At the District Court of Delaware on Tuesday, Astellas Pharma Inc. (API), Astellas Ireland Co. Ltd. (AICL), and Astellas Pharma Global Development (APGD) filed a complaint against 21 pharmaceutical companies alleging patent infringement.
The patent in question, deemed the ’780 patent, corresponds to APGD’s Myrbetriq extended-release tablets, containing active ingredient mirabegron, which is used to treat overactive bladder. This patent was issued Nov. 24, 2020, after previous patents for the product had expired; ’780 will expire no earlier than Sept. 28, 2029, the complaint said.
The defendants are as follows: Sandoz Inc., Actavis Elizabeth LLC, Actavis LLC, Teva Pharmaceuticals USA Inc., Apotex Inc., Apotex Corp., Aurobindo Pharma Ltd., Aurobindo Pharma USA Inc., Aurolife Pharma LLC, Sawai Pharmaceutical Co. Ltd., Sawai USA Inc., Prinston Pharmaceutical Inc., Zhejiang Huahai Pharmaceutical Co. Ltd., Huahai US Inc., Solco Healthcare US LLC, Windlas Healthcare Pvt. Ltd., Windlas Biotech Ltd., Zydus Pharmaceuticals (USA) Inc., Cadila Healthcare Ltd. (doing business as Zydus Cadila), Lupin Ltd., and Lupin Pharmaceuticals, Inc. According to the complaint, each defendant is a company that develops, manufactures, and/or distributes generic drugs for sale in the United States, and each has submitted an abbreviated new drug application (ANDA) to the Food and Drug Administration (FDA) for a generic version of Myrbetriq in 25 mg and/or 50 mg doses.
The plaintiffs alleged that “each Defendant has made, and continues to make, substantial preparation to engage in the commercial manufacture, use, offer to sell, or sale of its proposed ANDA Product prior to the expiration of the ’780 Patent.” The plaintiffs claimed they exclusively own “the rights to develop, import, market, sell, distribute, and promote any and all pharmaceutical formulations in finished package forms which contain mirabegron as the active ingredient in the United States” under the ’780 patent.
According to the complaint, the “Plaintiffs will be substantially and irreparably harmed” if the defendants are not enjoined by the court. The plaintiffs requested that the court rule the ANDAs submitted by each defendant and the manufacturing, using, selling, or distributing of the product by the defendants as infringements of the ’780 patent, as well as monetary and other relief if any of the defendants engage in the manufacturing, using, selling, or distributing of the product in the U.S. prior to the patent’s expiration.
The plaintiffs are represented by McCarter & English LLP.