AstraZeneca enters agreement with Hanmi Pharmaceuticals and Amneal Pharmaceuticals in US NEXIUM patent litigation

AstraZeneca today announced it has entered into an agreement with Hanmi Pharmaceutical and affiliates (“Hanmi”) and its US marketing partner Amneal Pharmaceuticals (“Amneal”) to resolve certain issues and appeal others in US Nexium 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 (“District Court”), 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 United States Court of Appeals for the Federal Circuit (“Federal Circuit”).

While the appeal is ongoing, if Hanmi were to receive final FDA approval and pursue an “at-risk launch” of its Esomeprazole Strontium 505(b)2 NDA product, AstraZeneca retains its right to seek injunctive relief from the Federal Circuit. AstraZeneca understands that Hanmi’s Esomeprazole Strontium 505(b)2 NDA product is not subject to automatic substitution with Nexium.