Court Opinion

ID: 9374911
Source: CourtListenerOpinion
Date Created: 2023-02-24 17:00:35.49197+00
Date Added: 2024-06-11T17:16:54.195891
License: Public Domain

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
Case: 23-1186    Document: 59      Page: 2   Filed: 02/24/2023

 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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                         AVADEL CNS PHARMACEUTICALS, LLC.

           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.
                         AVADEL CNS PHARMACEUTICALS, LLC.

 § 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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 AVADEL CNS PHARMACEUTICALS, LLC.

 (“[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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 8                            JAZZ PHARMACEUTICALS, INC. v.
                         AVADEL CNS PHARMACEUTICALS, LLC.

 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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 AVADEL CNS PHARMACEUTICALS, LLC.

 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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 10                           JAZZ PHARMACEUTICALS, INC. v.
                         AVADEL CNS PHARMACEUTICALS, LLC.

 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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 AVADEL CNS PHARMACEUTICALS, LLC.

 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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                         AVADEL CNS PHARMACEUTICALS, LLC.

 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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 14                           JAZZ PHARMACEUTICALS, INC. v.
                         AVADEL CNS PHARMACEUTICALS, LLC.

     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