Caraco v. Novo Nordisk: Supreme Court Alters the Landscape of Hatch-Waxman Litigation


On Monday, May 7th, PLI will be hosting a One Hour Briefing entitled, Caraco v. Novo Nordisk: Supreme Court Alters the Landscape of Hatch-Waxman Litigation by Adopting Expansive Interpretation of Counterclaims Provision.  This briefing will be conducted by Elaine Herrmann Blais and Robert D. Carroll, partners in the law firm Goodwin Procter LLP. The U.S. Supreme Court’s decision in Caraco Pharmaceutical Laboratories Ltd. v. Novo Nordisk A/S, clarified the circumstances in which generic drug companies can challenge the scope of the “use codes” for the patents that branded drug companies list in the FDA’s “Orange Book.”

The question before the Court was whether Congress has authorized a generic company to challenge a use code’s accuracy by bringing a counterclaim against the branded company’s patent infringement suit.  The relevant section of the Hatch-Waxman Act provides that a generic company “may assert a counterclaim seeking an order requiring the [brand company] to correct or delete the patent information [it] submitted . . . [to the FDA] on the ground that the patent does not claim . . . an approved method of using the drug.”  21 U.S.C. § 355(j)(5)(C)(ii)(I).

The Federal Circuit had given this provision a narrow reading that did not permit a generic company to challenge whether a use code accurately described the uses covered by the patent in question.  Unanimously reversing the Federal Circuit, the Supreme Court held that a generic manufacturer may use this provision to force the correction of a use code that inaccurately describes the branded company’s patent as covering methods of use that are broader than the scope of the patent in question, even if the use code encompasses methods validly encompassed by patent in question.

The one hour briefing is scheduled for 1pm on Monday, May 7th. Topics for the briefing will include:

  • What are the likely implications of the expanded scope for counterclaims in future Hatch-Waxman litigation?
  • What regulatory and procedural problems remain with respect to resolving incorrect patent use codes provided to the FDA?
  • Will Justice Sotomayor’s concurring opinion prompt the FDA or Congress to address the system for listing and challenging use codes through regulations or an amendment to the Hatch-Waxman Act?

 Register for the one hour briefing on Caraco v. Novo Nordisk today! For more information click here.

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