United States Federal Circuit

In an action brought pursuant to the Drug Price Competition and Patent Term Restoration Act of 1984, as amended by the Medicare Prescription Drug Improvement and Modernization Act of 2003 (Hatch-Waxman Act), arising from Novo Nordisk's (Novo) patent infringement suit against a generic drug manufacturer involving the drug repaglinide under the brand name Prandin, district court's grant of summary judgment in favor of defendant and its injunction order directing Novo to request the FDA to replace its patent use code U-968 listing for Prandin in the Orange Book with the former U-546 listing is reversed and vacated, as defendant does not have a statutory basis to assert a counterclaim requesting such injunctive relief because the Hatch-Waxman Act authorizes a counterclaim only if the listed patent does not claim any approved methods of using the listed drug.

Appellate Information

• Decided 04/14/2010
• Published 04/14/2010

Judges

Court

• United States Federal Circuit

Counsel