Hanmi Pharmaceutical, AstraZeneca generics, gastrointestinal news
The U.S. Court of Appeals for the Federal Circuit ruled that Hanmi's generic version of AstraZeneca's Nexium esomeprazole does not infringe on the pharma's U.S. Patent No. 5,714,504. On Dec. 17, 2013, Amneal Pharmaceuticals LLC (Bridgewater, N.J.) launched Hanmi's generic esomeprazole in the U.S. Last year, Amneal acquired exclusive rights to Hanmi's NDA for esomeprazole strontium delayed-release capsules.
In June 2013, Amneal, Hanmi 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 Nexium. Under the terms of the consent judgment, Amneal and Hanmi conceded the validity and enforceability of AstraZeneca's U.S. Patent No. 5,877,192 and the '504 patent. 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. The only issue on appeal was the construction of the claim term "alkaline salt" in the '504 patent. FDA approved Hanmi's generic on Aug. 6 (see BioCentury, June 17, 2013 & Sept. 23, 2013). ...