By Larry Neumeister
Associated Press
Friday, September 1, 2006

NEW YORK, Aug. 31 -- A federal judge blocked distribution Thursday of a generic version of blood thinner Plavix, finding it unlikely that the maker of the generic version, Apotex Inc. of Canada, could prove that the patent on the drug used by 48 million Americans was invalid.

U.S. District Judge Sidney H. Stein ruled after a two-day hearing at which Sanofi-Aventis SA and partner Bristol-Myers Squibb Co. said Apotex should be forced to stop selling the drug.

The judge denied demands by the companies that Apotex be forced to remove from the market the generic product it had already distributed.

Stein said Sanofi-Aventis had adequately demonstrated that questions Apotex raised as to the validity and enforceability of its patent were without substantial merit.

He said he also concluded Sanofi-Aventis would suffer irreparable harm if Apotex were permitted to continue distributing its generic product and that Apotex's hardships primarily result from the company's own calculated risk-taking.

The judge also considered the public interest of permitting competition to continue, noting that many Americans have saved a significant amount of money since Apotex entered the market.

"Although there are competing -- and substantial -- public interests at stake on both sides of this litigation, the balance of those competing public interests slightly favors Sanofi," the judge wrote. "The public interest in lower-priced drugs is balanced by a significant public interest in encouraging the massive investment in research and development that is required before a new drug can be developed and brought to market."

Apotex had argued that a patent protecting sales of Plavix from competitors was no longer valid and that it was in the public interest to permit sales of its generic version of the drug because lower prices mean even more people can use a lifesaving drug.

Bristol-Myers shares rose $2.09, to $23.84, in extended trading on the New York Stock Exchange. The ruling was issued after the close of regular trading.

U.S. shares of Sanofi-Aventis, which is based in France, rose $1.05, to $46, in after-hours trading.