Sanofi and B-MS settle with Apotex over Plavix

France's Sanofi-Aventis, the world's third-largest drugmaker, and US major Bristol-Myers Squibb have reached a tentative settlement over the patent infringement law suit in the US District Court for the Southern District of New York relating to the validity of a composition-of-matter patent for the antiplatelet drug Plavix (clopidogrel) by Canadian generic pharmaceutical group Apotex.

The trial in the law suit had previously been scheduled to begin in June 2006. As a result of the agreement, the Court has now suspended the trial date pending a possible finalization of the settlement. Under the terms that have been proposed, Sanofi-Aventis would grant Apotex a royalty-bearing license to manufacture and sell its US Food and Drug Administration-approved product in the USA, and Apotex would agree not to sell the agent in this territory until the effective date of the exclusive license, which would be on September 17, 2011, with the possibility of a date earlier in that year if the firm does not receive an extension of exclusivity for pediatric use.

The branded drug giants noted that the proposed settlement is subject to conditions, including antitrust review and clearance by the Federal Trade Commission, and stressed that if the litigation were reinstated, they intend to vigorously pursue their patent rights on Plavix. Apotex announced in January 2006 that it had received final approval of its Abbreviated New Drug Application for the agent from the FDA and, if the settlement was rejected, could launch a generic version of Plavix at its own risk.