On February 2, 2018, U.S. District Judge George H. Wu granted Genentech’s motion to dismiss a complaint brought by Amgen in the Central District of California seeking a declaratory judgment of non-infringement, invalidity, and unenforceability of twenty-seven patents related to Genentech’s cancer treatment biologic, Avastin® (bevacizumab).[i]

Judge Wu issued a tentative decision on January 11, 2018, stating he would grant the motion to dismiss, but stayed that decision until a determination was made in two related Delaware cases on Amgen’s motions to transfer venue to the Central District of California.[ii] The Delaware court denied Amgen’s motions to transfer venue on January 22, 2018.[iii]

Judge Wu granted the motion to dismiss based on the court’s “broad discretion under the Declaratory Judgment Act, including [his] concerns that Amgen’s suit in [the Central District of California] was anticipatory and that the concurrent proceedings in Delaware would lead to duplicative litigation.” He also based his decision on the reasons provided in the tentative decision, where he noted that he was declining to hear Amgen’s case because Amgen had not properly completed the negotiation process required by the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). He stated that he would decline “to hear a case where Amgen effectively attempted to bypass the BPCIA’s scheme for negotiations and eventual litigation.”

The dispute arose over Amgen’s attempts to seek approval from the FDA to market a biosimilar of Avastin®. The FDA approved Amgen’s Mvasi™ (bevacizumab-awwb) as a biosimilar to Genentech’s Avastin® on September 14, 2017.[iv] On October 6, 2017, Amgen provided its notice of commercial marketing to Genentech and immediately filed the declaratory judgment action in the Central District of California. That same day, Amgen reached out to Genentech to continue the final patent exchange procedures as required for the first phase of patent litigation under the BPCIA. Genentech learned of Amgen’s declaratory judgment action and immediately filed a lawsuit in Delaware alleging infringement of twenty-four of the twenty-seven Avastin®-related patents at issue in the declaratory judgment action. The parties completed the BPCIA’s required negotiation process on October 13, 2017, and Genentech brought its “first phase” lawsuit in Delaware on October 18, 2017, asserting infringement of twenty-five of the twenty-seven patents and alleging that Amgen failed to comply with its statutory obligations under the BPCIA. Genentech’s two Delaware cases have been consolidated. Amgen filed a motion to dismiss for failure to state a claim and for lack of subject matter jurisdiction, which is currently pending before the Delaware court.

[i] Amgen Inc. v. Genentech, Inc., Case No. 2:17-cv-07349 (C.D. Cal. Feb. 2, 2018) (Docket No. 63).

[ii] Amgen Inc. v. Genentech, Inc., Case No. 2:17-cv-07349 (C.D. Cal. Feb. 2, 2018) (Docket No. 56).

[iii] See Genentech, Inc. v. Amgen Inc., Civ. No. 17-1407-GMS (D. Del. Jan 22, 2017) (Docket Nos. 58 & 59) and Genentech, Inc. v. Amgen Inc., Civ. No. 17-1471-GMS (D. Del. Jan 22, 2017) (Docket No. 57).

[iv] https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm576112.htm