News|Articles|April 21, 2017

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.

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 Pharmaceutical Technology 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.

Source: United States District Court Central District of California  


Related to this article

AAPS PharmSci 360 2026: Spray Drying and ASD
Nitin Kumar Swarnakar, PhD, global application lab manager at BASF, talks about spray drying for drying amorphous solid dispersions and Raman spectroscopy’s role as a quantitative analytical tool.
AAPS PharmSci 360 2026: High-Loaded ASD
Nitin Kumar Swarnakar, PhD, global application lab manager at BASF in Tarrytown, spoke with PharmTech at AAPS PharmSci 360 about formulation and characterization challenges for amorphous solid dispersions.