Teva Pharmaceuticals announced that it launched a generic version of the antibiotic Biaxin® (clarithromycin) XL Filmtabs® following the decision rendered on Thursday June 22, 2006 by the U.S. Court of Appeals for the Federal Circuit vacating a June 2005 ruling which had granted Abbott’s motion for a preliminary injunction related to the product.

However, Abbott then filed an emergency motion in the U.S. District Court for the Northern District of Illinois to enjoin Teva from further sales of the product pending additional appeals despite the preliminary injunction being vacated. Teva then agreed to refrain from further sales of this product pending the outcome of the motion.

Teva contends that the preliminary injunction order is no longer in effect because the Federal Circuit, in a 2-1 decision, vacated the preliminary injunction. However, under the Federal Rules of Appellate Procedure and applicable case law, that opinion is not final and has no effect on the injunction unless and until a mandate has been issued by the Federal Circuit to the District Court and no such mandate has been issued, and no such mandate will issue at least until 7 days after Abbott’s (planned) petition for rehearing has been decided. Therefore, the preliminary injunction order remains in effect and Abbott is entitled to prevent Teva from violating the preliminary injunction order, in order to maintain the status quo. Abbott also wants the court to hold Teva in contempt and sanction it for violating the preliminary injunction order.

Andrx, also sued by Abbott, has filed a motion to vacate the District Court’s preliminary injunction order arguing that since Abbott has not established a likelihood of success on the merits per the Federal Circuit and that with generic competition entering the market, including Abbott’s own authorized generic, Abbott is no longer entitled to a presumption of irreparable harm. Teva’s removal of the generic from the marketplace will hurt Andrx’s chances based on the “pre-existing generic” argument.

Andrx also cites Abbott plans to come to market with its own generic version of Biaxin® XL (i.e., an authorized generic) if another party has launched a generic version of Biaxin® XL already. So far, Abbott’s Opposition to the Motion remains sealed. We’ll keep you posted on further developments.

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