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Caroline Hroncich was associate editor for Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International from 2015 to 2017.
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 BioPharm International, 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 BioPharm International’s request for comment at the time of publication.
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