CLARKSBURG – Mylan Pharmaceuticals is being sued for patent infringement of Boehringer's drug Pradaxa.
Boehringer Ingelheim Pharma GmbH & Co. KG; Boehringer Ingelheim International GmbH; and Boehringer Ingelheim Pharmaceuticals Inc. claim they are the holder of New Drug Application No. 22-512, by which the U.S. Food & Drug Administration first granted approval for 75 mg and 150 mg dabigatran etexilate mesylate capsules, according to a complaint filed Jan. 21 in the U.S. District Court for the Northern District of West Virginia.
The capsules described in the NDA are prescribed to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation and are sold by Boehringer under the trade name Pradaxa, according to the suit.
Boehringer claims it owns the patent, which was duly and legally issued on July 11, 2000.
Mylan filed with the FDA an Abbreviated New Drug Application, seeking approval to engage in the manufacture, use, sale, offer for sale and/or importation of 75 mg and 150 mg dabigatran etexilate mesylate capsules prior to the expiration of the patent, according to the suit.
Boehringer claims on Dec. 8, Mylan sent a letter to the plaintiffs representing that it filed the ANDA and sought its approval of its ANDA prior to the expiration of that patent.
Boehringer is seeking a judgment entered that Mylan has infringed on the patent by submitted the ANDA; and a permanent injunction be issued, restraining and enjoining Mylan from engaging in the commercial manufacture, use, offer to sell, or sale within the United States, or importation into the United States, of drugs or methods of administering drugs claimed in the patent.
Boehringer is being represented by James F. Companion and Yolanda G. Lambert of Schrader, Byrd & Companion PLLC; and Bruce M. Wexler, Joseph M. O'Malley Jr., Eric W. Dittmann, Isaac S. Ashkenazi, Leonard A. Mofredo of Paul Hastings LLP.
The case is assigned to District Judge Irene M. Keeley.
U.S. District Court for the Northern District of West Virginia case number: 1:15-cv-00010