Sanofi-Synthelabo, et al. v. Apotex Inc.

Sanofi-Synthelabo, et al. v. Apotex Inc.

S.D.N.Y. (2007)

On June 19, 2007, in a case in which Sanofi-Aventis and Bristol-Myers Squibb were represented by Fitzpatrick attorneys, Judge Sidney Stein of the United States District Court for the Southern District of New York issued an opinion upholding the validity of the patent covering Plavix® (clopidogrel bisulfate), one of the world’s best-selling prescription drugs.

In August 2006, Judge Stein preliminarily enjoined Apotex from selling generic clopidogrel bisulfate and the Federal Circuit upheld that injunction on December 10, 2006. Following a four-week bench trial, Judge Stein issued his June 19 ruling in which he credited the testimony of Sanofi and Bristol-Myers witnesses and concluded that “Apotex has failed to prove by clear and convincing evidence that the [Plavix®] patent is invalid or unenforceable and Sanofi is entitled to a permanent injunction prohibiting Apotex from further infringement.”