Bristol-Myers, sanofi say Apotex litigation settlement is under criminal investigation

New York, July 27 - Bristol-Myers Squibb Co. and sanofi-aventis said that the Antitrust Division of the U.S. Department of Justice is conducting a criminal investigation regarding the proposed settlement of litigation between the two companies and Apotex Inc. and Apotex Corp.

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

Litigation is currently on hold pending possible finalization of a previously announced settlement.

The settlement has already been amended in response to concerns raised by the Federal Trade Commission and state attorneys general.

"There remains significant risk that antitrust clearance will not be obtained," sanofi noted in a news release Thursday.

If that happens, litigation will resume and Bristol-Myers and sanofi said they intend to "vigorously pursue enforcement of their patent rights" for Plavix.

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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