AstraZeneca (AZN) Receives Favorable Decision in Crestor Patent Appeal

AstraZeneca (NYSE: AZN) announced 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.

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