The court granted plaintiff's motion to dismiss defendant's patent misuse and unclean hands counterclaims based on alleged improper Orange Book listing because the Hatch-Waxman Act precluded such claims. "The 2003 Amendment to the Hatch-Waxman Act 'provides a limited counterclaim to a generic manufacturer' in a Paragraph IV infringement action. The Act authorizes the generic manufacturer to assert a counterclaim 'on the ground that the patent does not claim either (aa) the drug for which the application was approved; or (bb) an approved method of using the drug.' . . . By describing the 2003 Amendment as providing 'a limited counterclaim' in [Novo Nordisk v. Caraco Pharm., Labs, Ltd., 601 F.3d 1359, 1364 (Fed. Cir. 2010)], the Federal Circuit strongly suggested that this provision created the only private right of action for an alleged infringer seeking to delist a patent from the Orange Book. . . . Although district courts are split on this issue, the cases denying counterclaims based on improper Orange Book listings comport with the Federal Circuit‘s interpretation of the 2003 Amendments. . . . Moreover, Defendant‘s [c]ounterclaims for patent misuse and unclean hands depend entirely on finding that Plaintiff improperly listed the [patent-in-suit] in the Orange Book [as alleged in defendant's first counterclaim], making these claims redundant."
Braintree Laboratories Inc. v. Amrutham, Inc., 2-11-cv-01854 (PAED February 27, 2012, Order) (Diamond, J.)