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Published on 9/1/2006 in the Prospect News Biotech Daily.

Injunction halts Apotex sales of generic Plavix in Sanofi-Aventis, Bristol-Myers Squibb patent case

By E. Janene Geiss

Philadelphia, Sept. 1 - Sanofi-Aventis and Bristol-Myers Squibb said Friday that the U.S. District Court for the Southern District of New York has granted a preliminary injunction ordering Apotex Inc. to halt its sales of a generic version of clopidogrel bisulfate product that competes with Plavix.

The court did not order the Weston, Ont., company to recall products already sold or shipped, according to a company new release.

The order was entered in connection with the patent infringement lawsuit relating to the validity of a composition of matter patent for clopidogrel bisulfate. Apotex launched Aug. 8 a generic version of clopidogrel bisulfate 75 mg tablets.

The injunction will remain in effect until the pending patent infringement lawsuit is resolved. Paris-based Sanofi-Aventis and New York-based Bristol-Myers Squibb said they believe the generic product infringes their intellectual property rights, which are the subject of the pending patent litigation. A trial has been set for Jan. 22, 2007.


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