BMS, Sanofi-Aventis Settle Over Generic Plavix

March 24, 2006
Patricia Van Arnum

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

ePT--the Electronic Newsletter of Pharmaceutical Technology

BMS, Sanofi-Aventis Settle Over Generic Plavix

Bristol-Myers Squibb Company

(BMS, New York, NY,

www.bms.com

) and

Sanofi-AventisSA

(Paris, France, http://en.sanofi-aventis.com ) have agreed to settle theirpatent infringement lawsuit with

Apotex Inc.

(Weston, ON, Canada,

www.apotex.com

)over a generic version of Plavix (clopidogrel), BMS’s top-selling drug with2005 sales of $7.7 billion.

The lawsuit relates to the validity of a composition of matter patent (the '265 patent) for Plavix. The trial for the lawsuit was scheduled to begin in June 2006. The US District Court for the Southern District of New York has now suspended the trial date pending the possible finalization of the proposed settlement.

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 FDA-approved clopidogrel bisulfate product in the United States. Apotex, in turn, would agree not to sell a clopidogrel product in the United States until the effective date of the license. The license allows Apotex to sell a generic version of Plavix eight months before the drug loses patent protection.

The license would be exclusive (except for the Plavix brand product) and would be effective on 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.

The proposed settlement is subject to approval by the US Federal Trade Commission and state attorneys general. The proposed settlement is terminated if it does not receive antitrust clearance.

Sanofi-Aventis and BMS also have approached Dr. Reddy’s Laboratories (Hyderabad, India, www.drreddys.com) to discuss a settlement with their patent infringement suit. Dr. Reddy also is challenging the ‘265 patent.