AZ enters agreement with Hanmi and Amneal in US Nexium patent litigation
AZ says this removes need for a trial and avoids ‘considerable’ costs
AstraZeneca has agreed with Hanmi Pharmaceutical, based in Seoul, South Korea and its US marketing partner Amneal Pharmaceuticals to ‘resolve some issues and appeal others’ in its US Nexium patent litigation regarding Hanmi’s Esomeprazole Strontium 505(b)2 NDA product.
AstraZeneca says this will eliminate 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 heartburn drug Nexium. The Consent Judgment also states that the Hanmi product does not infringe those patents under the District Court’s claim construction of December 2012.
However, AstraZeneca says this claim construction is ’erroneous’ and the firm will seek reversal on appeal. The agreement allows AstraZeneca to immediately file that appeal to the US Court of Appeals for the 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 says it retains its right to seek an injunction from the Federal Circuit.
AstraZeneca understands that Hanmi’s Esomeprazole Strontium 505(b)2 NDA product is not subject to automatic substitution with Nexium.
