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…
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