Abbott Wins Preliminary Injunction Against Sandoz in Biaxin XL Case

Abbott Labs v. Sandoz, No. 05-5373 (N.D. Ill. 2007)

This past Monday, Judge David H. Coar of the U.S. District Court for the Northern District of Illinois granted Abbott's motion for a preliminary injunction to stop Sandoz from selling a generic version of Biaxin XL (clarithromycin extended release tablets).  Abbott earns about $300 million each year in the U.S. from sales of Biaxin XL, an antibiotic used primarily for the treatment of bacterial infections of the skin and upper respiratory system.

The preliminary injunction against Sandoz is a reversal of fortune for Abbott, considering that last December Judge Coar denied Abbott's motion for a temporary restraining order.  Now, in a 61-page opinion, Judge Coar explained that "after having the benefit of a full hearing, this Court is able to better decide the merits of enjoining Sandoz from further selling or marketing its extended release formulation of clarithromycin."

Abbott alleged that Sandoz's generic version of Biaxin XL infringes U.S. Patent Nos. 6,010,718 and 6,551,616, which claim extended release formulations of clarithromycin.  Judge Coar found that Abbott demonstrated "a substantial likelihood of proving Sandoz's product infringes upon claims 1 and 4 of the '718 patent."  Moreover, he found that Sandoz's obviousness and inequitable conduct defenses lack substantial merit.

With regard to inequitable conduct, Judge Coar wrote that although Sandoz showed a substantial likelihood of proving materiality and intent to deceive with respect to the '616 patent, Abbott abandoned the '616 patent claim in question on its own volition and "it seems wholly inequitable to hold a patent invalid for fraudulent conduct in the prosecution of a claim that was withdrawn before actual prosecution had even begun."  Judge Coar further observed that "[r]edemption is one of the core principles of the American ethos."

Besides Sandoz, Abbott is fending off generic competition to Biaxin XL from Andrx, Ranbaxy, Roxane, and Teva.  In January, the Federal Circuit affirmed a preliminary injunction against Andrx.  Last August, Abbott and Teva settled their litigation, although on Tuesday Teva filed a complaint in the Southern District of New York to enforce the settlement.

Thanks very much to a helpful reader for bringing this case to my attention!