For Bristol, Plavix Ruling Bodes Well In Patent Trial

By PETER LOFTUS, Dow Jones Newswires
September 5, 2006

Bristol-Myers Squibb Co. (BMY) and Sanofi-Aventis (SNY) now have the upper hand in an upcoming patent trial over their blockbuster heart drug Plavix, if Thursday's court injunction in the case is any indication.

The main reason: In granting an injunction halting sales of a generic version of Plavix, U.S. Judge Sidney Stein in New York concluded that Bristol-Myers and Sanofi-Aventis were likely to prevail over generic marketer Apotex Inc. at a trial scheduled to begin in January. Stein is the judge who will deliver the verdict in the non-jury trial.

"It's a pretty good predictor of who's going to prevail," said Steven Lieberman, a patent attorney in Washington not involved in the case, who has represented both generic and brand-name pharmaceutical companies in litigation.

Bristol shares recently rose $1.20 to $22.95, while Sanofi'sAmerican depositary shares added 44 cents to $45.39.

If Bristol and Sanofi win the patent trial, they are likely to preserve the American market exclusivity for Plavix until the patent expires in 2011, barring further Apotex appeals. Plavix, a blood thinner designed to prevent recurring heart attacks and strokes, is the secondbiggest-selling drug in the world, with global sales of $5.9 billion in 2005.

The three companies have been locked in patent litigation over Plavix since 2002, when Apotex first filed for American regulatory approval to sell a generic version. Apotex says the patent for Plavix is invalid and unenforceable, while Bristol-Myers and Sanofi-Aventis dispute the claims. The Food and Drug Administration approved Apotex's application in January.