Case: 20-1407    Document: 96       Page: 1   Filed: 07/31/2020




   United States Court of Appeals
       for the Federal Circuit
                     ______________________

     TAKEDA PHARMACEUTICALS U.S.A., INC.,
               Plaintiff-Appellant

                               v.

         MYLAN PHARMACEUTICALS INC.,
                Defendant-Appellee
              ______________________

                      2020-1407, 2020-1417
                     ______________________

     Appeals from the United States District Court for the
 District of Delaware in No. 1:19-cv-02216-RGA, Judge
 Richard G. Andrews.
                 ______________________

                     Decided: July 31, 2020
                     ______________________

    PORTER F. FLEMING, Haug Partners LLP, New York,
 NY, argued for plaintiff-appellant. Also represented by
 EDGAR HAUG, JONATHAN HERSTOFF, CAMILLE YVETTE
 TURNER.

     MICHAEL S. SOMMER, Wilson, Sonsini, Goodrich &
 Rosati, PC, New York, NY, argued for defendant-appellee.
 Also represented by JESSICA MARGOLIS, SHERYL SHAPIRO
 BASSIN, STU A. WILLIAMS; SHYAMKRISHNA PALAIYANUR,
 Perkins Coie LLP, Austin, TX.

    CHARLES     B.    KLEIN,   Winston    &   Strawn    LLP,
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 2                  TAKEDA PHARMACEUTICALS U.S.A. v. MYLAN
                                   PHARMACEUTICALS INC.


 Washington, DC, for amici curiae Hikma Pharmaceuticals
 International Limited, Hikma Pharmaceuticals USA, Inc.
 Also represented by DAN HOANG, Chicago, IL.
                 ______________________

 Before PROST, Chief Judge, NEWMAN and HUGHES, Circuit
                         Judges.
       Opinion for the court filed by Chief Judge PROST.
      Dissenting opinion filed by Circuit Judge NEWMAN.
 PROST, Chief Judge.
      Takeda Pharmaceuticals U.S.A., Inc. appeals the deci-
 sion of the United States District Court for the District of
 Delaware denying a preliminary injunction based on the
 court’s conclusion that Takeda failed to show that it was
 likely to succeed on the merits or that it would be irrepara-
 bly harmed absent a preliminary injunction. For the rea-
 sons described below, we affirm.
                       I. BACKGROUND
                              A
     In 2016, Takeda sued Mylan Pharmaceuticals Inc. for
 patent infringement based on Mylan’s recently submitted
 Abbreviated New Drug Application (“ANDA”) for a generic
 version of Takeda’s Colcrys® product, which is a branded
 version of the drug colchicine. Takeda alleged that Mylan
 infringed seventeen patents listed in the Food and Drug
 Administration’s Orange Book as covering Colcrys® (“Li-
 censed Patents”). See Takeda Pharm. U.S.A., Inc. v. Mylan
 Pharm. Inc., No. 1:16-cv-987-RGA (D. Del.). The parties
 ultimately resolved the litigation through a Settlement
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 TAKEDA PHARMACEUTICALS U.S.A.    v. MYLAN                    3
 PHARMACEUTICALS INC.


 Agreement and License Agreement, effective November 7,
 2017 (“License Agreement”). 1
     The License Agreement allows Mylan to sell a generic
 colchicine product on a specified date, or in the event of cer-
 tain circumstances defined in Section 1.2, on an earlier
 date. Relevant to this appeal, Section 1.2(d) of the License
 Agreement defines one such circumstance, providing that
 Mylan is entitled to launch a generic product on:
     The date that is [a specified time period] after the
     date of a Final Court Decision (as defined in Ex-
     hibit A) holding that all unexpired claims of the Li-
     censed Patents that were asserted and adjudicated
     against a Third Party are either (i) not infringed,
     or (ii) any combination of not infringed and invalid
     or unenforceable[.]
 J.A. 88. Exhibit A defines a “Final Court Decision” as “the
 entry by a federal court of a final judgment from which no
 appeal (other than a petition to the Supreme Court for a
 writ of certiorari) had been or can be taken.” J.A. 102. The
 “Licensed Patents” include the seventeen Colcrys® Orange-
 Book listed patents that Takeda asserted against Mylan.
 J.A. 103. A “Third Party” is broadly defined as a “Person
 other than a Party or an Affiliate of a Party.” J.A. 105.
     According to Section 1.10 of the License Agreement, if
 Mylan breaches Section 1.2, the parties stipulate that such
 breach “would cause Takeda irreparable harm.” J.A. 94.
 Section 5 of the License Agreement further provides that


     1  Takeda entered a similar settlement and license
 agreement with Alkem Laboratories Limited based on
 Alkem’s ANDA for its generic Colcrys® product. That
 agreement is the subject of a separate appeal, which is re-
 solved in a concurrently issued opinion. See Takeda
 Pharm. U.S.A., Inc. v. Alkem Labs. Ltd., No. 20-1545 (Fed.
 Cir.).
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 4                  TAKEDA PHARMACEUTICALS U.S.A. v. MYLAN
                                   PHARMACEUTICALS INC.


 the agreement “shall be governed and interpreted in ac-
 cordance with the laws of the State of Delaware.” J.A. 97.
                              B
     Concurrent with its litigation against Mylan, Takeda
 also pursued patent infringement claims against Hikma
 Americas Inc. and Hikma Pharmaceuticals PLC (collec-
 tively “Hikma”) based on Hikma’s colchicine product Mit-
 igare®. See Takeda Pharm. U.S.A., Inc. v. West-Ward
 Pharm. Corp., No. 1:14-cv-1268-RGA-SRF (D. Del.) (“West-
 Ward Litigation”). Unlike Mylan’s generic product, but
 like Takeda’s branded Colcrys®, Hikma received approval
 to market Mitigare® through a § 505(b)(2) New Drug Ap-
 plication. Both Colcrys® and Mitigare® are 0.6 mg colchi-
 cine products that are administered orally, and both are
 indicated for the prevention of gout. Compare J.A. 719,
 with J.A. 763.
     Initially, Takeda asserted eight of the Licensed Patents
 against Hikma in the West-Ward Litigation. But after the
 parties voluntarily dismissed with prejudice five of those
 patents according to Federal Rule of Civil Procedure
 41(a)(1)(A)(ii), only three patents remained at issue in the
 case. Ultimately, in December 2018, the district court
 granted summary judgment in favor of Hikma, holding
 that Hikma did not infringe any asserted claim of the three
 remaining Licensed Patents. See Takeda Pharm., U.S.A.,
 Inc. v. West-Ward Pharm. Corp., No. 14-1268-RGA-SRF,
 2018 WL 6521922 (D. Del. Dec. 12, 2018). The court en-
 tered its final judgment of noninfringement the same day.
 Takeda did not appeal.
                              C
      In October 2019, Mylan notified Takeda that it planned
 to “immediately start selling” a generic colchicine product
 pursuant to Section 1.2(d) of the License Agreement.
 J.A. 786. Mylan asserted that the provision had been trig-
 gered by a “judgment of noninfringement in favor of West
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 PHARMACEUTICALS INC.


 Ward Pharmaceutical Corp. et al.,” which “Takeda did not
 appeal.” Id. On November 5, 2019, Takeda responded with
 a letter, which declined to indicate whether Takeda would
 pursue legal action against Mylan prior to breach of the Li-
 cense Agreement. See J.A. 794. Mylan subsequently
 launched its generic Colcrys® product on or about Novem-
 ber 25, 2019.
      Shortly after Mylan launched its product, on December
 2, 2019, Takeda filed a complaint in the United States Dis-
 trict Court for the District of Delaware, alleging breach of
 contract and patent infringement. Several days later,
 Takeda filed a motion for preliminary injunction, seeking
 to enjoin Mylan from commercially manufacturing, offer-
 ing to sell, or selling its generic colchicine product within
 the United States. To avoid an additional emergency mo-
 tion for a temporary restraining order, the parties stipu-
 lated that pending the district court’s resolution of
 Takeda’s request for a preliminary injunction, Mylan
 would suspend further sales and distribution of its generic
 Colcrys® product.
     After full briefing and oral argument, the district court
 issued an order denying Takeda’s motion for preliminary
 injunction. Takeda Pharm. U.S.A., Inc. v. Mylan Pharm.
 Inc., No. 19-2216-RGA, 2020 WL 419488 (D. Del. Jan. 27,
 2020) (“Order”). The district court held that Takeda “failed
 to show it is likely to succeed on the merits or that it will
 suffer irreparable harm.” Id. at *1.
     With respect to Takeda’s likelihood of success on the
 merits, the district court agreed with Mylan that Sec-
 tion 1.2(d) was triggered by the West-Ward Litigation, and
 therefore that the License Agreement permits Mylan to
 launch its generic colchicine product. Id. at *2. The court
 explained that according to Section 1.2(d), the West-Ward
 Litigation had resulted in a “Final Court Decision” that
 found all asserted claims of the three patents at issue “not
 infringed.” Id. The court rejected Takeda’s argument that
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 6                   TAKEDA PHARMACEUTICALS U.S.A. v. MYLAN
                                    PHARMACEUTICALS INC.


 Section 1.2(d) was not triggered because “the district court
 had only ruled on the three patents that were still at issue,
 and not the other five that Takeda had dismissed with prej-
 udice.” Id. Looking to the language of Section 1.2(d), the
 court stated that the License Agreement applies to patent
 claims that were “asserted and adjudicated,” not to patent
 claims that were “asserted or adjudicated.” Id. (emphases
 in original). Thus, according to the district court, only the
 unexpired claims of the three patents that were asserted
 and resulted in a final decision bore any relevance to Sec-
 tion 1.2(d). Id. Furthermore, the district court noted that,
 as a practical matter, Takeda’s proposed interpretation
 would prevent Mylan from ever relying on the clause to en-
 ter the market because Takeda could always “withdraw
 one patent (or one claim on one patent),” whether through
 gamesmanship or through the normal course of litigation,
 to avoid triggering Section 1.2(d). Id. at *3.
     The district court also rejected Takeda’s argument that
 the parties only intended for Section 1.2(d) to permit
 Mylan’s entrance into the market upon a change in the sta-
 tus quo of other generic Colcrys® products, not different
 products like Mitigare®. See id. The district court disa-
 greed because an objective, reasonable third party would
 not read Section 1.2(d) to be limited to generic equivalents
 of Colcrys® to the exclusion of § 505(b)(2) products like Mit-
 igare®. See id. The district court found this to be particu-
 larly true in the context of the License Agreement, where
 Sections 1.2(b), (e), and (f) included express references to a
 “Generic Equivalent” or “Authorized Generic Products” of
 Colcrys®, showing the parties knew how to limit provisions
 of the contract to generic Colcrys® products. Id.
     As to irreparable harm, the district court found that
 Takeda had not shown that it would suffer irreparable
 harm without a preliminary injunction. Id. at *3. To prove
 irreparable harm before the district court, Takeda primar-
 ily relied on the stipulation of irreparable harm in Sec-
 tion 1.10 of the License Agreement. See id. But because
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 TAKEDA PHARMACEUTICALS U.S.A.   v. MYLAN                   7
 PHARMACEUTICALS INC.


 Takeda had not demonstrated that it was likely to show
 that Mylan had breached the License Agreement, the dis-
 trict court found that Section 1.10’s stipulation did not ap-
 ply. Without the stipulation, the court found that “[m]oney
 damages would remedy any harm Takeda” would suffer as
 a result of Mylan launching its generic product. Id. Hav-
 ing found that Takeda is unlikely to succeed on the merits
 and that it would not suffer irreparable harm, the district
 court denied Takeda’s request for a preliminary injunction.
 Id.
     The district court also denied Takeda’s request for a
 stay pending appeal but ordered that the parties maintain
 the “status quo” until the end of day on January 31, 2020
 to give Takeda “an opportunity to seek immediate relief in
 the Court of Appeals.” Id. Takeda filed its notice of appeal
 the same day as the court’s order, and Takeda’s notice was
 docketed with this court the following day on January 28,
 2020.
      Together with its notice of appeal, Takeda filed an
 emergency motion requesting an injunction pending ap-
 peal, and requesting an interim injunction pending the res-
 olution of its motion. On January 29, 2020, we granted
 Takeda’s motion for an interim injunction “to the extent
 the district court’s order that Mylan ‘maintain the status
 quo’ shall remain in effect” pending our consideration of
 Takeda’s request for an injunction pending appeal.” Order,
 No. 20-1407 (Fed. Cir. Jan. 29, 2020), ECF No. 14 at 2. Fol-
 lowing briefing by both parties, on March 23, 2020, we de-
 nied Takeda’s request for an injunction pending appeal.
 Mylan subsequently re-launched its generic Colcrys® prod-
 uct.
    We now consider the merits of Takeda’s appeal. We
 have jurisdiction pursuant to 28 U.S.C. § 1292(c)(1).
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 8                   TAKEDA PHARMACEUTICALS U.S.A. v. MYLAN
                                    PHARMACEUTICALS INC.


                         II. DISCUSSION
     Takeda appeals the district court’s denial of its prelim-
 inary injunction request. Because we agree that Takeda is
 unlikely to succeed on the merits and has not shown that
 it will be irreparably harmed in the absence of an injunc-
 tion, we affirm.
                                A
      “A preliminary injunction is an extraordinary remedy
 never awarded as of right.” Winter v. Nat. Res. Def. Coun-
 cil, Inc., 555 U.S. 7, 24 (2008). We review a district court’s
 determination to grant or deny a preliminary injunction for
 abuse of discretion, and we review the court’s findings of
 fact for clear error. Abbott Labs. v. Andrx Pharm., Inc.,
 452 F.3d 1331, 1334 (Fed. Cir. 2006). “To the extent the
 court’s decision is based upon an issue of law, we review
 that issue de novo.” Endo Pharm. Inc. v. Actavis, Inc., 746
 F.3d 1371, 1374 (Fed. Cir. 2014).
     “A plaintiff seeking a preliminary injunction must es-
 tablish [1] that he is likely to succeed on the merits, [2] that
 he is likely to suffer irreparable harm in the absence of pre-
 liminary relief, [3] that the balance of equities tips in his
 favor, and [4] that an injunction is in the public interest.”
 Winter, 555 U.S. at 20; see also Titan Tire Corp. v. Case
 New Holland, Inc., 566 F.3d 1372, 1375–76 (Fed. Cir.
 2009).
                                B
      We first consider whether the district court correctly
 determined that Takeda is unlikely to succeed on the mer-
 its. Because we agree with the district court that the final
 judgment in the West-Ward Litigation likely triggers Sec-
 tion 1.2(d) of the License Agreement, permitting Mylan to
 market its generic colchicine product, we likewise agree
 that Takeda is unlikely to succeed on the merits.
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 TAKEDA PHARMACEUTICALS U.S.A.    v. MYLAN                    9
 PHARMACEUTICALS INC.


     Contract interpretation is a question of law. See Endo
 Pharm., 746 F.3d at 1374. Because “[g]eneral contract in-
 terpretation is not within the exclusive jurisdiction of the
 Federal Circuit,” Texas Instruments Inc. v. Tessera, Inc.,
 231 F.3d 1325, 1329 (Fed. Cir. 2000), and because “[t]he
 interpretation of private contracts is ordinarily a question
 of state law,” Volt Info. Scis., Inc. v. Brd. of Trs. of Leland
 Stanford Junior Univ., 489 U.S. 468, 474 (1989), in this
 case, we apply Delaware law to interpret the License
 Agreement. Furthermore, the governing law clause of the
 License Agreement states that it will be governed by Dela-
 ware law. J.A. 97.
     “Delaware adheres to an objective theory of contracts,”
 and therefore the “contract’s construction should be that
 which would be understood by an objective, reasonable
 third party.” Exelon Generation Acquisitions, LLC v. Deere
 & Co., 176 A.3d 1262, 1267 (Del. 2017) (internal citations
 omitted). “If a contract is unambiguous, extrinsic evidence
 may not be used to interpret the intent of the parties, to
 vary the terms of the contract, or to create an ambiguity.”
 Id.
      On appeal, Takeda argues that the district court erred
 in determining that it is unlikely to succeed because the
 district court misinterpreted the License Agreement. Spe-
 cifically, Takeda argues that the district court ignored the
 term “all” in Section 1.2(d), and by giving effect only to the
 word “adjudicated,” the court “read out the requirement
 that Section 1.2(d) is triggered only when ‘all’ asserted pa-
 tents are adjudicated.” Appellant’s Br. 22. Takeda there-
 fore argues that the West-Ward Litigation—which did not
 include a holding of noninfringement, invalidity, or unen-
 forceability for five of the Licensed Patents—does not trig-
 ger Section 1.2(d) because “not all the claims that were
 asserted in that case were held to be not infringed . . . by a
 Final Court Decision.” Appellant’s Br. 16 (emphases
 added); see also id. at 22–23. Takeda further argues that
 the district court’s interpretation of the License Agreement
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 10                  TAKEDA PHARMACEUTICALS U.S.A. v. MYLAN
                                    PHARMACEUTICALS INC.


 is counter to the parties’ intent to limit Section 1.2(d) to
 changes in status quo with respect to generic colchicine
 products, which do not include Hikma’s Mitigare® product
 at the center of the West-Ward Litigation. Appellant’s
 Br. 19–21.
       The plain language of Section 1.2(d), however, does not
 support Takeda’s interpretation. See Osborn ex rel. Osborn
 v. Kemp, 991 A.2d 1153, 1159–60 (Del. 2010) (“When the
 contract is clear and unambiguous, we will give effect to
 the plain-meaning of the contract’s terms and provisions.”).
 Section 1.2(d) clearly states that Mylan may launch its ge-
 neric colchicine product following “a Final Court Decision
 . . . holding that all unexpired claims of the Licensed Pa-
 tents that were asserted and adjudicated against a Third
 Party are . . . not infringed.” J.A. 88 (emphases added).
 Section 1.2(d) does not require, as Takeda suggests, a Final
 Court Decision for all claims that have merely been as-
 serted during the course of the litigation. Instead, the
 plain language of the clause requires a Final Court Deci-
 sion for all claims that are both asserted and adjudicated.
 See United States v. Geiser, 527 F.3d 288, 298-99 (3d Cir.
 2008) (interpreting the word “and” in a statute to require
 an applicant “meet two sets of requirements” because “[t]he
 usual meaning of the word ‘and’. . . is conjunctive” (citation
 omitted)).
     We reject Takeda’s interpretation because it would ren-
 der meaningless the “adjudication” requirement in Sec-
 tion 1.2(d). See Osborn, 991 A.2d at 1159 (“We will not read
 a contract to render a provision or term ‘meaningless or il-
 lusory.’” (citation omitted)). According to Takeda, we need
 only determine whether the claim was asserted to deter-
 mine whether a claim must be included in the Final Court
 Decision required for Section 1.2(d) to apply. But as the
 district court recognized, reading the License Agreement in
 this way leads to the absurd result that Takeda could pre-
 vent Mylan from ever relying on the clause by simply as-
 serting and then withdrawing a claim from a proceeding.
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 TAKEDA PHARMACEUTICALS U.S.A.   v. MYLAN                   11
 PHARMACEUTICALS INC.


 See Order at *3. We decline to allow for such gamesman-
 ship, particularly where doing so would be contrary to the
 plain language of the License Agreement.
     Takeda’s arguments in support of its interpretation are
 unpersuasive. Takeda argues that reading Section 1.2(d)
 to require that claims are both asserted and adjudicated
 renders superfluous the terms “all” and “asserted,” and
 gives effect only to the term “adjudicated” because all adju-
 dicated claims must have been asserted. Takeda is wrong.
 Takeda ignores that Section 1.2(d) requires that the claims
 be “asserted and adjudicated against a Third Party.”
 J.A. 88 (emphasis added). To be sure, not all adjudicated
 claims have necessarily been asserted against a third
 party. 2 The plain language of Section 1.2(d) thus requires
 that “all” claims relevant to the clause meet two conditions:
 namely “all” claims must be “asserted and adjudicated.” A
 claim that was asserted but not adjudicated, or adjudicated
 but not asserted, is not relevant to Section 1.2(d).
     Takeda additionally argues that the parties intended
 Section 1.2 of the License Agreement to permit Mylan to
 enter the market with its generic Colcrys® product either
 on a particular date or at an earlier date if there was a
 change in the status quo of either the market or the Li-
 censed Patents. Takeda’s argument fails for at least two
 reasons. First, and critically, the parties’ “intent” to limit
 Mylan’s market entrance under Section 1.2(d) based on
 changes in the generic Colcrys® market is absent from the
 language of the provision and would not be understood by
 an objective, reasonable third party. See Exelon Genera-
 tion, 176 A.3d at 1267. Section 1.2(d) makes no mention of


     2   For example, as Takeda acknowledged during oral
 argument, claims may be adjudicated but not asserted
 against a Third Party through a declaratory judgment ac-
 tion. Oral Arg. at 10:19–56, No. 20-1407 (Fed. Cir. June 8,
 2020), http://www.cafc.uscourts.gov/node/26299.
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 12                  TAKEDA PHARMACEUTICALS U.S.A. v. MYLAN
                                    PHARMACEUTICALS INC.


 generic Colcrys® products. Nor is Section 1.2(d) otherwise
 limited to court proceedings related to particular types of
 products. Indeed, Takeda admits that Section 1.2(d) “does
 not expressly exclude a litigation that does not involve a
 generic Colcrys® product.” Appellant’s Br. 19. For these
 reasons, it would be improper to import such a limitation
 into the License Agreement. See Lorillard Tobacco Co. v.
 Am. Legacy Found., 903 A.2d 728, 739 (Del. 2006) (Though
 “the role of a court is to effectuate the parties’ intent” when
 interpreting a contract, in so doing, the court is “con-
 strained by a combination of the parties’ words and the
 plain meaning of those words.”).
     Second, while Takeda asks us to consider the context
 in which the parties entered the License Agreement, such
 context fails to support Takeda’s interpretation. Takeda
 argues that the parties included Section 1.2(d) specifically
 to address a change in the status quo of the Licensed Pa-
 tents, since other clauses, including Sections 1.2(b) and
 1.2(f), were intended to address the change in status quo of
 the generic colchicine market. See Appellant’s Br. 25.
 Takeda thus asserts that Section 1.2(d) does not include
 any reference to “Generic Equivalents” like Sections 1.2(b)
 and 1.2(f) because it serves a different purpose. 3 See id.
 Takeda’s argument fails. Not only does Takeda’s argument
 show, as the district court recognized, that the parties
 knew how to limit Mylan’s market entry based on the



      3   The License Agreement defines “Generic Equiva-
 lent” to mean “a pharmaceutical product that has received
 FDA approval for marketing in the Territory pursuant to
 an ANDA approved pursuant to 21 U.S.C. § 355(G) or an
 application under 21 U.S.C. § 355(b)(2), each as an AB-
 rated generic version of the Colcrys product for which Col-
 crys is the Reference Listed Drug and which is covered by
 the Takeda NDAs, but excluding any Authorized Generic
 Product.” J.A. 104.
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 PHARMACEUTICALS INC.


 product at issue, see Order at *3, but it also confirms that
 the parties did not intend to so limit Section 1.2(d). Fur-
 thermore, the West-Ward Litigation, which resulted in a
 change in the status quo of three Licensed Patents, is ex-
 actly a circumstance Takeda asserts Section 1.2(d) was in-
 tended to cover. Accordingly, even to the extent it is proper
 to allow the subjective intent of the parties to control our
 interpretation of the License Agreement, Takeda has not
 shown that the parties intended to exclude the West-Ward
 Litigation from Section 1.2(d). 4
     When the License Agreement is correctly construed,
 there can be no dispute that the final judgment in the
 West-Ward Litigation triggered Section 1.2(d). During the
 course of the West-Ward Litigation, Takeda asserted eight
 Licensed Patents against Hikma, a Third Party. Of the
 eight asserted patents, the parties agree that five Licensed
 Patents were not adjudicated because the parties stipu-
 lated to the voluntarily dismissal of those patents. Indeed,
 Takeda has repeatedly and unequivocally stated that the



     4    We observe that the West-Ward Litigation was
 pending at the time the parties entered the License Agree-
 ment. There is no question therefore that Takeda knew
 litigation related to the Licensed Patents may involve a
 product that is not a generic Colcrys® product. To the ex-
 tent Takeda intended to exclude the West-Ward Litigation
 from the License Agreement, Takeda was free to express
 that intent in the agreement. We cannot rewrite the Li-
 cense Agreement because Takeda failed to communicate its
 intent. See Exelon Generation, 176 A.3d at 1267; Lorillard
 Tobacco, 903 A.2d at 739; see also JFE Steel Corp. v. ICI
 Ams., Inc., 797 F.Supp. 2d 452, 469 (D. Del. 2011) (“[W]hen
 two sophisticated parties bargain at arm’s length and enter
 into a contract, the presumption is even stronger that the
 contract’s language should guide the Court's interpreta-
 tion.”).
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 14                  TAKEDA PHARMACEUTICALS U.S.A. v. MYLAN
                                    PHARMACEUTICALS INC.


 five voluntarily dismissed patents were not adjudicated.
 Appellant’s Br. 24 (“With respect to the remaining five pa-
 tents, there was no adjudication at all. . . .”); Appellant’s
 Reply Br. 7 (“[T]he claims of five of the patents that were
 ‘asserted’ in the West-Ward Litigation were never adjudi-
 cated.”); see also, e.g., Appellant’s Br. 18–19, 25; Appel-
 lant’s Reply Br. 1, 8–9; J.A. 3195, 3857–58. 5 The parties
 further agree that all unexpired claims of the remaining
 three Licensed Patents were adjudicated when the district


      5  We note that Takeda switched course at oral argu-
 ment, suggesting that it had argued that the five patents
 voluntarily dismissed from the West-Ward Litigation were
 “adjudicated” according to Section 1.2(d) of the License
 Agreement. See, e.g., Oral Arg. at 4:40–5:05. Takeda’s as-
 sertions at oral argument are clearly contradicted by the
 record, and its new interpretation of the License Agree-
 ment is waived. See Prism Techs. LLC v. Spring Spectrum
 L.P., 849 F.3d 1360, 1373 n.5 (Fed. Cir. 2017); see also
 SmithKline Beecham Corp. v. Apotex Corp., 439 F.3d 1312,
 1319 (Fed. Cir. 2006). But even had Takeda properly pre-
 served this argument, we would not be persuaded by it.
 The plain language of Section 1.2(d)—which describes a
 “holding” resulting from a Final Court Decision—contem-
 plates an adjudication that is a substantive decision resolv-
 ing an issue of infringement, validity, or enforceability of
 the Licensed Patents. Section 1.2(d) includes no suggestion
 that an asserted patent is adjudicated through a self-exe-
 cuting, voluntary dismissal according to Federal Rule of
 Civil Procedure 41(a)(1)(A), which does not resolve any is-
 sue on the merits. To be sure, “[a] stipulated dismissal
 with prejudice . . . ordinarily should not itself count as the
 actual adjudication of any issue.” Levi Strauss & Co. v.
 Abercrombie & Fitch Trading Co., 719 F.3d 1367, 1373
 (Fed. Cir. 2013) (quoting 18A Charles Alan Wright & Ar-
 thur R. Miller, Federal Practice and Procedure § 4435 (2d
 ed. 2002)).
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 TAKEDA PHARMACEUTICALS U.S.A.    v. MYLAN                 15
 PHARMACEUTICALS INC.


 court entered summary judgment of noninfringement for
 those claims. See Appellant’s Br. 24; Appellee’s Br. 18–19.
 Takeda did not appeal the court’s noninfringement deci-
 sion. Thus, the West-Ward Litigation triggers Section
 1.2(d) because all unexpired claims of the three Licensed
 Patents that were “asserted and adjudicated” against a
 Third Party were held to be not infringed in a Final Court
 Decision. 6
    Accordingly, we agree with the district court that
 Takeda is unlikely to succeed on the merits.
                              C
      We now turn to consider whether the district court cor-
 rectly determined that Takeda failed to show that it will be
 irreparably harmed without a preliminary injunction. As
 it did before the district court, Takeda primarily relies on
 Section 1.10 of the License Agreement to prove irreparable
 harm. By its terms, Section 1.10 only offers Takeda a basis



     6    While the parties agreed during briefing that the
 five voluntarily dismissed patents in the West-Ward Liti-
 gation were not “adjudicated,” we recognize that amici cu-
 riae Hikma Pharmaceuticals USA, Inc. and Hikma
 Pharmaceuticals International Ltd. (“amici”), who are not
 parties to the License Agreement, argue that those five pa-
 tents were “adjudicated.” See generally Brief for Hikma
 Pharm. USA, Inc. and Hikma Pharm. Int’l Ltd. as Amici
 Curiae Supporting Appellants, No. 20-1407 (Fed. Cir. Mar.
 26, 2020), ECF No. 67. Amici argue that the West-Ward
 Litigation does not trigger Section 1.2(d) because only
 three of the eight “asserted and adjudicated” Licensed Pa-
 tents were held to be not infringed, invalid, or unenforcea-
 ble. Id. We are not persuaded by this argument, see supra
 § II(B) n.5, and in any case, decline to adopt an interpreta-
 tion of the License Agreement that was not briefed by any
 party to it.
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 16                  TAKEDA PHARMACEUTICALS U.S.A. v. MYLAN
                                    PHARMACEUTICALS INC.


 for establishing irreparable harm in the event Mylan
 breached Section 1.2. J.A. 94; see also Oral Arg. at 17:32–
 18:03 (Takeda’s counsel agreeing that Section 1.10 is pred-
 icated on a breach in the License Agreement). Because we
 conclude that it is unlikely Takeda can show that Mylan
 breached the License Agreement, see supra § II(B), we fur-
 ther conclude that Section 1.10 is not useful for establish-
 ing irreparable harm in this case. 7
     Without the stipulation of irreparable harm, Takeda
 makes no credible assertion that it cannot be compensated
 by monetary damages. Takeda states generally that each
 sale by Mylan reduces the units sold by Takeda and that
 Mylan’s sustained launch “likely will cause” Takeda to in-
 cur irreversible price erosion and long-term loss of market
 share. Appellant’s Br. 36. Though we have recognized that
 price erosion and loss of market share may in some cases
 be irreparable injuries, see Aria Diagnostics, Inc. v. Se-
 quenom, Inc., 726 F.3d 1296, 1304 (Fed. Cir. 2013), a bare
 assertion of irreparable harm is never sufficient to prove
 such harm or justify the “extraordinary remedy” of a pre-
 liminary injunction, see Winter, 555 U.S. at 24. 8 See also
 Frank’s GMC Truck Ctr., Inc. v. Gen. Motors Corp., 847



      7  Because we conclude that it is unlikely that Mylan
 breached the License Agreement, and therefore conclude
 that the stipulation of irreparable harm according to Sec-
 tion 1.10 is not applicable in this case, we need not consider
 the significance of the stipulation to the irreparable harm
 analysis.
      8  We recognize that Takeda cited one email showing
 that a single customer had switched from purchasing Par
 Pharmaceutical’s authorized generic product to Mylan’s ge-
 neric product. See Appellant’s Br. 36 (citing J.A. 809). This
 email, standing alone, offers no probative evidence that
 Takeda would be irreparably harmed and says nothing at
 all about Takeda’s price erosion or change in market share.
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 TAKEDA PHARMACEUTICALS U.S.A.    v. MYLAN                 17
 PHARMACEUTICALS INC.


 F.2d 100, 102–03 (3rd Cir. 1988) (“The availability of ade-
 quate monetary damages belies a claim of irreparable in-
 jury. . . . [S]ince Frank’s GMC has failed to articulate and
 adduce proof of actual or imminent harm which cannot oth-
 erwise be compensated by money damages, it has failed to
 sustain its substantial burden of showing irreparable
 harm”). Takeda’s nonspecific and unsupported assertion
 that Mylan’s sales “likely will cause” irreparable harm falls
 far short of establishing that irreparable harm has oc-
 curred, or will likely occur, absent a preliminary injunc-
 tion.
    Accordingly, we agree with the district court that
 Takeda has not shown that it would be irreparably harmed
 absent a preliminary injunction.
                              D
      Because we agree with the district court that Takeda
 failed to show that it is likely to succeed on the merits or
 that it would be irreparably harmed absent a preliminary
 injunction, we conclude that the district court did not abuse
 its discretion in denying Takeda’s request for a preliminary
 injunction.
                        CONCLUSION
     We have considered Takeda’s remaining arguments
 and find them unpersuasive. For the foregoing reasons,
 the district court’s denial of Takeda’s request for a prelim-
 inary injunction is affirmed.
                        AFFIRMED
Case: 20-1407    Document: 96       Page: 18    Filed: 07/31/2020




    United States Court of Appeals
        for the Federal Circuit
                   ______________________

      TAKEDA PHARMACEUTICALS U.S.A., INC.,
                Plaintiff-Appellant

                               v.

          MYLAN PHARMACEUTICALS INC.,
                 Defendant-Appellee
               ______________________

                    2020-1407, 2020-1417
                   ______________________

     Appeals from the United States District Court for the
 District of Delaware in No. 1:19-cv-02216-RGA, Judge
 Richard G. Andrews.
                   ______________________
 NEWMAN, Circuit Judge, dissenting.
     This appeal is from the district court’s denial of injunc-
 tive relief, despite the explicitly agreed provision for an im-
 mediate injunction on breach of the License Agreement. I
 respectfully dissent, for judicial refusal to enforce settle-
 ment terms violates fundamental principles of contract law
 and commerce, and negates the strong public policy favor-
 ing settlement of litigation on agreed terms.
     The settlement agreement provides for an im-
     mediate injunction
    Takeda Pharmaceuticals U.S.A., Inc. (“Takeda”) and
 Mylan Pharmaceuticals Inc. (“Mylan”) settled the infringe-
 ment suit that arose from Mylan’s Abbreviated New Drug
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 2                   TAKEDA PHARMACEUTICALS U.S.A. v. MYLAN
                                    PHARMACEUTICALS INC.


 Application (“ANDA”) for FDA approval of the generic
 equivalent to Takeda’s Colcrys® product (colchicine 0.6 mg
 tablets) for treatment of gout flares and familial Mediter-
 ranean fever. Mylan states that its generic counterpart is
 the “AB grade” equivalent of Colcrys®.
      The infringement settlement included the grant of li-
 censes to Takeda’s seventeen patents on the production,
 formulation, and use of colchicine, as listed in the FDA’s
 Orange Book; the last of the Takeda patents expires in
 2029. The License Agreement grants Mylan the licensed
 entry of its generic Colcrys® counterpart on a specified
 date, with provision for earlier entry on occurrence of any
 of several accelerating events defined in the License Agree-
 ment. The License Agreement states that breach by Mylan
 constitutes irreparable harm and is subject to immediate
 injunction. The Settlement Agreement and incorporated
 License Agreement were executed on November 7, 2017.
     On November 25, 2019, Mylan launched its generic
 counterpart to Colcrys®, stating that an accelerating event
 had occurred. Takeda immediately filed this suit for in-
 fringement and breach of contract, and moved the district
 court to enter the agreed injunction. The district court
 granted a brief stay, and passed the issue to the Federal
 Circuit. We granted a brief stay, but on March 23, 2020,
 this court lifted the stay, although the proposed hearing
 had not yet occurred. Mylan then launched its generic
 counterpart.
     We heard argument on the requested injunction on
 June 8, 2020, and my colleagues now hold that the acceler-
 ating event cited by Mylan had indeed occurred. I cannot
 agree, for the cited event relates to a different product of a
 different provider having a different FDA approval for dif-
 ferent uses, and is not a generic counterpart of Colcrys®.
 That product (brand name Mitigare®) and the then ongo-
 ing litigation is not mentioned in the License Agreement as
 possibly providing an accelerating event. Mitigare® had
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 TAKEDA PHARMACEUTICALS U.S.A.   v. MYLAN                   3
 PHARMACEUTICALS INC.


 been FDA-approved and marketed since 2014, Takeda had
 been in litigation concerning Mitigare® since 2014, and
 this court in that litigation held in 2015 that Takeda was
 not likely to succeed in establishing infringement—as was
 duly confirmed. 1 The termination of those proceedings
 cannot reasonably be deemed an accelerating event for
 Mylan’s generic Colcrys® entry.
     In contrast, in the case at hand, Mylan had conceded
 infringement and validity, and as a condition of the settle-
 ment and the license-assured generic entry, Mylan had
 agreed that irreparable harm would result from breach of
 specified agreement provisions, and that specific enforce-
 ment is appropriate, as set forth in ¶ 1.10 of the License
 Agreement:
     1.10. Specific Enforcement. Takeda shall be enti-
     tled to specific enforcement of the terms and condi-
     tions set forth in Paragraphs 1.2 and 1.4 of this
     License Agreement, and shall be entitled to imme-
     diate injunctive relief to prevent Mylan from mar-
     keting the Mylan ANDA product in breach of
     Paragraphs 1.2 and 1.4 of this License Agreement.
     Mylan acknowledges that marketing the Mylan
     ANDA Product in breach of Paragraph 1.2 of this
     License Agreement would cause Takeda irrepara-
     ble harm.



     1   Takeda Pharm. U.S.A., Inc. v. West-Ward Pharm.
 Corp., 72 F. Supp. 3d 539, 549 (D. Del. 2014) (denying pre-
 liminary injunction); id., 785 F.3d 625, 630–34 (Fed. Cir.
 2015) (affirming that Takeda is not likely to succeed on its
 infringement claim); id., No. 14-1268-RGA-SRF (D. Del.
 June 4, 2018) (Dkt. No. 377) (dismissal with prejudice of
 five unadjudicated patents); id., No. 14-1268-RGA-SRF,
 2018 WL 6521922 (D. Del. Dec. 12, 2018) (judgment of non-
 infringement of three patents).
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 4                   TAKEDA PHARMACEUTICALS U.S.A. v. MYLAN
                                    PHARMACEUTICALS INC.


 License Agreement at 8. This enforcement provision em-
 bodies the parties’ agreement concerning the balance of
 harms. Takeda points out that if it were to turn out that
 the requested injunction were wrongfully granted, Mylan
 could be made whole by the injunction bond required by
 Fed. R. Civ. P. 65(c); whereas if the injunction were wrong-
 fully denied Takeda could not be made whole from the mar-
 ket impact of Mylan’s entry. See Aria Diagnostics, Inc. v.
 Sequenom, Inc., 726 F.3d 1296, 1304–05 (Fed. Cir. 2013)
 (price erosion and loss of market share can be irreparable
 injuries). Thus Takeda argues that “[t]he balance of hard-
 ships favors an injunction because it would simply main-
 tain the status quo.” Takeda Br. 37 (quoting Temsa Ulasim
 Araclari Sanayi Ve Ticaret A.S. v. CH Bus Sales, LLC, No.
 CV 18-698-RGA, 2018 WL 4179456, at *3 (D. Del. Aug. 31,
 2018)).
     Takeda points out that Mylan agreed that the Mylan
 ANDA Product would “infringe one or more of the claims of
 the Licensed Patents” and that the Licensed Patents are
 “valid and enforceable.” License Agreement at 7 (¶ 1.8(a)).
 The License Agreement’s provision for injunctive relief was
 a negotiated condition of the settlement, balancing
 Takeda’s relinquishing of Hatch-Waxman benefits, see
 21 U.S.C. § 355(j)(5)(B)(iii).
     Delaware precedent is clear that “contractual stipula-
 tions as to irreparable harm alone suffice to establish that
 element for the purpose of issuing preliminary injunctive
 relief.” Cirrus Holding. Co. v. Cirrus Indus., Inc., 794 A.2d
 1191, 1209 (Del. Ch. 2001). See also TP Group-CI, Inc. v.
 Vetecnik, No. CV 16-00623-RGA, 2016 WL 5864030, at *2
 (D. Del. Oct. 6, 2016) (granting preliminary injunction
 where “Defendant agreed to ‘a remedy of . . . injunctive or
 other relief in order to enforce or prevent any violations’ of
 the restrictive covenants”) (ellipsis in original).
    This court has previously recognized that the Supreme
 Court has ruled that: “Irreparable harm, not adequately
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 TAKEDA PHARMACEUTICALS U.S.A.   v. MYLAN                    5
 PHARMACEUTICALS INC.


 compensable at law, may exist even if there is evidence
 that, for example, the patent owner is ‘willing[] to license
 its patent’.” Tex. Advanced Optoelectronic Sols., Inc. v.
 Renesas Elecs., Am., Inc., 895 F.3d 1304, 1331 (Fed. Cir.
 2018) (quoting eBay Inc. v. MercExchange, L.L.C., 547 U.S.
 388, 393 (2006)) (alteration in original); see also Amgen Inc.
 v. Apotex Inc., 827 F.3d 1052, 1060, 1066 (Fed. Cir. 2016)
 (holding that because “[t]he parties stipulated that [plain-
 tiff] will be irreparably harmed if [defendant] enters the
 market,” the courts should “grant [] a preliminary injunc-
 tion without addressing [preliminary-injunction] factors”).
     In refusing to enforce this agreed condition of the set-
 tlement, the court negates both judicial and public interest.
 See Hemstreet v. Spiegel, Inc., 851 F.2d 348, 350 (Fed. Cir.
 1988) (“The law strongly favors settlement of litigation,
 and there is a compelling public interest and policy in up-
 holding and enforcing settlement agreements voluntarily
 entered into.”).
     The court also negates the public interest in upholding
 the integrity of contracts. See TP Group-CI, 2016 WL
 5864030, at *3 (“The public interests at issue in this case
 are enforcing private contracts.”). And the court departs
 from its role in achieving stability through judicial process.
     The accelerating condition in ¶ 1.2(d) is not
     met by the Mitigare® litigation
     The License Agreement specifies events that could ac-
 celerate the fixed date of licensed entry of Mylan’s generic
 counterpart of Colcrys®. These events all concern other
 providers of generic Colcrys®, licensed and unlicensed.
 Mylan states that ¶ 1.2(d) authorizes the Mylan launch in
 November 2019:
     1.2. Generic Entry Dates. Mylan shall be entitled
     to make, use, import, market, offer for sale, sell,
     and distribute the Mylan ANDA Product during
     the period beginning on the first to occur of the
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 6                  TAKEDA PHARMACEUTICALS U.S.A. v. MYLAN
                                   PHARMACEUTICALS INC.


     following (each, a “Generic Entry Date”) and con-
     tinuing until the expiration of the last to expire of
     the Licensed Patents:
                           ***
     (d) The date that is [confidential] after the date of
     a Final Court Decision (as defined in Exhibit A)
     holding that all unexpired claims of the Licensed
     Patents that were asserted and adjudicated
     against a Third Party are either (i) not infringed,
     or (ii) any combination of not infringed and invalid
     or unenforceable.
 License Agreement at 2 (confidential matter omitted) (em-
 phasis in original).
     Mylan states that the conditions of ¶ 1.2(d) were met
 by litigation between Takeda and West-Ward Pharmaceu-
 tical Corp. on a different colchicine product, Mitigare®. As
 observed ante, Mitigare® had been marketed since 2014,
 with FDA approval based on a different NDA from a differ-
 ent producer, for different uses than Colcrys®. It is undis-
 puted that Mitigare® is not deemed an FDA equivalent of
 Colcrys®. And although Takeda had attempted to assert a
 few of its colchicine patents against Mitigare®, the attempt
 had failed. See n.1, ante.
     Nonetheless, my colleagues now hold that Takeda’s un-
 successful litigation against Mitigare® was an accelerating
 event to enable Mylan to market its generic counterpart of
 Colcrys®. This is not a reasonable interpretation of
 ¶ 1.2(d). Takeda points out that the litigation on Mit-
 igare® had been proceeding since 2014, yet is not men-
 tioned in the Settlement and License Agreements as an
 accelerating event for Mylan’s generic counterpart of Col-
 crys®.
     Courts “should be most chary about implying a contrac-
 tual protection when the contract could easily have been
 drafted to expressly provide for it.” Oxbow Carbon &
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 TAKEDA PHARMACEUTICALS U.S.A.   v. MYLAN                   7
 PHARMACEUTICALS INC.


 Minerals Holdings, Inc. v. Crestview-Oxbow Acquisition,
 LLC, 202 A.3d 482, 507 (Del. 2019). Takeda cannot rea-
 sonably be assumed to have intended to tie entry of the
 Mylan generic to the Mitigare® litigation, for rulings ad-
 verse to Takeda had occurred in 2015, before the Colcrys®
 litigation against Mylan had begun.
     “When interpreting a contract, the role of [the] court is
 to effectuate the parties’ intent.” Lorillard Tobacco Co. v.
 Am. Legacy Found., 903 A.2d 728, 739 (Del. 2006). It is not
 reasonable to hold that Takeda would have agreed to the
 spin that my colleagues place on ¶ 1.2(d). My colleagues’
 interpretation of the Settlement and License Agreements
 to authorize Mylan’s generic launch based on ¶ 1.2(d), ac-
 companied by judicial withholding of the contracted rem-
 edy for agreed irreparable harm, are not appropriate. I
 respectfully dissent.
