AstraZeneca settles with Hanmi and Amneal over Nexium; Prepares for olaparib regulatory filing

Anglo-Swedish drug major AstraZeneca (LSE: AZN) today (May 3) said it has entered into an agreement with South Korean firm Hanmi Pharmaceutical and its US marketing partner, privately-held generics drugmaker Amneal Pharmaceuticals, to resolve certain issues and appeal others in US Nexium (esomeprazole) patent litigation regarding Hanmi’s Esomeprazole Strontium 505(b)2 NDA product. The agreement eliminates the need for a trial at the US District Court for the District of New Jersey, thus avoiding considerable trial costs.

Under the terms of a Consent Judgment resolving the litigation, Amneal and Hanmi have conceded the validity and enforceability of AstraZeneca’s US Patent Numbers 5,714,504 and 5,877,192 that protect Nexium. The Consent Judgment also provides that the Hanmi product does not infringe those patents under the District Court’s claim construction of December 2012. However, AstraZeneca believes that the District Court’s claim construction is erroneous and will seek reversal on appeal.

The agreement also allows AstraZeneca to immediately file that appeal (without trial, post-trial briefing, and the extended time necessary for the District Court to issue its rulings) to the US Court of Appeals for the Federal Circuit.