AstraZeneca said that the court held the ‘314 patent to be non-obvious and properly reissued and it also found that no inequitable conduct was committed by any Shionogi employee.
AstraZeneca stated that the ‘314 patent covers rosuvastatin calcium, the active ingredient in Crestor. This patent expires in 2016.
AstraZeneca added that Judge Farnan’s subsequent entry of judgment is expected to preclude the FDA from issuing final approvals for the defendants’ abbreviated new drug applications (ANDAs) prior to the expiration of the ‘314 patent.
AstraZeneca said that nine generic drug manufacturers filed ANDAs along with Paragraph IV certifications of non-infringement, invalidity, or unenforceability with respect to the Crestor patents in 2007.
Following this, 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 ‘314 substance patent.
Additionally, the suits were consolidated on Multidistrict Litigation and tried in the US District Court, District of Delaware, by order of the Judicial Panel. Trial began on February 22, 2010 before Judge Farnan and ended on March 3, 2010.
Judge Farnan also held that Apotex USA was liable as a submitter and is therefore bound to the court’s decision.
David Brennan, CEO of AstraZeneca, said: “We are pleased with the court’s decision upholding the validity and enforceability of the ‘314 substance patent.”