Dr. Reddy’s Burns Down to Aciphex Patent Dispute

ut Eisai Inc has successfully defended its U.S. Patent 5,045,552 (the ‘552 patent) for the heart burn drug Aciphex, knocking down India-based Dr. Reddy’s Laboratories and Israel-based Teva Pharmaceuticals Industries Ltd. move to launch their respective generic versions of Aciphex before the ‘552 patent expiry in May 2013. Aciphex, generically known as Rabezpraxole Sodium, is co-marketed by PriCara (Unit of Ortho-McNeil) and Eisai in the United States raking up US sales of US $1 billion in 2006. In its ruling, the US District Court Southern District of New York ruled that the ‘552 patent is enforceable, which in earlier ruling, confirmed the validity of the ‘552 patent. During trial Dr. Reddy’s and Teva alleged, among other things, that the ‘552 patent is unenforceable because of Eisai’s inequitable conduct before the United States Patent & Trademark Office during prosecution of the patent, which judge Gerard Lynch ruled against Dr. Reddy’s and Teva after defendants (Dr. Reddy’s and Teva) failed to establish the defense of inequitable conduct by clear and convincing evidence.