A U.S. Supreme Court ruling in April makes it easier for the makers of generic drugs to bring successful counterclaims against brand-name drug companies that try to thwart them from bringing products to market. In a 9-to-0 decision, the court reversed a ruling by the U.S. Court of Appeals for the Federal Circuit, finding that a district court judge was right to conclude in 2009 that Danish pharma giant Novo Nordisk A/S must correct information it provided to the Food and Drug Administration about its diabetes drug Prandin. The decision should allow Caraco Pharmaceutical Laboratories Ltd., a subsidiary of Sun Pharmaceutical Industries Limited, to market a generic version.
More significantly, the ruling expands the scope of the so-called counterclaim provision of the Hatch-Waxman Act, which lets generic companies challenge the accuracy of patent information that branded drug companies supply to the FDA. In doing so, the ruling sheds light on a murky provision of Hatch-Waxman. Under the law, the FDA won’t approve generic drugs for uses covered by patents owned by branded drug makers.
