As we previously reported, Genentech has filed two pending cases (Case Nos. 1:17-cv-01407 and 1:17-cv-01471) in the District of Delaware related to Amgen’s proposed Mvasi (bevacizumab-awwb), a biosimilar of Genentech’s Avastin.  On December 6, 2017, Genentech filed a sealed amended and supplemental complaint in Case No. 1:17-cv-01407, and on December 13, Genentech filed a redacted version.  Last month Amgen filed a sealed motion to dismiss Count 1 of Genentech’s amended and supplemental complaint, and a redacted version was filed last week.

Count 1 of Genentech’s amended and supplemental complaint, which is partially redacted, seeks a declaratory judgment related to Amgen’s marketing of its proposed biosimilar.  Amgen asserts that Count I should be dismissed for failure to state a claim under Fed. R. Civ. P. 12(b)(6), and for lack of subject matter jurisdiction under Fed. R. Civ. P. 12(b)(1).  According to Amgen’s motion, Amgen represented during the patent dance that it “had not intended to begin commercial marketing of its ABP 215 biosimilar product before the expiration” of certain patents.  Amgen also asserts that it “provided notice to Genentech under paragraph (8)(A) that it ‘will commence commercial marketing of Mvasi™ (a/k/a ABP215) no earlier than 180 days from the date of this letter [October 6, 2017].”

In its motion to dismiss, Amgen argues that Genentech has “not plausibly alleged that Amgen made a legally binding and enforceable representation concerning the expected date of its first commercial marketing,” and that Genentech “mischaracterize[d] both Amgen’s statement of future intention and the statutory language [of the BPCIA].”  Amgen also argues that Genentech has not plausibly alleged “reasonable or detrimental reliance” on any representation made by Amgen.  Further, Amgen asserts that the “express remedy provided in the BPCIA for an alleged violation of paragraph (3)(B)(ii)—a declaratory judgment action for patent infringement, validity, or enforcement—excludes all other remedies, including the relief requested by Plaintiffs in Count 1.”

According to the court’s docketed schedule, Genentech’s opposition to Amgen’s motion is due on January 17, 2018, and Amgen’s reply brief is due on January 31, 2018.

We will continue to monitor this litigation.  Stay tuned to Big Molecule Watch for further updates.