Sanofi and Regeneron seek non-infringement declaration against Amgen

Sanofi and Regeneron have filed a declaratory judgment of non-infringement claiming that their product Dupixent (dupilumab) does not infringe a patent belonging to Amgen.

Dupixent is a monoclonal antibody that was developed to treat atopic dermatitis, a type of eczema.

According to the suit, Dupixent was developed using Regeneron’s “revolutionary VelocImmune mouse technology”.

“Regeneron and Sanofi invested many years of research efforts and hundreds of millions of dollars in developing Dupixent,” said the suit.

The case, filed on Monday, March 20 at the US District Court for the District of Massachusetts, centres on US patent number 8,679,487, titled “Anti-interleukin-4 receptor antibodies”.

Amgen is the owner of the ‘487 patent and, according to the suit, registered the patent in the 2000s when it attempted to develop a monoclonal antibody treatment for asthma known as AMG-317.

Amgen allegedly abandoned the development of AMG-317 after the failure of a clinical trial.

The suing companies said in the complaint: “Given 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 US .”

Immunex is a subsidiary of Amgen.

Sanofi and Regeneron have asked the district court for a declaration of non-infringement of the patent involved in the case.

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