Case: 23-1186 Document: 59 Page: 1 Filed: 02/24/2023
United States Court of Appeals
for the Federal Circuit
______________________
JAZZ PHARMACEUTICALS, INC.,
Appellant
v.
AVADEL CNS PHARMACEUTICALS, LLC,
Appellee
______________________
2023-1186
______________________
Appeal from the United States District Court for the
District of Delaware in No. 1:21-cv-00691-GBW, Judge
Gregory Brian Williams.
______________________
Decided: February 24, 2023
______________________
STEVEN J. HOROWITZ, Sidley Austin LLP, Chicago, IL,
argued for plaintiff-appellant. Also represented by
GABRIEL P. BRIER, FRANK CHARLES CALVOSA, FRANCIS
DOMINIC CERRITO, ELLYDE R. THOMPSON, Quinn Emanuel
Urquhart & Sullivan, LLP, New York, NY.
GABRIEL K. BELL, Latham & Watkins LLP, Washing-
ton, DC, argued for defendant-appellee. Also represented
by CHARLES S. DAMERON, SARAH ELIZABETH PROPST, AUDRA
SAWYER; KENNETH G. SCHULER, MARC NATHAN ZUBICK,
Chicago, IL; KIRA ALEXIS DAVIS, KATHERINE MCNUTT, Mor-
rison & Foerster LLP, Los Angeles, CA; DARALYN JEANNINE
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2 JAZZ PHARMACEUTICALS, INC. v.
AVADEL CNS PHARMACEUTICALS, LLC.
DURIE, REBECCA EMILY WEIRES, San Francisco, CA; DANIEL
M. SILVER, McCarter & English, LLP, Wilmington, DE.
DAVID BOOKBINDER, Niskanen Center, Inc., Washing-
ton, DC, for amici curiae Elianan Bookbinder, Robin Feld-
man, Brian Mahn, Niskanen Center, Public Interest
Patent Law Institute.
______________________
Before LOURIE, REYNA, and TARANTO, Circuit Judges.
LOURIE, Circuit Judge.
Jazz Pharmaceuticals, Inc. (“Jazz”) appeals from an or-
der of the United States District Court for the District of
Delaware granting a motion for an injunction brought by
Avadel CNS Pharmaceuticals, Inc. (“Avadel”). See Jazz
Pharms., Inc. v. Avadel CNS Pharms., LLC, No. 21-cv-
00691,
2022 WL 17084371 (D. Del. Nov. 18, 2022) (“Deci-
sion”). The injunction directed Jazz to take measures to
delist U.S. Patent 8,731,963 (“the ’963 patent”) from the
U.S. Food and Drug Administration’s (“the FDA’s”) Ap-
proved Drug Products with Therapeutic Equivalence Eval-
uations publication, more colloquially known as the
“Orange Book.” For the following reasons, we lift our stay
of the injunction and affirm.
BACKGROUND
Jazz holds an approved New Drug Application (“NDA”)
for the narcolepsy drug Xyrem®. J.A. 1445. Xyrem’s active
ingredient is sodium gamma-hydroxybutyrate (“GHB”),
which is also known as sodium oxybate.
Id. GHB exerts a
heavily sedating effect, which is theorized to grant deep-
ened nighttime sleep, resulting in improved daytime wake-
fulness. GHB is prone to heavy misuse and is infamously
known as a date-rape drug. Given that misuse, the FDA
conditioned approval of Jazz’s NDA upon development of
Risk Evaluation and Mitigation Strategies (“REMS”),
which include protocols that must be followed prior to
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prescribing or dispensing Xyrem.
Id. Xyrem’s REMS orig-
inally restricted distribution to a single-pharmacy system,
although the FDA waived that requirement in 2017. J.A.
5660.
The ’963 patent relates to Jazz’s single-pharmacy dis-
tribution system, which controls access to abuse-prone pre-
scription drugs prescribed to narcolepsy patients through
a central pharmacy and computer database by tracking
prescriptions, patients, and prescribers. Representative
claims 1 and 6 are presented below:
1. A computer-implemented system for
treatment of a narcoleptic patient with a pre-
scription drug that has a potential for misuse,
abuse or diversion, comprising:
one or more computer memories for stor-
ing a single computer database having a
database schema that contains and inter-
relates prescription fields, patient fields,
and prescriber fields;
said prescription fields, contained within
the database schema, storing prescrip-
tions for the prescription drug with the po-
tential for abuse, misuse or diversion,
wherein the prescription drug is sold or
distributed by a company that obtained
approval for distribution of the prescrip-
tion drug;
said patient fields, contained within the
database schema, storing information suf-
ficient to identify the narcoleptic patient
for whom the company’s prescription drug
is prescribed;
said prescriber fields, contained within the
database schema, storing information suf-
ficient to identify a physician or other pre-
scriber of the company’s prescription drug
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4 JAZZ PHARMACEUTICALS, INC. v.
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and information to show that the physi-
cian or other prescriber is authorized to
prescribe the company’s prescription drug;
a data processor configured to:
process a database query that operates
over all data related to the prescription
fields, prescriber fields, and patient
fields for the prescription drug; and
reconcile inventory of the prescription
drug before the shipments for a day or
other time period are sent by using said
database query to identify information
in the prescription fields and patient
fields;
wherein the data processor is config-
ured to process a second database
query that identifies that the narcolep-
tic patient is a cash payer and a physi-
cian that is interrelated with the
narcoleptic patient through the schema
of the single computer database;
said identifying that the narcoleptic pa-
tient is a cash payer by said second da-
tabase query being an indicator of a
potential misuse, abuse or diversion by
the narcoleptic patient and being used
to notify the physician that is interre-
lated with the narcoleptic patient
through the schema of the single com-
puter database.
’963 patent at col. 8 l. 39–col. 9 l.13 (emphasis added).
6. The system of claim 1 wherein the prescrip-
tion drug comprises gamma hydroxyl butyr-
ate (GHB).
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Id. col. 9 ll. 27–28.
Under the Hatch-Waxman Act (“the Act”), when a drug
developer files an NDA, information on each patent “for
which a claim of patent infringement could reasonably be
asserted” must be submitted to the FDA if the patent
claims either (i) the drug submitted for approval, or a for-
mulation or composition thereof, or (ii) “a method of using
such drug for which approval is sought or has been granted
in the application.”
21 U.S.C. § 355(b)(1)(A)(viii). For “pa-
tents that claim a method of use, the applicant must sub-
mit information only on those patents that claim
indications or other conditions of use for which approval is
sought or has been granted in the NDA.”
21 C.F.R.
§ 314.53(b)(1). The FDA publishes that information in the
Orange Book, arming the patent owner with the ability to
trigger a presumptive, thirty-month suspension of the
FDA’s approval of a competitive product.
In 2014, Jazz listed the ’963 patent in the Orange Book
as covering a method of using Xyrem. In 2017, three of the
’963 patent’s 28 claims were found unpatentable in an inter
partes review proceeding. See Amneal Pharms. LLC v.
Jazz Pharms., Inc., No. IPR2015-01903,
2017 WL 1096638
(P.T.A.B. Mar. 22, 2017). The remaining claims expired in
December 2022. Because Jazz received a grant of pediatric
exclusivity, however, the ’963 patent prevents the FDA
from approving follow-on products until June 2023. Deci-
sion at *1; J.A. 6350.
The Orange Book was intended to meet the conflicting
goals of generic applicants who wish to market approved
products via an abbreviated approval pathway and holders
of NDAs who own patents claiming approved products and
their uses. See H.R. Rep. No. 98-857, pt. 1, at 14−15, 27−28,
32−33 (1984), reprinted in 1984 U.S.C.C.A.N. at 2647−48,
2660−61, 2665−66,
1984 WL 37416 (Leg. Hist.); see also
21 U.S.C. § 355(j) (describing Abbreviated New Drug Ap-
plications (“ANDAs”));
id. § 355(b)(2) (describing
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6 JAZZ PHARMACEUTICALS, INC. v.
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§ 505(b)(2)1 NDAs, which differ from stand-alone NDAs in
that at least some of the information required for approval
comes from studies not conducted by or for the applicant or
for which the applicant has a right of reference or use). Un-
der the Act, a § 505(b)(2) applicant must file a certification
with respect to each patent listed in the Orange Book that
claims the drug or method of using the drug for which the
applicant seeks approval. See
21 U.S.C. § 355(b)(2)(A).
In December 2020, Avadel submitted an NDA for GHB-
based drug FT218, along with amendments pursuant to
§ 505(b)(2) and a proposed REMS. Unlike Xyrem, which
requires the patient to wake up a few hours into the night
to ingest a second dose, FT218 is dosed once nightly. Deci-
sion at *1. FT218’s REMS also uses multiple pharmacies
and databases for ensuring proper drug handling. Despite
these differences, and the fact that Avadel had filed an
NDA, not an ANDA, the FDA required Avadel to file a cer-
tification regarding the ’963 patent’s single-pharmacy sys-
tem. Jazz subsequently sued Avadel for infringement of
the ’963 patent. Avadel contemporaneously sued the FDA,
alleging that it violated the Administrative Procedure Act
(“APA”) by requiring certification over the ’963 patent. No-
tably, the FDA does not verify that submitted patents ac-
tually meet statutory listing criteria, nor does the FDA
proactively remove improperly listed patents. See Apotex,
Inc. v.
Thompson, 347 F.3d 1335, 1347 (Fed. Cir. 2003)
1 This number refers to the original section number
from the Federal Food, Drug, and Cosmetic Act of 1938,
Pub. L. No. 75-717 (codified as amended at
21 U.S.C. § 301
et seq.) (“FDCA”), which has been superseded by
21 U.S.C.
§ 355(b)(2). The industry continues to refer to this type of
abbreviated application using the original FDCA section
number. We will also.
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(“[T]he FDA’s . . . duties with respect to Orange Book list-
ings are purely ministerial.”).
Another remedy for an improper listing is for an ac-
cused infringer to counterclaim when it is sued, seeking an
order requiring the patent owner to correct or delete a list-
ing under
21 U.S.C. § 355(c)(3)(D)(ii)(I) for NDA filers and
under § 355(j)(5)(C)(ii)(I) for ANDA filers. Avadel’s suit
against the FDA was accordingly dismissed after the dis-
trict court identified that § 355(c)(3)(D)(ii)(I) provided
Avadel with a separately available and adequate remedy
for its alleged harms. See Avadel CNS Pharms., LLC v.
Becerra, No. 1:22-cv-02159,
2022 WL 16650467, at *6−9
(D.D.C. Nov. 3, 2022).
Avadel thus responded to Jazz’s infringement asser-
tions with a counterclaim seeking delisting of the ’963 pa-
tent for failure to claim a drug or method of use. In
evaluating the counterclaim, the district court found that,
as a matter of claim construction, the ’963 patent claims a
system and thus does not claim an approved method of use.
The district court subsequently ordered Jazz to ask the
FDA to delist the ’963 patent. Jazz filed a notice of appeal
and moved the district court and this court to stay the in-
junction pending appeal. On November 29, 2022, we issued
a temporary stay pending resolution of the concurrent dis-
trict court motion. After the district court denied Jazz’s
stay motion on December 5, 2022, we extended the stay un-
til the issues on appeal could be evaluated by this court on
the merits. We have jurisdiction under
28 U.S.C.
§ 1292(c)(1).
DISCUSSION
We review a district court’s grant of a permanent in-
junction for abuse of discretion. Novo Nordisk A/S v. Car-
aco Pharm. Lab’ys, Ltd.,
688 F.3d 766, 767 (Fed. Cir. 2012).
An abuse of discretion may be established by showing that
the court either made a clear error of judgment in weighing
relevant factors, or exercised its discretion based on an
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error of law or on findings that were clearly erroneous. Joy
Techs., Inc. v. Flakt, Inc.,
6 F.3d 770, 772 (Fed. Cir. 1993).
Jazz contends that the district court abused its discre-
tion in finding that the ’963 patent is not a method-of-use
patent for listing and delisting purposes under the FDCA.
It further contends that, even if the ’963 patent was not a
method-of-use patent, the court abused its discretion in de-
termining that § 355(c)(3)(D)(ii)(I) provides a delisting
remedy. We address each argument in turn.
I.
First, we consider whether the district court erred in
determining that the ’963 patent is not a method-of-use pa-
tent under the FDCA. Jazz asserts that this inquiry in-
volves asking two questions: (1) what does the patent
claim, and (2) is the patented invention either “the drug for
which the application was approved” or “an approved
method of using the drug”? We address each question in
turn.
A.
We first address whether the district court erred in de-
termining what the ’963 patent claims in the context of a
listing/delisting inquiry. Jazz contends that patent law
does not provide the correct framework for determining
whether a patent should be listed in the Orange Book. Ap-
pellant’s Br. at 27 (“[T]he disputed phrase in the FDCA is
not directed to a patent-law question at all[.]”); id. at 29
(“[T]he Orange Book listing rules codified in the FDCA
have nothing to do with . . . patent-law problems.”).
The listing requirements set forth in
21 U.S.C. § 355(b)
concern whether, inter alia, a patent “claims a method of
using [the] drug for which approval is sought or has been
granted in the application.” Similarly, the listing require-
ments set forth in
21 C.F.R. § 314.53(b)(1) concern patents
that “claim[] the drug or a method of using the drug,” set-
ting forth additional requirements “[f]or patents that claim
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a method of use” and for when “the method(s) of use
claimed by the patent do[] not cover an indication or other
approved condition of use in its entirety.” An inquiry into
whether a patent may be properly listed or delisted from
the Orange Book therefore clearly requires a determina-
tion of what that patent claims.
Jazz has acknowledged that analyzing a patent in that
context involves asking the question, “what does the patent
claim,” and that the answer should be derived using the
tools and framework of patent law, including claim con-
struction. Appellant’s Reply Br. at 4. It therefore seems
undisputed that these statutes and regulations involve de-
termining what a patent claims and that this determina-
tion raises issues of patent law. Apotex, 347 F.3d at 1344;
Caraco Pharm. Lab’ys, Ltd. v. Novo Nordisk A/S,
566 U.S.
399, 405 (2012).
Jazz further asserts that “what the ’963 patent claims
turns out to be largely uncontroversial,” describing the
claims as reciting “elements of a REMS-based procedure to
ensure that Xyrem® can be safely prescribed by doctors and
safely used by patients. Avadel does not appear to disa-
gree.” Appellant’s Reply Br. at 5; see also Appellant’s Br.
at 6 (“The ’963 patent, properly construed, claims a
method.”); id. at 26 (“In short, the patent claims a
method.”); id. at 55−58. Avadel, of course, does disagree.
Appellee’s Br. at 52−55. We do also.
Claim construction is a question of law that we review
de novo. Cybor Corp. v. FAS Techs., Inc.,
138 F.3d 1448,
1454 (Fed. Cir. 1998) (en banc). “It is a ‘bedrock principle’
of patent law that ‘the claims of a patent define the inven-
tion[,] which the patentee is entitled . . . to exclude.’” Phil-
lips v. AWH Corp.,
415 F.3d 1303, 1312 (Fed. Cir. 2005) (en
banc) (quoting Innova/Pure Water, Inc. v. Safari Water Fil-
tration Sys., Inc.,
381 F.3d 1111, 1115 (Fed. Cir. 2004)); see
also Vitronics Corp. v. Conceptronic, Inc.,
90 F.3d 1576,
1582 (Fed. Cir. 1996) (“[W]e look to the words of the claims
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themselves . . . to define the scope of the patented inven-
tion.”).
The district court determined that the ’963 patent
claims recite systems, not methods. Decision at *2−3. Jazz
contends that the word “system” as it appears in the ’963
patent claims is, essentially, a synonym for “method.” Ap-
pellant’s Br. at 56−58. But method claims require the per-
formance of steps; claims that describe physical
components of a whole are system, or apparatus, claims.
See Finjan, Inc. v. Secure Computing Corp.,
626 F.3d 1197,
1204 (Fed. Cir. 2010); In re Kollar,
286 F.3d 1326, 1332
(Fed. Cir. 2002) (noting the “distinction between a claim to
a product, device, or apparatus, all of which are tangible
items, and a claim to a process, which consists of a series
of acts or steps”).
Each of the ’963 patent’s three independent claims de-
scribes a “computer-implemented system” that comprises
“one or more computer memories” and a “data processor.”
’963 patent at col. 8 l. 39−col. 9 at l. 13 (independent claim
1);
id. col. 10 l. 27−col. 11. l. 6 (independent claim 23);
id.
col. 11 l. 7−col. 12 l. 10 (independent claim 24). As the dis-
trict court correctly analyzed in its Markman Order, these
claims recite “an assemblage of components,” defining a
system. J.A. 5723. Jazz has not identified any description
in the patent specification or prosecution history to alter
that conclusion. The claims to a system comprising com-
puter memories and a data processor are not claims to a
method.
That the claimed systems can be used in the course of
treating patients suffering from narcolepsy does not alter
the fact that these are system claims. See MasterMine Soft-
ware, Inc. v. Microsoft Corp.,
874 F.3d 1307, 1315−16 (Fed.
Cir. 2017) (finding that the inclusion of active verbs and
other functional language describing the capabilities of a
claimed system does not transform a system claim into a
method claim); see also HTC Corp. v. IPCom GmbH & Co.,
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667 F.3d 1270, 1277 (Fed. Cir. 2012). We therefore find
that the claims of the ’963 patent were properly construed
by the district court as system claims, not method claims.
B.
We next turn to whether the system claimed in the ’963
patent is “an approved method of using the drug” under
21 U.S.C. § 355(c)(2) and § 355(c)(3)(D)(ii)(I).
According to Jazz, FDA regulation
21 C.F.R.
§ 314.53(b)(1), which describes listing patents that “claim
conditions of use,” informs the analysis of whether a patent
claims “an approved method of using the drug” under
§ 355. Jazz contends that this regulation yields a broader
definition of “method” than permitted by the language of
patent law and that this broader definition encompasses
the claims of the ’963 patent. More specifically, it contends
that Xyrem prescribers were bound to follow the approved
REMS; that is, the use of Xyrem, including using it to treat
patients with narcolepsy, was conditioned on following the
REMS. Because Xyrem’s approved REMS involved the sin-
gle pharmacy system that is described in the ’963 patent,
the ’963 patent describes a listable condition of use for
which approval had been granted in the NDA. Jazz thus
contends that the district court erred by ending its analysis
after construing the ’963 patent claims as system claims,
rather than further inquiring into whether § 314.53(b)(1)
nevertheless allows these system claims to be listed as
method-of-use claims.
Avadel responds in part by asserting that Jazz forfeited
this argument. We need not address forfeiture because we
conclude that, regardless of forfeiture, Jazz misreads the
regulation describing method-of-use patents. Section
314.53 does not broaden the term “method” such that recit-
ing a condition of use turns a system patent into a listable
method-of-use patent. Rather, this regulation narrows
that category of listable patents to those that (1) claim
methods of use, wherein (2) those methods of use are
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directly relevant to the NDA in question. See
21 C.F.R.
§ 314.53(b)(1) (“For patents that claim a method of use, the
applicant must submit information only on those patents
that claim indications or other conditions of use for which
approval is sought or has been granted in the NDA.”). The
fact that the ’963 patent claims recite a system that was,
at least prior to 2017, implicated in a condition of using
Xyrem, does not disturb the determination that the claims
do not recite a listable method of use, which makes this
regulatory provision inapplicable.
Jazz also points to subsections of
21 U.S.C. § 355 that
use the phrase “conditions of use,” in an attempt to estab-
lish that this term is inclusive of all patents claiming ele-
ments of an approved REMS. Appellant’s Br. at 34−36. We
are not persuaded. The subsections to which Jazz points
(e.g., § 355(d)(5), 355(e)(5), and 355(j)(2)) describe condi-
tions of use evaluated for efficacy, implicating “relevant sci-
ence,” “clinical investigations,” as well as “establishing
effectiveness” and determining whether a “new drug can be
expected to have the same therapeutic effect as the listed
drug when administered” according to the approved “con-
ditions of use prescribed, recommended, or suggested in the
labeling.” The scope of “conditions of use” in those provi-
sions, however, does not expand the meaning of “method of
using the drug” in the statutory provision at issue here,
which must take its meaning from the patent laws.
Jazz asserts that, to the extent these listing statutes
are ambiguous, deference should be given to the FDA’s in-
terpretation reflected in regulation § 314.53 under Chev-
ron, U.S.A., Inc. v. Natural Resource Defense Council, Inc.,
467 U.S. 837 (1984). As explained above, we do not find
§ 314.53 to be an interpretation of the distinct statutory
delisting provision at issue here, which we think must be
interpreted to borrow the patent-law meaning of “method”
in its reference to claiming methods of using a drug. More-
over, even if we thought the delisting language ambiguous
as to that question, which we do not, Chevron deference
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cannot be given here because the FDA has not definitively
answered the question whether REMS patents more
broadly should or can be listed in the Orange Book. Alt-
hough the FDA has opened several notice-and-comment in-
quiries into whether REMS patents belong in the Orange
Book, it has never proclaimed an official agency stance on
that issue, instead proclaiming that “its duties with respect
to Orange Book listings are purely ministerial.” Apotex,
347 F.3d at 1347; see also J.A. 3986 n.34 (“Consistent with
its ministerial role, FDA has not evaluated what the ’963
patent actually covers or whether the [method] use code
published in the Orange Book accurately reflects what is
covered by the ’963 patent.”).
Avadel also highlights that the FDA only requires list-
ing patents “for which a claim of patent infringement could
reasonably be asserted,” and that Congress explicitly pro-
hibited companies from using REMS requirements to
“block or delay” ANDA and § 505(b)(2) approvals.
21 U.S.C. § 355-1(f)(8). Although § 355-1(f)(8) does not ex-
pressly provide that a REMS patent may not be asserted
against potential infringers, Avadel suggests that listing a
REMS patent would allow a patent owner to “block or de-
lay” ANDA and § 505(b)(2) filers in violation of that stat-
ute. Appellee’s Br. at 46; see also Appellant’s Br. at 10
(recognizing that “submission of an application under Sec-
tion 505(b)(2) for a drug claimed in a patent or the use of
which is claimed in a patent listed in the Orange Book is a
statutory act of infringement”). Because we find that the
district court did not err in concluding that the ’963 patent
must be delisted, we need not address Avadel’s broader ar-
guments about REMS patents, more generally.
II.
We finally consider Jazz’s argument that
21 U.S.C.
§ 355(c)(3)(D)(ii)(I) is not available to provide Avadel with
a delisting remedy for the ’963 patent.
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Jazz asserts that, in 2014, the regulatory framework
permitted Jazz to list the ’963 patent, which, it says, at a
minimum fell into a category of patents neither required
nor forbidden to be listed. According to Jazz, because it
was permissive to list the ’963 patent in 2014,
§ 355(c)(3)(D)(ii)(I) does not provide Avadel with the power
to request an order to delist it now. We disagree.
As the district court correctly analyzed, the delisting
statute does not require us to consider whether the patent
holder violated the law by listing the patent in the first in-
stance. It simply provides that those accused of infringing
a listed patent may request an order requiring the patent
holder to correct or delete listings for patents that do not
claim the drug or a method of using the drug. As the ’963
patent claims neither and has been asserted in a patent
infringement action against Avadel, § 355(c)(3)(D)(ii)(I)
provides Avadel with a delisting remedy. The district court
therefore correctly ordered Jazz to seek delisting of the ’963
patent from the Orange Book.
CONCLUSION
We have considered Jazz’s remaining arguments and
find them unpersuasive. For the foregoing reasons, we af-
firm and lift our stay of the injunction requiring Jazz to ask
the FDA to delist the ’963 patent. As the original date to
comply with the injunction has expired, we modify the in-
junction insofar as restarting the 14-day period for compli-
ance prescribed by
21 C.F.R. § 314.53(f)(2)(i) to be within
14 days of this decision.
AFFIRMED
