Hanmi Pharmaceutical, AstraZeneca generics, gastrointestinal news
The U.S. Court of Appeals for the Federal Circuit temporarily enjoined Hanmi from launching its generic version of AstraZeneca's Nexium esomeprazole in the U.S. pending resolution of an appeal by the pharma. The court directed Hanmi to respond to AstraZeneca's motion for injunctive relief by Sept. 20. Hamni could not be reached for confirmation of its response. AstraZeneca is directed to reply by Sept. 24.
In June, Amneal Pharmaceuticals LLC (Bridgewater, N.J.), Hamni and AstraZeneca entered into a consent judgment in the U.S. District Court for the District of New Jersey to resolve aspects of litigation regarding two patents covering Nexium. Under the terms of the consent judgment, Amneal and Hanmi conceded the validity and enforceability of AstraZeneca's U.S. Patent Nos. 5,714,504 and 5,877,192. The judgment also provided that a generic from Hanmi does not infringe on those patents; in July, AstraZeneca filed an appeal in the U.S. Court of Appeals seeking a reversal of the district court's claim construction. FDA approved Hanmi's generic on Aug. 6 (see BioCentury, June 17). ...