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James R. Barney

AstraZeneca Seeks to Halt Mylan's 2nd Seroquel® ANDA

December 2, 2010

Law360

AstraZeneca Pharmaceuticals Inc., has launched its second patent infringement suit against Mylan Pharmaceuticals Inc., in response to the generic-drug maker's most recent bid for regulatory approval to manufacture a copycat version of schizophrenia treatment Seroquel XR®. The drugmaker claims in the suit lodged Monday in the U.S. District Court for the Northern District of West Virginia that Mylan infringed U.S. Patent Numbers 4,879,288 and 5,948,437 through its submission of an abbreviated new drug application for permission to manufacture a 200 mg strength version of generic Seroquel XR®. AstraZeneca seeks a declaration that both patents remain valid and enforceable and are directly and willfully infringed by the generics maker's second ANDA filing. The complaint also asks the court to consolidate the instant suit with the earlier action against Mylan, as well as with nine additional suits currently pending in the District of New Jersey. AstraZeneca is represented by Finnegan.

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Branded Hatch-Waxman (ANDA) Litigation and Trials

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