US Appeals Court lifts temporary injunction against Hanmi's 505(b)2 NDA esomeprazole strontium product

US Appeals Court lifts temporary injunction against Hanmi's 505(b)2 NDA esomeprazole strontium product

Wednesday, 2 October 2013

AstraZeneca today announced that the US Court of Appeals for the Federal Circuit (CAFC) lifted a temporary injunction against the US launch of Hanmi's 505(b)2 NDA esomeprazole strontium product.

AstraZeneca's CAFC appeal of claim construction from the US District Court for the District of New Jersey remains ongoing, with briefing to be completed by 18 October and oral argument scheduled in the next months.

If Hanmi were to launch its 505(b)2 NDA esomeprazole strontium product, depending on the outcome of the CAFC appeal, Hanmi's launch would be at risk of owing AstraZeneca patent-infringement damages. AstraZeneca understands that Hanmi's 505(b)2 NDA esomeprazole strontium product is not AB-rated and is not automatically substitutable for Nexium.

NOTES TO EDITORS

About the underlying litigation

In June 2013, AstraZeneca entered into an agreement with Hanmi Pharmaceutical and affiliates ("Hanmi") and Amneal Pharmaceuticals ("Amneal") to streamline litigation issues regarding Hanmi's proposed 505(b)2 NDA esomeprazole strontium product.

Under terms of the agreement, Amneal and Hanmi have conceded the validity and enforceability of AstraZeneca's US Patent Nos. 5,714,504 and 5,877,192 that protect Nexium. The US District Court for the District of New Jersey ("District Court") entered a Consent Judgment.

In July 2013, AstraZeneca filed a Notice of Appeal in the US Court of Appeals for the Federal Circuit ("Federal Circuit") regarding critical aspects of the District Court's December 2012 construction. Among issues, AstraZeneca is seeking a reversal of claim construction.

On 6 August, Hanmi Pharmaceutical received US FDA approval for its 505(b)2 NDA esomeprazole strontium product.

On 13 September, the US CAFC issued a temporary injunction against the US launch of Hanmi's 505(b)2 NDA esomeprazole strontium product.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com

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