Case: 21-2369 Document: 51 Page: 1 Filed: 02/08/2022
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`United States Court of Appeals
`for the Federal Circuit
`______________________
`
`NIPPON SHINYAKU CO., LTD.,
`Plaintiff-Appellant
`
`v.
`
`SAREPTA THERAPEUTICS, INC.,
`Defendant-Appellee
`______________________
`
`2021-2369
`______________________
`
`Appeal from the United States District Court for the
`District of Delaware in No. 1:21-cv-01015-LPS, Judge
`Leonard P. Stark.
`______________________
`
`Decided: February 8, 2022
`______________________
`
`WILLIAM R. PETERSON, Morgan, Lewis & Bockius LLP,
`Houston, TX, argued for plaintiff-appellant. Also repre-
`sented by CHRISTOPHER JOHN BETTI, MARIA DOUKAS,
`KRISTA VINK VENEGAS, AMANDA SCOTT WILLIAMSON, Chi-
`cago, IL; AMY M. DUDASH, Wilmington, DE.
`
` MICHAEL J. FLIBBERT, Finnegan, Henderson, Farabow,
`Garrett & Dunner, LLP, Washington, DC, argued for de-
`fendant-appellee. Also represented by AARON GLEATON
`CLAY; CHARLES E. LIPSEY, J. DEREK MCCORQUINDALE,
`Reston, VA; ALISSA KEELY LIPTON, Boston, MA.
` ______________________
`
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`NIPPON SHINYAKU CO., LTD. v. SAREPTA THERAPEUTICS, INC.
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`
`Before NEWMAN, LOURIE, and STOLL, Circuit Judges.
`LOURIE, Circuit Judge.
`Nippon Shinyaku Co., Ltd. (“Nippon Shinyaku”) ap-
`peals from the decision of the United States District Court
`for the District of Delaware denying its motion for a pre-
`liminary injunction. See Nippon Shinyaku Co.v. Sarepta
`Therapeutics, Inc., No. 21-cv-1015, 2021 WL 4989489 (D.
`Del. Oct. 25, 2021) (“Decision”); see also J.A. 5–6. For the
`reasons provided below, we reverse the decision of the dis-
`trict court, and remand for entry of a preliminary injunc-
`tion.
`
`BACKGROUND
`I. The Mutual Confidentiality Agreement
`On June 1, 2020, Nippon Shinyaku and Sarepta Ther-
`apeutics, Inc. (“Sarepta”) executed a Mutual Confidential-
`ity Agreement (“MCA”). J.A. 508–16. As stated in the
`MCA, the purpose of the agreement was for the parties “to
`enter into discussions concerning the Proposed Transac-
`tion,” which the MCA defined as “a potential business rela-
`tionship relating to therapies for the treatment of
`Duchenne Muscular Dystrophy.” J.A. 508–09.
`The MCA established a “Covenant Term,” which was
`“the time period commencing on the Effective Date and
`ending upon twenty (20) days after the earlier of: (i) the
`expiration of the Term, or (ii) the effective date of termina-
`tion.” J.A. 509. Section 6 of the MCA contained a mutual
`covenant not to sue, whereby each party agreed that during
`the Covenant Term it:
`shall not directly or indirectly assert or file any le-
`gal or equitable cause of action, suit or claim or oth-
`erwise initiate any litigation or other form of legal
`or administrative proceeding against the other
`Party . . . in any jurisdiction in the United States
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`or Japan of or concerning intellectual property in
`the field of Duchenne Muscular Dystrophy.
`J.A. 512 (MCA § 6.1). Section 6 further stated:
`For clarity, this covenant not to sue includes, but is
`not limited to, patent infringement litigations, de-
`claratory judgment actions, patent validity chal-
`lenges before the U.S. Patent and Trademark
`Office or Japanese Patent Office, and reexamina-
`tion proceedings before the U.S. Patent and Trade-
`mark Office . . . .
`Id. (emphasis added).
`As noted, the covenant not to sue was time limited and
`applied only during the Covenant Term. Id. Importantly,
`the MCA also included a forum selection clause to govern
`patent and other intellectual property disputes between
`the parties after the expiration of the Covenant Term. The
`forum selection clause in Section 10 of the MCA states in
`relevant part:
`[T]he Parties agree that all Potential Actions
`arising under U.S. law relating to patent in-
`fringement or invalidity, and filed within two (2)
`years of the end of the Covenant Term, shall be
`filed in the United States District Court for
`the District of Delaware and that neither Party
`will contest personal jurisdiction or venue in the
`District of Delaware and that neither Party will
`seek to transfer the Potential Actions on the
`ground of forum non conveniens.
`J.A. 513–14 (MCA § 10) (emphases added). “Potential Ac-
`tions” is defined in Section 1 of the MCA as “any patent or
`other intellectual property disputes between [Nippon
`Shinyaku] and Sarepta, or their Affiliates, other than the
`EP Oppositions or JP Actions, filed with a court or ad-
`ministrative agency prior to or after the Effective Date
`in the United States, Europe, Japan or other countries in
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`NIPPON SHINYAKU CO., LTD. v. SAREPTA THERAPEUTICS, INC.
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`connection with the Parties’ development and commercial-
`ization of therapies for Duchenne Muscular Dystrophy.”
`J.A. 509 (MCA § 1) (emphases added).
`The Covenant Term ended on June 21, 2021, at which
`point the two-year forum selection clause in Section 10 of
`the MCA took effect. Yet, on June 21, 2021—the same day
`the Covenant Term ended—Sarepta filed seven petitions
`for inter partes review (“IPR”) at the Patent Trial and Ap-
`peal Board (“the Board”).
`II. Proceedings in the District of Delaware
`On July 13, 2021, Nippon Shinyaku filed a complaint
`in the U.S. District Court for the District of Delaware as-
`serting claims against Sarepta for breach of contract, de-
`claratory judgment of noninfringement and invalidity with
`respect to Sarepta’s patents, and infringement of Nippon
`Shinyaku’s patents. See J.A. 475. In its breach of contract
`claim, Nippon Shinyaku alleged that Sarepta breached the
`MCA by filing seven IPR petitions, which “directly contra-
`venes the MCA’s forum selection clause, which requires
`that Sarepta and Nippon Shinyaku bring any such patent
`challenges in the United States District Court for the Dis-
`trict of Delaware.” J.A. 475–76. In conjunction with its
`complaint, Nippon Shinyaku filed a motion for a prelimi-
`nary injunction asking the court to enjoin Sarepta from
`proceeding with its IPR petitions and to require that
`Sarepta withdraw the petitions. See J.A. 861.
`On September 24, 2021, the district court denied Nip-
`pon Shinyaku’s motion for a preliminary injunction.
`J.A. 5–6. Referencing the four well-established prelimi-
`nary injunction factors, the court stated:
`Nippon Shinyaku has failed to persuade the Court
`that it is likely to succeed on the merits, that it will
`suffer cognizable irreparable harm in the absence
`of extraordinary preliminary relief, that the
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`balance of harms tips in its favor, or that the public
`interest warrants the relief that it seeks.
`J.A. 6. The court concluded by noting that “[i]n due course,
`the Court will issue a memorandum that more fully ex-
`plains its reasoning.” Id.
`On October 25, 2021, the district court issued its mem-
`orandum order explaining its reasoning for denying Nip-
`pon Shinyaku’s preliminary injunction motion. The court
`focused the bulk of its analysis on the first preliminary in-
`junction factor, explaining three primary reasons why Nip-
`pon Shinyaku “has not shown a reasonable probability that
`Sarepta breached the mutual confidentiality agreement.”
`Decision, 2021 WL 4989489, at *2.
`The district court’s first reason was based on a per-
`ceived “tension” that would exist between Sections 6 and
`10 of the MCA if the forum selection clause were inter-
`preted to preclude IPRs. Id. The court reasoned that,
`“[a]lthough Sections 6 and 10 implicate different time peri-
`ods, it would be odd if Section 6 expressly deferred the fil-
`ing of IPR petitions for one year and twenty days only for
`them to be impliedly delayed for two additional years,
`likely making them time-barred and never available.” Id.
`(emphases in original). Thus, the court stated, “[t]he best
`reading of Section 6 is that the parties intended to allow
`IPRs to proceed after the Covenant Term expired.” Id.
`The district court’s second reason was based on other
`language in Section 10 of the MCA. The court acknowl-
`edged that “Section 10 obliquely refers to IPR proceedings
`through its mention of ‘Potential Actions,’ which is defined
`to include proceedings before administrative agencies such
`as the PTAB.” Id. at *3. But, the court reasoned, “[r]ead
`in full context, however, Section 10 applies only to cases
`filed in federal court.” Id. The court emphasized Sec-
`tion 10’s discussion of patent infringement disputes, venue
`transfers on the basis of forum non conveniens, and con-
`testing of venue and personal jurisdiction, all of which
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`NIPPON SHINYAKU CO., LTD. v. SAREPTA THERAPEUTICS, INC.
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`relate to federal district court litigation and are categori-
`cally inapplicable to IPR proceedings at the Board. Id. The
`court thus concluded that, “while the definition of ‘Poten-
`tial Actions’ in Section 1 literally encompasses IPRs, the
`use of that term in Section 10 is best understood as limited
`to cases in federal district court.” Id.
`The district court’s third reason was based on the prac-
`tical effects of interpreting Section 10’s forum selection
`clause as precluding IPRs for two years following the Cov-
`enant Term. In light of the timing of Nippon Shinyaku’s
`complaint for patent infringement in this case, the court
`noted that “[i]f Sarepta is forced to wait until June 2023 [to
`file IPR petitions], as Nippon Shinyaku insists, then its
`IPR petitions will be time-barred” under 35 U.S.C. § 315(b).
`Id. The court found that “the [MCA] as a whole does not
`evince a shared expectation and intent that Sarepta was
`waiving its right to file IPR petitions.” Id.
`The district court then turned to the remaining prelim-
`inary injunction factors. For the second factor, the court
`found that “Nippon Shinyaku has also failed to show that
`it will suffer irreparable harm if the [c]ourt does not grant
`a preliminary injunction.” Id. The court essentially found
`that Nippon Shinyaku’s irreparable harm arguments fell
`with its contract interpretation arguments regarding the
`forum selection clause. Id. (“[T]his argument depends on
`the faulty assumption that Nippon Shinyaku contracted it-
`self out of that potential situation.”). Similarly, with re-
`spect to the third and fourth preliminary injunction
`factors—the balance of hardships and public interest—the
`court found that Nippon Shinyaku’s arguments “depend,
`yet again, on the flawed presumption that Sarepta’s IPR
`petitions cannot be filed until June 21, 2023.” Id. at *4.
`Thus, the court concluded that “Nippon Shinyaku did not
`meet its burden on any of the factors it must establish in
`order to obtain a preliminary injunction.” Id.
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`III. The Instant Appeal
`Nippon Shinyaku filed this appeal on September 29,
`2021—five days after the district court’s original order
`denying the preliminary injunction motion, and a month
`before the district court issued its order explaining its rea-
`soning. Nippon Shinyaku immediately moved for expe-
`dited briefing on October 1, 2021, and then filed its opening
`brief on October 4, 2021. After the district court issued its
`memorandum order explaining its reasoning, Sarepta filed
`its responsive brief on November 2, 2021 and Nippon
`Shinyaku filed its reply on November 9, 2021.
`On January 10, 2022, Nippon Shinyaku submitted a
`letter pursuant to Fed. R. App. P. 28(j) advising us that the
`Board granted institution in two of the seven IPR proceed-
`ings that Nippon Shinyaku seeks to enjoin. We held argu-
`ment in the case the following day on January 11, 2022,
`during which counsel for Nippon Shinyaku advised us that
`the deadlines for the Board to issue institution decisions in
`the remaining IPR proceedings were approaching. As of
`January 13, 2022, the Board has granted institution in all
`seven IPRs at issue in this case.
`Because Nippon Shinyaku appeals from an interlocu-
`tory order of the district court in a case in which a party
`has asserted a claim arising under an Act of Congress re-
`lating to patents, we have jurisdiction under 28 U.S.C.
`§ 1292(c)(1). See also 28 U.S.C. § 1292(a)(1); 28 U.S.C.
`§ 1295(a)(1).
`
`DISCUSSION
`I
`We generally review a denial of a preliminary injunc-
`tion using the law of the regional circuit, here the Third
`Circuit. See Murata Mach. USA v. Daifuku Co., 830 F.3d
`1357, 1363 (Fed. Cir. 2016) (citing Trebro Mfg., Inc. v. Fire-
`fly Equip., LLC, 748 F.3d 1159, 1165 (Fed. Cir. 2014)).
`“However, the Federal Circuit has itself built a body of
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`precedent applying the general preliminary injunction con-
`siderations to a large number of factually variant patent
`cases, and gives dominant effect to Federal Circuit prece-
`dent insofar as it reflects considerations specific to patent
`issues.” Id. (quoting Trebro, 748 F.3d at 1165). Both the
`Federal Circuit and the Third Circuit review a denial of a
`preliminary injunction for abuse of discretion. See id.; see
`also Adams v. Freedom Forge Corp., 204 F.3d 475, 484 (3d
`Cir. 2000). Under that standard, we review underlying
`questions of law de novo. Antares Pharma, Inc. v. Medac
`Pharma Inc., 771 F.3d 1354, 1357 (Fed. Cir. 2014).
`District courts generally consider four factors in evalu-
`ating a motion for a preliminary injunction: (1) whether the
`moving party has shown a reasonable likelihood of success
`on the merits; (2) whether the moving party will suffer ir-
`reparable harm in the absence of a preliminary injunction;
`(3) whether the balance of hardships tips in the moving
`party’s favor; and (4) the impact of a preliminary injunction
`on the public interest. See, e.g., Luminara Worldwide, LLC
`v. Liown Elecs. Co., 814 F.3d 1343, 1352 (Fed. Cir. 2016)
`(citing Winter v. Nat. Res. Def. Council, Inc., 555 U.S. 7, 20
`(2008)); Ferring Pharms., Inc. v. Watson Pharms., Inc., 765
`F.3d 205, 210 (3d Cir. 2014). However, under both Federal
`Circuit and Third Circuit precedent, the first factor—i.e.,
`likelihood of success on the merits—is a necessary showing
`to establish entitlement to a preliminary injunction. See,
`e.g., Somerset Pharm., Inc. v. Dudas, 500 F.3d 1344, 1346
`(Fed. Cir. 2007) (citing Nat’l Steel Car, Ltd. v. Canadian
`Pac. Ry., Ltd., 357 F.3d 1319, 1324–25 (Fed. Cir. 2004));
`Holland v. Rosen, 895 F.3d 272, 286 (3d Cir. 2018) (citing
`In re Revel AC, Inc., 802 F.3d 558, 568 (3d Cir. 2015)).
`Here, the district court’s finding that Nippon Shinyaku
`did not show it was likely to succeed on the merits turned
`entirely on the court’s interpretation of the MCA. The par-
`ties agreed that the MCA “shall be governed by and inter-
`preted in accordance with the laws of the State of
`Delaware.” J.A. 513 (MCA § 10). Therefore, this appeal
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`presents “a question of contract interpretation under Dela-
`ware law, which we review de novo.” Studiengesellschaft
`Kohle, m.b.H. v. Hercules, Inc., 105 F.3d 629, 632 (Fed. Cir.
`1997) (citing Cyrix Corp. v. Intel Corp., 77 F.3d 1381, 1384
`(Fed. Cir. 1996)); see also Volt Info. Sciences, Inc. v. Bd. of
`Trustees of Leland Stanford Junior Univ., 489 U.S. 468,
`474 (1989) (“[T]he interpretation of private contracts is or-
`dinarily a question of state law . . . .”); Howmedica Osteon-
`ics Corp. v. Wright Med. Tech., Inc., 540 F.3d 1337, 1347
`(Fed. Cir. 2008) (“Construction of a contract is an issue of
`law that we review without deference.” (citing Intel Corp.
`v. VIA Techs., Inc., 319 F.3d 1357, 1361 (Fed. Cir. 2003))).
`II
`In interpreting a contract, “Delaware adheres to the
`‘objective’ theory of contracts, i.e. a contract’s construction
`should be that which would be understood by an objective,
`reasonable third party.” Estate of Osborn v. Kemp, 991
`A.2d 1153, 1159 (Del. 2010) (quoting NBC Universal v.
`Paxson Commc’ns, No. 650-N, 2005 WL 1038997, at *5
`(Del. Ch. Apr. 29, 2005)). Under Delaware law, we must
`“read a contract as a whole” and “give each provision and
`term effect, so as not to render any part of the contract
`mere surplusage.” Id. (quoting Kuhn Constr., Inc. v. Dia-
`mond State Port Corp., 990 A.2d 393, 396–97 (Del. 2010)).
`Importantly, “when the contract is clear and unambiguous,
`we will give effect to the plain-meaning of the contract’s
`terms and provisions.” Id. at 1159–60 (citing Rhone-Pou-
`lenc Basic Chem. Co. v. Am. Motorists Ins. Co., 616 A.2d
`1192, 1195 (Del. 1992)).
`In this case, the plain language of the forum selection
`clause in Section 10 of the MCA resolves the dispute. Sec-
`tion 10 states clearly that “all Potential Actions arising un-
`der U.S. law relating to patent infringement or invalidity,
`and filed within two (2) years of the end of the Covenant
`Term, shall be filed in the United States District Court for
`the District of Delaware.” J.A. 513–14. The express
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`definition of “Potential Actions” includes “patent or other
`intellectual property disputes . . . filed with a court or ad-
`ministrative agency,” J.A. 509 (emphasis added), and the
`district court acknowledged that the “definition of ‘Poten-
`tial Actions’ in Section 1 literally encompasses IPRs.” De-
`cision, 2021 WL 4989489, at *3. Sarepta does not contend
`otherwise. The MCA’s forum selection clause is thus un-
`ambiguous, and we must “give effect to the plain meaning
`of [its] terms.” Estate of Osborn, 991 A.2d at 1159–60.
`Under the plain language of Section 10, Sarepta was
`required to bring all disputes regarding the invalidity of
`Nippon Shinyaku’s patents—including the allegations and
`contentions contained in Sarepta’s IPR petitions—in the
`District of Delaware. Sarepta instead brought those dis-
`putes in the form of IPR petitions at the Board, which con-
`travened the plain language of the forum selection clause
`in Section 10 of the MCA.
`
`III
`Sarepta makes a number of arguments in support of
`the district court’s interpretation of the forum selection
`clause in Section 10 of the MCA. We address these argu-
`ments below.
`We first consider Sarepta’s suggestion that our reading
`of Section 10’s forum selection clause would lead, not to a
`preclusion of IPRs, but rather to a requirement that IPR
`petitions must be filed in the federal district court in Dela-
`ware. We reject that suggestion because such a require-
`ment would not fall within what an “objective, reasonable
`third party” would have understood from the language of
`the forum selection clause. See Estate of Osborn, 991 A.2d
`at 1159 (emphasis added). Any such nonsensical result
`stems from the parties’ decision to define the future-tense
`term “Potential Actions” using past-tense language about
`where such disputes may have been “filed.” See J.A. 509
`(emphasis added). But the choice of wording in the “Defi-
`nitions” section of the MCA does not upend our reasonable
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`interpretation of the forum selection clause. See Falcon
`Steel Co. v. Weber Eng’g Co., 517 A.2d 281, 285–86 (Del.
`Ch. 1986) (refusing to incorporate by reference terms which
`made a reasonable reading of the contract nonsensical).
`We next turn to Sarepta’s arguments in defense of the
`district court’s reasoning. Sarepta first echoes the district
`court’s concern about the supposed “tension” between Sec-
`tions 6 and 10 of the MCA, stressing the legal requirement
`that we give effect to all terms of the contract and “if possi-
`ble, reconcile all the provisions of the instrument.” See Alta
`Berkeley VI C.V. v. Omneon, Inc., 41 A.3d 381, 385–86 (Del.
`2012) (quoting Elliott Assoc., L.P. v. Avatex Corp., 715 A.2d
`843, 854 (Del. 1998)); see also O’Brien v. Progressive N. Ins.
`Co., 785 A.2d 281, 287 (Del. 2001) (a court must consider
`the contract as a whole rather than “any single passage in
`isolation” (citing Aetna Cas. and Sur. Co. v. Kenner, Del.
`Supr., 570 A.2d 1172, 1174 (1990))). Nippon Shinyaku re-
`sponds that, absent some ambiguity in the plain language
`of Section 10, there was no reason for the court to look at
`Section 6 at all. Moreover, Nippon Shinyaku argues that
`the two provisions are not in conflict with each other be-
`cause they apply at different times, which the district court
`acknowledged. See Decision, 2021 WL 4989489, at *2
`(“Sections 6 and 10 implicate different time periods . . . .”).
`We agree with Nippon Shinyaku that there is no con-
`flict or tension between the two sections of the MCA. Dur-
`ing the Covenant Term, Section 6 prohibited the parties
`from “directly or indirectly assert[ing] or fil[ing] any legal
`or equitable cause of action, suit or claim or otherwise ini-
`tiat[ing] any litigation or other form of legal or administra-
`tive proceeding . . . of or concerning intellectual property in
`the field of Duchenne Muscular Dystrophy.” J.A. 512
`(MCA § 6.1). In essence, the covenant not to sue broadly
`prohibited the parties from litigating any issue relating to
`patents, regardless of the forum. See id. (expressly clarify-
`ing that the covenant not to sue includes “patent infringe-
`ment litigations, declaratory judgment actions, [and]
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`patent validity challenges before the U.S. Patent and
`Trademark Office”). Upon the expiration of the Covenant
`Term, however, Section 6’s covenant not to sue was no
`longer in effect, and the parties were thus no longer pro-
`hibited from asserting claims relating to patent infringe-
`ment or invalidity. At that point, to the extent either party
`wished to assert or file any such claims, Section 10’s forum
`selection clause merely required that such claims “arising
`under U.S. law relating to patent infringement or invalid-
`ity” be filed in “the United States District Court for the Dis-
`trict of Delaware.” J.A. 514 (MCA § 10). This framework—
`which reflects harmony, not tension, between Sections 6
`and 10 of the MCA—is entirely consistent with our inter-
`pretation of the plain meaning of the forum selection
`clause, as set forth above.
`Sarepta next defends the district court’s reasoning that
`other language in Section 10 indicates that the forum se-
`lection clause is best read as limited only to federal district
`court litigation. We disagree. To be sure, the district court
`was correct that issues of patent infringement, forum non
`conveniens, and jurisdiction challenges are inapplicable to
`IPR proceedings. See Decision, 2021 WL 4989489, at *3
`(citing Sinochem Int’l Co. v. Malay. Int’l Shipping Corp.,
`549 U.S. 422, 430 (2007); AVX Corp. v. Presidio Compo-
`nents, Inc., 923 F.3d 1357, 1361 (Fed. Cir. 2019)). But it
`does not follow that the parties’ inclusion of those issues in
`the forum selection clause means that they intended to cat-
`egorically exclude IPRs. We think the better reading of
`Section 10 recognizes the parties’ agreement that, after one
`party files an action relating to patent infringement or in-
`validity in the District of Delaware—as a filing party is re-
`quired to do—the other party will not “contest personal
`jurisdiction or venue in the District of Delaware” or “seek
`to transfer . . . on the ground of forum non conveniens.”
`J.A. 514.
`Finally, Sarepta argues that the district court correctly
`determined that neither party intended to bargain away its
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`right to file IPR petitions, which, due to the time bar in 35
`U.S.C. § 315(b), would be the practical effect of our reading
`of the forum selection clause. Again, we disagree with
`Sarepta and the district court. As a general principle, this
`court has recognized that parties are entitled to bargain
`away their rights to file IPR petitions, including through
`the use of forum selection clauses. For example, in Dodo-
`case VR, Inc. v. MerchSource, LLC, 767 F. App’x 930, 935
`(Fed. Cir. 2019) (non-precedential), we affirmed a district
`court’s grant of a preliminary injunction on the basis that
`a defendant had likely violated a forum selection clause by
`filing IPR petitions, even though the forum selection clause
`did not explicitly mention IPRs. Even in Kannuu Pty Ltd.
`v. Samsung Electronics Co., 15 F.4th 1101, 1106–10 (Fed.
`Cir. 2021), where we determined that the parties’ forum
`selection clause did not extend to IPRs, that determination
`was based on the specific language in the forum selection
`clause at issue in that case. Inherent in our holding in
`Kannuu was an understanding that a differently worded
`forum selection clause would preclude the filing of IPR pe-
`titions. See id. In the case before us now, we have such a
`forum selection clause, which uses a defined term that the
`district court acknowledged “literally encompasses IPRs.”
`Decision, 2021 WL 4989489, at *3.
`Moreover, it is apparent that the practical effects about
`which the district court was concerned—i.e., that Sarepta’s
`IPRs will be time barred by the time the forum selection
`clause expires—resulted from Nippon Shinyaku’s filing of
`a patent infringement complaint, not from the parties’ en-
`try into the MCA itself. We are not persuaded that our in-
`terpretation of the forum selection clause should be
`impacted by Nippon Shinyaku’s filing of a complaint, which
`was an event that occurred more than a year after the par-
`ties entered into the MCA. Cf. Osram Sylvania, Inc. v.
`Townsend Ventures, LLC, No. 8123-VCP, 2013 WL
`6199554, at *19 (Del. Ch. Nov. 19, 2013) (“The courts will
`not imply terms to ‘rebalanc[e] economic interests after
`
`

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`Case: 21-2369 Document: 51 Page: 14 Filed: 02/08/2022
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`14
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`NIPPON SHINYAKU CO., LTD. v. SAREPTA THERAPEUTICS, INC.
`
`events that could have been anticipated, but were not, that
`later adversely affected one party to a contract.’” (quoting
`Nemec v. Shrader, 991 A.2d 1120, 1128 (Del. 2010))). At
`the time the parties entered into the MCA, it was not a
`given that Nippon Shinyaku would file a complaint for pa-
`tent infringement during the period governed by the forum
`selection clause; indeed, it seems possible that if Sarepta
`had not first filed its IPR petitions, Nippon Shinyaku never
`would have filed its complaint. Under our interpretation
`of the forum selection clause, if Nippon Shinyaku had not
`filed a complaint for patent infringement—or even if Nip-
`pon Shinyaku had filed a complaint, but had done so more
`than a year after the Covenant Term ended—Sarepta
`would have had time to file its IPR petitions after the expi-
`ration of the forum selection clause and before they were
`time barred by 35 U.S.C. § 315(b). Thus, the practical ef-
`fect that Sarepta’s IPRs will now be time barred is irrele-
`vant to determining the parties’ intent at the time they
`included the forum selection clause in the MCA.
`For the foregoing reasons, we are unpersuaded by
`Sarepta’s arguments that the district court correctly inter-
`preted Section 10 of the MCA as allowing the filing of IPR
`petitions. We conclude as a matter of law that the forum
`selection clause in Section 10 of the MCA precludes the fil-
`ing of IPR petitions during the two-year period following
`the expiration of the Covenant Term on June 21, 2021. Be-
`cause Sarepta filed IPR petitions during that time in viola-
`tion of the forum selection clause in Section 10, Nippon
`Shinyaku is likely to succeed on the merits of its claim for
`breach of contract.
`
`IV
`Having determined that Nippon Shinyaku is likely to
`succeed on the merits of its breach of contract claim, we
`turn to the other three factors relevant to the preliminary
`injunction analysis. As noted above, the district court de-
`termined that Nippon Shinyaku’s arguments with respect
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`Case: 21-2369 Document: 51 Page: 15 Filed: 02/08/2022
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`NIPPON SHINYAKU CO., LTD. v. SAREPTA THERAPEUTICS, INC. 15
`
`to all three factors rose and fell with its arguments regard-
`ing likelihood of success on the merits. We agree, and for
`the following reasons we find that Nippon Shinyaku has
`satisfied the remaining preliminary injunction factors in
`this case as a matter of law.
`With regard to irreparable harm, Nippon Shinyaku has
`argued that, absent a preliminary injunction, it will be de-
`prived of its bargained-for choice of forum and forced to lit-
`igate its patent rights in multiple jurisdictions. We have
`held that such harm constitutes irreparable harm suffi-
`cient to meet the standard for a preliminary injunction.
`See Gen. Protecht Grp., Inc. v. Leviton Mfg. Co., 651 F.3d
`1355, 1363 (Fed. Cir. 2011). Our binding precedent com-
`pels the same result here.
`We also agree with Nippon Shinyaku that the balance
`of hardships tips in its favor. Without a preliminary in-
`junction, Nippon Shinyaku will suffer the irreparable harm
`previously described, and Sarepta will potentially get mul-
`tiple bites at the invalidity apple, including in a forum it
`bargained away. In contrast, if a preliminary injunction is
`entered, Sarepta will still have an opportunity to litigate
`the invalidity of Nippon Shinyaku’s patents, but it will
`have to do so only in the District of Delaware rather than
`also at the Board. Again, our holding in General Protecht
`is directly on point: “Having contracted for a specific forum,
`[Sarepta] should not be heard to argue that the enforce-
`ment of the contract into which it freely entered would
`cause hardship.” 651 F.3d at 1365.
`Finally, with respect to the public interest, we reject
`the notion that there is anything unfair about holding
`Sarepta to its bargain. While it is certainly true that Con-
`gress desired to serve the public interest by creating IPRs
`to allow parties to quickly and efficiently challenge pa-
`tents, it does not follow that it is necessarily against the
`public interest for an individual party to bargain away its
`opportunity to do so. It is well established that forum
`
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`16
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`NIPPON SHINYAKU CO., LTD. v. SAREPTA THERAPEUTICS, INC.
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`selection clauses “are prima facie valid and should be en-
`forced,” M/S Bremen v. Zapata Off-Shore Co., 407 U.S. 1,
`10 (1972), and we have held that “[t]here is no public inter-
`est served by excusing a party’s violation of its previously
`negotiated contractual undertaking to litigate in a particu-
`lar forum.” Gen. Protecht, 651 F.3d at 1366.
`CONCLUSION
`We have considered Sarepta’s remaining arguments
`but we find them unpersuasive. For the foregoing reasons,
`we conclude that Nippon Shinyaku has shown that all four
`preliminary injunction factors weigh in its favor. Accord-
`ingly, we reverse the decision of the district court, and we
`remand for entry of a preliminary injunction.
`REVERSED AND REMANDED
`COSTS
`
`Costs against Appellee.
`
`