Sanofi and Regeneron File Suit Against Amgen in Patent Case

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Sanofi and Regeneron are asking a federal court to issue a judgment of non-infringement for Amgen’s ‘487 patent.

Sanofi and Regeneron are asking a federal court to weigh in on a potential patent infringement lawsuit involving Amgen. Sanofi and Regeneron requested the court issue a “declaratory judgement of non-infringement” of Amgen’s ‘487 patent covering IL-4 inhibitors in advance of a patent challenge by Amgen. The preemptive measure by Sanofi/Regeneron was initiated to protect the companies from a lawsuit for their investigational atopic dermatitis monoclonal antibody (mAb) Dupixent (dupilumab).

Sanofi and Regeneron filed a lawsuit on March 20, 2017 in federal court in Boston, MA, after allegedly learning that Amgen had hired counsel to litigate a patent infringement case related to an IL-4 inhibitor. According to court documents, Dupixent is the only IL-4 inhibitor expected to come to market in the near future, and therefore, the companies found it likely that Amgen was gearing up for a patent infringement suit involving their investigational therapeutic antibody.

Sanofi and Regeneron argue Dupixent is a “game-changer” treatment for atopic dermatitis and a lawsuit may delay its FDA approval. Dupixent is currently facing a PDUFA date of March 29, 2017; however, it is possible approval of the drug may be delayed because of this most recent legal filing.

In an emailed statement to Pharmaceutical Technology, a spokesperson from Amgen said that the company “does have a patent covering the product and we will defend our patent rights.” Sanofi and Regeneron did not respond to Pharmaceutical Technology’s request for comment at the time of publication.

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In court documents, Sanofi and Regeneron cited Amgen’s “long history of aggressively enforcing its patents against competitors”-and ongoing litigation over Sanofi and Regeneron’s drug Praluent-as reasons for filing court documents. Amgen has had a tumultuous history with patent litigation. In 2015, the company took issue with Sandoz’s biosimilar Zarxio (filgrastim-sndz), the first FDA approved biosimilar and a competitor to Amgen’s Neupogen (filgrastim). Amgen asked the court to block Zarxio’s release to market, citing patent infringement. A judge later ruled against Amgen, although the case did delay the release of Zarxio for a short time.

Source: The United States District Court of Massachusetts