By Donald Zuhn --
Sanofi-Aventis and Bristol-Myers Squibb announced today (June 19, 2007) that the U.S. District Court for the Southern District of New York has issued a ruling in their favor in an infringement action against Apotex. Sanofi and BMS filed the action in March of 2002, contending that Apotex' filing of an ANDA for clopidogrel bisulfate tablets infringed Sanofi's U.S. Patent No. 4,847,265, which is directed to clopidogrel bisulfate. The '265 patent is exclusively licensed to Bristol-Myers Squibb Sanofi Pharmaceuticals Holding Partnership, which sells clopidogrel bisulfate tablets under the trademark Plavix®.
In an 82-page opinion, District Court Judge Stein found that Apotex had "concededly infringed" Sanofi's '265 patent and had failed to prove by clear and convincing evidence that the '265 patent is invalid or unenforceable. Judge Stein enjoined Apotex from engaging in any activity that infringes the '265 patent, which expires on November 17, 2011, and announced that the amount of damages would be determined in future proceedings.
For more information regarding this decision, please see:
- Bristol-Myers Squibb's press release
- Sanofi-Aventis' press release
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