November 01, 2006
Apotex challenges Plavix court ruling
Apotex yesterday urged a federal appeals court to allow it to sell generic Plavix until a patent case with the two marketers of the brand drug is resolved.
Lawyers for the Canadian generics firm appeared in a Washington, D.C., court seeking to reverse an earlier decision halting generic sales of the blood thinner. The preliminary injunction came in August and was granted to Plavix co-marketers Bristol-Myers Squibb and Sanofi-Aventis.
The firms had failed to settle a legal challenge of the Plavix patent brought by Apotex, despite extensive negotiations. Under the settlement, Apotex would have delayed the launch of the generic until 2011 in exchange for certain payments from BMS and Sanofi-Aventis. After talks broke down, and in defiance of the patent, Apotex launched its generic Aug. 8.
On Aug. 31, the US District Court for the Southern District of New York granted the injunction but did not order a recall of products already sold or shipped. The judge said the patent was likely to be enforceable. By that time, however, Apotex had flooded the market with Plavix copies.
Both branded drug firms have argued in court that generic Plavix would cause permanent price erosion. BMS said third-quarter sales were reduced by as much as $600 million. Apotex, meanwhile, has claimed it needs to recoup costs from ramping up its manufacturing capacity and will suffer if the injunction remains.
The underlying Plavix patent trial is set for January.