Cephalon and Mylan Settle Generic PROVIGIL Patent Infringement Suit

PR Newswire reported on Tuesday, January 10, 2006:

Cephalon, Inc. (Nasdaq: CEPH) announced today that it has entered into an agreement with Mylan Pharmaceuticals Inc. to settle its pending patent infringement dispute in the United States related to PROVIGIL(R) (modafinil) Tablets [C-IV].

In connection with the settlement, Cephalon will grant Mylan a non-exclusive royalty-bearing right to market and sell a generic version of PROVIGIL in the United States.  Mylan's license will become effective in October 2011, unless Cephalon obtains a pediatric extension for PROVIGIL which would permit entry by Mylan in April 2012.  An earlier entry by Mylan may occur based upon the entry of another generic version of PROVIGIL.

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

The parties will promptly file a dismissal with prejudice with the United States District Court for the District of New Jersey that will conclude all pending litigation between the parties regarding PROVIGIL.  This settlement and the previously announced settlements with Teva Pharmaceutical Industries Ltd. and its affiliate and Ranbaxy Laboratories Limited 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 ("the '516 Patent") which covers pharmaceutical compositions and methods of treatment with the form of modafinil contained in PROVIGIL.  The'516 patent expires in October 6, 2014 and may be extended by six months (to April 6, 2015) upon submission of pediatric study data that is acceptable to the U.S. Food and Drug Administration.