Drug company wants to stop Mylan's generic Actonel

MORGANTOWN – A pharmaceutical company wants to thwart Mylan's attempts to produce and market a generic version of its patented drug.

Warner Chilcott Company and Hoffmann-La Roche filed a lawsuit April 9 in U.S. District Court against Mylan Pharmaceuticals for its attempts to produce a generic version of the drug Actonel.

Roche claims it developed the drug, which is used to treat and prevent osteoporosis, and patented it on March 20, 2007.

On Feb. 23, Mylan notified the plaintiffs that it had submitted a new drug application to the FDA seeking its approval to manufacture and sell 150 milligram tablets of risedronate sodium – a generic version of the plaintiffs' patented drug Actonel, according to the complaint.

In its letter to the plaintiffs, Mylan informed them that it did not believe it was infringing on their patent because of a certification contained in the plaintiffs' new drug application, the suit states.

However, the plaintiffs contend Mylan submitted its new drug application before the expiration of the plaintiffs' patent. If the FDA approves Mylan's new drug application, the plaintiffs claim they face "substantial and irreparable harm."

In their complaint, the plaintiffs seek a declaration that their patent is enforceable, a judgment that Mylan's risedronate sodium tablets infringe on the plaintiffs' patent, an order that Mylan's new drug application for the risedronate sodium tablets cannot be approved before the plaintiffs' patent's expiration date and an order preventing Mylan from manufacturing or selling the risedronate sodium tablets in the United States before the plaintiffs' patent's expiration date. In addition, they seek damages if Mylan does sell the tablets, plus costs and other relief the court deems just.

Frank E. Simmerman Jr. and Chad L. Taylor of Simmerman Law Office in Clarksburg will be representing them. William F. Lee, Vinita Ferrera and Allen C. Nunnally of Wilmer, Cutler, Pickering, Hale and Dorr in Boston; David B. Bassett of Wilmer, Cutler, Pickering, Hale and Dorr in New York; and Mark E. Waddell of Loeb and Loeb in New York will serve of counsel.

U.S. District Court case number: 1:10-cv-59