Baxalta Incorporated and Baxalta GmbH (collectively “Baxalta” or “Plaintiffs”) filed a Complaint in the United States District Court for the District of Delaware on May 4, 2017, against Genentech, Inc. (“Genentech”) and Chugai Pharmaceutical Co. Ltd., (“Chugai,” and collectively with Genentech “Defendants”) alleging that Defendants’ bispecific monoclonal antibody emicizumab infringes claims 1, 4, 15, 17 and 19 of U.S. Patent No. 7,033,590 (“the ’590 patent”) under 35 U.S.C. § 271(a), (b), (c) or (g). The Complaint contains a separate count seeking a declaratory judgement that Defendants will directly infringe, or will actively induce and/or contribute to infringement of valid and enforceable claims of the ’590 before its expiration in violation of 35 U.S.C. § 271(a), (b), (c) or (g).
The ’590 patent, entitled “Factor IX/Factor IXa Activating Antibodies and Antibody Derivatives,” issued on April 25, 2006 from an application filed on September 14, 2000, claims priority to a foreign application filed on September 14, 1999. According to the Complaint, the ’590 patent was assigned to Plaintiffs in March 2016. Plaintiffs are wholly-owned subsidiaries of Shire plc.
Emicizumab (ACE910) is an investigational bispecific monoclonal antibody designed to bring together factors IXa and X to activate the natural coagulation cascade and restore the blood clotting process. Emicizumab was created by Chugai Pharmaceutical Co., Ltd. and is being co-developed by Chugai, Roche, and Genentech. Genentech announced in September 2015 that FDA granted breakthrough therapy designation to emicizumab based on the results of a Phase I study in people with severe hemophilia A. Breakthrough therapy status gives an application priority at the FDA and typically reduces the target goal for approval (BSUFA date) from the standard ten months after submission to just six months. In December 2016, Genentech reported positive results from a Phase III study, indicating that emicizumab met its primary endpoint. The Complaint does not affirmatively allege that Genentech has already filed its emicizumab application with FDA, but rather alleges that “on information and belief, the filing of Defendants’ BLA for emicizumab with the FDA to obtain licensure is either ongoing or is imminent.” The Complaint further alleges that Defendants stated in publicly available information that they expect to launch emicizumab in the United States in the fourth quarter of 2017.
The Delaware litigation is Civ. No. 17-cv-00509, and the case has been assigned to Judge Sleet. Defendants have not yet filed an Answer or otherwise responded to the Complaint.
Baxalta previously filed a suit against Chugai in Japan in May 2016, alleging patent infringement based on, inter alia, the use of emicizumab in clinical trials there. Chugai has denied the allegations of infringement in Japan as reported here.