Friday, March 2, 2012

Hatch-Waxman Precludes Misuse and Unclean Hands Counterclaims Based on Alleged Improper Orange Book Listing

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.)

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