On Tuesday, a suit in the District of Delaware was filed by plaintiffs Ferring Pharmaceuticals Inc., Ferring International Center S.A., Ferring B.V., and Polypeptide Laboratories A/S against defendants Eugia Pharma Specialties LTD., Aurobindo Pharma LTD., and Auromedics Pharma LLC. The complaint for patent infringement comes after the defendant’s filing of an Abbreviated New Drug Application (ANDA) with the Food and Drug Administration (FDA) where they sought approval to produce and market a generic version of the plaintiff’s drug Firmagon.
The plaintiffs, according to the complaint, hold the necessary patents for Firmagon, which the FDA approved in late 2008 for the “treatment of patients with advanced prostate cancer.” More recently, defendant Eugia filed an ANDA in which they requested approval to manufacture and sell a generic version of Firmagon prior to the expiration of the patents held by the plaintiffs which protected their rights to the drug.
Alongside their ANDA, the defendants collectively submitted a certification in which they described the patents-in-suit as invalid, unenforceable, and further noted that their new generic Firmagon would not infringe upon any of the patents-in-suit. They later provided the plaintiffs with a notice letter detailing their belief that the patents were invalid and unenforceable as well as their intent to produce and market their ANDA product pending the approval of the FDA.
The package insert for a product usually details instructions and details for administration of the drug. The plaintiffs assert in the complaint that the packaging for the defendant’s ANDA product “will be substantially similar to the package insert for Firmagon in all material respects,” therefore infringing on the patents-in-suit.
The complaint cites eight separate counts of infringement. As a result, the plaintiffs are seeking declarations that each of the patents-in-suit are valid and enforceable, that the defendant’s ANDA constituted infringement, that the defendant’s may not infringe upon the patents prior to their expiration, compensatory damages, pre-judgement and post-judgement interest, and any other relief deemed just by the court.
The plaintiffs are represented in the litigation by Womble Bond Dickinson.