This excerpt taken from the CEPH 8-K filed Jan 25, 2010.
Item 8.01 Other Events.
On January 22, 2010, Cephalon, Inc. (Cephalon) filed a lawsuit in U.S. District Court in Delaware against Sandoz Inc. (Sandoz) for infringement of U.S. Patent Nos. 7,132,570; 7,297,346; and RE37,516 for the Cephalon product NUVIGIL® (armodafinil) Tablets [C-IV]. The lawsuit is based upon an Abbreviated New Drug Application (ANDA) filed by Sandoz seeking approval from the U.S. Food and Drug Administration (FDA) for a generic equivalent of armodafinil to be sold in the United States. Sandoz alleges that the above NUVIGIL patents are invalid, unenforceable and/or will not be infringed by Sandozs manufacture, use or sale of the product described in its ANDA.
The filing of this lawsuit is provided for by the Hatch-Waxman Act, a federal statute governing certain aspects of generic drug approvals. Under that statute, the filing of the lawsuit stays any FDA approval of the Sandoz ANDA until the earlier of entry of a district court judgment in favor of Sandoz or 30 months from Cephalons December 2009 receipt of a Paragraph IV certification letter from Sandoz.
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.