AstraZeneca announced 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 judgement will preclude the US 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.

Beginning in 2007, nine generic drug manufacturers filed ANDAs along with Paragraph IV certifications of non-infringement, invalidity, or unenforceability with respect to the Crestor patents. AstraZeneca and Shionogi (the owner of the ‘314 patent) filed patent infringement suits against eight manufacturers (various parent or subsidiary entities of Apotex, Aurobindo, Cobalt, Mylan, Par, Sandoz, Sun and Teva) who had challenged the ‘314 substance patent. The ‘314 patent, which expires in 2016, covers rosuvastatin calcium, the active ingredient in Crestor. These suits were consolidated by order of the Judicial Panel on Multidistrict Litigation and tried in the US District Court, District of Delaware. Trial commenced on 22 February 2010 before Judge Farnan and ended on 3 March 2010.