The opinion
Case: 22-1943 Document: 61 Page: 1 Filed: 05/14/2024
United States Court of Appeals
for the Federal Circuit
______________________
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
______________________
Appeal from the United States District Court for the
District of Maine in No. 1:18-cv-00218-JDL, Chief Judge
Jon D. Levy.
______________________
Decided: May 14, 2024
______________________
MICHAEL NEWMAN, Mintz, Levin, Cohn, Ferris, Glov-
sky and Popeo, P.C., Boston, MA, argued for plaintiffs-ap-
pellees. 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
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2 COPAN ITALIA SPA v.
PURITAN MEDICAL PRODUCTS COMPANY LLC
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. (collec-
tively, “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 im-
mune 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, dis-
miss 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 sev-
eral 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 “dam-
ages caused to Plaintiff by Defendant’s unlawful acts of pa-
tent infringement,” as well as a permanent injunction. J.A.
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COPAN ITALIA SPA v. 3
PURITAN MEDICAL PRODUCTS COMPANY LLC
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 Dec-
laration Under the Public Readiness and Emergency Pre-
paredness Act for Medical Countermeasures Against
COVID-19, which declared the COVID-19 pandemic a pub-
lic 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 par-
ties further indicated in their stay motion that they ex-
pected “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
1 Copan later dropped its request for injunctive re-
lief. J.A. 4552-53.
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4 COPAN ITALIA SPA v.
PURITAN MEDICAL PRODUCTS COMPANY LLC
Preparedness Act for Medical Countermeas-
ures Against COVID-19 (the “PREP Act Dec-
laration”), 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 Counter-
measures” 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 per-
son defined in Section V of the PREP Act Dec-
laration. Therefore, in accordance with
Sections IV and VII of the PREP Act Declara-
tion as well as the PREP Act (42 U.S.C.
§ 247d-6d), the Air Force expressly acknowl-
edges and agrees that Contractor shall be im-
mune 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 pa-
tent infringement claims to the extent they were directed
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COPAN ITALIA SPA v. 5
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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 ex-
pressly 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 Admin-
istration (“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 im-
munity from liability for patent infringement. In Copan’s
view, the PREP Act does not apply to claims for patent in-
fringement; 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” un-
der the PREP Act. The court acknowledged that Puritan
had asked that the court take judicial notice of what ap-
peared 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 fac-
tory, or even flocked swabs.” J.A. 8. Nor did the letter in-
dicate that any factory had been built, or any swabs
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6 COPAN ITALIA SPA v.
PURITAN MEDICAL PRODUCTS COMPANY LLC
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 com-
plaint 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 de-
fends 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, Pu-
ritan argues that we have jurisdiction by virtue of applica-
tion of the collateral order doctrine.
We have determined that we lack jurisdiction, for rea-
sons 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 (2009) (“Alt-
hough ‘final decisions’ typically are ones that trigger the
entry of judgment, they also include a small set of prejudg-
ment 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 gov-
erned by Federal Circuit law.” DePuy Synthes Prods., Inc.
v. Veterinary Orthopedic Implants, Inc., 990 F.3d 1364,
1368 (Fed. Cir. 2021).
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COPAN ITALIA SPA v. 7
PURITAN MEDICAL PRODUCTS COMPANY LLC
As we have explained, for a district court order to come
within the collateral order exception, it must “at a mini-
mum satisfy three conditions: It must [1] ‘conclusively de-
termine 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. 2013) (alteration in original) (quoting
Richardson-Merrell, Inc. v. Koller, 472 U.S. 424, 431
(1985)). If any one of these conditions is not met, the col-
lateral order doctrine does not apply, and we lack jurisdic-
tion to review the order in question. See generally Mod.
Font Applications LLC v. Alaska Airlines, Inc., 56 F.4th
981, 985 (Fed. Cir. 2022) (discussing two examples where
orders failed to meet requirements of collateral order doc-
trine).
Puritan argues that the district court’s denial of its mo-
tion to dismiss meets the requirements for a reviewable col-
lateral order. In Puritan’s view, the district court
conclusively determined that Puritan lacks immunity from
suit and also lacks immunity from liability under the PREP
Act. To Puritan, this is an important issue, as it goes to
whether Puritan can be required to defend itself against an
allegation of patent infringement and whether it can be
held liable for such infringement. It is also, Puritan ar-
gues, an issue entirely distinct from the merits of whether,
in fact, Puritan infringes. Puritan further contends that
the immunity issue is unreviewable on appeal, as it will
have been irrevocably deprived of its immunity from suit
after the case proceeds through trial to an appeal.
Copan counters that the denial of Puritan’s partial mo-
tion to dismiss is not reviewable under the collateral order
doctrine. According to Copan, the district court did not con-
clusively determine that Puritan lacks immunity under the
PREP Act; instead, the district court only held that, to this
point, Puritan has not demonstrated that it is entitled to
immunity. Copan further insists that the immunity issue
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8 COPAN ITALIA SPA v.
PURITAN MEDICAL PRODUCTS COMPANY LLC
is intertwined with the merits of its patent infringement
claim and, in fact, is more properly viewed as a damages
question (i.e., can Copan recover for infringement by swabs
made at the P3 factory or is its recovery limited to damages
from infringement by swabs made outside P3?), as Puritan
admits the swabs made at P3 are identical to other swabs.
Copan also contends the issue on which Puritan seeks re-
view is not particularly important because trial will be nec-
essary on its non-P3 infringement claims regardless of
whether Puritan prevails on its P3 immunity motion.
We find that the district court’s denial of Puritan’s par-
tial motion to dismiss does not conclusively determine any
issue. Therefore, Puritan has not shown that the collateral
order doctrine’s requirements are satisfied. Accordingly,
we dismiss for lack of appellate jurisdiction.
III
The first requirement that must be satisfied to invoke
our jurisdiction under the collateral order doctrine is to
show that the district court’s order “conclusively deter-
mined” the disputed issue. Here, that requirement would
be met by a showing that the trial court conclusively deter-
mined that Puritan lacks immunity from patent infringe-
ment under the PREP Act. Puritan cannot show that the
trial court arrived at such a determination because the rec-
ord makes plain it did not.
The PREP Act, when applicable, confers two types of
immunity: immunity from suit and immunity from liabil-
ity. See 42 U.S.C. § 247d-6d(a)(1). The essence of immun-
ity from suit “is its possessor’s entitlement not to have to
answer for his conduct in a civil damages action.” Mitchell
v. Forsyth, 472 U.S. 511, 525 (1985). Immunity from liabil-
ity means that one cannot be held to pay or otherwise be
accountable for whatever loss one has caused. See Wood v.
Strickland, 420 U.S. 308, 319-20 (1975) (discussing differ-
ences between immunity from suit and immunity from
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COPAN ITALIA SPA v. 9
PURITAN MEDICAL PRODUCTS COMPANY LLC
liability), abrogated on other grounds by Harlow v. Fitzger-
ald, 457 U.S. 800 (1982).
The PREP Act’s immunity provision reads as follows
(with bracketed numerals added):
[i] a covered person shall be immune from suit
and liability under Federal and State law
with respect to [ii] 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 [iii]
a declaration [of a public health emergency]
has been issued with respect to such counter-
measure.
42 U.S.C. § 247d-6d(a)(1). Thus, as it relates to the issues
presented here, PREP Act immunity extends to (i) covered
persons, (ii) for losses 2 somehow connected to a covered
countermeasure, when (iii) a public health emergency has
been declared with respect to the countermeasure, and (iv)
the covered countermeasures are distributed under certain
means specified in the declaration. See Maney v. Brown,
91 F.4th 1296, 1298 (9th Cir. 2024). The PREP Act in-
cludes among its definition of “covered countermeasures” a
2 The Act defines “loss” as
including – (i) death; (ii) physical, mental, or
emotional injury, illness, disability, or condi-
tion; (iii) fear of physical, mental, or emotional
injury, illness, disability, or condition, includ-
ing any need for medical monitoring; and (iv)
loss of or damage to property, including busi-
ness interruption loss.
42 U.S.C. § 247d-6d(a)(2)(A).
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10 COPAN ITALIA SPA v.
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“qualified pandemic or epidemic product.” 42 U.S.C.
§ 247d-6d(i)(1)(A). 3
Invoking these provisions of the PREP Act, Puritan
moved to dismiss the patent infringement claims as to the
accused swabs manufactured at its P3 facility because they
sought to recover for “loss” from which Puritan was im-
mune, on the grounds that (i) Puritan is a “covered person,”
(ii) the flocked swabs manufactured at the P3 facility were
“covered countermeasures” (iii) with respect to which a
public health emergency (COVID-19) had been declared,
and (iv) the flocked swabs were distributed (based on its
contract with the Air Force) under a means specified in the
emergency declaration. 4
The district court found that the record was not ade-
quate to allow it to make a finding as to the “covered coun-
termeasure” and distribution requirements. See J.A. 9
(“[T]he Air Force’s statement leaves some doubt as to
whether the flocked swabs from P3 are covered counter-
measures.”); J.A. 10 (holding that “without a more fulsome
record of the relevant facts,” court could not “conclude with
certainty that all of the flocked swabs manufactured at the
P3 factory are related to a federal agreement”); J.A. 10 (“In
light of the evidentiary gaps I have noted, the dismissal of
the amended complaint is not supported because the lim-
ited record before me does not show that the PREP Act af-
firmative defense has been proven.”). Referring to the
documents Puritan asked it to judicially notice, the court
3 Where immunity applies, the injured individual or
their survivors may seek compensation from the Counter-
measures Injury Compensation Program. See 42 U.S.C.
§ 247d-6e.
4 There is no dispute that the March 10, 2020 HHS
declaration was a declaration of a public health emergency
with respect to the countermeasure.
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COPAN ITALIA SPA v. 11
PURITAN MEDICAL PRODUCTS COMPANY LLC
explained: “Puritan’s proposed evidence does not establish
that Puritan carried through with its contractual obliga-
tions, that it did so at its P3 factory, or that all of the
flocked swabs from its P3 factory (as opposed to some sub-
set) are produced in relation to its government contract.”
J.A. 10. Therefore, because immunity had not been estab-
lished, the court denied Puritan’s motion to dismiss, and at
the same time permitted Puritan to amend its answer to
assert its PREP Act immunity affirmative defense.
Clearly, the district court is contemplating further liti-
gation will be necessary before a conclusive determination
can be reached as to whether immunity is available to Pu-
ritan in this case. The district court did not make any fac-
tual or legal determination that Puritan’s flocked swabs
made at its P3 facility are not immune. Instead, it simply
– and preliminarily – held that it was not in a position to
make these determinations at this time. This is not a “con-
clusive determination” of the immunity issue.
Our conclusion is supported by Supreme Court prece-
dent arising in the similar context of qualified immunity
for government officials. In Ortiz v. Jordan, 562 U.S. 180,
188 (2011), for example, the Supreme Court explained that
“immediate appeal from the denial of summary judgment
on a qualified immunity plea is available when the appeal
presents a ‘purely legal issue’ . . . . However, instant ap-
peal is not available . . . when the district court determines
that factual issues genuinely in dispute preclude summary
adjudication.” Just as there is a lack of appellate jurisdic-
tion for interlocutory review of a district court denial of a
motion for summary judgment of qualified immunity based
on “[d]isputed facts relevant to resolving . . . immunity
pleas,” id. at 191, so, too, here, we lack jurisdiction to re-
view the district court’s denial of Puritan’s PREP Act im-
munity motion to dismiss, as that denial was based on
genuine, material disputed facts. See also Johnson v.
Jones, 515 U.S. 304, 316 (1995) (holding interlocutory
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12 COPAN ITALIA SPA v.
PURITAN MEDICAL PRODUCTS COMPANY LLC
appeal is not available where “issue . . . at stake” is “the ex-
istence, or nonexistence, of a triable issue of fact”). 5
IV
A
In urging us to reach a different conclusion and find
appellate jurisdiction, Puritan principally emphasizes the
immunity from suit provided by the PREP Act. According
to Puritan, it is losing its immunity from suit each day that
the patent infringement claims relating to P3 remain pend-
ing, as each such day requires Puritan to mount a defense
to this portion of Copan’s claims – even though Puritan ex-
pects the courts will ultimately agree that it is immune
from any liability for P3 activities. See, e.g., Opening Br.
at 5-7; Puerto Rico Aqueduct & Sewer Auth. v. Metcalf &
Eddy, Inc., 506 U.S. 139, 143-44 (1993) (“[A]bsent immedi-
ate appeal, the central benefits of qualified immunity –
avoiding the costs and general consequences of subjecting
public officials to the risks of discovery and trial – would be
forfeited.”); In re World Trade Ctr. Disaster Site Litig., 521
F.3d 169, 180 (2d Cir. 2008) (describing defendant’s loss of
“its asserted right not to stand trial”). Puritan argues that
“[t]he PREP Act shields Puritan from pretrial and trial re-
garding infringement allegations directed to the P3 factory
and Puritan has chosen to exercise this right.” Reply Br.
at 6-7.
5 It is true, of course, as Puritan points out, that not
every denial of summary judgment that happens to involve
disputed facts is unappealable. See Behrens v. Pelletier,
516 U.S. 299, 312-13 (1996); Reply Br. at 2-3. Here, how-
ever, the sole basis for the district court’s denial of Puri-
tan’s motion to dismiss was its identification of factual
issues that it felt could not be resolved on the present rec-
ord.
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Not all issues impacting immunity from suit are neces-
sarily subject to collateral order appellate review. See
Johnson, 515 U.S. at 313-18 (holding that evidentiary suf-
ficiency determinations in qualified immunity cases are not
immediately appealable even where they “force[] public of-
ficials to trial”); Digital Equip. Corp. v. Desktop Direct, Inc.,
511 U.S. 863, 883 (1994) (holding that order vacating dis-
missal is not appealable collateral order even when parties
negotiated for immunity to suit).
We find the circumstances presented here to be most
comparable to those in which courts have found immunity-
from-suit issues not to be reviewable under the collateral
order doctrine. Again, the district court denied Puritan’s
motion to dismiss based on its determination that the rec-
ord revealed a genuinely disputed material fact; it did not
deny the motion based on a legal conclusion. It held im-
munity was not shown to be applicable, but did not hold
that immunity cannot be available in the circumstances
presented. The district court, as we have stressed, did not,
therefore, “conclusively determine” any issue, so we have
no proper collateral order to review. 6
To address what it characterizes as a loss of immunity
from suit, Puritan proposes as an “alternative [form of]
6 Notably, the PREP Act expressly provides for inter-
locutory appellate review of denials of a particular type of
motions to dismiss: when defendants fail to obtain dismis-
sal of allegations of willful misconduct in suits proceeding
in the United States District Court for the District of Co-
lumbia. See 42 U.S.C. § 247d-6d(e)(1), (10); Cannon v. Wa-
termark Ret. Cmtys., Inc., 45 F.4th 137, 146-48 (D.C. Cir.
2022) (explaining that subsection (e)(10) does not apply to
all assertions of immunity under PREP Act). It is undis-
puted that Puritan’s motion to dismiss does not come
within this statutory authorization of interlocutory review.
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14 COPAN ITALIA SPA v.
PURITAN MEDICAL PRODUCTS COMPANY LLC
relief” other than reversal that we order the district court
to limit discovery to the immunity issue, and address its
affirmative defense, before proceeding to patent-related
discovery. We will not interfere with the district court’s
broad case management discretion by ordering it to pro-
ceed in this manner. Nevertheless, on remand the district
court may wish to consider structuring this litigation in a
manner that could allow it to make a conclusive determi-
nation on Puritan’s PREP Act immunity defense before
this case otherwise proceeds any further. 7
B
Puritan’s other main attack on the conclusion we have
reached is to argue that our disposition is inconsistent with
what other circuits have done in PREP Act cases. We are
not persuaded.
In Hampton v. California, 83 F.4th 754, 761 (9th Cir.
2023), the district court denied the defendants’ motion to
dismiss based on PREP Act immunity. There was no dis-
pute that the defendants were “covered persons” and that
the COVID tests involved were “covered countermeasures.”
See id. at 763. All that was contested was whether the
claims by the plaintiff – the spouse of a former inmate who
had contracted COVID-19 while incarcerated and passed
away – were 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). “The district court rejected all of Defendants’
claims to immunity.” Hampton, 83 F.4th at 761. In other
words, the district court made a conclusive determination
as a matter of law that immunity was not available. Here,
by contrast, the district court did not conclusively hold that
7 At oral argument, Copan agreed that the immunity
issue should be placed “front and center” and prioritized on
remand. Oral Arg. at 30:31-55, 32:51-33:15.
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PREP Act immunity is unavailable; it only decided that Pu-
ritan has not yet made the factual showing required to es-
tablish such immunity. That the situation confronted by
the Ninth Circuit in Hampton involved an appealable col-
lateral order in no way demonstrates that the very differ-
ent order we are reviewing also meets the requirements of
the collateral order doctrine.
Two subsequent Ninth Circuit cases simply follow
Hampton and add no analysis relevant to the issue of re-
viewability. See Maney, 91 F.4th at 1299 (“We have juris-
diction over Defendants’ immediate appeal of the district
court’s denial of PREP Act immunity. Hampton, 83 F.4th
at 761-62 (holding that a denial of PREP Act immunity is
immediately appealable under the collateral order doc-
trine).”); Harris v. Allison, 2023 WL 6784355, at *1 (9th
Cir. Oct. 13, 2023) (“We have jurisdiction under the collat-
eral order doctrine to review a district court’s rejection of
immunity under the Public Readiness and Emergency Pre-
paredness (“PREP”) Act, 42 U.S.C. § 247d-6d, at the motion
to dismiss stage. See Hampton v. California, __ F.4th __,
2023 WL 6406760, at *4-5 (9th Cir. 2023).”).
Nor does Solomon v. St. Joseph Hospital, cited by Pu-
ritan, change our opinion. 62 F.4th 54 (2d Cir. 2023). In
Solomon, the Second Circuit concluded it had “appellate ju-
risdiction to determine whether the district court had ju-
risdiction,” and, thus, it did “not decide whether
Defendants’ interlocutory appeal [based on PREP Act im-
munity] is proper under the collateral-order doctrine.” Id.
at 59.
None of these cases dealt with a situation in which, as
here, “the district court determines that factual issues gen-
uinely in dispute preclude summary adjudication.” Ortiz,
562 U.S. at 188. In cases such as ours, where the district
court determines it requires “a more fulsome record of the
relevant facts” before resolving the immunity question,
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16 COPAN ITALIA SPA v.
PURITAN MEDICAL PRODUCTS COMPANY LLC
J.A. 10, the “conclusive determination” prong of the collat-
eral order doctrine is not satisfied.
C
Finally, Puritan argues that the questions of fact the
trial court relied on in denying its motion to dismiss were
forfeited because Copan did not actually dispute them. Re-
latedly, Puritan contends that the court improperly identi-
fied its own disputed issues of fact and then relied on those
disputes to deny Puritan’s motion. See generally United
States v. Sineneng-Smith, 590 U.S. 371, 375 (2020) (“[I]n
both civil and criminal cases, in the first instance and on
appeal . . . , we rely on the parties to frame the issues for
decision and assign to courts the role of neutral arbiter of
matters the parties present.”). Puritan is incorrect.
Copan, in its briefing opposing the motion to dismiss,
stated its belief that the record contained disputed issues
of material fact. J.A. 4344-45. Copan expressly requested
that “at a minimum” it be given an opportunity to “explore
the factual basis” for Puritan’s allegations before dismissal
could even be considered. Id. The district court did not act
inappropriately in denying the motion to dismiss based on
factual disputes and its desire for a more fulsome record.
V
As the first requirement for application of the collateral
order doctrine is not present, we need not consider whether
the additional factors have been established. Accordingly,
we dismiss for lack of jurisdiction.
DISMISSED