Bristol-Myers Squibb Company and sanofi-aventis announced earlier this week that they have reached a tentative settlement agreement with Apotex Inc. and Apotex Corp. regarding the pending Plavix® patent infringement lawsuit. The proposed settlement agreement will allow Apotex to market and sell its generic version of Plavix® (clopidogrel bisulfate, prescribed to patients with peripheral arterial disease (PAD) to reduce the risks of heart attack, stroke, and vascular death) in the United States beginning on September 17, 2011, with Apotex paying royalties to Bristol-Myers Squibb and sanofi-aventis after that date, and with Bristol-Myers Squibb and sanofi-aventis splitting an undisclosed payment to Apotex. Apotex was sued in the U.S. District Court for the Southern District of New York for the alleged infringement of U.S. Patent No. 4,847,265 (“Dextro-rotatory enantiomer of methyl alpha-5 (4,5,6,7-tetrahydro (3,2-c) thieno pyridyl) (2-chlorophenyl)-acetate and the pharmaceutical compositions containing it”), of which the validity of the patent was challenged. The license to Apotex will be exclusive with the exception of the Plavix® brand product (currently under agreement whereby sanofi-aventis manufactures the product and Bristol-Myers Squibb markets the product in the U.S.).

U.S. Patent No. 4,847,265: LINK
Bristol-Myers Squibb Press Release: LINK
Sanofi-aventis Press Release (From the Press Room): LINK
Plavix® Product Webpage: LINK