District Court Denies Abbott's TRO Motion in Biaxin XL Case Against Sandoz

Savient Pharms. v. Sandoz, No. 05 C 5373 (N.D. Ill. 2006)

In a short opinion and order signed last Friday, Judge David H. Coar of the U.S. District Court for the Northern District of Illinois denied Abbott Labs' motion for a Temporary Restraining Order aimed at keeping Sandoz from launching its generic version of Biaxin XL (extended-release clarithromycin tablets). Biaxin XL, which is used primarily to treat bacterial infections of the skin and upper respiratory system, has annual sales of $255 million in the United States.

Besides Sandoz, Teva has filed an ANDA for generic Biaxin XL.  In Abbott's litigation against Teva, Judge Coar granted Abbott's motion for a preliminary injunction.  However, last summer the Federal Circuit vacated that decision, holding that Teva had raised a substantial question regarding the validity of Abbott's U.S. Patent No. 6,010,718.  Abbott asserted the same patent against Sandoz, and while Judge Coar found that the Federal Circuit decision did not preclude Abbott's assertion that there were no substantial questions of validity (because it was a ruling made in connection with preliminary relief), he stated that "the practical effect of that court's holding still militates toward the denial of the TRO in the instant case."

Judge Coar wrote:

Given the holding of the Federal Circuit Court of Appeals and the deference owed thereto, this Court will not reach a result inconsistent with that holding absent a substantial showing that on a more complete record, the Federal Circuit would have reached a different result.  While Abbott has put forth argument and suggests some evidence that the Teva Case's analysis may have been flawed, on the limited record in the TRO hearing, this Court is not persuaded that the Federal Circuit's reasoning is not controlling in this (Sandoz) case as to the likelihood of prevailing on the invalidity claims.

Abbott and Teva settled their litigation shortly after the Federal Circuit decision in that case (link). Abbott's case against Sandoz now proceeds toward trial.