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 Case: 21-2369 Document: 51 Page: 3 Filed: 02/08/2022

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 afte