BMS, SA Win Plavix Patent Suit

The U.S. District Court for the Southern District of New York has upheld the patent for the API of Plavix, allowing Bristol-Myers Squibb and Sanofi-Aventis to retain exclusivity of the antiplatelet drug through November 2011. The companies were battling in court with Apotex, a generic manufacturer based in Toronto.

An ill-conceived “exclusive generic” agreement between BMS and Apotex opened  a loophole that allowed Apotex to sell enormous amounts of generic Plavix to wholesalers. As part of the agreement, BMS could not pursue an injunction for the first five days of Apotex’s sales. This may have cost BMS nearly $2 billion in sales. Another side-agreement limits the amount of damages that BMS and SA can request, but that may be overturned in court, permitting the “innovator” companies to seek triple-damages.

Apotex plans to appeal the ruling. The company contends that the case is very similar to the one it conducted regarding Pfizer’s Norvasc,  which Apotex lost at the circuit court level but won on appeal.