ARTICLE | Politics & Policy

Supreme Court clarifies Hatch-Waxman counterclaim provision

April 18, 2012 1:08 AM UTC

The U.S. Supreme Court ruled unanimously in Caraco Pharmaceutical Laboratories Ltd. et. al. v. Novo Nordisk A/S et al. that generics companies can use the counterclaim provision in the Hatch-Waxman Act to challenge inaccurate patent information submitted to FDA by NDA sponsors. The court said in its opinion that the provision can be used to force the correction of overly broad "use codes" -- descriptions of the methods of use protected by patents. FDA uses the codes to evaluate whether an ANDA infringes patents for a branded drug, but does not verify the accuracy of the codes because it lacks the expertise and authority to review patent claims, according to the court.

The decision overturns a 2010 decision from the U.S. Court of Appeals for the Federal Circuit, which ruled that generics companies can only assert counterclaims if no patents listed in the Orange Book claim any approved methods of using the listed drug. ...