Court Upholds Sanofi-Aventis's Plavix Patent

June 21, 2007
Pharmaceutical Technology Editors
ePT--the Electronic Newsletter of Pharmaceutical Technology

New York (June 19)-The US District Court for the Southern District of New York affirmed the validity and enforceability of Sanofi-Aventis's patent on clopidogrel bisulfate, the active ingredient in the company's coronary artery disease treatment "Plavix."

New York (June 19)-The US District Court for the Southern District of New York affirmed the validity and enforceability of Sanofi-Aventis’s (Paris) patent on clopidogrel bisulfate. Clopidogrel is the active ingredient in “Plavix,” the company’s treatment for coronary artery disease. The court’s decision effectively maintains patent protection for this product in the United States until November 2011. Sanofi-Aventis and Bristol-Myers Squibb (BMS, New York) market the Plavix treatment jointly.

The Court found that Apotex’s (Weston, ON, Canada) generic clopidogrel bisulfate infringed on sanofi-aventis’s patent, and prohibited Apotex from marketing the product in the United States until its patent expires. The Court rejected sanofi’s and BMS’s request to make Apotex recall product it had already shipped.

On August 31, 2006, the Court granted Sanofi’s and BMS’s request for a preliminary injunction to halt sales of Apotex’s generic version of clopidogrel. Apotex subsequently filed a motion to stay the injunction, which the Court denied.