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Antitrust
In re Plavix Indirect Purchaser Antitrust Litigation

Chimicles & Tikellis LLP is a member of the Court-appointed Executive Committee in an antitrust class action that was commenced on behalf of the International Brotherhood of Electrical Workers Local 98 Health & Welfare Plan against Sanofi-Aventis, Sanofi-Synthelabo, Inc., Sanofi-Aventis U.S. L.L.C., Bristol-Myers Squibb Sanofi Pharmaceutical Holding Partnership (collectively “Sanofi”), Bristol-Myers Squibb Co. (“BMS”), and Apotex Corporation (“Apotex”) (collectively “Defendants”) in the United States District Court for the Southern District of Ohio. The consolidated action, captioned In re Plavix Indirect Purchaser Antitrust Litigation, No. 1:06-cv-00226-MHW, seeks to certify a Class that consists of all persons and entities in the United States that purchased clopidogrel bisulfate tablets, including Plavix, for consumption by themselves, their families, or their members, employees, insureds, participants, or beneficiaries (the “Class”) during the period from January 20, 2006, through the date on which the anticompetitive conduct effects of the Defendants’ conduct cease (the “Class Period”).

Sanofi and BMS jointly market clopidogrel bisulfate tablets under the brand-name Plavix® (“Plavix”). Plavix is a prescription drug used primarily to treat patients who are at risk for heart attack and stroke. Plavix is the second best selling drug in the world, with more than $6 billion in sales expected this year.

The antitrust class action seeks declaratory, injunctive, and monetary relief resulting from an unlawful agreement whereby Apotex, a major generic pharmaceutical manufacturer, has agreed not to market a generic version of Plavix. Apotex was prepared to launch its generic version of Plavix in January of 2006, when the Federal Food and Drug Administration granted final marketing approval. Instead of launching its generic product, however, Apotex entered into an agreement with Sanofi and BMS (the “Agreement”) to withhold its product from the market in exchange for cash payments from Sanofi and BMS.

The Defendants also agreed to settle patent infringement litigation that Sanofi and BMS had brought against Apotex, alleging that Apotex’s generic Plavix drug product infringed upon one of Sanofi’s patents. The proposed settlement of the patent infringement case is provisional, and subject to approval by the Federal Trade Commission (“FTC”) and state attorneys general. Until the FTC and state attorneys general complete their review of the proposed settlement – and regardless of whether the settlement is approved – Apotex has agreed to refrain from selling generic Plavix in exchange for monetary payments. On June 25, 2006, Sanofi and BMS announced that they had amended the Agreement due to “concerns” raised by the FTC and state attorney generals.

According to the Complaint, the Agreement entered into between would-be horizontal competitors is per se unlawful (or an unreasonable restraint of trade) under federal and state antitrust laws. The complaint alleges that the Agreement has denied Plaintiffs and other Plavix customers and third-party payors of the benefits of competition from less expensive, generic versions of Plavix. As a result, according to the Complaint, Plaintiffs and members of the Class have paid supracompetitive prices for clopidogrel bisulfate tablets. Since the filing of the Complaint, both Sanofi and BMS have announced that the Agreement is also the subject of a criminal investigation by the Antitrust Division of the United States Department of Justice.

The consolidated class action complaint can be viewed here.
For further information, please contact JamesMalone@chimicles.com or JosephSauder@chimicles.com

 

 

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   Monday, May 12th, 2008



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