Sterne, Kessler, Goldstein & Fox secured a victory on behalf of Teva Pharmaceuticals in the U.S. Court District Court for the District of New Jersey in a case involving a patent-infringement suit filed by Corcept Therapeutics. On December 29, 2023, the district court held that Teva does not infringe the two patents asserted at trial, finding that Corcept had failed to show that direct infringement is likely or that Teva’s label would induce infringement.
Teva Pharmaceuticals USA, Inc. is a leading manufacturer of generic and proprietary drug products. Teva applied for FDA approval to market a generic version of Korlym (mifepristone), a drug indicated to control hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing’s syndrome who have type II diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery. Corcept Therapeutics, Inc., the holder of the Korlym NDA, filed a Hatch-Waxman lawsuit against Teva alleging infringement of two patents listed in the Orange Book for Korlym. The suit grew to include nine patents, all of which cover methods of use of mifepristone, but all but two patents were dropped before trial. The case went to trial in September 2023. The district court opinion is available here.