We reported earlier this month that, in early October, Genentech filed a complaint under seal against Amgen in the District of Delaware based on Amgen’s FDA-approved aBLA for MVASI® (bevacizumab-awwb), a biosimilar of Avastin®. Yesterday, a redacted version of that Complaint became available on the public docket. There is also a related declaratory judgment action pending in the Central District of California.
In its Complaint, Genentech alleges infringement of 24 patents. Genentech alleges that Amgen failed to comply with its statutory obligations under the BPCIA by refusing to provide Genentech with any documents other than Amgen’s aBLA. Genentech states that it had asked Amgen for “other information” that would help Genentech determine which patents to assert against Amgen, but Amgen allegedly refused to turn over any documents except its aBLA. On February 15, 2017, Genentech sued Amgen for allegedly failing to comply with its statutory obligations; that suit was dismissed for lack of subject matter jurisdiction. Genentech alleges that it then served Amgen with a list of 27 patents that could be infringed by Amgen’s product, but later declined to provide infringement contentions about two of those patents.
Genentech alleges that on May 23, 2017, Amgen served disclosures purportedly pursuant to 42 U.S.C. § 262(l)(3)(B). According to the complaint, Amgen made a promise in those disclosures (the nature of that promise is redacted), and Amgen’s contention in its related declaratory judgment complaint that it can launch Mvasi® as early as 180 days from October 6, 2017 is in derogation of that promise. Count 1 of the Complaint seeks a declaratory judgment in connection with Amgen’s purported breach of its alleged promise, seemingly (based on the unredacted information) regarding the earliest permissible timing for Amgen’s launch.
Genentech alleges that on July 22, 2017, it served infringement and validity contentions pursuant to 42 U.S.C. § 262(l)(3)(C). Genentech then alleges that, after receiving these contentions, Amgen refused to negotiate regarding the scope of the litigation under 42 U.S.C. § 262(l)(4), unreasonably delaying until it provided notice of commercial marketing under 42 U.S.C. § 262(l)(8) and filed a lawsuit on the same day seeking declaratory judgment with respect to the patents in Genentech’s list, before the conclusion of negotiations under 42 U.S.C. § 262(l)(4).
Because Genentech views this as an attempt to deprive Genentech of the right to thoroughly evaluate infringement and choose an appropriate forum, Genentech filed suit for infringement, declaratory judgment, and additional relief, including an order declaring that Amgen’s actions are contrary to the BPCIA.