., 519 U.S. 337, 340 (1997)). “[I]f the statutory language is

unambiguous and the statutory scheme is coherent and consistent, then [my] inquiry

must cease.” Penobscot Nation v. Frey, 3 F.4th 484, 490 (1st Cir. 2021) (quotation

modified). I may consider legislative history only if the language of the statute is not

plain and unambiguous. Fin. Oversight, 919 F.3d at 128.

The language of the PREP Act explains that immunity applies 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.” 42 U.S.C. § 247d-6d(a)(1) (emphasis

added). The PREP Act further explains that “immunity . . . applies to any claim for loss

that has a causal relationship with the administration to or use by an individual of a

covered countermeasure, including a causal relationship with the . . . manufacture

[or] . . . distribution . . . of such countermeasure.” Id. § 247d-6d(a)(2)(B) (emphasis

added).

“As a noun, ‘individual’ ordinarily means ‘[a] human being, a person.’ Mohamad

v. Palestinian Auth., 566 U.S. 449, 454 (2012) (quoting 7 Oxford English Dictionary 880

(2d ed. 1989)); FCC v. AT&T Inc., 562 U.S. 397, 403 (2011) (“When a statute does not

define a term, we typically give the phrase its ordinary meaning.”). The Supreme Court

“routinely uses ‘individual’ to denote a natural person, and in particular to distinguish

between a natural person and a corporation.” Mohamad, 566 U.S. at 454 (citing

Goodyear Dunlop Tires Operations, S.A. v. Brown, 564 U.S. 915, 924 (2011)).

Defining the term “individual” according to its ordinary meaning is consistent

with the PREP Act’s statutory scheme for two reasons. Redd v. Amazon.com, Inc., No.

20 C 6485, 2024 WL 2831463, at *3 (N.D. Ill. June 4, 2024) (“It is a fundamental canon

of statutory construction that the words of a statute must be read in their context and

with a view to their place in the overall statutory scheme.”). First, nothing in the PREP

Act indicates Congress intended for the term “individual” to have a broader meaning

than natural person. Second is Congress’s inclusion of both the terms “person” and

“individual” in the statute. See id. § 247d-6d(a)(1). The PREP Act defines the term

“person,” and does so to include “an individual, partnership, corporation, association,

entity, or public or private corporation, including a Federal, State, or local government

agency or department.” 42 U.S.C. § 247d-6d(i)(5). “[I]t is a well-established canon of

statutory interpretation that the use of different words or terms within a statute

demonstrates that Congress intended to convey a different meaning for those words.”

S.E.C. v. McCarthy, 322 F.3d 650, 656 (9th Cir. 2003). Because the PREP Act defines

“person” expansively to include “individuals” and “corporate entities,” the meaning of

“individual” can only be understood as distinct from corporate entities and referring to a

natural person. See Aziz v. Alcolac, Inc., 658 F.3d 388, 393 (4th Cir. 2011) (“[W]hen

Congress uses the noun ‘individual’—rather than the broader term ‘person’—it should

ordinarily be construed to mean a human being or natural person.”).

Courts that have addressed whether or not the PREP Act shields an alleged injury

caused by an entity’s failure to administer a countermeasure similarly indicate their

adoption of the premise that the “physical provision” of the countermeasure requires an

individual person receive the countermeasure See Casabianca v. Mount Sinai Med. Ctr.,

2014 WL 10413521, at *4–*5 (N.Y. Sup. Ct. Dec. 2, 2014). (“The language makes clear

that the [countermeasure] must be administered to or used by a patient.”); Mackey v.

Tower Hill Rehab., LLC, 569 F. Supp. 3d 740, 746 (N.D. Ill. 2021) (finding no causal

relationship existed between the plaintiff’s claim and defendant’s use of a covered

countermeasure where the individual person failed to use the countermeasure);

DeAngelo v. Artis Senior Living of Elmhurst, LLC, No. 22 C 02538, 2022 WL 3357276,

at *3 (N.D. Ill. Aug. 15, 2022) (similar).

In one case, the Northern District of Illinois interpreted PREP Act immunity

expansively to cover claims pursuant to the Biometric Information Privacy Act (“BIPA”).

Redd, 2024 WL 2831463, at *3 (“Section 247d-6d(a)(2)(a) defines ‘loss’ in sweeping

terms to mean ‘any type of loss, including’—not limited to—the enumerated

examples.”). Even then, however, the question of immunity rested on the defendant’s

physical provision of the countermeasure to an individual to bring forth the plaintiff’s

injury. See id. at *4 (reasoning that the defendant’s administration of a thermal camera

system—a covered countermeasure—to check employees’ temperatures in order to

mitigate the spread of COVID-19 “without informed consent clearly played some role in

bringing about or contributing to [the plaintiff’s alleged] injury” and thus the claim fell

within the parameters of PREP Act immunity (quotation modified)); Eaton v. Big Blue

Healthcare, Inc., No. 2:20-CV-2291, 2020 WL 4815085 (D. Kan. Aug. 19, 2020)

(describing a case in which “[t]here was no question that the claim of loss—

administration of a vaccine without consent—was ‘caused by, arose out of, related to, or

resulted from the administration to . . . an individual of a covered countermeasure’”

because a vaccine was administered to a child (quotation modified) (quoting Parker v.

St. Lawrence Cty. Pub. Health Dept., 102 A.D.3d 140, 143 (N.Y. App. Div. 2012))); see

also Hogan v. Lincoln Med. Partners, 2025 ME 22, 331 A.3d 463 (holding PREP Act

immunity applied to defendants that administered a COVID-19 vaccine to children

without parental consent). Thus, I am able to deduce that the PREP Act requires the

relationship between manufacturing a countermeasure and administering a

countermeasure to an individual to include some step towards physically providing the

countermeasure to a person to bring forth the immunized claim.

Defining the term “individual” to encompass only an individual person is also

consistent with the regulatory scheme of the Declaration. As stated, the Declaration

prescribes that the term “administration” of a covered countermeasure requires

“physical provision of the countermeasure to a recipient.” 85 Fed. Reg. 15198 at 15200.

As such, the object of the phrase “administration to” must be an individual recipient for

the action to be covered by PREP Act immunity. Casabianca, 2014 WL 10413521, at *4

(concluding the PREP Act did not apply to an injury that was not “caused by physical

provision of a countermeasure to a recipient”). The HHS Secretary’s definition of

“administration” clarifies that administration involves the physical provision of a

countermeasure, and, through the examples provided in the Declaration, the physical

provision of a countermeasure must be connected to an individual person receiving the

countermeasure. These examples include administering vaccinations to patients,

handing drugs to patients, and managing and overseeing distribution sites where

patients are physically provided with the countermeasures—such as providing security,

queuing, and other similar activities. 85 Fed. Reg. at 15200. All of these examples

involve providing a countermeasure to an individual person and support the notion that

the object of the term “administration” is an individual person. Accordingly, I conclude

the term “individual” in the PREP Act refers to an individual person.

Puritan argues its production of flocked swabs amounts to the immunized use,

rather than an administration, of a countermeasure. Under Puritan’s interpretation of

the statute, the phrase “use by an individual” includes a corporate entity manufacturing

or distributing a covered countermeasure. Puritan’s argument is unavailing for two

reasons, however. First, Puritan’s interpretation is premised on an incorrect

interpretation of the term “individual” in Section 247d-6d(a)(1), which I have already

dispelled. Second, courts interpreting the PREP Act distinguish the term “use” from the

term “administration” only to address or identify the operator of the covered

countermeasure; that is a whether an entity “administered” a covered countermeasure

to an individual, such as through on-site diagnostic testing or vaccination performed by

those hired to do so, or whether an individual person “used” the covered

countermeasure themself, such as at-home diagnostic testing or masking. See, e.g.,

Lopez v. Life Care Ctrs. of Am., Inc., No. CV 20-0958, 2021 WL 1121034, at *10 (D.N.M.

Mar. 24, 2021) (assessing simultaneously whether the plaintiff’s alleged injury

constitutes as an “administration or use” of a covered countermeasure). Ultimately, the

focus of the language is whether the alleged harm is causally connected to the

countermeasure as it relates to the individual. What distinguishes the terms is whether a

covered person administered the countermeasure to the individual or whether a covered

person provided an individual with the countermeasure for the individual’s own use.

Because Puritan’s production of flocked swabs does not fall into either category, it is not

a “use” of a covered countermeasure by an individual.

II. The PREP Act’s meaning of “loss” does not include patent infringement.

The PREP Act immunizes “all claims of loss caused by, arising out of, relating to,

or resulting from the administration to or the use by an individual of a covered

countermeasure.” 42 U.S.C. 247d-6d(a)(1). Puritan argues that the term “loss” in the

PREP Act immunity provision is broad and covers patent infringement claims. Puritan

supports its claims with its interpretation of the PREP Act’s legislative history. Copan,

drawing on the context of the provisions in the PREP Act and its understanding of the

legislative history, argues that applying PREP Act immunity to patent infringement

claims falls outside the bounds of immunity and Congress’s intent. Further, Copan

argues that including patent infringement claims under the shield of immunity would

render the PREP Act unconstitutional. According to Copan, the meaning of “loss” in the

immunity provision refers only to claims that concern physical injury, such as medical

malpractice, wrongful death, and causes of action concerning product liability or

negligence.

The PREP Act grants immunity to “all claims for loss,” 42 U.S.C. § 247d-6d(a)(1),

and defines “loss” only as “any type of loss, including “(i) death; (ii) physical, mental, or

emotional injury, illness, disability, or condition; (iii) fear of physical, mental, or

emotional injury, illness, disability, or condition, including any need for medical

monitoring; and (iv) loss of or damage to property, including business interruption

loss.” Id. In Happel v. Guilford Cnty. Bd. of Educ., the North Carolina Supreme Court

found that the types of losses covered by PREP Act immunity are claims “ordinarily

associated with tort law.” 913 S.E.2d 174, 193 (N.C. 2025). Drawing on the United States

Supreme Court’s opinion in Fischer v. United States, the Happel court employed the

canons of noscitur a sociis and ejusdem generis, which led to the conclusion that, while

non-exhaustive, the examples provided in the PREP Act suggest that immunity is

limited to claims for personal injury. Id.; see Fischer v. United States, 603 U.S. 480, 487

(2024) (“The canon of noscitur a sociis teaches that a word is given more precise

content by the neighboring words with which it is associated. And under the related

canon of ejusdem generis, a general or collective term at the end of a list of specific

items is typically controlled and defined by reference to the specific classes . . . that

precede it.” (quotation modified)). I agree. All of the examples listed in the statute of the

types of losses covered by the PREP Act relate to some form of tortious injury involving

personal injury or property damage. Particularly, the examples in the first three

paragraphs, 42 U.S.C. § 247-6d(a)(2)(A)(i)–(iii), identify losses as those that are

manifestations of personal injury. Those three paragraphs contextualize the respective

class of “loss” that the PREP Act is intended to protect—tortious physical injuries. As I

explain further below, the inclusion of “business interruption loss” does not reference a

distinct injury that cuts against this understanding of the types of losses able to receive

PREP Act immunity. Although this list is non-exhaustive, the examples Congress

delineated in the first three paragraphs of the PREP Act illustrate that immunity is

limited to claims that involve some form of tortious physical injury.

The exception to PREP Act immunity in the statute also provides contextual

support for determining the limits of the term “loss.” See 42 U.S.C. § 247d-6d(d)(1).

According to the terms of the exception provision, PREP Act immunity does not shield

claims for “death or serious physical injury proximately caused by willful misconduct.”

Id. With this specific reference to physical injury in mind, it is unlikely Congress

intended the PREP Act to reject the use of the immunity shield for claims of willful

misconduct resulting in physical injury but otherwise extend immunity to claims for

willful misconduct that leads to other types of injuries. This focus on bodily injury in the

sole exception to broad liability immunity reinforces the notion that PREP Act immunity

is primarily concerned with shielding claims that arise from physical harm, and that the

term “loss” in the immunity provision is best understood as referring to tortious

physical injuries rather than abstract or purely economic harms.

The PREP Act compensates “loss” through the Covered Countermeasure Process

Fund (“CCPF”) for “eligible individuals for covered injuries directly caused by the

administration or use of a covered countermeasure pursuant to such declaration.” Id.

§ 247d-6e(a). Under the CCPF, “covered injur[ies]” are those resulting in “serious

physical injury or death.” Id. § 247-6e(e)(3). Similar to the statutory exception to

covered losses, the CCPF refers specifically to coverage for physical injuries resulting

from the administration or use of a covered countermeasure. Id. Furthermore, the

determination of compensation eligibility and amounts under the CCPF must be

premised on “reliable, valid, medical and scientific evidence.” Id. § 247d-6e(b)(4)–

(5)(A). The guidelines explaining what constitutes a covered injury and the evidence

that a claimant can use to obtain compensation further supports my determination that

covered losses must be a form of physical injury. Like the exception provision, the CCPF

provides context to an understanding of the PREP Act that immunizes claims involving

some form of tortious personal injury or property damage, not patent infringement.

Viewed together, the examples mentioned above, see 42 U.S.C. § 247d-6d(a)(2)(A)(i)–

(iii), the exception provision, and boundaries of the CCPF all support the notion that the

term “loss” in the PREP Act’s immunity provision encompasses tortious claims

involving physical injury.

Now, I turn back to the last example provided in the statute—“business

interruption loss.” Id. § 247d-6d(a)(2)(A)(iv). Puritan argues Congress’s inclusion of

“business interruption loss” in the examples of the losses covered by the PREP Act

supports the notion that PREP Act immunity applies to economic damages resulting

from patent infringement claims. Copan takes the position that since the phrase

“business interruption loss” is connected to “loss of or damage to property,” the harm

must fall in the category of physical damage to property. Copan further construes

“business interruption loss” consistent with the economic loss rule in tort law and its

requirement that personal injury or property damage exist for recovery to be

permissible.

The relevant provision explains that “loss” in the PREP Act includes “loss of or

damage to property, including business interruption loss.” Id. The provision itself uses

“business interruption loss” as a derivative of “loss of or damage to property.” See

Fischer, 603 U.S. at 488 (“[A] general phrase can be given a more focused meaning by

the terms linked to it.”). Thus, the plain language signifies that PREP Act immunity

applies to loss of or damage to property resulting in business interruption loss, not that

the PREP Act considers and protects business interruption loss as a distinct, broader

form of loss outside the context of loss of or damage to property. The distinction

between “loss of” property and “damage to” property is relevant only in the sense that

the harm to the property must result in either an entire “loss of” the property or partial

“damage to” the property. It does not posit a meaning that would thrust under the shield

of immunity a distinct class of losses that entail purely economic losses. E.g., Lawrence

Gen. Hosp. v. Cont’l Cas. Co., 90 F.4th 593, 600 (1st Cir. 2024) (noting that an

insurance policy covering “‘direct physical loss of or damage to’ property requires some

‘distinct, demonstrable, physical alteration of the property.’”). Reading the provision in

context, the only plausible understanding of the type of property losses protected by

PREP Act immunity are those involving tortious claims for physical damage to property,

including claims for business interruption loss.

Other court decisions hold consistently that all claims receiving PREP Act

immunity rest in some form of tortious personal injury or property damage. See, e.g.,

Casabianca, 2014 WL 10413521, at *4 (stating PREP Act immunity extends to losses

related to “slip and fall injuries and vehicle accidents that are connected to the

vaccination process, be it at a retail store or some other facility.”); Maney v. Brown, 91

F.4th 1296, 1301 (9th Cir. 2024) (holding PREP Act immunity applied to the plaintiff’s

Eighth Amendment claims arising out of death of inmates due to vaccine prioritization);

Hudak v. Elmcroft of Sagamore Hills, 58 F.4th 845, 856 (6th Cir. 2023) (finding the

plaintiff did not allege the defendant’s administration or use of a countermeasure

caused the plaintiff’s illness or death); see also Brown v. Watson, 21-CV-138-JPG, 2023

WL 2788693, at *2 (S.D. Ill. Apr. 5, 2023) (“The scope of this immunity is broad in that

it includes any type of physical, mental, or emotional loss or property damages that has

‘a causal relationship with the administration to or use by an individual of a covered

countermeasure.’” (quoting 42 U.S.C. § 247d-6d(a)(2))). This line of cases further

supports the notion that Congress did not intend for the economic losses that a plaintiff

suffers through patent infringement to be shielded by PREP Act immunity. As patent

infringement does not involve any form of personal injury or physical property damage,

it cannot be understood to fit within the meaning of “loss” in the PREP Act.

The “causal relationship” requirement for immunity protection under the PREP

Act provides further support for my conclusion. Immunity applies to “any claim for loss

that has a causal relationship with the administration to or use by an individual of a

covered countermeasure . . . .” 42 U.S.C. § 247-6d(a)(2)(B). As such, Puritan’s

manufacture of flocked swabs must have more than a distant link in the chain of events

leading to the claim of loss for immunity to apply. There must be a causal connection

between a covered person administering the countermeasure to an individual person or

an individual person’s use of a covered countermeasure, and the claim for personal

injury. The phrases “relating to,” “caused by,” “arising out of,” and “resulting from” in

the immunity provision, id. § 247-6d(a)(1), all “take[] on a more targeted meaning,”

Hampton, 83 F.4th at 764. (“It is not enough that some countermeasure’s use could be

described as relating to the events underpinning the claim in some broad sense.”). In

Hampton, the Ninth Circuit found an insufficient causal relationship between the

administration of the countermeasure and the alleged injury where the plaintiff’s claim

arose out of allegations that the defendant’s failure to administer COVID tests

contributed to the spread of the virus and resulted in the plaintiff’s death. 83 F.4th at

763–64 (“At the very least, then, for PREP Act immunity to apply, the underlying use or

administration of a covered countermeasure must have played some role in bringing

about or contributing to the plaintiff’s injury.”); cf. Maney, 91 F.4th at 1301 (prison’s

decision to prioritize vaccination distribution to protection officers had a sufficient

causal connection to the administration or use of the countermeasure to invoke

immunity). Consistent with this line of cases, Puritan’s manufacture of flocked swabs

does not have a sufficient causal relationship with administering to an individual or an

individual’s use of a covered countermeasure. To be covered, the at-issue claim must

have a causal connection with the covered person physically providing the

countermeasure to an individual that is beyond merely producing or distributing the

countermeasure to different entities.

III. Patents are protected by the Fifth Amendment.

Copan asserts that including patent infringement claims under the shield of

PREP Act immunity would result in a violation of the Fifth Amendment.4 Puritan argues

4 Puritan first challenges Copan’s ability to bring forth its constitutional challenge by raising Copan’s

failure to name the United States (or one of its agencies or employees) as a party and failing to properly

notify the U.S. Attorney General of its constitutional challenge to a federal statute. See Fed. R. Civ. P. 5.1;

D. Me. Local R. 5.1; see also Woodlands Senior Living, LLC v. MAS Med. Staffing Corp., 502 F. Supp. 3d

564, 570 (D. Me. 2020) (noting the judge ordered the plaintiff to comply with Rule 5.1), vacated on other

grounds, No. 19-CV-00230, 2021 WL 2043189 (May 21, 2021); Kenyon v. Cedeno-Rivera, 47 F.4th 12, 24

against such a conclusion and asserts that patents are a limited monopoly subject to the

boundaries provided by laws like the PREP Act.

“Statutes should be given a constitutional as opposed to an arguably

unconstitutional interpretation whenever fairly possible.” IMS Health Inc. v. Ayotte,

550 F.3d 42, 63 (1st Cir. 2008) (citing Arizonans for Official English v. Arizona, 520

U.S. 43, 78 (1997) (“[Federal courts] will first ascertain whether a construction . . . is

fairly possible that will contain the statute within constitutional bounds.” (quotation

modified))), abrogated on other grounds by Sorrell v. IMS Health Inc., 564 U.S. 552

(2011).

The Fifth Amendment provides that the government may not deprive a person of

“life, liberty, or property, without due process of law” nor take private property for

public use “without just compensation.” U.S. Const. Amend. V. It is well established that

patents, as personal property, see 35 U.S.C. § 261, are protected by the Due Process and

Takings Clauses of the Fifth Amendment. See James v. Campbell, 104 U.S. 356, 357–58

(1882) (holding the government’s appropriation or use of a patent requires just

compensation under the Fifth Amendment); Horne v. Dep’t of Agric., 576 U.S. 350,

358–60 (2015) (reiterating that real property and personal property receive the same

protections under the Fifth Amendment); see also Oil States Energy Servs., LLC v.

(1st Cir. 2022) (finding it permissible for the court to analyze the constitutionality of the statute because,

although untimely, Rule 5.1 notice was provided to the Attorney General); cf. Puffer’s Hardware, Inc. v.

Donovan, 742 F.2d 12, 18 (1st Cir. 1984) (certifying the constitutional challenge of the statute to the state

attorney general while still issuing a decision to uphold the statute). However, Rule 5.1(d) provides that “a

party’s failure to file and serve the notice, or the court’s failure to certify, does not forfeit a constitutional

claim or defense that is otherwise timely asserted.” Fed. R. Civ. P. 5.1(d). Since Copan timely filed its

opposition brief in this matter, I will not treat Copan’s procedural deficiencies as a bar against its

constitutional arguments. In any event, I consider the Fifth Amendment Argument here relevant only as

additional support for my conclusion above that patent infringement is not within the scope of PREP Act

immunity.

Greene’s Energy Grp., LLC, 584 U.S. 325, 344 (2018) (stating the Court was not

“suggesting that patents are not property for purposes of the Due Process Clause or the

Takings Clause”). Thus, the Fifth Amendment expressly prohibits government entities

from the unauthorized use of a patented invention, and these same principles apply to

“the use or manufacture of a [patented] invention . . . by a contractor for the

Government.” See 28 U.S.C. § 1498(a). Applying PREP Act immunity to the patent

infringement claims in this case would cause such effect—Puritan, acting as a

government contractor, would be immunized for any alleged infringement, or taking of

Copan’s patented invention, that resulted from Puritan’s production of flocked swabs.

Therefore, an interpretation of the PREP Act that includes the alleged patent

infringement at issue here would constitute an unconstitutional reading of the statute.

Puritan’s assertion that the United States has waived sovereign immunity to

compensate patent holders for this very situation is not convincing. See 28 U.S.C.

§ 1498(a) (providing a cause of action to patentees for the unauthorized use of their

invention by the federal government and its contractors). The Supreme Court has held

that the government’s “infringement of a patent . . . does not by itself violate the

Constitution,” particularly where there exists a remedy for the patent owner to seek

compensation. Fla. Prepaid Postsecondary Educ. Expense Bd. v. College Sav. Bank, 527

U.S. 627, 643 (1999) (analyzing whether a state infringing upon a patent constitutes a

violation of the Due Process Clause of the Fourteenth Amendment where the patentee

can seek compensation under Patent Remedy Act). And § 1498(a) does provide

patentees an avenue for compensation resulting from the United States or its

contractors’ use or manufacture of a patented invention without a license from the

patentee. However, an alleged infringer’s ability to invoke this affirmative defense is

premised on the federal government’s authorization or consent to the defendant’s

performance of the infringing acts. TVI Energy Corp. v. Blane, 806 F.2d 1057, 1060

(Fed. Cir. 1986) (analyzing whether the alleged infringement occurred with the United

States’ authorization or consent). Courts assessing whether the United States authorized

or consented to a defendant’s infringing actions analyze if the federal government did so

either expressly or implicitly. See Federal Acquisition Regulation, 48 C.F.R. § 52.227-1

(2025) (hereinafter “FAR 52.227”); TVI Energy Corp, 806 F.2d at 1060 (“Authorization

or consent by the Government can be expressed in a form other than [an explicit] letter.

In proper circumstances, Government authorization can be implied.” (citation

omitted)).

Here, the stipulated facts support the conclusion that, rather than authorizing or

consenting to Puritan’s allegedly infringing acts, the United States instead aimed to

protect itself from any alleged patent infringement claims. The P3 Contract stated

explicitly that Puritan would indemnify the federal government for any claim of patent

infringement. See ECF No. 289-2 at 16. Thus, the P3 Contract cannot be understood as

authorization to Puritan to infringe upon Copan’s patented technology by the United

States. Puritan’s assertion that the government referenced the PREP Act in the

definitized P3 Contract with specific regard to Puritan’s pending litigation with Copan

and to ensure Puritan was immune from suit is not substantiated by the undisputed

facts. None of the facts here indicate that the government added the section in the P3

Contract referencing the PREP Act to specifically reference (and immunize against)

Copan’s patent infringement claims against Puritan. In fact, just below the section on

the PREP Act, the definitized version of the P3 Contract states “[a]ll other terms and

conditions remain unchanged.” Thus, the indemnification clause remained in effect in

the final terms of the P3 Contract and required Puritan to indemnify the Government

for any prospective patent infringement claims. Robishaw Eng’g Inc. v. United States,

891 F. Supp. 1134, 1141 n.11 (E.D. Va. 1995) (“Of course, the government may, and often

does, shift its liability under § 1498 onto contractors by inserting a patent

indemnification clause in its contracts.” (citing FAR 52.227)).

See ECF No. 294-7. No such procurement contract

exists in the facts here. As stated, the P3 Contract does not evince the government’s

authorization or consent to Puritan for its allegedly infringing acts.

I also note that while the P3 Contract did require Puritan to expand its

production of flocked swabs for the government’s effort to combat the COVID-19

pandemic, Puritan’s use of flocked swabs both preceded the start of the pandemic and

the formation of the P3 Contract. Copan had already commenced its suit against Puritan

for allegedly infringing upon Copan’s flocked swabs, and the Court stayed the matter at

the parties’ request so the parties could focus on production of COVID-19 related

devices. See ECF No. 168. Because there was no resolution of whether Puritan’s flocked

swabs infringed upon Copan’s patented technology, the government could not have

plausibly known that Puritan’s flocked swabs resulted in infringement; the issue has not

been decided. Therefore, § 1498 does not negate my conclusion. The PREP Act does not

immunize Puritan from Copan’s patent infringement claims.

CONCLUSION

For the reasons above, Defendant’s motion for partial summary judgment is

DENIED.

SO ORDERED.

Dated this 25th day of July, 2025

/s/ Stacey D. Neumann

U.S. DISTRICT JUDGE