Sanofi-Synthelabo et al. v. Apotex, No. 2007-1438 (Fed. Cir. 2008)
In an opinion released last Friday, the Federal Circuit affirmed the decision of the U.S. District Court for the Southern District of New York, following a 2007 bench trial, that Sanofi's U.S. Patent No. 4,847,265 is not invalid for anticipation or obviousness. The '265 patent covers clopidogrel bisulfate, the active ingredient in Sanofi and Bristol-Myers Squibb's blockbuster heart medication Plavix. A botched settlement of the case in 2006 led to Apotex's at-risk launch of its generic Plavix, followed by a preliminary injunction against Apotex, and ultimately the departure of executives from BMS.
Claim 3 of the '265 patent is directed to clopidogrel bisulfate: "Hydrogen sulfate of the dextro-rotatory isomer of methyl alpha-5(4,5,6,7-tetrahydro(3,2-c)thienopyridyl)(2-chlorophenyl)-acetate substantially separated from the levo-rotatory isomer." Apotex stipulated to infringement and argued that claim 3 is invalid as anticipated by and obvious over Sanofi's U.S. Patent No.
