On Wednesday in the District of Delaware, a seizure medication developer filed a complaint against a generic pharmaceutical company, alleging that the defendant infringed its patent for the drug Aptiom.
Portuguese company Bial – Portela & CA and its subsidiary, Bial – Holding, along with Delaware corporation Sunovion Pharmaceuticals, which primarily conducts business in Massachusetts, asserted that they hold New Drug Application (NDA) No. 022416 with the Food and Drug Administration (FDA) and United States Patent No. 10,912,781, corresponding to therapeutic seizure drug Aptiom. The patent-in-suit is set to expire on Oct. 23, 2028, according to the complaint.
The plaintiffs claimed that India-based Dr. Reddy’s Laboratories Ltd. (DRL) and its United States subsidiary submitted Abbreviated New Drug Application (ANDA) No. 211238 in order to manufacture, sell, and distribute tablets of eslicarbazepine acetate, the generic version of Aptiom, allegedly before the expiration of the patent-in-suit.
“DRL has represented to the FDA that DRL’s Generic Product is pharmaceutically and therapeutically equivalent to Plaintiffs’ APTIOM® tablets,” the complaint said, claiming that the defendants knowingly have infringed on the plaintiffs’ patent.
Arguing that the defendants have “committed — or aided, abetted, induced, contributed to, or participated in the commission of — the tortious act of patent infringement,” the plaintiffs claimed that they will be “irreparably harmed” if the defendants are not ordered to cease plans to manufacture, sell, and distribute their ANDA product.
Among the relief requested by the plaintiffs is a judgment that DRL has infringed on the plaintiffs’ patent-in-suit, an enjoinment from pursuing approval for the defendants’ ANDA and from working to manufacture, use, or sell DRL’s ANDA product before the patent-in-suit expires, and monetary relief.