Mylan Inc. has announced the United States District Court for the Northern District of West Virginia issued a decision upholding the validity of all patents asserted by Mylan, protecting Perforomist (formoterol fumarate) Inhalation Solution. Mylan previously sued Teva alleging that Teva's Abbreviated New Drug Application (ANDA) for this product infringed four Mylan patents covering Perforomist. After a full trial, the Court entered a judgment finding infringement of the patents-in-suit, rejecting Teva's defenses, and enjoining Teva from making, using, offering to sell, selling or importing the inhalation product described in Teva's ANDA. The Court's decision also prevents Teva's ANDA, which has yet to receive a tentative approval from the U.S. Food and Drug Administration (FDA), from receiving final approval prior to expiration of U.S. Patent Nos. 6,667,344; 6,814,953; 7,348,362; and 7,462,645, which cover Perforomist through June 2021.
Mylan CEO Heather Bresch commented: "The court's decision to recognize the validity of the patents covering Mylan's Perforomist@ Inhalation Solution not only affirms the strength of our intellectual property on this product, but also our broader respiratory portfolio, including Mylan's combination product currently in development. We are excited about the growth of our respiratory franchise and look forward to continuing to meet unmet needs in this increasingly important space."