Judge Joseph Farnan, Jr., of the U.S. District Court, District of Delaware has found that the substance patent protecting AstraZeneca’s Crestor (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.
According to the London-based AstraZeneca, Farnan's subsequent entry of judgment will preclude the FDA from issuing final approvals for the defendant's abbreviated new drug applications prior to the expiration of the ‘314 patent in 2016, including Mylan Pharmaceuticals and Apotex.
"We are pleased with the court's decision upholding the validity and enforceability of the ‘314 substance patent," said David Brennan, CEO of AstraZeneca.
Farnan also held that Apotex was liable as a submitter and is therefore bound to the court's decision, AstraZeneca reported.