By Memorandum Opinion entered by The Honorable Gregory M. Sleet in Genentech, Inc. et al. v. Amgen Inc., Civil Action No. 17-1407-GMS (D.Del. April 17, 2018), the Court granted defendant Amgen’s motion to dismiss the claim of plaintiffs Genetech and City of Hope (collectively “Genetech”) requesting a declaratory judgment that Amgen cannot market Mvasi™ before December 18, 2018.
Mvasi™ is a biosimilar version of Genetech’s Avastin®. During the “patent dance” prescribed by the Biologics Price Competition and Innovation Act (“BPCIA”), 42 U.S.C. § 262(l), Amgen made a statement pursuant to 42 U.S.C. §262(l)(3)(B) that it did not intend to begin commercial marketing of Mvasi™ before December 18, 2018. Id. at *1. Amgen later provided notice that it would not start commercial marketing of Mvasi™ before April 4, 2018 – eight months earlier than the date it previously provided. Genetech filed its claim requesting a declaratory judgment seeking to enforce Amgen’s earlier representation that it would not commence the commercial marketing of Mvasi™ before December 18, 2018. Id. at *3. Amgen moved to dismiss Genetech’s commercial marketing claim asserting that it failed to state a claim and that the Court lacked subject matter jurisdiction under Federal Rules of Civil Procedure 12(b)(6) and 12(b)(1). Id. at *1.
Upon review, the Court determined there was not yet an “actual controversy” to warrant the Court exercising jurisdiction over Genentech’s commercial marketing claim under the Declaratory Judgment Act. Id. at *4. In other words, because it was already beyond April 4, 2018 and, other than the notice of commercial marketing, there was no indication that Mvasi™ had actually launched or would be launched before December 18, 2018, the commercial marketing claim was not of “sufficient immediacy” to warrant the issuance of a novel declaratory judgment. Id. The Court noted that, if the claim ripens into an “actual controversy” – meaning Amgen launches Mvasi™ before December 18, 2018 – there would be an opportunity for Genentech to seek a temporary restraining order or preliminary injunction at that time. Id.
A copy of the Memorandum Opinion is attached.