Genfit S. A. v. CymaBay Therapeutics

District Court, N.D. California·Decided January 21, 2022·No. 3:21-cv-00395·Unknown

Opinion

GENFIT S. A., Case No. 21-cv-00395-MMC

Plaintiff, ORDER GRANTING MOTION TO v. DISMISS SECOND AMENDED COMPLAINT Defendant.

Before the Court is defendant CymaBay Therapeutics Inc.’s (“CymaBay”) motion, filed November 8, 2021, to dismiss plaintiff GENFIT S.A.’s (“GENFIT”) Second Amended Complaint (“SAC”), pursuant to Rule 12(b)(6) of the Federal Rules of Civil Procedure. GENFIT has filed opposition, to which CymaBay has replied. Having read and considered the papers filed in support of and in opposition to the motion, the Court rules as follows.1 BACKGROUND2 GENFIT is a “late-stage clinical biopharmaceutical company” engaged in developing treatments for patients suffering from primary biliary cholangitis (“PBC”), a “liver-related” disease for which there is currently no cure. (See SAC ¶¶ 19, 22-23.) Clinical trials, which “involve the administration of [a] drug candidate to human subjects under the supervision of qualified investigators,” are “a necessary prerequisite before any

1 By order filed January 18, 2022, the Court took the matter under submission. 2 The following facts are taken from the allegations of the operative complaint, the new drug therapy will be approved by regulatory authorities,” such as the U.S. Food and Drug Administration (“FDA”) (see SAC ¶ 45), and are “conducted under the guidance of protocols, which detail, among other things, the objective of the trial, the parameters to be used in monitoring safety, and the effectiveness criteria to be evaluated” (see SAC ¶ 49). In early 2019, GENFIT began designing a protocol (the “Protocol”) for Phase 3 of its clinical trial, known as ELATIVE. (See SAC ¶ 53.) On March 1, 2019, GENFIT “entered into a one-year collaboration agreement” (“Collaboration Agreement”) with Dr. Gideon Hirschfield (see SAC ¶ 66),3 a “world-renowned leader in liver medicine” and “highly sought-after investigator for clinical trials in PBC” (see SAC ¶ 68) who “agreed and was intended to serve as the lead investigator” and an “advisor to GENFIT in connection with the ELATIVE trial” (see SAC ¶ 67). The Collaboration Agreement, as well as a Confidential Disclosure Agreement (“CDA”) between Dr. Hirschfield and GENFIT, contained confidentiality provisions that “prohibited” Dr. Hirschfield from “disclos[ing] any of GENFIT’s [c]onfidential [i]nformation to any third party without prior written approval from GENFIT.” (See SAC ¶ 69; see also SAC ¶¶ 71-72.) According to GENFIT, Dr. Hirschfield, on July 17, 2020, “surreptitiously sent” an email (“July 17 Email”) containing GENFIT’s “trade secret Protocol and . . . Confidential Strategic Information” (“CSI”) to CymaBay (see SAC ¶ 81), GENFIT’s “most direct and key competitor” (see SAC ¶ 82) and with whom Dr. Hirschfield “works closely” as a “lead principal investigator” and “close advisor” (see SAC ¶ 85 (internal quotation and alteration omitted)). GENFIT alleges that, “between at least July 17, 2020 and the end of August 2020,” CymaBay “disclosed” the Protocol and CSI to “certain CymaBay employees . . . [,] generated internal documents that included references to the Protocol . . . [,]” and “then disclosed those documents . . . to at least eight of its service provides, all of whom were assisting CymaBay . . . with the design of its [own] protocol.” (See SAC ¶ 113.)

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Genfit S. A. v. CymaBay Therapeutics, (N.D. Cal. 2022).

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