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Press release from Business Wire

CRESTOR® US Patent Upheld by Court of Appeals for the Federal Circuit

Friday, December 14, 2012

CRESTOR® US Patent Upheld by Court of Appeals for the Federal Circuit13:21 EST Friday, December 14, 2012 WILMINGTON, Del. (Business Wire) -- AstraZeneca (NYSE: AZN) announced today that the Court of Appeals for the Federal Circuit has upheld the decision of the District Court, District of Delaware, finding that the substance patent protecting CRESTOR (rosuvastatin calcium) (RE37,314 – the ‘314 patent) is valid and enforceable. The defendants may seek a rehearing and/or review by the U.S. Supreme Court. Absent a reversal of this decision, none of the Abbreviated New Drug Applications (ANDAs) filed by Apotex, Aurobindo, Cobalt, Glenmark, Mylan, Par, Sandoz, Sun, Teva and Torrent may be approved by the FDA prior to expiration of the ‘314 patent. The ‘314 patent, which expires in 2016, covers rosuvastatin calcium, the active ingredient in CRESTOR. The Federal Circuit also held that Apotex Corp. was liable as a submitter and is therefore bound by the District Court's decision. NOTES TO EDITORSAbout the Trial Beginning in 2007, nine generic drug manufacturers filed ANDAs along with Paragraph IV certifications of non-infringement, invalidity, or unenforceability with respect to the CRESTOR ‘314 substance patent. AstraZeneca and Shionogi (the owner of the ‘314 patent) filed patent infringement suits against eight manufacturers (various parent or subsidiary entities of Apotex, Aurobindo, Cobalt, Mylan, Par, Sandoz, Sun and Teva) who had challenged the ‘314 substance patent. These suits were consolidated by order of the Judicial Panel on Multidistrict Litigation and tried in the U.S. District Court, District of Delaware. Trial commenced on February 22, 2010 before Judge Farnan and ended on March 3, 2010. In June 2010, the US District Court for the District of Delaware found the ‘314 patent valid and enforceable and infringed by the eight generic defendants. 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 U.S. or our AZ&Me™ Prescription Savings programs, please visit: www.astrazeneca-us.com or call 1-800-AZandMe (292-6363). AstraZenecaMedia Inquiries UK:Esra Erkal-Paler, +44 207 604 8030Esra.Erkal-Paler@astrazeneca.comorMedia Inquiries US:Tony Jewell, +1 302 885 4594Tony.Jewell@astrazeneca.comorInvestor Inquiries 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 Inquiries USEd Seage, +1 302 886 4065 mob: +1 302 373 1361Colleen Proctor, +1 302 886 1842 mob: + 1 302 357 4882