US District Court upholds Mylan's US patents on Perforomist Inhalation Solution

US generics major Mylan (Nasdaq: MYL) says the US 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. Notwithstanding, Mylan’s stock fell 4.16% to $49.97 by close of trading on Monday.

Mylan previously sued Israeli generics giant Teva Pharmaceutical Industries (NYSE: TEVA) alleging that the latter’s Abbreviated New Drug Application for this product infringed four Mylan patents covering Perforomist (The Pharma Letter July 18, 2013). 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 US Food and Drug Administration, from receiving final approval prior to expiration of US Patent Nos 6,667,344; 6,814,953; 7,348,362; and 7,462,645, which cover Perforomist through June 2021.