Clopidogrel bisulfate: CAFC affirmed district court's decision and upheld product patent

Innovator Sanofi-aventis and Bristol-Myers Squibb announced Here that the U.S. Court of Appeals for the Federal Circuit has upheld the June 19, 2007 decision by the U.S. District Court for the Southern District of New York holding the product patent covering clopidogrel bisulphate, the active ingredient in Plavix®, valid and enforceable.
Apotex filed an ANDA for a generic version of Plavix (Clopidogrel bisulfate) with a paragraph IV certification in early 2001 and was subsequently sued by innovator Sanofi-Synthelabo and Bristol-Myers Squibb (BMS) for infringement of following product patent listed in Orange book,
US4847265 (Expiring on Nov 17, 2011)-which covers Dextro-rotatory isomer of methyl alpha-5(4,5,6,7-tetrahydro(3,2-c)thieno pyridyl) (2-chlorophenyl)-acetate substantially separated from the levo-rotatory isomer and its pharmaceutically acceptable salts
The 30 month stay on Apotex ANDA approval expired in 2005 and its ANDA was subsequently approved in 2006. Apotex launched its product at risk with 180 days exclusivity but was enjoined after 23 days by preliminary injunction by District court on appeal from innovator. Later, US district court upheld the validity of disputed patent. Subsequently, Apotex appealed against the decision in CAFC, which upheld the district court’s decision. As a result of this ruling, the '265 patent protection for this product is maintained in the United States until November 2011.
Decision of Court of appeal for federal circuit Here