Astellas Announces Favorable Ruling in Patent Infringement Case

Tokyo, May 7, 2012 - Astellas Pharma Inc. ("Astellas", headquarters: Tokyo; President and CEO: Yoshihiko Hatanaka) announced that on May 1, 2012, the U.S. District Court for the District of Delaware found both the patents in a suit brought against Mylan Pharmaceuticals Inc. (“Mylan”) to be valid and entered judgment in favor of OSI Pharmaceuticals, LLC (a US affiliate of Astellas), Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX; RHHBY), and Pfizer Inc. (NYSE:PFE).

On March 19, 2009, Genentech, OSI Pharmaceuticals, and Pfizer filed a patent infringement lawsuit in the U.S. District Court in Delaware against Mylan for infringement of U.S. Patent Nos. 5,747,498 (reissued as RE 41,065) and 6,900,221, which cover Tarceva® (erlotinib) tablets and their use. The lawsuit was based on an Abbreviated New Drug Application (ANDA) filed by Mylan seeking permission from the FDA to manufacture and market a generic version of Tarceva before the expiration of the U.S. patents covering Tarceva.

For inquiries or additional information Astellas Pharma Inc. Corporate Communications Tel: +81-3-3244-3201 Fax: +81-3-5201-7473 http://www.astellas.com/en

Posted: May 2012


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