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Caraco v. Novo Nordisk: Supreme Court Alters the Landscape of Hatch-Waxman Litigation by Adopting Expansive Interpretation of Counterclaims Provision

Recorded on: May. 8, 2012
Running Time: 01:04:41

Running Time Segment Title Faculty Format
[01:04:41] Caraco v. Novo Nordisk: Supreme Court Alters the Landscape of Hatch-Waxman Litigation by Adopting Expansive Interpretation of Counterclaims Provision Robert D. Carroll ~ Goodwin Procter LLP
Elaine Herrmann Blais ~ Goodwin Procter LLP
 On-Demand MP3 MP4
Taken from the briefing Caraco v. Novo Nordisk: Supreme Court Alters the Landscape of Hatch-Waxman Litigation by Adopting Expansive Interpretation of Counterclaims Provision recorded May, 2012.

On April 17, 2012, the U.S. Supreme Court released its decision Caraco Pharmaceutical Laboratories Ltd. v. Novo Nordisk A/S, clarifying 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 FDA uses the “use codes” provided by branded drug manufacturers to determine whether a generic company’s proposed use of a drug would infringe a method-of-use patent held by the manufacturer of the brand-name version.  The FDA assumes the accuracy of the use codes provided by branded drug manufacturers, and decides whether to approve a generic drug on that basis.  Therefore the breadth of the use code stated by a branded drug company to the FDA is significant, because, in the words of the Court, it “may make the difference between approval and denial of a generic company’s application.” An overbroad use code can prevent FDA from approving a generic drug for an unpatented use until after a patent for a different use has expired.

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.

This briefing was conducted by Elaine Herrmann Blais and Robert D. Carroll, partners in the law firm Goodwin Procter LLP.  Ms. Blais focuses her practice on intellectual property litigation, particularly with respect to patent litigation, including extensive litigation under the Hatch-Waxman Act.  Mr. Carroll focuses his practice on intellectual property litigation and complex business disputes, and has litigated cases under the Hatch-Waxman Act.

Lecture Topics  [Total Time: 01:04:41]
  • 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?

Presentation Material

  • Caraco v. Novo Nordisk: Supreme Court Alters the Landscape of Hatch-Waxman Litigation by Adopting Expansive Interpretation of Counterclaims Provision
    Elaine Herrmann Blais, Robert D. Carroll
  • Caraco v. Novo Nordisk: Supreme Court Alters the Landscape of Hatch-Waxman Litigation by Adopting Expansive Interpretation of Counterclaims Provision 
Speaker(s)
Elaine Herrmann Blais ~ Goodwin Procter LLP
Robert D. Carroll ~ Goodwin Procter LLP

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