Orange Book Blog

In re Andrx Pharmaceuticals, Inc., Misc. Docket No. 943 (Fed. Cir. 2010)

In 2002, Astra prevailed over Andrx in Paragraph IV litigation concerning Andrx's ANDA for a generic version of Prilosec (omeprazole).  Shortly before and during the course of the bench trial, Astra learned that Andrx had manufactured multiple batches of its ANDA product on a commercial scale.

In 2008, following affirmance by the Federal Circuit of the district court decisions on infringement and validity, Astra filed a motion for leave to file a supplemental complaint to seek monetary damages for Andrx's commercial-scale manufacture of its infringing ANDA product.  In an opinion filed in February of this year, the district court granted Astra's motion.

Andrx responded by petitioning the Federal Circuit for a writ of mandamus to direct the district court to vacate its order granting Astra leave to file its supplemental complaint.  Yesterday, in a four-page opinion, the Federal Circuit denied Andrx's petition.

In its opinion yesterday, the Federal Circuit began by noting, "A party seeking a writ of mandamus bears the burden of proving that it has no other means of obtaining the relief desired.  The court explained that "Andrx has not shown why it cannot effectively raise any challenge to the district court's determination to allow Astra's damages claim after an appeal from final judgment."  According to the court, a writ of mandamus is an extraordinary writ, and "Extraordinary writs are not substitutes for appeals, even if hardship may result from delay and perhaps unnecessary trial."

Perhaps more interesting than the Federal Circuit's denial of Andrx's mandamus petition is what the district court will do with Astra's damages claim.  It appears that Andrx never marketed its commercial-scale batches and, for this reason, Andrx argued to the district court that Astra's supplemental complaint would be futile.  The district court disagreed, however, noting that Astra may be entitled to reasonable-royalty damages based simply on Andrx's manufacture of the batches.  The damages questions may answered, initially at least, by a jury.