Novo Nordisk, Sun Pharmaceutical endocrine/metabolic news

The U.S. Supreme Court will hear oral arguments on Dec. 5 in the case of Caraco Pharmaceutical Laboratories Ltd. et al. v. Novo Nordisk A/S et al. The case will determine the proper scope of the counterclaim provision of the Hatch-Waxman Act, which supplies a mechanism for judicial resolution of disputes about the accuracy of the patent information that FDA requires NDA holders submit.

Last year, the U.S. Court of Appeals for the Federal Circuit ruled in the suit that counterclaims can only be asserted if no patents listed in the Orange Book claim any approved methods of using the listed drug. The circuit court added that language of the counterclaim provision only permits generic drug makers to obtain court orders to require patent holders to change or modify patent information, which is defined as the patent number and expiration date and does not include use code narratives. ...