Teva Pulls Generic Biaxin XL Off the Market Following Emergency Motion Filed by Abbott
In response to an emergency motion for preliminary injunction enforcement filed by Abbott Laboratories on June 26 in the U.S. District Court for the Northern District of Illinois, Teva Pharmaceuticals USA, Inc. announced on June 27 that it will cease sales of a generic version of Abbott's Biaxin XL (clarithromycin extended release), which Teva had initiated following a June 22 decision by the U.S. Court of Appeals for the Federal Circuit vacating the district court's June 2005 preliminary injunction order. As previously reported here, a divided Federal Circuit panel held that Teva had raised substantial questions as to the validity of Abbott's patents covering Biaxin XL, and thus vacated the preliminary injunction order.
Abbott's emergency motion asserted that the preliminary injunction order remained in effect until the Federal Circuit issued a mandate to the District Court, which would generally not occur until at least 21 days following entry of the Federal Circuit's judgment. Abbott's motion noted that this time period is likely to be further extended, as it intends to file a petition for rehearing, which would automatically stay the mandate until disposition of the petition. Abbott's motion requests the District Court not only to order Teva to comply with the preliminary injunction order, but also to hold Teva in contempt and sanction it for violating the preliminary injunction order.
In a June 27 press release, Teva announced that Abbott agreed to a briefing schedule concluding on June 29 and that Teva agreed to refrain from further sales of this product pending the outcome of the motion. Teva's response in pulling its generic Biaxin XL off the market after approximately 3-4 days is puzzling, as one would assume that the issues raised by Abbott in its motion were fully considered by Teva prior to market entry.
Teva's response also serves to undercut at least one argument made by generic rival Andrx Pharmaceuticals, in its June 26 motion to vacate the District Court's preliminary injunction order entered against it. Andrx was also sued by Abbott in the Northern District of Illinois over the same Biaxin XL patents that Teva was sued on. In a consolidated order in November 2005, the district court preliminarily enjoined Andrx and Ranbaxy from selling a generic equivalent of Biaxin XL. Appeals to the Federal Circuit by Ranbaxy and Andrx are pending. In its motion to vacate the District Court's preliminary injunction order, Andrx argued (in part) that, given generic entry into the Biaxin XL market by Teva, Abbott was no longer entitled to a presumption of irreparable harm. At least for now, that argument appears unavailing.
Because of the UNAVAILABILITY of Clarithromycin, I have to pay double the copayment, which I dont appreciate, law suits should not rest on the patients wallet. keep the Generic on the market until the issue is resolved
Posted by: barbara Webb | May 13, 2007 at 05:52 PM