Warner Chilcott Announces Favorable Decision in DORYX Preliminary Injunction Proceedings
DUBLIN, Ireland, Sept. 22, 2011 (GLOBE NEWSWIRE) -- Warner Chilcott plc (Nasdaq:WCRX) today announced that the U.S. District Court for the District of New Jersey granted its motion for a preliminary injunction against Mylan Inc. and its affiliate Mylan Pharmaceuticals Inc. (together "Mylan"). The preliminary injunction prevents Mylan from launching a generic version of a DORYX 150 mg product before the District Court renders a decision in the on-going litigation relating to the U.S. Patent No. 6,958,161 (the "161 Patent") covering Warner Chilcott's DORYX products. No trial date has been set.
In granting the motion, the District Court found that Warner Chilcott and its co-plaintiff, Mayne Pharma International Pty. ("Mayne"), demonstrated a reasonable likelihood of success on the merits of their claim that the '161 Patent is valid and infringed by Mylan's 150 mg generic DORYX product.
Warner Chilcott markets and sells DORYX, a tetracycline-class oral antibiotic, in the United States under a license agreement with Mayne, which owns the '161 Patent. The DORYX 150 mg product currently represents in excess of 95% of Warner Chilcott's DORYX franchise based on total prescriptions according to IMS Health, Inc.
While Warner Chilcott and Mayne intend to continue to vigorously defend the '161 Patent and pursue their legal rights in their pending suits against Mylan and the other defendants that have submitted abbreviated new drug applications to the FDA seeking approval to manufacture and sell generic versions of a DORYX 150 mg product, the Company can offer no assurance as to when the lawsuits will be decided, whether the lawsuits will be successful or that generic equivalents of a DORYX 150 mg product will not be approved and enter the market prior to the expiration of the '161 Patent in 2022.
Warner Chilcott is a leading specialty pharmaceutical company currently focused on the women's healthcare, gastroenterology, dermatology and urology segments of the North American and Western European pharmaceuticals markets. The Company is fully integrated with internal resources dedicated to the development, manufacturing and promotion of its products. WCRX-G
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CONTACT: Emily Hill