Warner Chilcott Announces Decision on Appeal of DORYX Preliminary Injunction

Warner Chilcott plc

today announced that the U.S. Court of Appeals for the Federal Circuit vacated a preliminary injunction granted by the U.S. District Court for the District of New Jersey against Mylan Inc. and its affiliate Mylan Pharmaceuticals Inc. and remanded the matter to the District Court for further proceedings. In vacating the District Court's September 2011 preliminary injunction that prohibited Mylan from launching a generic version of a DORYX 150 mg product before a decision at trial, the Federal Circuit found that the District Court failed to hold an evidentiary hearing and to make sufficient findings with respect to Mylan's invalidity defenses. Warner Chilcott and Mayne Pharma International Pty., which owns the U.S. Patent No. 6,958,161 covering DORYX products, intend to continue to vigorously defend the '161 Patent and pursue their legal rights in their pending suit against Mylan. More specifically, Warner Chilcott and Mayne expect to seek rehearing of today's decision at the Federal Circuit and, if necessary, seek a temporary restraining order from the District Court to allow for the consolidation of the preliminary injunction hearing with the trial on the merits. The trial is currently expected to occur in the first quarter of 2012. Warner Chilcott markets and sells DORYX, a tetracycline-class oral antibiotic, in the United States under a license agreement with Mayne. As previously disclosed, in September 2011 Warner Chilcott received FDA approval for a dual-scored DORYX 150 mg product and filed a citizen petition requesting that the FDA refrain from granting final approval of any DORYX abbreviated new drug application seeking to manufacture and sell generic versions of a DORYX 150 mg product, unless certain conditions were satisfied by the ANDA filer. In the event that the Federal Circuit denies Warner Chilcott's and Mayne's motion for rehearing, the District Court denies Warner Chilcott's and Mayne's motion for a temporary restraining order, and Mylan receives final FDA approval of its generic version of a DORYX 150 mg product, Mylan could elect to launch its product "at risk" before the District Court renders a decision in the ongoing litigation relating to the '161 Patent. The Company can offer no assurance as to when the lawsuits will be decided, whether the lawsuits will be successful, whether the FDA will grant its citizen petition request, or whether generic equivalents of a DORYX 150 mg product will be approved and enter the market prior to the expiration of the '161 Patent in 2022.