Trastuzumab Patent Litigation Updates

As we have reported, over the course of the past thirteen months Plaintiffs Genentech, Inc. and City of Hope sued each of Pfizer, Celltrion and Teva, Amgen and Samsung Bioepis in the District of Delaware for patent infringement under the BPCIA based on their submissions of aBLAs seeking FDA approval of their respective proposed biosimilars of Herceptin® (trastuzumab).  Yesterday, on December 4, 2018, Plaintiffs and Pfizer submitted a stipulation and proposed order of dismissal indicating that they have entered into a settlement agreement and agreed to dismiss all claims and counterclaims without prejudice.  Judge Connolly ordered the dismissal on the same day.

Celltrion and Teva, Amgen, and Samsung Bioepis all remain as defendants in their respective cases.