On July 2, 2018, Genentech filed suit against Eli Lilly and Company (“Lilly”) in the Southern District of California alleging Lilly’s Taltz® infringes newly issued U.S. Patent 10,011,654 (“the ʼ654 patent”).  According to the complaint, the ʼ654 patent issued at 12:00 am Eastern time on July 3, 2018, and the complaint was filed immediately thereafter.

Taltz® was first approved in the United States in 2016 and is currently approved for the treatment of adults with active psoriatic arthritis or moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.   Lilly also recently announced that Taltz® met the primary and key secondary endpoints in a Phase 3 study evaluating the safety and efficacy of Taltz® for the treatment of Ankylosing Spondylitis.

The active ingredient in Taltz® is ixekizumab, a humanized monoclonal antibody specific for interleukin 17A.  Ixekizumab functions by blocking the activity of interleukin 17A, a pro-inflammatory cytokine.   The newly issued ʼ654 patent is titled “Antibodies Directed to IL-17A/IL-17F Heterodimers.”  Claim 1 recites “[a]n isolated humanized monoclonal antibody that binds to an IL-17A/IL-17F heterodimer comprising the polypeptide of SEQ ID NO: 3 and the polypeptide of SEQ ID NO: 4 with or without their associated signal peptides.”  Genentech alleges that ixekizumab binds to the heterodimer specified in the claim, and thus infringes that claim.

In its prayer for relief, Genentech requests that instead of being granted a permanent injunction, it be awarded “a running or ongoing royalty adequate to compensate Genentech for ongoing infringement.” Genentech further alleges that prior to filing the lawsuit, it notified Lilly that the ʼ654 patent would soon issue and offered Lilly a license at a royalty rate to be determined by arbitration, but Lilly declined.  Taltz® reportedly generated U.S. revenue of $486 million in 2017.

We will continue to keep you apprised of further developments.