Bristol-Myers, sanofi fail to receive anti-trust clearance for Plavix settlement

New York, July 28 - sanofi-aventis and Bristol-Myers Squibb said that their agreement with Apotex Inc. and Apotex Corp. to settle a patent infringement lawsuit failed to receive required antitrust clearance from the state attorneys general.

The agreement also required the approval of the Federal Trade Commission. The FTC has not yet advised the companies of its decision.

However, the agreement requires the approval of both the FTC and the states attorneys general to become effective, sanofi and Bristol-Myers noted.

The original trial date for the litigation had been suspended pending possible finalization of the proposed settlement and no new date has been set.

Bristol-Myers and sanofi disclosed earlier in the week that the Antitrust Division of the U.S. Department of Justice is conducting a criminal investigation regarding the proposed settlement.

The legal dispute between the companies is over the composition-of-matter patent for Plavix, which runs through 2011.

As previously announced, under the terms of the proposed settlement, sanofi-aventis would grant Apotex a royalty-bearing license under the patent to manufacture and sell its Food and Drug Administration-approved clopidogrel bisulfate product in the United States, and Apotex would agree not to sell a clopidogrel product in the United States until the effective date of the license, the release said.

The license would be exclusive (except for the Plavix brand product) and would be effective Sept. 17, 2011, with the possibility of an effective date earlier in 2011 if Sanofi-Aventis does not receive an extension of exclusivity for pediatric use under the patent.

If a third party obtains a final decision that the patent is invalid or unenforceable, under certain circumstances the license to Apotex may become effective earlier, the release said.

Sanofi is a pharmaceutical company with headquarters in Paris.

Bristol-Myers Squibb is a New York-based pharmaceutical and related health care company.

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