Sanofi-Aventis, Bristol-Myers settle Plavix litigation with Apotex

By Elaine Rigoli

Tampa, Fla., March 21 - Sanofi-Aventis and Bristol-Myers Squibb Co. announced Tuesday that they have reached an agreement subject to certain conditions with Apotex, Inc. and Apotex Corp., to settle the patent infringement lawsuit pending between the parties in the U.S. District Court for the Southern District of New York.

The lawsuit relates to the validity of a composition of matter patent for clopidogrel bisulfate (the '265 patent), a medicine made available in the United States by Sanofi-Aventis and Bristol-Myers Squibb as Plavix, according to a news release.

Under the terms of the proposed settlement, Sanofi-Aventis would grant Apotex a royalty-bearing license under the '265 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 '265 patent.

If a third party obtains a final decision that the '265 patent is invalid or unenforceable, under certain circumstances, the license to Apotex may become effective earlier, the release said.

The trial in the lawsuit had previously been scheduled to begin in June.

As a result of the agreement, the court has now suspended the trial date pending the possible finalization of the proposed settlement.

Sanofi is a global pharmaceutical company with headquarters in Paris.

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

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