Warner files lawsuit for Infringement of Doryx (US 6,958,161) Patent

Warner and one of its subsidiaries and "Mayne", a subsidiary of Hospira Inc. have filed a lawsuit against Sandoz Inc. in the District Court for the District of New Jersey for infringement of Mayne's U.S. Patent No. 6,958,161 (the "'161 Patent") which covers DORYX, a tetracycline-class oral antibiotic.

Warner markets and sells DORYX DR tablets in 150, 100 and 75 mg strengths under a license agreement with Mayne. Warner Chilcott previously announced the filing of similar lawsuits against each of Mutual Pharmaceutical Company, Inc., Mylan Pharmaceuticals Inc. and Impax Laboratories, Inc. on December 23, 2008. The lawsuit is in response to the submission of an ANDA) to the USFDA by Sandoz requesting approval to manufacture and sell generic versions of DORYX 100 and 75 mg DR tablets prior to the expiration in 2022 of the '161 Patent. Warner Chilcott and Mayne intend to vigorously defend the '161 Patent and pursue their legal rights.

Warner paragraph IV certification for DORYX

Warner Chilcott's subsidiaries and Hospira have received Paragraph IV Certification Notices from Mutual Pharmaceutical Company, Inc. and Mylan Pharmaceuticals Inc. ("Mylan") advising that each such company has filed an ANDA for generic versions of DORYX 100 and 75 mg delayed-release tablets. DORYX is a tetracycline-class oral antibiotic protected by Mayne's Patent No. 6,958,161 (the "161 Patent") which expires in 2022. The '161 Patent has been listed in the FDA's Orange Book pursuant to the transition provisions of the QI Program Supplemental Funding Act of 2008 enacted October 8, 2008.