Amgen Asks Court to Weigh in on Dupixent, Claims Infringement

Amgen is once again asking the court to weigh in on a patent infringement case. In March 2017, Sanofi and Regeneron asked a federal court to issue a declaratory judgment of non-infringement indicating that their drug Dupixent (dupilumab) does not infringe on Amgen’s ‘487 patent covering IL-4 inhibitors. Although the court has not yet responded to this request, in early April 2017 Amgen issued a complaint of patent infringement against Sanofi/Regeneron involving the same ‘487 patent.

This comes as no surprise, as Amgen told BioPharm International in March that it planned to defend patents surrounding IL-4 inhibitors. In this new complaint, Amgen is asking the court to confirm that Dupixent infringes on the company’s ‘487 patent.

Dupixent received FDA approval in late March, just days after Sanofi and Regeneron filed the pre-emptive lawsuit against Amgen. In court documents Sanofi/Regeneron cited Amgen’s aggressive patent litigation history as justification to anticipate an infringement case. The companies also said it learned that Amgen had hired counsel to litigate a case involving an IL-4 inhibitor. At that time Dupixent was the only IL-4 inhibitor expected to come to market, and Sanofi/Regeneron found it reasonable to suspect they would soon be facing allegations of infringement from Amgen.