The court upheld AstraZeneca's exclusive right to market rosuvastatin in the US until 2016. The judge’s decision prevents the FDA from issuing final approvals for the generic Abbreviated New Drug Applications (ANDAs) prior to the expiration of the ‘314 patent in 2016.

This comes as a huge relief to the UK-based drug manufacturer, which is set to lose patent protection on a series of drugs in the next few years. Annual sales of Crestor reached US$4.5 billion in 2009 and in 2014 are predicted, by some analysts, to reach US$8.6 billion.

In 2007, nine generic drug manufacturers had filed ANDAs containing paragraph IV certifications of non-infringement, invalidity, or unenforceability with respect to the Crestor patents.

AstraZeneca and Shionogi (the owner of the ‘314 patent) in response filed patent infringement suits against eight manufacturers (Apotex, Aurobindo, Cobalt, Mylan, Par, Sandoz, Sun and Teva) who had challenged the ‘314 substance patent.

The generics companies had claimed the Crestor patent was invalid on the grounds it was an obvious invention, and that it was fraudulently obtained and improperly reissued. They alleged that Shionogi had withheld documents from the US Patent and Trademark Office in order to obtain the patent through deception.

The US court dismissed the claims and found that “no inequitable conduct was committed by any Shionogi employee” and found the '314 patent to be “non-obvious and properly reissued”.

“We are pleased with the court’s decision upholding the validity and enforceability of the ‘314 substance patent,” said Chief Executive Officer, AstraZeneca, Mr David Brennan. “The court’s decision reaffirms the strength of the intellectual property protecting Crestor”.

The decision, although expected, is not good news for the generics companies who had been hoping to gain another piece of the huge statin pie, but will now have to wait until 2016.

Reference:

AstraZeneca Press release, CRESTOR Patent Upheld By US Court, 30 June 2010