Cephalon, Ranbaxy settle patent infringement lawsuit over Provigil

By E. Janene Geiss

Philadelphia, Dec. 22 - Cephalon, Inc. announced Thursday that it has entered into an agreement with Ranbaxy Laboratories Ltd. to settle its pending patent infringement dispute in the United States related to Provigil (modafinil) tablets.

In connection with the settlement, Cephalon said it will grant Ranbaxy a non-exclusive royalty bearing right to market and sell a generic version of Provigil in the United States.

Ranbaxy's license will become effective in October 2011 in the absence of a pediatric extension for Provigil, which would delay the entry date by six months, to April 2012.

An earlier entry by Ranbaxy may occur based upon the entry of another generic version of Provigil, officials said.

The companies also agreed to a series of business arrangements related to modafinil.

Ranbaxy has agreed to grant to Cephalon a non-exclusive license, effective immediately, to certain of its worldwide intellectual property rights related to modafinil in exchange for milestone payments, officials said.

Cephalon said it also has agreed to enter into certain arrangements with Ranbaxy related to Ranbaxy's supply of the active pharmaceutical ingredient modafinil.

The terms of the agreement are confidential, officials said, and are subject to review by the U.S. Federal Trade Commission. Financial terms were not disclosed.

Both companies will promptly file a dismissal with prejudice with the U.S. District Court for the District of New Jersey that will conclude all pending litigation between the parties regarding Provigil, officials said.

This settlement and the previously announced settlements with Teva Pharmaceutical Industries Ltd. and Teva Pharmaceuticals USA, Inc. do not affect the status of the ongoing Provigil patent litigations between Cephalon and certain other generic companies that are pending in the U.S. District Court in New Jersey.

These lawsuits claim infringement of Cephalon's U.S. Patent No. RE37,516, which covers pharmaceutical compositions and methods of treatment with the form of modafinil contained in Provigil.

The patent expires Oct. 6, 2014 and may be extended by six months, to April 6, 2015, upon submission of pediatric study data that is acceptable to the Food and Drug Administration.

Cephalon is a Frazer, Pa., biopharmaceutical company dedicated to the discovery, development and marketing of innovative products to treat sleep and neurological disorders, cancer and pain.

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