Plavix Patent Settlement Runs into Trouble

US State Regulatory made a knock-out punch to Bristol-Myers Squibb and Sanofi-Aventis, rejecting their patent litigation settlement with Apotex for blockbuster anti-clotting drug Plavix, generically known as Clopidogrel Bisulfate. This move came as federal investigators examine the revised terms of that patent settlement with Apotex in a criminal probe. Bristol and Sanofi filed revised terms last month to the state attorneys general and Federal Trade Commission, who were revising the settlement deal. Earlier, Bristol and Sanofi proposed an agreement in which they would pay Apotex US $ 40 million to drop a patent challenge relating to Plavix, the sixth best-selling drug in the U.S., with annual sales of US $ 3.5 billion. In return, Apotex would launch a generic in 2011, eight months before a key U.S. Patent No. 4,847,265 (the ‘265) covering dextro-enantiomer of clopidogrel actually expired.