Sanofi/B-MS prevail over US Plavix patent

The US District Court for the Southern District of New York has upheld the validity and enforceability of US patent 4,847,265 covering clopidogrel bisulfate, the active ingredient in French drug major Sanofi-Aventis and US firm Bristol-Myers Squibb's co-marketed blockbuster blood-thinning drug Plavix, maintaining the key patent protection for this product in the USA until November 2011.

The Court also ruled that Canadian drugmaker Apotex' generic clopidogrel bisulfate infringes Sanofi-Aventis' patent, and has enjoined Apotex from marketing this product in the USA until the patent expires.

Pending resolution of the patent litigation, the situation has had a serious financial impact on both Sanofi-Aventis and B-MS since Apotex flooded the US drug wholesale chain with cheaper dgeneric clopidogrel last year. Although the Canadian firm was ordered to halt sales of its product, the existing supplies on the market meant that the originators' Plavix sales were decimated.