BMS, SANOFI-AVENTIS FILE FOR INJUNCTION AGAINST APOTEX

Sanofi-aventis and Bristol-Myers Squibb (BMS) have asked a U.S. federal court for a preliminary injunction to stop Apotex from selling its generic version of their blockbuster blood thinner Plavix, but a patent agreement they signed with Apotex may prevent them from getting it, according to one legal expert.

The drugmakers requested the injunction on grounds they will suffer "irreparable harm" from Apotex's product (clopidogrel bisulfate). But sanofi-aventis and BMS agreed to allow Apotex to compensate them if it launched generic Plavix before a patent suit over the drug was resolved. The court may deny the injunction request, because case law defines irreparable harm as harm that cannot be compensated by money, according to one legal expert who asked to not be named.

BMS and French drugmaker sanofi-aventis filed the motion Aug. 14 in the U.S. District Court for the Southern District of New York. The drugmakers resumed patent litigation against Apotex after the settlement collapsed in the wake of a Department of Justice criminal probe and a rejection by state attorneys general. The hearing is scheduled for Aug. 18.

The patent settlement was first proposed to resolve patent litigation sanofi-aventis filed against Apotex in 2002 in the U.S. District Court for the Southern District of Ohio after Apotex filed to market a generic version of Plavix. In March, sanofi-aventis and BMS offered to settle the litigation by paying Apotex at least $40 million to not launch its generic Plavix until the patent expired in September 2011, an arrangement known as a reverse payment. Since Apotex was the first firm to successfully challenge the Plavix patent, no other company could sell a generic version before it does. BMS sells Plavix in the U.S. for sanofi-aventis.

The drugmakers insist that Apotex's launch has inflicted "massive, ultimately irreparable harm" and "respectfully request that Apotex be enjoined pending the outcome of a trial that is likely to uphold a patent that Apotex is infringing on a scale not previously witnessed within the pharmaceutical industry," the filing said. (http://www.fdanews.com/did/5_160/)