MORGANTOWN -- A French company has filed suit against Mylan, alleging it infringed on a patent for a prescription drug to help improve wakefulness.

Cephalon Inc. and Cephalon France claims it holds a new drug application for Nuvigil tablets, which is used to improve wakefulness in patients with excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome, narcolepsy and shift work sleep disorder.

However, Mylan filed a new drug application seeking approval to market a generic form of the medication, according to the complaint filed Dec. 14 in U.S. District Court for the Northern District of West Virginia.

"By submitting its ANDA No. 20-0043 under 505(j) of the Federal Food, Drug, and Cosmetic Act for the purpose of obtaining approval to engage in the commercial manufacture, use, or sale of Mylan's generic armodafinil products before the expiration of the 516 patent, Mylan has infringed the 516 patent," the suit states.

Because of the infringement, Cephalon says it has been damaged and will continue to be damaged unless the infringement is prevented.
In its two-count complaint, Cephalon alleges infringement of two of its patents for the medication.

It is asking the court to declare that Mylan's request for approval of the generic form of medication before the expiration of Cephalon's patents is an act of infringement, to issue a permanent injunction preventing Mylan from infringing any claims of patents-in-suit with Mylan's generic products and to issue a permanent injunction preventing Mylan from seeking approval for its generic medication until after Cephalon's patents expire. In addition, it is asking the court to order that the FDA's approval of Mylan's generic drug be given no sooner than the expiration date of Cephalon's patent, to declare that Mylan has no defense against Cephalon's infringement allegations and to award Cephalon costs and other relief the court deems just.

It will be represented by Charles E. Lipsey of Finnegan, Henderson, Farabow, Garrett and Dunner in Reston, Va., by Thomas L. Irving, Barbara R. Rudolph, Mark J. Feldstein and Laura P. Masurovsky of Finnegan, Henderson, Farabow, Garrett and Dunner in Washington, D.C., and by James F. Companion and John Porco of Schrader, Byrd and Companion in Wheeling.

U.S. District Court case number: 1:09-cv-165

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