New BPCIA Complaint: Genentech Sues Amgen over Proposed Trastuzumab Biosimilar (UPDATED)

Today, Genentech filed a complaint in the District of Delaware against Amgen concerning its aBLA for ABP 980, a proposed biosimilar of Herceptin® (trastuzumab).

Genentech alleges infringement of 37 patents directed to a variety of different subject matters. According to the complaint, the parties engaged in the patent dance, during which Genentech listed all 37 of these patents pursuant to subsection (l)(3)(A) and (l)(7) of the BPCIA and the parties agreed to litigate all 37 patents in a single action for patent infringement pursuant to subsection (l)(6).

With regard to notice of commercial marketing, Genentech states that “on May 15, 2018, while the parties’ negotiations pursuant to § 262(l)(4) were underway, Amgen purported to notify Genentech pursuant to 42 U.S.C. § 262(l)(8)(A) that it intends to commence commercial marketing of ABP 980 in the United States no earlier than 180 from May 15, 2018 (i.e., October 28, 2018).”

This is the third aBLA for a biosimilar of Herceptin® to be subject to a BPCIA complaint from Genentech. As we have reported, Genentech is engaged in BPCIA litigations in the District of Delaware against Pfizer and against Celltrion and Teva concerning their respective proposed trastuzumab biosimilars.  Both of those cases are assigned to Judge Sleet.  In addition, several of the patents that Genentech is asserting against Amgen are already the subject of instituted IPR proceedings, including U.S. Patent Nos. 6,407,213, 7,846,441, 7,892,549, 6,627,196, 7,371,379 and 9,249,218.

Stay tuned to Big Molecule Watch for updates about this new litigation.

UPDATE: The new Genentech v. Amgen litigation has been docketed as Civil Action No. 18-924.