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Press release from Business Wire

US District Court Finds SEROQUEL XR Formulation Patent Valid and Infringed

Thursday, March 29, 2012

US District Court Finds SEROQUEL XR Formulation Patent Valid and Infringed17:27 EDT Thursday, March 29, 2012 WILMINGTON, Del. (Business Wire) -- AstraZeneca (NYSE: AZN) 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 March 22, 2012, which found the formulation patent protecting SEROQUEL XR to be invalid. In the Netherlands, however, on March 7, 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 EDITORSAbout 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 September 29, 2011, AstraZeneca granted Handa a license to the 5,948,437 patent effective November 1, 2016, or earlier under certain circumstances. Additionally, on October 5, 2011, AstraZeneca settled its patent infringement action against Accord. AstraZeneca granted Accord a license to the 5,948,437 patent effective November 1, 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 commercialization 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 about AstraZeneca in the US or our AZ&Me Prescription Savings Programs, please visit: www.astrazeneca-us.com or call 1-800-AZandMe (292-6363). AstraZenecaMedia Inquiries USStephanie Andrzejewski +1 302 885 8896Julia Walker +1 302 885 5172orMedia EnquiriesEsra Erkal-Paler +44 20 7604 8030Sarah Lindgreen +44 20 7604 8033orInvestor Enquiries UKJames Ward-Lilley +44 20 7604 8122 mob: +44 7785 432613Karl Hård +44 20 7604 8123 mob: +44 7789 654364Nicklas Westerholm +44 20 7604 8124 mob: +44 7585 404950orInvestor Enquiries USEd Seage +1 302 886 4065 mob: +1 302 373 1361Jorgen Winroth +1 212 579 0506 mob: +1 917 612 4043