Teva and Cephalon Settle Provigil Patent Litigation

Teva Pharmaceutical Industries Ltd. and Teva Pharmaceuticals USA, Inc. announced on Friday, December 9, 2005 in a press release that:

They have entered into an agreement with Cephalon, Inc. to settle their pending patent infringement disputes in the United States and the United Kingdom related to PROVIGIL® (modafinil) Tablets [C-IV].

In connection with the settlement, Cephalon will grant Teva a non-exclusive royalty-bearing right to market and sell a generic version of PROVIGIL. Teva’s license in the United States will become effective in October 2011 absent a pediatric extension for PROVIGIL, which would delay the entry date by six months (to April 2012). Outside the United States, the parties agreed to comparable terms for the license effective date, which generally allow for entry in October 2012. An earlier entry by Teva in any of the territories may occur based upon the entry of another generic version of PROVIGIL.

The companies also agreed to a series of business arrangements related to modafinil. Specifically, Teva has agreed to grant to Cephalon a non-exclusive license, effective immediately, to its worldwide intellectual property rights related to the manufacture, development and formulation of modafinil in exchange for royalty payments. Cephalon has also agreed to enter into certain arrangements with Teva related to Teva’s manufacture and supply of the active pharmaceutical ingredient modafinil.

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 dismissals with prejudice with the United States District Court for the District of New Jersey and United Kingdom High Court of Justice, Chancery Division, which will conclude all pending litigations between the parties regarding PROVIGIL. Cephalon’s U.S. Patent No. RE37,516 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.