AstraZeneca (NYSE: AZN) 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.