Plavix deal fails to get US antitrust OK

US pharmaceutical major Bristol-Myers Squibb and leading French drugmaker Sanofi-Aventis say that their agreement, as amended, with Canada-headquartered generics group Apotex to settle the patent infringement law suit pending between the companies in the US District Court for the Southern District of New York, has failed to receive the required antitrust clearance from the state Attorneys General (Marketletters passim).

The law suit relates to the validity of a composition of matter patent for clopidogrel bisulfate (the '265 patent), which is the active ingredient of the blockbuster blood thinning drug Plavix that is co-marketed in the USA by Sanofi-Aventis and B-MS. When, on March 21, they initially announced the settlement, which would allow Apotex to sell generic Plavix under an exclusive license after June 2011, the companies admitted that there was a significant risk that required antitrust clearance would not be obtained.

The accord also requires the approval of the US Federal Trade Commission, which has not yet advised the companies of its decision. The originally scheduled trial date had been suspended pending possible finalization of the proposed settlement. A new trial date has not yet been established. As previously disclosed, the two drug majors have filed patent infringement claims against three other generic pharmaceutical companies with respect to the '265 patent.