CRESTOR Patent Upheld By US Court

Wednesday, 30 June 2010 AstraZeneca announced today that Judge Joseph Farnan, Jr., US District Court, District of Delaware, has found that the substance patent protecting CRESTOR (RE37,314 – the ‘314 patent) is valid and enforceable. In its ruling, the court found that no inequitable conduct was committed by any Shionogi employee. The court also held the ‘314 patent to be non-obvious and properly reissued. Judge Farnan’s subsequent entry of judgment will preclude the FDA from issuing final approvals for the defendants’ Abbreviated New Drug Applications (ANDAs) prior to the expiration of the ‘314 patent in 2016. “We are pleased with the court’s decision upholding the validity and enforceability of the ‘314 substance patent,” said David Brennan, Chief Executive Officer, AstraZeneca. “The court’s decision reaffirms the strength of the intellectual property protecting CRESTOR.’’ Judge Farnan also held that Apotex USA was liable as a submitter and is therefore bound to the court’s decision. About 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 patents. 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. The ‘314 patent, which expires in 2016, covers rosuvastatin calcium, the active ingredient in CRESTOR. These suits were consolidated by order of the Judicial Panel on Multidistrict Litigation and tried in the US District Court, District of Delaware. Trial commenced on 22 February 2010 before Judge Farnan and ended on 3 March 2010. tags Corporate and financial AstraZeneca Websites This website is intended for people seeking information on AstraZeneca's worldwide business. Our country sites can be located in the AZ Network. Veeva ID: Z4-8411 Date of next review: August 2020 Resources All resources Open Innovation Externally sponsored scientific research MedImmune US prescription assistance programmes Global clinical trials information Medicines Report a possible side effect Pearl Therapeutics Quick links Media Investor Relations Partnering Careers Sustainability Modern Slavery Statement Supplier information Social Media Facebook LinkedIn Twitter Glassdoor utility links Legal notice and Terms of Use Privacy notice Cookie policy Site map Contact us © AstraZeneca 2019 You are now leaving AstraZeneca.com You have selected a link that will take you to a site maintained by a third party who is solely responsible for its contents. AstraZeneca provides this link as a service to website visitors. AstraZeneca is not responsible for the privacy policy of any third party websites. We encourage you to read the privacy policy of every website you visit. Click ‘cancel’ to return to AstraZeneca’s site or ‘continue’ to proceed. Cancel Continue ? Important notice for users You are about to access AstraZeneca historic archive material. Any reference in these archives to AstraZeneca products or their uses may not reflect current medical knowledge and should not be used as a source of information on the present product label, efficacy data or safety data. Please refer to your approved national product label (SmPC) for current product information. I have read this warning and will not be using any of the contained product information for clinical purposes. I disagree I agree ? ?

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