Jazz Pharmaceuticals, Inc. v. Avadel Cns Pharmaceuticals, LLC

United States Court of Appeals
for the Federal Circuit
______________________
JAZZ PHARMACEUTICALS, INC.,
Plaintiff-Appellee
v.
AVADEL CNS PHARMACEUTICALS, LLC,
Defendant-Appellant
______________________
2024-2274
______________________
Appeal from the United States District Court for the
District of Delaware in No. 1:21-cv-00691-GBW, Judge
Gregory Brian Williams.
--------------------------------------------------
JAZZ PHARMACEUTICALS, INC., JAZZ
PHARMACEUTICALS IRELAND LIMITED,
Plaintiffs-Appellees
v.
AVADEL CNS PHARMACEUTICALS, LLC,
Defendant-Appellant
______________________
2024-2277
______________________
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Appeal from the United States District Court for the
District of Delaware in No. 1:21-cv-01138-GBW, Judge
Gregory Brian Williams.
--------------------------------------------------
JAZZ PHARMACEUTICALS, INC., JAZZ
PHARMACEUTICALS IRELAND LIMITED,
Plaintiffs-Appellees
v.
AVADEL CNS PHARMACEUTICALS, LLC,
Defendant-Appellant
______________________
2024-2278
______________________
Appeal from the United States District Court for the
District of Delaware in No. 1:21-cv-01594-GBW, Judge
Gregory Brian Williams.
______________________
Decided: May 6, 2025
______________________
FRANK CALVOSA , I, Quinn Emanuel Urquhart & Sulli-
van, LLP, New York, NY, argued for plaintiff-appellee.
Also represented by G ABRIEL P. BRIER, FRANCIS D OMINIC
CERRITO, QUENTIN JORGENSEN, ELLYDE R. THOMPSON;
ISAAC S AIDEL-G OLEY , Boston, MA.
G ABRIEL K. BELL, Latham & Watkins LLP, Washing-
ton, DC, argued for defendant-appellant. Also represented
by ALEXANDER G. SIEMERS; KENNETH G. S CHULER , M ARC
N ATHAN Z UBICK, Chicago, IL; HERMAN H. YUE , New York,
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NY; KIRA ALEXIS D AVIS, Morrison & Foerster LLP, Los An-
geles, CA; D ARALYN JEANNINE D URIE , San Francisco, CA;
D ANIEL M. S ILVER , McCarter & English, LLP, Wilmington,
DE.
______________________
Before L OURIE , REYNA , and TARANTO, Circuit Judges.
LOURIE, Circuit Judge.
Avadel CNS Pharmaceuticals, LLC (“Avadel”) appeals
from the decision of the U.S. District Court for the District
of Delaware permanently enjoining it from seeking ap-
proval from the U.S. Food and Drug Administration (“the
FDA”) of its product, Lumryz, for the treatment of idio-
pathic hypersomnia, as well as from marketing Lumryz for
that indication. Jazz Pharms., Inc. v. Avadel CNS Pharms.
LLC, No. 21-cv-691, 2024 WL 4005200 (D. Del. Aug. 27,
2024) (“Permanent Injunction Order”); see Jazz Pharms.,
Inc. v. Avadel CNS Pharms. LLC, No. 21-cv-691, 2024 WL
4100159 (D. Del. Aug. 27, 2024) (“Decision”). As the district
court later clarified in an order denying Avadel’s motion to
stay the injunction pending appeal, Avadel is specifically
enjoined from: (1) offering open-label extensions to clinical
trial participants, (2) applying for FDA approval of Lumryz
for idiopathic hypersomnia, and (3) initiating new clinical
trials or studies after the Permanent Injunction Order’s ef-
fective date. Jazz Pharms., Inc. v. Avadel CNS Pharms.
LLC, No. 21-cv-691 (D. Del. Sep. 24, 2024) (“Stay Order”),
J.A. 38–44.
For the following reasons, we reverse-in-part, vacate-
in-part, and remand.
BACKGROUND
I
Jazz Pharmaceuticals, Inc. and Jazz Pharmaceuticals
Ireland Limited (collectively, “Jazz”) manufacture and sell
two sodium oxybate products: Xyrem®, a sodium oxybate
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oral solution approved for the treatment of excessive day-
time sleepiness (“EDS”) and cataplexy in adult and pediat-
ric patients with narcolepsy, and Xywav®, a low-sodium
oxybate product approved for the same indications as
Xyrem, as well as for the treatment of idiopathic hyper-
somnia. Idiopathic hypersomnia, or “IH,” is a chronic neu-
rological condition “on a spectrum with narcolepsy” that is
similarly characterized by EDS. J.A. 5666. Xywav is the
first and, currently, only FDA-approved treatment for IH.
Jazz is not without competition, however. On Decem-
ber 15, 2020, Avadel submitted a New Drug Application
(“NDA”) to the FDA pursuant to section 505(b)(2) of the
Federal Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C.
§ 355(b)(2), seeking approval of its own product, Lumryz, a
once-nightly formulation of sodium oxybate for the treat-
ment of EDS and cataplexy in adults with narcolepsy. An
NDA filed under that section is commonly referred to as a
“paper NDA,” which, unlike an Abbreviated New Drug Ap-
plication (“ANDA”), requires the applicant to submit safety
and efficacy data. See AstraZeneca LP v. Apotex, Inc.,
633 F.3d 1042, 1045–46 (Fed. Cir. 2010). But such data
need not have been developed by the applicant; rather, the
applicant may rely on existing FDA findings of safety and
efficacy for already-approved drugs, or on other studies not
performed by the applicant. Takeda Pharms. U.S.A., Inc.
v. W.-Ward Pharm. Corp., 785 F.3d 625, 629 (Fed. Cir.
2015). Avadel’s paper NDA relied in part on the FDA’s
findings of safety and efficacy for Jazz’s Xyrem.
J.A. 9255–56.
On March 23, 2021, three months after Avadel submit-
ted its paper NDA, Jazz filed a patent application entitled
“GHB [(i.e., oxybate)] Formulation and Method for its Man-
ufacture,” which issued on October 19, 2021, as U.S. Patent
11,147,782 (“the ’782 patent”). Relevant here, claims 14
and 24 of the ’782 patent recite:
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14. A unit dose comprising a formulation of
gamma-hydroxybutyrate,
wherein the formulation comprises:
a plurality of immediate release particles
comprising gamma-hydroxybutyrate;
a plurality of modified release particles
comprising gamma-hydroxybutyrate;
a viscosity enhancing agent; and
an acid;
wherein the viscosity enhancing agent and
the acid are separate from the immediate
release particles and the modified release
particles.
24. The unit dose of claim 14, wherein the
unit dose is a sachet.
’782 patent, col. 26 ll. 9–20, 54–55. The ’782 patent will
expire on February 18, 2036.
Neither of Jazz’s Xyrem and Xywav products practices
claim 24 of the ’782 patent, the only asserted claim in this
litigation. Indeed, the ’782 patent is not listed in the Or-
ange Book for either Xyrem or Xywav, indicating Jazz’s
view that the ’782 patent does not claim those drugs or
their use. See 21 U.S.C. § 355(b)(1)(A)(viii) (providing the
statutory requirements for listing a patent in the Orange
Book). As such, in pursuing its paper NDA for Lumryz,
Avadel did not need to make—and, indeed, did not make—
any patent certifications under § 355(b)(2)(A) as to the ’782
patent.1
1 As with an ANDA, a paper NDA requires the appli-
cant to submit a certification that, for example, any patent
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II
On November 10, 2021, roughly one month after the
’782 patent issued and eleven months after Avadel submit-
ted its paper NDA, Jazz filed a complaint in the U.S. Dis-
trict Court for the District of Delaware, alleging that
Avadel’s FDA submission “constitute[d] infringement [of
the ’782 patent] under 35 U.S.C. § 271(e)(2)(A).” J.A.
10167. That statute provides:
It shall be an act of infringement to submit an ap-
plication . . . described in section 505(b)(2) of [the
FDCA] for a drug claimed in a patent . . . if the pur-
pose of such submission is to obtain approval under
[the FDCA] to engage in the commercial manufac-
ture, use, or sale of a drug . . . claimed in a pa-
tent . . . before the expiration of such patent.
§ 271(e)(2)(A). In its claim for relief, Jazz sought, inter alia,
a permanent injunction under 35 U.S.C. § 271(e)(4)(B),2 as
well as damages for any of Avadel’s infringement “other
than those acts expressly exempted by 35 U.S.C.
§ 271(e)(1).”3 J.A. 10169–70. Accordingly, at the time of
that “claims the drug” for which the relied-upon investiga-
tions were conducted “is invalid or will not be infringed by
the manufacture, use, or sale of the new drug for which the
application is submitted.” See § 355(b)(2)(A)(i)–(iv).
2 For an act of infringement under § 271(e)(2), as
Jazz’s complaint alleged, the statute provides that “injunc-
tive relief may be granted . . . to prevent the commercial
manufacture, use, offer to sell, or sale within the United
States or importation into the United States of an approved
drug . . . .” § 271(e)(4)(B).
3 The statute expressly excludes from infringement
any infringing activities done “solely for uses reasonably
related to the development and submission of information”
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the initial filing of Jazz’s complaint, this lawsuit appeared
to fall within the bounds of the Hatch-Waxman Act insofar
as the alleged infringement “ar[ose] from Avadel’s filing of
a New Drug Application.” J.A. 10157 (emphasis added).
That is, Jazz’s claims were based on an artificial act of in-
fringement under § 271(e)(2), and not on any actual acts of
infringement under § 271(a)–(c). See J.A. 10167; J.A. 7741
(Avadel letter to district court explaining that “Jazz initi-
ated this series of actions under the Hatch-Waxman Act”);
see also Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 676
(1990) (explaining that § 271(e)(2) “define[s] a new (and
somewhat artificial) act of infringement for a very limited
and technical purpose that relates only to certain drug ap-
plications”).
That changed, however, on May 1, 2023, when the FDA
approved Avadel’s paper NDA and on June 5, 2023, when
Avadel commercially launched Lumryz.4 Consequently, on
June 8, 2023, the parties stipulated, subject to the district
court’s approval, to allow Jazz leave to amend its com-
plaint. Stipulation to Amend Complaint, Jazz Pharms.,
Inc. v. Avadel CNS Pharms. LLC, No. 21-cv-1594 (D. Del.
June 8, 2023), ECF No. 209. Specifically, Jazz amended its
complaint to remove any allegations of “artificial”
to the FDA. § 271(e)(1) (“the safe-harbor provision” or “the
safe harbor”).
4 Because the ’782 patent is not listed in the Orange
Book for Xyrem, the filing of Jazz’s complaint did not trig-
ger a 30-month regulatory stay on the FDA’s approval of
Avadel’s paper NDA. See 21 U.S.C. § 355(c)(3)(C); see also
Oral Arg. 9:30–9:38, available at https://oralargu-
ments.cafc.uscourts.gov/default.aspx?fl=24-2274_0207202
5.mp3 (counsel for Avadel noting that “the reason we’re not
dealing with an automatic stay is we’re not dealing with an
Orange Book-listed patent here. Jazz doesn’t practice the
patent that [it’s] asserting.”).
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infringement under § 271(e)(2), replacing them with af-
firmative allegations that Avadel had and would infringe
the ’782 patent under each of § 271(a)–(c) by making and
selling the now-FDA-approved Lumryz. Compare J.A.
10167–68, with J.A. 10007. Jazz further amended its com-
plaint to remove its prayer for a permanent injunction un-
der § 271(e)(4)(B), but otherwise maintained its requests
for injunctive relief and damages against infringing activi-
ties, other than damages for acts exempted by § 271(e)(1).
Compare J.A. 10169–70, with J.A. 10008.
Following discovery and prior to trial, the parties stip-
ulated that Lumryz would infringe claim 24 of the ’782 pa-
tent if that claim was not found to be invalid. J.A. 4312.
And after a five-day trial, a jury found that Avadel had
failed to prove the invalidity of that claim. J.A. 4387–89.
The jury awarded Jazz a reasonable royalty of $233,562.83
for Avadel’s past infringement. J.A. 4390.
III
On April 12, 2024, following trial, Jazz moved for a per-
manent injunction under 35 U.S.C. § 283 seeking to pre-
vent Avadel from making, using, or selling Lumryz until
expiration of the ’782 patent, February 18, 2036.
J.A. 4545–47. Jazz proposed to exclude from the injunc-
tion, however, Avadel’s making, using, and selling Lumryz
“(a) for the patients who have been prescribed Lumryz as
of the effective date of the injunction . . . ; (b) in currently-
ongoing clinical trials and studies; (c) to update data in old
studies if necessary; and (d) to re-run necessary tests for
quality control for regulators or customers.” J.A. 4550.
And, “[f]or the avoidance of doubt,” Jazz proposed that alt-
hough Avadel “may continue to use Lumryz in currently-
ongoing clinical trials and studies . . . , [it] may not seek ap-
proval from the [FDA] for any indication that was not al-
ready part of Lumryz’s approved product labeling as of
March 4, 2024.” Id. Jazz’s motion was fully briefed, and
an oral hearing was held on June 4, 2024.
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While Jazz’s motion was pending, on August 1, 2024,
Avadel launched its REVITALYZ clinical trial, a “double-
blind, placebo-controlled, randomized withdrawal, multi-
center study of the efficacy and safety of Lumryz with an
open-label extension period in patients diagnosed with
[IH].” J.A. 7529 (citing Safety and Efficacy of [Lumryz] in
Idiopathic Hypersomnia (REVITALYZ), ClinicalTrials.gov,
https://clinicaltrials.gov/study/NCT06525077?term=NCT0
6525077&rank=1). Relevant here, an open-label extension
(“OLE”) period “allows clinical trial participants to receive
a trial drug past the formal completion of the trial, both to
gather additional safety data for submission to the FDA
and to maintain continuity of patient treatment.”
J.A. 7511–12.
On August 27, 2024, the district court granted in part
Jazz’s motion. Specifically, it granted a “limited perma-
nent injunction prohibiting Avadel from seeking approval
from the [FDA] and marketing Lumryz for the treatment
of IH.” Permanent Injunction Order, at *1. But, as Jazz
had proposed, it excluded from the injunction Avadel’s
making, using, and selling Lumryz for use “in currently-
ongoing clinical trials and studies.” Id. It further adopted
Jazz’s proposed language that, “[f]or the avoidance of
doubt, . . . while Avadel may continue to use Lumryz in
currently-ongoing clinical trials and studies . . ., Avadel
may not seek approval of Lumryz from the FDA for the
treatment of IH or for any indication that was not already
part of Lumryz’s approved product labeling as of March 4,
2024.” Id. Avadel filed a Notice of Appeal the next day.
J.A. 341.5
5 The district court also denied in part Jazz’s motion.
Specifically, the court refused to enjoin Avadel from mak-
ing, using, and selling Lumryz for the treatment of narco-
lepsy—its FDA-approved indication. See Decision, at *1.
The court found that enjoining such activities threatened a
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IV
One week later, on September 3, 2024, Avadel filed an
emergency motion in the district court to stay the injunc-
tion pending appeal, arguing that enjoining Avadel from
initiating new clinical trials and seeking approval from the
FDA to market Lumryz for the treatment of IH (or any
other indication) “overlook[ed] a crucial feature of federal
patent law”—the safe-harbor provision. J.A. 7496. Avadel
argued that, under the safe harbor, the enjoined activities
are “entirely non-infringing,” such that the injunction ex-
ceeds its lawful scope. J.A. 7502. And it told the court that
Jazz had demanded that, pursuant to the injunction,
Avadel cease enrolling new patients in its ongoing
REVITALYZ trial and “terminate the [OLE] period for
those who ha[d] already been enrolled” and prescribed
Lumryz as part of that trial. J.A. 7511. Jazz opposed the
motion, arguing that Avadel’s arguments were misplaced
because the safe harbor is an affirmative defense that
Avadel never pleaded or pursued, and that therefore had
been waived. J.A. 7542.
In a memorandum order, the district court denied
Avadel’s motion to stay the injunction. See Stay Order,
J.A. 39. In doing so, the court “[found] it pertinent to dis-
cuss and clarify the scope of conduct enjoined.” Id., J.A. 40.
It began by clarifying what activities were not covered by
the injunction. Under the injunction’s “explicit terms,” the
district court explained, Avadel may continue to make, use,
and sell Lumryz for its REVITALYZ clinical study because
that trial was initiated prior to entry of the injunction. Id.,
“substantial harm to the public interest” that outweighed
any irreparable injury to Jazz. Id. at *9. Instead, the court
determined that Jazz is entitled to a reasonable royalty for
Avadel’s ongoing sales of Lumryz for narcolepsy. Id. at *13.
Jazz does not appeal from that partial denial, so we do not
address it further.
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J.A. 40–41. It further clarified that Avadel was not en-
joined from enrolling new subjects in that already ongoing
study. Id. at 41. And finally, it stated that, “while the [Per-
manent Injunction Order] enjoins Avadel from seeking
FDA approval for IH, [it] does not enjoin Avadel from sub-
mitting information or results from ongoing studies to the
FDA.” Id.
The district court then clarified that Avadel is enjoined
from: “(1) offering open-label extensions to [REVITALYZ]
trial participants; (2) applying for FDA approval of Lumryz
for IH; and (3) initiating new clinical trials or studies after
the [Permanent Injunction Order]’s effective date.” Id.
Having clarified the specific activities precluded by the in-
junction, the court proceeded to determine whether Avadel
had made the requisite showings as to each of those activ-
ities to warrant a stay. And finding that Avadel had not
demonstrated a substantial risk of immediate and irrepa-
rable harm for any of those activities, the district court de-
nied the motion. Id.
Avadel timely amended its Notice of Appeal to include
both the Permanent Injunction Order and the Stay Order.
Jazz Pharms., No. 21-cv-1594 (D. Del. Sep. 27, 2024), ECF
No. 584. We have jurisdiction under 28 U.S.C.
§ 1292(c)(1).6
6 On October 2, 2024, a motions panel of this court
granted Avadel’s motion to stay the district court’s injunc-
tion “insofar as it enjoins ‘initiating new clinical trials or
studies,’” but declined to stay the injunction in all other re-
spects due to Avadel’s “failure to establish irreparable in-
jury.” Appeal No. 24-2274, ECF No. 30.
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D ISCUSSION
I
An injunction is a “drastic and extraordinary remedy”
rooted in well-established principles of equity. Apple Inc.
v. Samsung Elecs. Co., 735 F.3d 1352, 1359 (Fed. Cir. 2013)
(quoting Monsanto Co. v. Geertson Seed Farms, 561 U.S.
139, 165 (2010)). To show entitlement to a permanent in-
junction, a plaintiff must establish: “(1) that it has suffered
an irreparable injury; (2) that remedies available at law,
such as monetary damages, are inadequate to compensate
for that injury; (3) that, considering the balance of hard-
ships between the plaintiff and defendant, a remedy in eq-
uity is warranted; and (4) that the public interest would
not be disserved by a permanent injunction” (“the eBay fac-
tors”). eBay Inc. v. MercExchange, L.L.C., 547 U.S. 388,
391 (2006). “[D]istrict courts are frequently admonished
not to issue sweeping injunctions against potentially in-
fringing activities in patent cases, but to restrict the scope
of the injunction to the particular adjudicated infringing
activity.” Aspex Eyewear, Inc. v. Marchon Eyewear, Inc.,
672 F.3d 1335, 1344 (Fed. Cir. 2012) (collecting cases). Per-
manent injunctions of proper scope are provided for by law.
But this is not such a case.
We review the district court’s grant of a permanent in-
junction and the scope of that injunction for abuse of dis-
cretion. Joy Techs., Inc. v. Flakt, Inc., 6 F.3d 770, 772 (Fed.
Cir. 1993). “An abuse of discretion may be established by
showing that the court made a clear error of judgment in
weighing relevant factors or exercised its discretion based
upon an error of law or clearly erroneous factual findings.”
Novo Nordisk of N. Am., Inc. v. Genentech, Inc., 77 F.3d
1364, 1367 (Fed. Cir. 1996). Legal error therefore consti-
tutes an abuse of discretion. See id.
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II
For clarity and precision, we address each of the indi-
vidually enjoined activities separately. Those activities are
(1) initiating new clinical trials for Lumryz, (2) offering
open-label extensions in ongoing clinical trials, and (3) ap-
plying for FDA approval of Lumryz for IH. See Stay Order,
J.A. 41.
A. Initiating New Clinical Trials for Lumryz
In 1984, Congress enacted the Hatch-Waxman Act
with one of its purposes being “mak[ing] available more low
cost generic drugs.” H.R. Rep. No. 98-857, pt. 1, at 14
(1984), as reprinted in 1984 U.S.C.C.A.N. 2647, 2647. To
that end, Congress created the safe-harbor provision,
§ 271(e)(1), “to establish that experimentation with a pa-
tented drug product, when the purpose is to prepare for
commercial activity which will begin after a valid patent
expires, is not a patent infringement.” Id. at 45–46 (abro-
gating Roche Prods., Inc. v. Bolar Pharm. Co., 733 F.2d 858
(Fed. Cir. 1984)). Congress determined that “experimental
activity does not have any adverse economic impact on the
patent owner’s exclusivity during the life of a patent, but
prevention of such activity would extend the patent owner’s
commercial exclusivity beyond the patent expiration date.”
Id. at 46 (also emphasizing that, upon patent expiration,
“immediate competition should be encouraged”). As such,
Congress provided that, “[i]n any action for patent infringe-
ment brought under [§ 271], no injunctive or other relief
may be granted which would prohibit the making, using,
offering to sell, or selling within the United States or im-
porting into the United States of a patented invention un-
der [the safe-harbor provision, § 271(e)(1)].” 35 U.S.C.
§ 271(e)(3) (emphasis added).
The plain language and purposes of the Hatch-Wax-
man Act make it clear that enjoining Avadel from initiating
new clinical trials for Lumryz (for IH or otherwise) until
expiration of the ’782 patent is unlawful and, therefore, an
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abuse of discretion. That activity is statutorily non-infring-
ing under § 271(e)(1) and statutorily precluded from being
enjoined under § 271(e)(3). As the Supreme Court has ex-
plained, it is “apparent from the statutory text” that
§ 271(e)(1) “exempt[s] from infringement . . . all uses of pa-
tented inventions that are reasonably related to the devel-
opment and submission of any information under the
FDCA . . . necessarily includ[ing] preclinical studies of pa-
tented compounds that are appropriate for submission to
the FDA.” Merck KGaA v. Integra Lifesciences I, Ltd.,
545 U.S. 193, 202 (2005). The injunction prohibiting
Avadel from initiating new clinical trials is therefore over-
broad as a matter of law.
Resisting that conclusion, Jazz challenges that the safe
harbor provides an “affirmative defense” requiring factual
development that Avadel failed to plead or develop in the
district court such that it is waived. Jazz Br. 29–42. Jazz
argues, for example, that “Avadel presented no evidence
that each use of Lumryz in each future clinical trial” qual-
ifies for safe-harbor protection, and that “Avadel has not
proved . . . that its IH activities are solely for uses reason-
ably related to the development and submission of infor-
mation to the FDA.” Id. at 45–47. We are unpersuaded.
Jazz is correct that, in some circumstances, reliance on
the safe harbor requires factual development. E.g., Amgen
Inc. v. Hospira, Inc., 944 F.3d 1327, 1337 (Fed. Cir. 2019);
Edwards Lifesciences Corp. v. Meril Life Scis. Pvt. Ltd.,
96 F.4th 1347, 1353 (Fed. Cir. 2024). But that is because
applicability of the safe harbor typically arises in situations
where the patent owner alleges that certain past or current
activities of the defendant, activities that the defendant be-
lieves fall within the scope of the safe harbor, constitute
infringement. In those cases, then, there is a burden on
the defendant to establish in fact that the accused activities
are non-infringing under the safe harbor. And those cases
are resolved when the factfinder adjudicates that issue.
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This case, however, is factually and procedurally
unique in our safe-harbor jurisprudence. The subject of
this appeal is not whether any current or former activities
of Avadel with respect to Lumryz are infringing. Indeed,
Avadel stipulated that its manufacture, use, and sale of
Lumryz infringe the ’782 patent. Avadel therefore does not
invoke § 271(e)(1) as a defense to negate its own liability.
Instead, Avadel’s argument is that the district court’s for-
ward-looking injunction is unlawful on its face insofar as it
necessarily enjoins Avadel from making, using, and selling
Lumryz “solely for uses reasonably related to the develop-
ment and submission of information” to the FDA, i.e., non-
infringing activities, in violation of § 271(e)(3). That facial
challenge, contrary to Jazz’s position, is a purely legal in-
vocation of the safe harbor and does not require factual de-
velopment.
We therefore reject Jazz’s argument that Avadel
waived its reliance on the safe-harbor provision. At most,
Avadel forfeited its argument by unclearly developing it in
the district court. See SmithKline Beecham Corp. v. Apotex
Corp., 439 F.3d 1312, 1320 (Fed. Cir. 2006) (explaining
that a party forfeits undeveloped arguments on appeal).
But we have discretion to consider forfeited arguments, see
In re Google Tech. Holdings LLC, 980 F.3d 858, 863 (Fed.
Cir. 2020), and we exercise that discretion here where
Avadel’s argument turns entirely on a legal question.
What is more, Jazz has never alleged that any of
Avadel’s activities with respect to its future clinical trials
are infringing. Therefore, there has never been an oppor-
tunity for Avadel to develop any facts to support a safe-har-
bor defense as to those activities, let alone sufficient facts
to allow a factfinder to adjudicate that issue. Put simply,
Jazz’s argument that Avadel “presented no evidence that
each use of Lumryz in each future clinical trial” qualifies
for safe-harbor protection is premature. Jazz Br. 46 (em-
phases added). As we have explained, § 271(e)(3) “makes
clear that no injunction may issue until the § 271(e)(1)
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exception has been adjudicated and ruled out.” Eli Lilly &
Co. v. Medtronic, Inc., 915 F.2d 670, 674 (Fed. Cir. 1990),
superseded by statute on other grounds as discussed in Ro-
tec Indus., Inc. v. Mitsubishi Corp., 215 F.3d 1246, 1251
(Fed. Cir. 2000). Thus, Jazz’s additional argument that,
even if initiating new clinical trials is non-infringing, the
district court has discretion to “narrowly enjoin[]” non-in-
fringing activities “as necessary to prevent infringing con-
duct,” falls short. See Jazz Br. 57–60 (citing TiVo Inc. v.
EchoStar Corp., 646 F.3d 869, 890 n.9 (Fed. Cir. 2011) (en
banc)). Although that may be true in other contexts, Jazz’s
argument cannot be squared with the plain language of
§ 271(e)(3), which leaves no room for such discretion here.
Accordingly, we reverse the district court’s injunction
prohibiting Avadel from initiating any new clinical trials
for Lumryz as unlawfully overbroad. Reversal, as opposed
to vacatur, is appropriate here where the enjoined activi-
ties have never been accused of infringement. As such,
there is no support in the record to sustain a determination
one way or the other on whether the safe-harbor provision
applies to those activities. Cf. Eli Lilly, 915 F.2d at 674–75
(vacating permanent injunction that preemptively carved
out § 271(e)(1) activities where merits case had been re-
manded for trial on the applicability of the safe harbor to
those accused activities).
We do note that our conclusion does not necessarily
leave Jazz without recourse. If Jazz comes to believe that
Avadel is making, using, or selling Lumryz, a product ad-
judicated to be infringing, for uses other than those “rea-
sonably related to the development and submission of
information” to the FDA, Jazz is free to challenge those ac-
tivities.7 At that point, we agree that, to negate liability, it
7 We do not speculate which activities may, in light
of the district court’s refusal to enjoin Avadel from making,
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may be “incumbent upon Avadel to plead” its entitlement
to safe-harbor protection as to each of those accused activ-
ities. Jazz Br. 32. But to enjoin Avadel outright from those
activities at this juncture, before they have been adjudi-
cated to infringe, exceeds the bounds of the law.
B. Offering OLEs in Ongoing Clinical Trials
Next, we consider the scope of the injunction insofar as
it enjoins Avadel from offering OLEs to trial participants,
including those currently enrolled in the ongoing
REVITALYZ trial. See Stay Order, J.A. 41. As noted
above, OLEs allow clinical trial participants to continue
taking the drug after their trial participation is complete.
See J.A. 7512. This may be done to maintain continuity of
patient treatment and to “better characterize the safety of
a drug late in its development.” Id. (citing Expanded Ac-
cess to Investigational Drugs for Treatment Use—Questions
and Answers, U.S. Dep’t of Health & Hum. Servs. (2017),
https://www.fda.gov/media/85675/download). Pursuant to
the district court’s clarification of the injunction, see Stay
Order, J.A. 41, Avadel cannot offer this OLE period to pa-
tients enrolled in the ongoing REVITALYZ trial. As such,
those patients will be terminated from Lumryz treatment
upon the end of their participation in the trial.
The parties debate extensively on appeal the nature of
OLEs and whether Avadel’s use of OLEs is an activity pro-
tected by the safe harbor. We do not comment on those
arguments. Those arguments were not raised in the dis-
trict court until Avadel’s emergency motion to stay the in-
junction pending appeal. Therefore, the district court only
addressed that activity in the context of clarifying the scope
of the injunction—not whether those activities could or
should be enjoined in the first place pursuant to the eBay
using, or selling Lumryz for narcolepsy, be suitable for such
a claim.
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factors. Moreover, much like Avadel’s activities related to
its future clinical trials discussed above, whether Avadel’s
use of an OLE period is a safe-harbor activity is a question
of fact that has not yet been accused, let alone adjudicated.
Accordingly, because this activity has never been ac-
cused of infringement, and because “[t]he statute clearly
requires that the § 271(e)(1) issue be decided prior to the
grant of injunctive relief,” Eli Lilly, 915 F.2d at 674, we re-
verse the injunction insofar as it enjoins Avadel from offer-
ing OLEs to patients in clinical trials. Only if and when
that activity is adjudicated to fall outside the protection of
the safe harbor, and only if and when the district court
finds the eBay factors to favor an injunction, may it be per-
manently enjoined.
C. Applying for FDA Approval of Lumryz for IH
Finally, we consider whether the district court abused
its discretion by enjoining Avadel from applying for FDA
approval of Lumryz for any indication that was not part of
its label as of March 4, 2024. For the following reasons, we
vacate the injunction in this respect and remand.
Avadel argues that enjoining it from submitting an ap-
plication for FDA approval of the IH indication constituted
legal error because the Hatch-Waxman Act “makes clear
that seeking FDA approval in and of itself is not infringing
activity.” Avadel Br. 24. Avadel’s argument is two-
pronged. First, it argues that “the mere submission of an
FDA application” is not a “use” of a patented invention and
therefore not an infringement under § 271(a). Id. Alterna-
tively, it argues that, even if the submission is a “use,” the
safe harbor provides that “uses reasonably related to
the . . . submission of information” to the FDA are non-in-
fringing. Id. at 24–25. And because “[a]n application for
FDA approval is a ‘submission of information’ to the FDA,”
that application is necessarily non-infringing. Id. at 25.
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We agree that the submission of an application to the
FDA is not infringement under § 271(a). That activity is
not a making, using, offering to sell, selling, or importing
of a patented invention. And because applicability of the
safe harbor is dependent on there being a predicate infring-
ing activity (indeed, absent an infringing act, there would
be no need for safe-harbor protection), submitting an appli-
cation for FDA approval is not an activity that triggers the
safe harbor.
Although we need not reach Avadel’s alternative argu-
ment that submitting an application to the FDA, even if it
were an infringing “use,” would be protected under the safe
harbor, we briefly note that the argument rests on a mis-
reading of the statute. The “solely for uses” clause of
§ 271(e)(1) modifies the infringing act—it does not define
the infringing act itself. That is, the inquiry looks to the
alleged infringing activity—the making, using, selling, of-
fering to sell, or importing—and asks whether the purpose
of that activity was “solely for uses reasonably related to
the . . . submission of information” to the FDA. § 271(e)(1);
see Amgen, 944 F.3d at 1339. It does not follow from the
plain language that the “submission of information” itself
is non-infringing under that provision.
But concluding that the submission of an application to
the FDA is not infringement under § 271(a) does not end
the matter because that activity is infringement under
§ 271(e)(2). That section, which neither party meaning-
fully addresses on appeal, provides:
It shall be an act of infringement to submit an ap-
plication under section 505(j) of the [FDCA] or de-
scribed in section 505(b)(2) of [the FDCA] for a drug
claimed in a patent or the use of which is claimed
in a patent.
§ 271(e)(2)(A) (emphasis added). That language plainly
states that the submission of an ANDA (under section
505(j) of the FDCA) or a paper NDA (under section
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505(b)(2) of the FDCA) for a drug claimed in a patent is an
act of infringement. That understanding is consistent with
precedent (and our conclusion above) that such submis-
sions are not actual acts of infringement under § 271(a) be-
cause they are not a making, using, or selling of the
patented invention, but instead artificial acts of infringe-
ment that provide a basis for litigation. See Glaxo, Inc. v.
Novopharm, Ltd., 110 F.3d 1562, 1569 (Fed. Cir. 1997)
(“The act of infringement that gives rise to a case or contro-
versy under section 271(e)(2) has been stated to be ‘artifi-
cial,’ in the sense that a specific infringing composition has
not yet been made, used, or sold, and is thus not necessarily
available for a court to compare to the claims.” (quoting Eli
Lilly, 496 U.S. at 677)). Even Avadel admits that the sub-
mission of an ANDA under section 505(j) of the FDCA
would be “an act of artificial infringement if the purpose of
the submission is to obtain approval with respect to ‘a drug
claimed in a patent or the use of which is claimed in a pa-
tent.’” Avadel Br. 24 n.7 (quoting § 271(e)(2)(A)). Curi-
ously, however, Avadel leaves out of its recitation of the
statutory language that the submission of a paper NDA un-
der section 505(b)(2) of the FDCA is also an artificial act of
infringement when it is done for that purpose. And that is
where we observe a critical, unresolved, and unbriefed is-
sue underlying the parties’ arguments on appeal.
As noted above, Avadel’s initial submission for ap-
proval of Lumryz for the treatment of narcolepsy was a pa-
per NDA filed under § 505(b)(2) of the FDCA, 21 U.S.C.
§ 355(b)(2). See J.A. 9255, 9267. But because Jazz’s ’782
patent is not listed in the Orange Book, Avadel did not sub-
mit with its application a patent certification under
§ 355(b)(2)(A)(iv) (a “paragraph iv” certification) as to that
patent, which would have given notice to Jazz of Avadel’s
FDA filing and entitled Jazz to a 30-month stay of the
FDA’s approval of that application upon the initiation of a
lawsuit. See § 355(c)(3)(C). One way or another, even with-
out that paragraph iv notice, Jazz learned of Avadel’s filing
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and brought its claim for infringement under 35 U.S.C.
§ 271(e)(2)(A), alleging that Avadel’s submission of its pa-
per NDA constituted infringement.
At oral argument, Avadel argued for the first time that
its paper NDA for Lumryz would not trigger a claim for in-
fringement under § 271(e)(2) because the ’782 patent is not
an Orange Book patent. See Oral Arg. 12:06–12:13 (coun-
sel for Avadel arguing that Avadel’s supplemental NDA
would not trigger § 271(e)(2) because “there’s no Orange
Book-listed patent, there’s no paragraph iv certification
that would trigger [§ 271(e)(2)] infringement”). Thus, in
Avadel’s view, it is not the submission of the paper NDA
itself that triggers infringement, but the accompanying cer-
tification giving notice to a patent owner of that submis-
sion.8 Put otherwise, Avadel argues that only applications
for FDA approval that require paragraph iv certifications
against Orange Book patents trigger infringement under
§ 271(e)(2). Avadel admitted at argument that that inter-
pretation of § 271(e)(2) is “not in the text necessarily,” but
suggested that “the Supreme Court has read it to be.” See
Oral Arg. 11:57–12:05 (not citing authority). Jazz does not
appear to have taken a firm position on this issue.
Avadel is incorrect in its assertion that it is the certifi-
cation relating to an Orange Book patent that constitutes
8 We observe that this position may be consistent
with Avadel’s answer to Jazz’s original complaint, which
included an “Improper Hatch-Waxman Suit” defense, al-
leging that, based on Avadel’s paper NDA for the narco-
lepsy indication, “Jazz is not entitled to any relief under
that Statute, including a permanent injunction pursuant
to 35 U.S.C. § 271(e)(4)(B).” J.A. 10381. But because this
dispute transformed into one arising under § 271(a)–(c)
mid-litigation, upon the FDA’s approval of Lumryz, the
merits of that defense were never adjudicated.
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the artificial act of infringement. Section 271(e)(2) makes
plain that it is the submission of the application, ANDA or
paper NDA, that is the infringement. Further, the statute
provides that such submission is infringement if it seeks
approval of “a drug claimed in a patent or the use of which
is claimed in a patent.” § 271(e)(2) (emphases added). The
provision does not mention or otherwise appear to limit the
act of infringement to only Orange Book patents. Rather,
its plain language would seem to render any ANDA or pa-
per NDA submitted in the face of any existing patent that
claims the applied-for drug or its use to be an act of in-
fringement.
On the other hand, the placement of § 271(e)(2) within
the context of the Hatch-Waxman Act suggests that the
provision may only apply where the ANDA or paper NDA
seeks approval of a drug claimed in an Orange Book patent.
That interpretation would comport with Congress’s inten-
tion of triggering litigation, after notice is given to a patent
owner and regulatory approval is stayed, to hasten the in-
troduction of generic drugs to the market if the relevant
patents are found to be invalid or not infringed. Indeed,
portions of the legislative history of the Act suggest that
Congress “expect[ed] that infringement actions . . . w[ould]
only be brought in the instance described in section
271(e)(2), where a party submitting an [ANDA] certifies
that a patent is invalid or non-infringed and gives the re-
quired notice of that certification to the patent owner.”
H.R. Rep. No. 98-857, pt. 1, at 46 (emphases added). After
all, we have not been made aware of any cases before or
after the enactment of the Hatch-Waxman Act where a reg-
ulatory filing alone was held to be a patent infringement.
Nonetheless, as the issue was raised only at oral argu-
ment and not briefed, we leave it for the district court to
address in the first instance on remand, if it remains con-
tested. But the resolution of that issue may be determina-
tive in resolving the parties’ dispute about the scope of the
injunction.
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If Avadel’s submission of its paper NDA for Lum-
ryz—for the treatment of IH or any other indication—is an
act of infringement under § 271(e)(2), then the district
court’s injunction barring Avadel from seeking FDA ap-
proval of any new indications of Lumryz was unlawful.
That is because the injunction exceeds the scope of the lim-
ited remedies available to a patent owner for that artificial
act of infringement. Specifically, under § 271(e)(4), “the
only remedies” that would be available are: (1) an order set-
ting the effective date of any FDA approval of Lumryz to be
no sooner than February 18, 2036, the expiration date of
the ’782 patent; (2) an injunction preventing Avadel’s com-
mercial activities relating to Lumryz; and (3) damages for
any of Avadel’s past commercial activities relating to Lum-
ryz. § 271(e)(4)(A)–(C).9 None of those remedies permits a
court to enjoin an adjudicated infringer from applying for
additional FDA approvals of a patented drug. To conclude
otherwise would run afoul of not only the text of the stat-
ute, but also the precise purpose of the Hatch-Waxman Act
to encourage “immediate competition” upon expiration of
relevant patents. H.R. Rep. No. 98-857, at 46. If Avadel
cannot apply for approval of Lumryz until after the ’782
patent expires, Jazz will receive a de facto extension of pa-
tent term to which it is not otherwise entitled for the
amount of time it takes the FDA to consider and grant that
application. See Eli Lilly, 496 U.S. at 676.
If, however, Avadel’s submission of its paper NDA is
not an act of infringement under § 271(e)(2), then the rem-
edies available to Jazz are no longer limited by § 271(e)(4).
In that case, it was not improper for the district court to
9 The fourth remedy specified in § 271(e)(4)(D) ap-
plies only to certain cases involving the Biologics Price
Competition and Innovation Act of 2009, Pub. L. No.
111–148, §§ 7001–7003, 124 Stat. 119, 804–21 (2010). Ac-
cordingly, it is not relevant here.
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consider whether enjoining Lumryz from engaging in that
activity was warranted based on a full consideration of the
eBay factors. However, because that activity would not
constitute infringement—under either § 271(e)(2) or
§ 271(a)—to properly enjoin that activity, the district court
must have concluded that the injunction was necessary to
prevent infringement. See Johns Hopkins Univ. v. CellPro,
Inc., 152 F.3d 1342, 1367 (Fed. Cir. 1998) (explaining that
an injunction may reach non-infringing activities, but that
“[i]t is necessary . . . that the injunction prevent infringe-
ment” of a patent); accord TiVo Inc., 646 F.3d at 890 n.9.
Here, the district court enjoined Avadel from seeking
FDA approval of new indications because it found that
“Lumryz’s entrance into the IH market would undoubtedly
cause Jazz to suffer significant injury.” Decision, at *10.
Unlike the narcolepsy indication, the district court ex-
plained, “Jazz’s Xywav is the only FDA-approved treat-
ment for IH,” and therefore, “Avadel’s entrance into the
market would strip Jazz of a unique selling point critical to
growing its reputation and goodwill.” Id. That analysis is
insufficient to support the injunction at issue here.
It well may be that Jazz would be irreparably harmed
upon Lumryz’s entrance into the IH market. But entitle-
ment to an injunction requires a showing that there is a
“causal nexus” between the alleged irreparable harm and
the enjoined activity. See Apple Inc., 735 F.3d at 1359–60
(explaining that a patentee must establish “that a suffi-
ciently strong causal nexus relates the alleged harm to the
alleged infringement”). Here, the only findings to support
enjoining Avadel from seeking FDA approval relate to the
harm Jazz would suffer if Avadel were to enter the market
for the IH indication—not if Avadel were merely to apply
for FDA approval of that indication. Although Avadel’s
ability to enter the market is, in part, dependent on Avadel
seeking FDA approval, it does not follow that enjoining
Avadel’s application would be necessary to prevent in-
fringement. See Johns Hopkins Univ., 152 F.3d at 1367.
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Future infringement, e.g., commercialization of Lumryz for
IH, can only occur if and when the FDA approves Lumryz
for that indication. And any number of things may prevent
that approval from ever arriving. Avadel may decide the
financial investment in pursuing the approval does not
comport with its business prospects. Clinical trials may
fail. The district court’s analysis is simply too speculative
and tenuous to reasonably conclude from its findings that
enjoining Avadel from applying for FDA approval is neces-
sary to prevent future infringement.
For those reasons, we vacate the injunction insofar as
it bars Avadel from submitting an application for FDA ap-
proval of any indication not part of Lumryz’s approved
product label as of March 4, 2024, and we remand to the
district court. On remand, if the issue remains contested,
the district court is instructed to consider in the first in-
stance whether Avadel’s submission of a paper NDA for an
additional indication of Lumryz would be an act of infringe-
ment under 35 U.S.C. § 271(e)(2). If so, as discussed above,
the district court must conclude that that activity cannot
be enjoined. If, however, the district court determines that
that submission would not be an act of infringement, the
district court must address the eBay factors anew in ac-
cordance with this opinion before again enjoining that ac-
tivity.
CONCLUSION
We have considered the parties’ remaining arguments
and find them unpersuasive. We reverse the injunction to
the extent it enjoins Avadel from initiating new clinical tri-
als for Lumryz and from offering OLE periods to current
clinical trial participants. We vacate the injunction to the
extent it enjoins Avadel from seeking FDA approval for
new indications of Lumryz, and remand to the district
court for reconsideration of that issue in light of this opin-
ion.
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REVERSED-IN-PART, VACATED-IN-PART, AND
REMANDED
COSTS
The parties shall bear their own costs.
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