Genentech Files Patent Infringement Complaint Against Lilly Regarding Lilly’s Taltz® Product

Last week, Genentech Inc. filed a complaint against Eli Lilly and Company (Lilly) in the United States District Court for the Southern District of California alleging infringement of U.S. Patent No. 10,011,654 (’654 patent) based on Eli Lilly’s commercial manufacture, use, sale, offer for sale and/or importation of Taltz® (ixekizumab) in the United States.  According to the complaint, the ’654 patent, titled “Antibodies Directed to IL-17A/IL-17F Heterodimers,” issued last week on July 3, 2018 and claims humanized monoclonal antibodies that bind to the IL-17A/F heterodimer.

Taltz®, which was first approved by the U.S. FDA on March 22, 2016, and launched in the U.S. later that year, is a humanized IgG4 monoclonal antibody and interleukin-17A antagonist that is FDA-approved for the treatment of adults with (a) moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy or (b) active psoriatic arthritis.  Genentech alleges that Taltz® meets every limitation of at least claims 1, 4, 5, and 7 of the ’654 patent.

Genentech further alleges that it offered Lilly a license to the ’654 patent but Lilly rejected that offer.  Specifically, the complaint states:  “On June 27, 2018, Genentech notified Lilly that the ’654 patent would  issue on July 3, 2018, and offered Lilly a license at a royalty rate to be determined by arbitration. Lilly rejected the offer. Lilly knows of the ’654 patent, Genentech’s infringement allegations, and the evidence of infringement represented by its own admissions. Thus, any subsequent manufacture, use, import, offer for sale, and/or sale of Taltz is willful.”

The case is docketed as Civil Action No. 3:18-cv-01518 and is assigned to District Judge Dana M. Sabraw.