US DISTRICT COURT FINDS SEROQUEL XR® FORMULATION PATENT VALID AND INFRINGED

2012-03-30

AstraZeneca today announced that the US District Court for the District of New Jersey has found the formulation patent protecting SEROQUEL XR® (quetiapine fumarate) extended release tablets to be valid. The court also ruled that Anchen Pharmaceuticals, Inc., Osmotica Pharmaceutical Corporation, Torrent Pharmaceuticals Limited, Torrent Pharma Inc., Mylan Pharmaceuticals Inc. and Mylan Inc. have infringed the SEROQUEL XR formulation patent. The SEROQUEL XR formulation patent expires in 2017.

This follows a decision made in the UK on 22 March 2012, which found the formulation patent protecting SEROQUEL XR to be invalid. In the Netherlands, however, on 7 March 2012, the District Court in The Hague found the formulation patent protecting SEROQUEL XR to be valid.

AstraZeneca is pleased with the US District Court’s decision, which the company believes underlines the strength of its patents.

- ENDS -

NOTES TO EDITORS

About the Trial

In October 2011, the US District Court for the District of New Jersey conducted a trial of the pending patent infringement actions against four generic filers: Anchen Pharmaceuticals, Inc., Osmotica Pharmaceutical Corporation, Torrent Pharmaceuticals Limited, Torrent Pharma Inc., Mylan Pharmaceuticals Inc. and Mylan Inc.

Prior to the October trial, AstraZeneca settled its patent infringement case against Handa. On 29 September 2011, AstraZeneca granted Handa a license to the 5,948,437 patent effective 1 November 2016, or earlier under certain circumstances.

Additionally, on 5 October 2011, AstraZeneca settled its patent infringement action against Accord. AstraZeneca granted Accord a license to the 5,948,437 patent effective 1 November 2016, or earlier under certain circumstances. In both instances, the Court dismissed the action against the filers.

Today’s judgment is limited to the US market only and is not valid in other countries. 

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation of prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease. 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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