Eugia Pharma Sued for Patent Infringement Over Generic Version of Erleada

Several pharmaceutical companies and other organizations filed a complaint in the District of New Jersey against Eugia Pharma and other pharmaceutical companies for the alleged infringement of the plaintiffs’ patents-in-suit via the proposed generic version of the drug Erleada.

According to Thursday’s complaint, from 2013 to 2018, the plaintiffs (Aragon Pharmaceuticals Inc., Janssen Biotech Inc., The Regents of the University of California, and Sloan Kettering Institute for Cancer Research) had registered a number of patents related to the treatment of prostate cancer diseases, including the patents for the drug Erleada.

In April 2022, the defendants (Eugia Pharma Specialties Limited, AuroBindo Pharma USA Inc., and AuroMedics Pharma LLC) notified the plaintiffs that they had sent in an Abbreviated New Drug Application (ANDA) to the Food and Drug Administration (FDA) to market the generic version of Erleada.

The plaintiffs allege that the defendants’ letter stated they needed FDA approval to engage in the manufacture and sale of the Proposed ANDA Product. In May, the plaintiffs requested technical information regarding the ANDA product, but the defendants did not respond. The plaintiffs contend that the defendants impeded the plaintiffs’ ability to verify that their patents had not been infringed upon.

The complaint states that the plaintiffs are unaware as to any other means of obtaining technical information regarding the proposed ANDA product; and that, upon information and belief, the defendants’ ANDA product violates the plaintiffs’ patents-in-suit because it allegedly contains the active ingredient apalutamide and will be used to treat prostate cancer.

The plaintiffs seek the following for relief: an entry into declaratory judgement that the defendants have infringed on the patents registered by the plaintiffs, an enjoinment preventing the defendants from engaging in the manufacture and sale of the ANDA product that infringes on the plaintiff’s patent, and an award of damages and costs.

The plaintiffs are represented by Robinson Miller LLC.