Bloomberg News

AstraZeneca Wins U.S. Ruling to Block Generic Crestor

December 14, 2012

AstraZeneca Plc (AZN), the U.K.’s second- biggest drugmaker, won an appeals court ruling that will block generic versions of its top-selling cholesterol medicine Crestor in the U.S. until July 2016.

The patent on the main ingredient is valid and enforceable, the U.S. Court of Appeals for the Federal Circuit in Washington said in an opinion posted on its website today. The court rejected challenges made by generic-drug makers including Mylan Inc. (MYL:US) and Teva Pharmaceutical Industries Ltd. (TEVA)

The ruling ensures AstraZeneca won’t lose sales of a product that brought in $2.3 billion in U.S. revenue in the first nine months of the year. Total sales of Crestor, whose chemical name is rosuvastatin, account for 22 percent of London- based AstraZeneca’s revenue.

“AstraZeneca is pleased with the court’s decision to uphold the validity of Crestor’s substance patent,” Tony Jewell, a company spokesman, said in an e-mail. “The decision reaffirms the strength of the intellectual property protecting Crestor.”

The generic-drug companies, except Apotex Inc., conceded that they infringed the patent for the compound rosuvastatin and focused their challenge on claims the patent covered an obvious variation of earlier compounds.

They also claimed AstraZeneca and patent partner Shionogi & Co. (4507), based in Osaka, Japan, didn’t disclose important information to the U.S. Patent and Trademark Office. Failure to report information that could bear on the originality of a product could lead to a patent being thrown out.

Crestor Patents

The appeals court panel in a 2-1 decision upheld a lower court ruling that rejected those arguments, and found that Apotex’s copy would infringe the patent. The challengers also included Aurobindo Pharma Ltd. (ARBP), Par Pharmaceutical Cos. and Sun Pharmaceutical Industries Ltd. (SUNP)

The Federal Circuit in February upheld the dismissal of Crestor suits over patents that expire in 2018 and 2021 that cover the methods of using the active ingredient for certain types of patients.

The generic-drug companies can ask the full court to reconsider today’s decision, or appeal to the U.S. Supreme Court.

AstraZeneca American depositary receipts, each representing one ordinary share, closed unchanged at $47.46. The stock had been down more than 1 percent before the ruling was issued.

The case is In Re Rosuvastatin Calcium Patent Litigation, 2010-1460, U.S. Court of Appeals for the Federal Circuit (Washington).

The lower court combined case is In re Rosuvastatin Calcium Patent Litigation, 08-1949, U.S. District Court, District of Delaware (Wilmington).

To see the patent: RE37,314.

To contact the reporter on this story: Susan Decker in Washington at sdecker1@bloomberg.net

To contact the editor responsible for this story: Bernard Kohn at bkohn2@bloomberg.net


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