We reported last week that Sanofi-Aventis U.S. LLC, Genzyme Corporation, and Regeneron Pharmaceuticals, Inc. had filed suit in Massachusetts seeking a declaratory judgment that their Dupixent® (dupilumab) product does not infringe Amgen’s U.S. Patent No. 8,679,487 (“the ’487 patent”). The litigation was filed on March 20, 2017. In a one-two punch combination, Sanofi and Regeneron filed a petition for inter partes review (“IPR”) of the ‘487 patent with the Patent Trial and Appeal Board (“PTAB”) just three days later on March 23, 2017, and before any substantive activity occurred in the litigation.
The proceeding is IPR2017-01129. The real parties-in-interest for Petitioner are the same three plaintiffs in the litigation, Sanofi-Aventis U.S. LLC, Genzyme Corp. and Regeneron Pharmaceuticals, Inc. The ‘487 patent, entitled “Anti-interleukin-4 receptor antibodies,” issued on March 25, 2014, with a total of 17 claims. Claim 1, the only independent claim, is directed to “an isolated human antibody that competes with a reference antibody for binding to human interleukin-4 (IL-4) receptor.” 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.
As previously reported, 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 was March 29, 2017. FDA met the target date, granting approval for dupilumab on Tuesday, one day ahead of schedule. Sanofi and Regeneron announced that the product will be available to patients in the U.S. this week.