Sanofi-Aventis U.S. LLC, Genzyme Corporation, and Regeneron Pharmaceuticals, Inc. (collectively “Plaintiffs”) filed a Complaint in the United States District Court for the District of Massachusetts seeking a declaratory judgment from the Court that the development, manufacturing, sale, and promotion of Dupixent® (dupilumab) does not infringe U.S. Patent No. 8,679,487 (“the ’487 patent”). The ‘487 patent, entitled “Anti-interleukin-4 receptor antibodies,” issued on March 25, 2014, with a total of 17 claims. The ’487 patent is assigned to Immunex Corporation (“Immunex”), which was acquired by Amgen in 2002.
Dupilumab is a monoclonal antibody intended to inhibit signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13), two key cytokines believed to be the drivers of type 2 helper T-cell (Th2)-mediated inflammation. Regeneron submitted a biologics license application (“BLA”) for dupilumab to the FDA on July 29, 2016, seeking approval of the product for the treatment of moderate to severe atopic dermatitis in adults. Atopic dermatitis, the most common form of eczema, is a chronic inflammatory skin disease. FDA accepted the application for review in September 2016 and granted the dupilumab application priority status, reducing the target goal for approval from the standard ten months after acceptance to just six months. The PDUFA (FDA goal) date for the dupilumab application is March 29, 2017.
Plaintiffs state in the Complaint that Amgen had previously attempted to develop a monoclonal antibody treatment for asthma (AMG-317) that inhibited the activity of interleukin 4 (IL-4) and interleukin 13 (IL-13) and further allege that Amgen “abandoned” its development efforts after the product showed “disappointing” results in Phase II clinical trials. The Complaint acknowledges that Amgen’s development efforts resulted in a number of patents, including the ’487 patent. According to the Complaint, counsel for Regeneron and Sanofi learned just days ago that “Amgen has hired litigation counsel to prosecute a patent infringement litigation related to Amgen’s work on antibodies to the IL-4 receptor and is in the process of retaining experts.” The Complaint further states that Amgen “has a long history of aggressively enforcing its patents against competitors” and notes that Amgen is “currently engaged in an unrelated patent litigation concerning Sanofi and Regeneron’s product Praluent®”.
The case is Civ. No. 17-cv-10465 and has been assigned to Judge Woodlock. Amgen has not yet filed an Answer to the Complaint, and Amgen and has not filed a suit accusing Sanofi and Regeneron of infringing the ’487 patent. A threshold question for the Court to consider will likely be whether the Complaint sets forth facts sufficient to establish the existence of an “actual controversy” between the parties regarding infringement of the ’487 patent.
Federal Courts are prohibited from issuing advisory opinions. To establish jurisdiction under the Declaratory Judgment Act, it is necessary for the Plaintiff to demonstrate “that there is a substantial controversy, between parties having adverse legal interests, of sufficient immediacy and reality to warrant” relief. See Medimmune, Inc. v. Genentech, 549 U.S. 118 (2007); see also 28 U.S.C. §§ 2201-2202.
We will continue to provide updates as the litigation continues.