This week Sanofi-Aventis and Regeneron Pharmaceuticals took aim at Amgen’s U.S. Patent No. 8,679,487 on two fronts, filing a declaratory judgment action in district court and a petition for inter partes review in the U.S. Patent & Trademark Office.  The ’487 patent is directed to an “isolated human antibody that competes with a reference antibody for binding to human IL-4 interleukin-4 (IL-4) receptor.”

On March 20, 2017, Sanofi and Regeneron filed a declaratory judgment action against Amgen in the District Court for the District of Massachusetts, seeking a judgment that Sanofi and Regeneron’s Dupixent® product does not infringe the ‘487 patent.  According to the complaint, “Dupixent® is a game-changer in the fight against atopic dermatitis” and “[o]n July 29, 2016, Regeneron submitted a Biologics License Application (BLA) for Dupixent® to the FDA and received a so-called ‘PDUFA date’ of March 29, 2017.”  Sanofi and Regeneron allege that “[g]iven that Dupixent® is the only IL-4 inhibitor expected to come to market in the near future, Regeneron and Sanofi believe that Amgen and Immunex will sue them for infringement of the claims of the ’487 Patent at a time of defendants’ choosing and for the purpose of impairing plaintiffs’ ability to sell Dupixent® in the United States.”

On March 23, 2017, Sanofi and Regeneron filed an IPR (IPR No. 2017-01129) seeking review of the ‘487 patent.  The petition alleges that all claims of the ‘487 patent are invalid under 35 U.S.C. §§ 102(a) and 102(b), based on a prior art publication.

Stay tuned to the Big Molecule Watch Blog for additional updates.