PharmExec Blog

AZ Celebrates Crestor Patent Win

p433crestorThe US District Court in Delaware upheld AstraZeneca’s patent for its blockbuster statin Crestor (rosuvastatin), ending a dispute that could have crippled the drugmaker’s billion-dollar cash cow.

Crestor’s patent is not scheduled to expire until 2016. However, a group of generics firms had claimed that a substance patent (314) protecting one of the active ingredients in Crestor was invalid, and that other companies had the right to file abbreviated new drug applications for generic versions of the cholesterol treatment. AstraZeneca sued them when they filed the applications, and a judge agreed with AZ.

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

The defendants claimed that Shionogi Seiyaku Kabushiki Kaisha—the patents original owner—engaged in shady tactics to get approval from the US patent office.  The court, however, disagreed chalking any filing discrepancies up to clerical errors.

“The court is not persuaded that the evidence presented by defendants rises to the level of the clear and convincing evidence required to establish inequitable conduct,” said Judge Joseph Farnan, US District Court in Delaware.

“While in hindsight it may be attractive to construct a deliberate scheme of deceptive intent from the actions of these individuals given the success of Crestor in the marketplace, it is at least equally plausible from their testimony and the contemporaneous documentary evidence, that a scheme to defraud was the furthest thing from the minds of these individuals at the relevant time, and that their vision was limited to the overwhelming demands they faced daily in their severely understaffed department.”

The generics companies also argued that the patent should not stand because the substance could have been created by anyone. The judge disagreed, and stated “there was much skepticism in the industry concerning the safety of rosuvastatin and the court finds it telling that no other pharmaceutical companies attempted to create a comparable product despite research in the area and the economic incentives of entering an additional player in the statin market.”

Analysts predict that the generics firms will fight the decision, but none of the companies have made a public statement as of Wednesday afternoon.

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