IP Matters, Including Drug Maker's Counterclaim Under Hatch-Waxman - Intellectual Property Law - Federal Circuit
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IP Matters, Including Drug Maker's Counterclaim Under Hatch-Waxman

Novo Nordisk A/S v. Caraco Pharm. Labs., Ltd., No. 10-1001 concerned an action brought under 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 patent infringement action against a generic drug manufacturer involving the drug repaglinide under the brand name Prandine. 

The Hatch-Waxman Act authorizes a counterclaim by a generic manufacturer only if the listed patent does not claim any approved methods of using the listed drug, and the terms of the counterclaim provision do not authorize an order compelling the patent holder to change its use code narrative.  Therefore, defendant does not have a statutory basis to assert a counterclaim requesting injunctive relief and district court's grant of summary judgment in favor of defendant and its injunction order directing Novo Nordisk to request the FDA to replace its patent use code U-968 for Prandin in the Orange Book with the former U-546 listing is reversed and vacated.

In re Suitco Surface, Inc., No. 09-1418 involved a challenge to the decision of the PTO rejecting certain claims of '514 patent directed to floor finishing material for use on athletic courts, bowling alleys, and other floor surfaces, as anticipated during a reexamination proceeding.  However, because the PTO based its rejection on its unreasonable construction of the phrase "material for finishing the top surface of the floor," the decision is vacated in part.  With respect to its "uniform" limitation, PTO's decision is affirmed as its finding is supported by substantial evidence. 

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