Bristol-Myers Squibb and Sanofi-Aventis announced that in response to concerns raised by the Federal Trade Commission (“FTC”) and state attorneys general to the previously announced proposed settlement the companies reached with Apotex relating to patent infringement litigation on Plavix(R) (clopidogrel bisulfate), the companies and Apotex have amended the agreement. Plavix, a blood thinner, is the world’s second-best selling drug. Review of the modified agreement by the FTC and state attorneys general continues.

Among other revisions, under the terms of the modified agreement, Apotex’s license to manufacture and sell its FDA approved clopidogrel bisulfate product in the United States would be effective on June 1, 2011, rather than September 17, 2011, as disclosed in the press release issued by the companies on March 21, 2006.

In the original deal, Apotex agreed to settle the litigation in exchange for at least $40 million and received a licence to sell a generic version of Plavix in September 2011, eight months earlier than the patent’s maximum lifespan.

The FTC has challenged similar arrangements, arguing that they are anti-competitive and hurt consumers, and asked the Supreme Court to hear a case involving Schering-Plough in which a similar deal was struck. Although the Supreme Court declined to take on that case, the FTC has signalled that it will continue to strike down deals between big drug companies and generic manufacturers that involve so-called “reverse payments”.

There is no assurance that the revised agreement will address all of the concerns of the FTC and state attorneys general and there remains a significant risk that antitrust clearance will not be obtained.

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