Astellas Pharma Alleges Infringement of Myrbetriq Patent Against Generic Manufacturers

On Wednesday in the District of Delaware, Astellas Pharma Inc. and its subsidiaries filed a complaint against four defendant entities, alleging that the defendants’ generic pharmaceutical products infringe on the patent covering an Astellas drug product, Myrbetriq.

Astellas Pharma, as owner of United States Patent No. 10,842,780, covering overactive bladder treatment drug Myrbetriq, along with patent-in-suit licensee Astellas Ireland Co. Ltd. and Myrbetriq New Drug Application owner Astellas Pharma Global Development Inc., challenged the generic drug products of pharmaceutical manufacturers comprising four separate entities: Aurobindo Pharma Ltd., Aurobindo Pharma USA Inc., and Aurolife Pharma LLC (collectively, Aurobindo); Actavis Elizabeth LLC, Actavis LLC, and Teva Pharmaceuticals USA Inc. (collectively, Actavis); Zydus Pharmaceuticals USA Inc. and Zydus Cadila (collectively, Zydus); and Lupin Ltd. and Lupin Pharmaceuticals Inc. (collectively, Lupin), according to the complaint.

Each generic manufacturer entity sent a letter to the plaintiffs to notify them that they all had submitted Abbreviated New Drug Applications (ANDAs) to the Food and Drug Administration (FDA) for mirabegron extended-release tablets, the generic version of Myrbetriq, in varying strengths. Every defendant claimed in its letter that the plaintiffs’ patent was “invalid, unenforceable, and/or will not be infringed” by the circulation of the defendants’ ANDA products.

Given that the patent-in-suit is set to expire on Sept. 28, 2029, according to the Orange Book, the FDA’s patent database, Astellas disputed the defendants’ claims that their generic mirabegron products are noninfringing.

According to the complaint, by the defendants filing ANDAs for mirabegron products, they are representing to the FDA that their products will have “the same active ingredient, method of administration, dosage form, and dosage amount” as Myrbetriq.

The plaintiffs asserted that unless the defendants are enjoined, Astellas will be “substantially and irreparably harmed” by the alleged conduct of the generic drug manufacturers.

Astellas and its affiliates are seeking judgment that the defendants’ alleged conduct constitutes infringement, enjoinment of the defendants from continuing their alleged actions, and monetary relief, among other damages.

The plaintiffs are represented by McCarter & English LLP.