preliminary injunction : CAFC Alert

Forum Selection Clause Can Prevent IPR Fights

| March 25, 2022

Nippon Shinyaku Co., Ltd. v. Sarepta Therapeutics, Inc.

Decided on February 8, 2022

Lourie (author), Newman, and Stoll


The Federal Circuit reversed the district decision’s denial of a preliminary injunction for Nippon Shinyaku because its agreement with Sarepta was clear to exclude filing IPR petitions, and Sarepta’s filing of IPR petitions clearly breached the agreement with Nippon Shinyaku.


            On June 1, 2020, Nippon Shinyaku and Sarepta Therapeutics, Inc. (“Sarepta”) executed a Mutual Confidentiality Agreement (“MCA”) to enter into discussions for a potential business relationship relating to therapies for the treatment of Duchenne Muscular Dystrophy (“DMD”).

            Section 6 of the MCA included a mutual covenant not to sue during the Covenant Term[1]:

shall not directly or indirectly assert or file any legal or equitable cause of action, suit or   claim or otherwise initiate any litigation or other form of legal or administrative proceeding against the other Party . . . in any jurisdiction in the United States or Japan of or concerning intellectual property in the field of Duchenne Muscular Dystrophy.

            Section 6 further stated:

For clarity, this covenant not to sue includes, but is not limited to, patent infringement litigations, declaratory judgment actions, patent validity challenges before the U.S. Patent and Trademark Office or Japanese Patent Office, and reexamination proceedings before the U.S. Patent and Trademark Office . . . .

            After the expiration of the Covenant Term, the forum selection clause in Section 10 of the MCA is applied:

[T]he Parties agree that all Potential Actions arising under 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 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.

            Here, “Potential Actions” is defined 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 administrative agency prior to or after the Effective Date in the United States, Europe, Japan or other countries in connection with the Parties’ development and commercialization of therapies for Duchenne Muscular Dystrophy.”

            The Covenant Term ended on June 21, 2021, at which point the two-year forum selection took effect.  On June 21, 2021, Sarepta filed seven petitions for IPR.

District Court

            On July 13, 2021, Nippon Shinyaku filed a complaint in the U.S. District Court for the District of Delaware asserting claims against Sarepta for breach of contract, among other things.  Nippon Shinyaku alleged that Sarepta breached the MCA by filing seven IPR petitions.  Nippon Shinyaku filed a motion for a preliminary injunction to enjoin Sarepta from proceeding with IPR petitions.

            On September 24, 2021, the district court denied Nippon Shinyaku’s motion for a preliminary injunction and issued its memorandum order with the following reasons:

  • There would be a “tension” that would exist between Sections 6 and 10 if the forum selection clauses were interpreted to exclude IPRs.
  • Section 10 applies only to cases filed in federal court.
  • Practical effects of interpreting Section 10 as excluding IPRs for two years following the Covent Term.
  • Finally, Nippon Shinyaku did not meet its burden on second (suffer irreparable harm), third (balance of hardship), fourth (public interest) PI factors in order to obtain a preliminary injunction.

Federal Circuit

            The CAFC reviewed a denial of a preliminary injunction using the law of the regional circuit (Third Circuit) for abuse of discretion. 

            The CAFC focused on the court’s interpretation of the MCA.

            Based on the plain language of the forum selection clause in Section 10 of the MCA, the CAFC held that the forum selection clause is unambiguous because the definition of “Potential Actions” includes “patent or other intellectual property disputes… filed with a court or administrative agency,” and the district court acknowledged that the definition of Potential Actions literally encompasses IPRs.

            The CAFC held that under the plain language of Section 10, Sarepta should have brought all disputes regarding the invalidity of Nippon Shinyaku’s patents in the District of Delaware. 

            The CAFC rejected Sarepta’s argument that IPR petitions must be filed in the federal district court in Delaware.  Also, the CAFC held that there is no conflict or tension between Sections 6 and 10.  The CAFC noted that this reflects harmony, not tension between two sections and this framework is “entirely consistent with our interpretation of the plain meaning of the forum selection clause.” 

            Finally, the CAFC noted that other factors of a preliminary injunction favored Nippon Shinyaku.  As for irreparable harm, the CAFC agreed with Nippon Shinyaku’s argument that they would be “deprived of its bargained-for choice of forum and forced to litigate its patent rights in multiple jurisdictions.”  As for balance of hardships, Nippon Shinyaku would suffer the irreparable harm, and Sarepta would potentially get multiple chances at a forum it bargained away.  As for public interest, the CAFC rejected any notion that there is “anything unfair about holding Sarepta to its bargain.”

            Therefore, the CAFC reversed the decision of the district court and remanded for entry of a preliminary injunction.


  • Companies will need to be extra careful when drafting nondisclosure and joint development agreements now that the CAFC held that clauses in those agreements can give up right to file challenges at the PTAB.
  • Contracts can be used to waive the right to AIA review.
  • This is a cautionary tale for attorneys to start paying attention to boilerplate parts of contracts.
  • This is the first time that the CAFC held that it is not again the public interest to have forum selection clauses that exclude PTAB proceedings.

[1] Covenant Term is defined as “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 termination.”

Apple is bit at CAFC: The Court reversed and remanded a preliminary injunction obtained at the District Court against Samsung’s Galaxy Nexus Smartphone

| October 17, 2012

Apple Inc. v. Samsung Electronics, Ltd. et al.

Decided: October 11, 2012

Panel:  Prost, Moore, and Reyna.  Opinion by Prost.


The CAFC reversed the District Court’s finding that there was irreparable harm to Apple by allowing sales of the Galaxy Nexus.  The CAFC held that there was an insufficient causal nexus between the claimed invention and the sales of the product.  The Court also addressed Apple’s likelihood of success to interject claim construction.

Read More/続きを読む

Presumption of validity attaches to all issued patents, even incorrectly issued patents

| July 5, 2012

Sciele Pharma Inc. v. Lupin Ltd.

July 2, 2012

Panel: Lourie, Prost, Moore.  Opinion by Moore


Shionogi (new name for Sciele Pharma) obtained US Patent No. 6,866,866 (“the ‘866 patent”) which included broader claims that were intended to be cancelled in favor of narrower claims in response to a rejection.  Shionogi brought suit against Lupin for infringement of the ‘866 patent including claims that were to be cancelled.  Lupin began selling the alleged infringing product and Shionogi moved for a preliminary injunction.  The District Court granted Shionogi’s request for preliminary injunction and Lupin appealed.  On appeal, the CAFC stated that even though the ‘866 patent issued with the incorrect claims, the ‘866 patent nonetheless had a presumption of validity and that the clear and convincing evidentiary standard applied for invalidating the patent.  The CAFC also stated that there is not a heightened standard just because references were considered by the PTO.  With the proper clear and convincing evidentiary standard applied to the ‘866 patent, the CAFC stated that Lupin has raised a substantial question of invalidity, and thus, the preliminary injunction is vacated.

Read More/続きを読む

A showing of causal nexus is required between infringement and alleged harm to patentee

| May 23, 2012

Apple, Inc. v. Samsung Electronics Co., Ltd., et al.

May 14, 2012

Panel:  Bryson, Prost, and O’Malley.  Opinion by Bryson.  Concurrence-in-part and dissent-in-part by O’Malley.


Apple filed suit against Samsung alleging infringement of Apple’s U.S. Design Patent Nos. D593,087 (“the D’087 patent”), D618,677 (“the D’677 patent”), D504,889 (“the D’889 patent”), and U.S. Patent No. 7,469,381 (“the ’381 patent”).  Apple’s iPhone embodies the design in the D’087 patent and D’677 patent, and Apple’s iPad embodies the design in the D’889 patent.  Both iPhone and iPad embody a software feature known as the “bounce-back” feature of the ‘381 patent.  The district court denied Apple’s motion for a preliminary injunction with respect to each of the accused devices and all four asserted patents.  Apple appealed.  The CAFC affirms the denial of a preliminary injunction with respect to the D’087, D’677, and ’381 patents, but vacates and reminds with respect to the D’889 patent.


Read More/続きを読む

KSR Reigned In For A Preliminary Injunction

| January 18, 2012

Celsis in Vitro, Inc. v Cellzdirect, Inc. and Invitrogen Corp.

January 9, 2012

Panel:  Rader, Gajarsa, and Prost.  Opinion by Rader; Dissent by Gajarsa.


While Rader’s majority opinion affirmed the district court’s grant of a preliminary injunction despite defendant’s obviousness challenge, Gajarsa’s dissenting opinion asserts that the majority’s decision disregards the Supreme Court’s KSR flexible guidelines regarding the finding of obviousness in the mere repetition of well-known techniques to achieve a desired result, and in the application of “obvious to try.”  Gajarsa’s dissent also notes that this is a preliminary injunction, and the standard is not whether defendant has shown obviousness by clear and convincing evidence, but rather, whether defendant has shown a “substantial question of invalidity” to defeat a preliminary injunction.  Perhaps, the strongest position for the majority opinion is its consideration of the showing of a “teaching away” in the record, as well as deference given to the district court’s determinations of credibility of the parties’ expert witnesses.

Read More/続きを読む

Subscribe | 登録



词典 / 辞書 / 사전
  • dictionary
  • dictionary
  • 英語から日本語

Double click on any word on the page or type a word:

Powered by