sanofi-aventis and Bristol-Myers Squibb announced that the US District Court for the Southern District of New York has granted a preliminary injunction ordering Apotex Inc. and Apotex Corp. (Apotex) to halt its sales of a generic version of clopidogrel bisulfate product that competes with Plavix. The Court, however, did not order Apotex to recall products already sold/shipped.
The order was entered in connection with the patent infringement lawsuit pending among the parties relating to the validity of a composition of matter patent for clopidogrel bisulfate. On August 8, 2006, Apotex announced that it had launched a generic version of clopidogrel bisulfate 75 mg tablets, a sanofi-aventis press release said.
The Court has ordered the companies to post a bond in the amount of $400 million to provide security to Apotex should the Court conclude at the end of the patent litigation that the injunction was wrongly imposed. The injunction will remain in effect until the pending patent infringement lawsuit is resolved.
The companies continue to believe that the Apotex generic product infringes their intellectual property rights, which are currently the subject of the pending patent litigation. The companies intend to continue to vigorously defend their patent rights against infringement. A trial has been set for January 22, 2007.