Case: 21-2369 Document: 51 Page: 1 Filed: 02/08/2022
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.
______________________
Case: 21-2369 Document: 51 Page: 2 Filed: 02/08/2022
2 NIPPON SHINYAKU CO., LTD. v. SAREPTA THERAPEUTICS, INC.
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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NIPPON SHINYAKU CO., LTD. v. SAREPTA THERAPEUTICS, INC. 3
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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4 NIPPON SHINYAKU CO., LTD. v. SAREPTA THERAPEUTICS, INC.
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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NIPPON SHINYAKU CO., LTD. v. SAREPTA THERAPEUTICS, INC. 5
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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6 NIPPON SHINYAKU CO., LTD. v. SAREPTA THERAPEUTICS, INC.
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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NIPPON SHINYAKU CO., LTD. v. SAREPTA THERAPEUTICS, INC. 7
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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8 NIPPON SHINYAKU CO., LTD. v. SAREPTA THERAPEUTICS, INC.
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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NIPPON SHINYAKU CO., LTD. v. SAREPTA THERAPEUTICS, INC. 9
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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10 NIPPON SHINYAKU CO., LTD. v. SAREPTA THERAPEUTICS, INC.
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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NIPPON SHINYAKU CO., LTD. v. SAREPTA THERAPEUTICS, INC. 11
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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12 NIPPON SHINYAKU CO., LTD. v. SAREPTA THERAPEUTICS, INC.
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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NIPPON SHINYAKU CO., LTD. v. SAREPTA THERAPEUTICS, INC. 13
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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14 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
Case: 21-2369 Document: 51 Page: 15 Filed: 02/08/2022
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
Case: 21-2369 Document: 51 Page: 16 Filed: 02/08/2022
16 NIPPON SHINYAKU CO., LTD. v. SAREPTA THERAPEUTICS, INC.
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.
