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US court upholds Crestor patent

The US District Court, District of Delaware, has found that the substance patent protecting Crestor is valid and enforceable

The US District Court, District of Delaware, has found that the substance patent protecting Crestor is valid and enforceable. The ruling, delivered by Judge Joseph Farnan Jr, followed a suit filed by AstraZeneca (AZ) and Shionogi against eight generic drug manufacturers that had challenged the '314 substance patent covering rosuvastatin calcium (the active ingredient in Crestor).

According to Judge Farnan, no inequitable conduct was committed by any employees of Shionogi. 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 Food and Drug Administrtaion (FDA) from issuing final approvals for the defendants' Abbreviated New Drug Applications (ANDAs) prior to the expiration of the '314 patent in 2016.

David Brennan, CEO, AZ, commented: "We are pleased with the court's decision upholding the validity and enforceability of the '314 substance patent. The court's decision reaffirms the strength of the intellectual property protecting Crestor."

Crestor is AZ's third best-selling drug, achieving sales of $4.5bn in 2009.

30th June 2010

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