WEST VIRGINIA RECORD

CLARKSBURG – Mylan again finds itself named as a defendant in a patent infringement case.

Schering Corporation and MSP Singapore Company filed a lawsuit Dec. 18 in U.S. District Court against Mylan. Cephalon Inc. and Cephalon France also filed a nearly identical patent infringement lawsuit on Dec. 14 against the company for Mylan's alleged attempt to sell a generic version of Nuvigil.

In their lawsuit, Schering and MSP claim they hold an FDA-approved new drug application for Vytorin, a drug used to reduce cholesterol in patients with primary hyperlipidemia or mixed hyperlipidemia.

However, Mylan filed a new drug application seeking approval to market a generic version of the medication, according to the complaint.

"Mylan's filing of ANDA No. 200-082 for the purpose of obtaining approval to engage in the commercial manufacture, use, offer for sale, and/or sale of Mylan's ANDA product before the expiration date of the '966 and '721 Patents as an act of infringement of the '966 and '721 Patents," the suit states.

If the FDA allows Mylan to infringe the patent, Schering and MSP claim they will suffer irreparable injury.

In their lawsuit, the plaintiffs seek a declaration that their patents are valid and enforceable; a judgment that their patents would be infringed by Mylan's generic version of the drug; an order that Mylan's generic version of the drug not be approved until the patent's expiration on April 25, 2017; an order preventing Mylan from selling the generic version of the drug until the patent's expiration; damages; pre-judgment interest; attorneys' fees; costs; and other relief the court deems just.

Schering and MSP will be represented by Frank E. Simmerman Jr. of Simmerman Law Office in Clarksburg and by David T. Pritikin of Sidley Austin in Chicago.

U.S. District Court case number: 1:09-cv-167