US Supreme Court Rejects Plavix Patent Challenge

By Kristina Peterson, Of DOW JONES NEWSWIRES

WASHINGTON -(Dow Jones)- The U.S. Supreme Court on Monday rejected a generic drug maker's appeal challenging a patent for a blockbuster blood-thinning drug developed by Sanofi-Aventis (SNY) and co-marketed by Bristol-Myers Squibb Co. ( BMY).

The dispute arose after the Canadian generic drug maker Apotex Corp. (AOX.YY) applied to market a generic version of the anti-blood clotting drug Plavix shortly before its original patent expired in 2003.

France-based Sanofi sued Apotex for patent infringement because Sanofi researchers had separated Plavix's two main molecules and successfully applied for a second patent on just the effective molecule in the drug.

Apotex argued that the second patent, which does not expire until 2011, should not have been granted. Two years ago the Supreme Court ruled in KSR v. Teleflex that a patent can't be awarded to the results of a procedure that is "obvious to try."

But both a U.S. judge in New York the U.S. Court of Appeals for the Federal Circuit in Washington upheld the patent's validity, ruling that the results of the drug tests could not have been predicted, even if trying the experiment itself were obvious.

"This entrenched confusion harms brand-name product developers and would-be generic competitors," attorneys for Apotex wrote in their petition to the high court. "Both types of companies make decisions about which products to develop and market based on standards of patentability."

Over the summer Apotex also filed a request that the U.S. Patent and Trademark Office re-examine the patent. In separate proceedings, Bristol-Meyers pleaded guilty in June 2007 to making false statements to the Federal Trade Commission over a then-proposed settlement of the case and paid a $1 million fine.

The Supreme Court declined the case without comment on Monday.

The case is Apotex Corp v. Sanofi and Bristol-Myers Squibb, 09-117.

-By Kristina Peterson, Dow Jones Newswires; 202-862-6619; Kristina.peterson@ dowjones.com

  (END) Dow Jones Newswires
  11-02-091033ET
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