Battle over a Blood Thinner Goes to Court The bitter patent fight over the world's second best-selling drug, Plavix, is playing out in a Manhattan courtroom.

Battle over a Blood Thinner Goes to Court

The bitter patent fight over the world's second best-selling drug, Plavix, played out Friday in a Manhattan courtroom. Bristol Myers Squibb and Sanofi-Aventis are bidding to stop sales of generic copies of Plavix by the Canadian company Apotex. Apotex stunned Bristol and Sanofi when it began shipping generic Plavix to U.S. pharmacies ten days ago. The key patent on Plavix, a blood thinner used to prevent strokes and heart attacks, doesn't expire until 2011.

On Friday, Bristol and Sanofi asked Judge Sidney H. Stein of the U.S. District Court of the Southern District of New York to compel Apotex to immediately stop shipping Plavix to wholesalers. The companies also want the judge to force Apotex to take back what they've already sold to wholesalers.

"You can never put this Humpty Dumpty back together if it's not stopped,'' their attorney, Evan Chesler told the court.

In court filings, the companies have argued that if Apotex isn't stopped, other drugmakers will start selling their generic versions of Plavix. A trial on the underlying patent dispute won't be held until next year. Bristol and Sanofi argue that even if their patent is eventually upheld, they will have been irreparably damaged, because consumers and insurers will want brand-name Plavix at the lower, generic prices to which they will have become accustomed.

Chesler told the court Friday that if generic sales of Plavix aren't stopped, all drug research would be hurt. "It will kill future clinical efforts,'' he argued.

Meanwhile, Robert Silver, a lawyer for Apotex, argued that stopping sales of generic Plavix would hurt patients and the public interest. Brand-name Plavix costs about $4 a pill in the U.S. Apotex sells the generic version for an estimated 10 to 20 percent less. Silver said Bristol and Sanofi's patent on Plavix is ``invalid and unenforceable."

Judge Stein will base his decision on several factors, including the strength of the underlying patent on Plavix. The hearing will continue on Monday, and a decision could come as early as Tuesday.

Of the three companies involved, Bristol, which sells Plavix in the U.S., has the most at stake. Last year, Bristol sold over $3 billion of Plavix, which is the company's biggest drug and accounts for a third of its profits.

Until a few weeks ago, Bristol thought it would have that money coming in until 2011, when the key Plavix patent expires. If Bristol fails to stop Apotex, that money could almost disappear in a few months.

The company is staring at such a dramatic erosion of revenue and profits that many analysts believe Bristol might not survive as an independent company if it can't protect its Plavix franchise. They say it has many promising drugs in development but they won't come to market and start generating profits in time to save the company.

Even before Apotex's surprise shipments of Plavix, this patent fight had taken an extraordinary turn. Bristol and Sanofi are targets of a criminal investigation by the Department of Justice. The two drug companies had previously signed agreements with Apotex, agreeing to pay Apotex to keep its generic Plavix off the market until just a few months before their patent expired in 2011. The deal, however, ran into trouble after the announcement of the criminal probe and a rejection by state attorneys general. It's believed the criminal investigation focuses on undisclosed aspects of that deal.