Orange Book Use Codes: Impact of Caraco v. Novo Nordisk

Pursuing, Avoiding or Defending Against Counterclaims to Correct Method-of-Use Patents

Apr. 17 Supreme Court ruling creates sea change for use code challenges in Hatch-Waxman suits

Recording of a 90-minute premium CLE webinar with Q&A

Conducted on Tuesday, June 5, 2012

Recorded event now available

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Course Materials

This CLE course will provide guidance to patent counsel on the impact of the U.S. Supreme Court's decision in Caraco v. Novo Nordisk and offer counsel tactics for dealing with method-of-use patents.


The Supreme Court's Apr. 17, 2012, Caraco v. Novo Nordisk ruling held that a generic manufacturer may employ 21 U.S.C. sect. 355(j)(5)(C)(ii)(I)'s counterclaim provision to force correction of a use code that inaccurately describes the brand’s patent as covering a particular method of use.

The landmark decision, the Court's first abbreviated new drug application (ANDA) case since Hatch-Waxman was passed, opens a door to generic manufacturers to seek to limit the scope of the use codes. The decision will influence the balance between innovation and competition.

Patent counsel of both brand and generic manufacturers must understand the impact of the Caraco decision. Both brands and generics may well receive more scrutinization in their FDA submissions. Both patent and FDA counsel must be prepared to maneuver the new Caraco shoals surrounding use codes.

Listen as our authoritative panel of patent counsel examines the Supreme Court decision in Caraco, the concurring opinion, and its likely impact. The panel will provide an in depth and comprehensive examination of strategy and tactics regarding use codes in the post-Caraco era. Caraco most likely signals a quantum leap in scrutiny of use codes, raising the possibility of increased antitrust and FTC scrutiny in addition to pitched battles in Hatch Waxman proceedings extending to the statutory counterclaim.



  1. Caraco v. Novo Nordisk
    1. The decisions at the district court, Federal Circuit, and Supreme Court
    2. Keys to the Supreme Court’s reversal of the Federal Circuit’s decision
    3. Likely impact of the Supreme Court decision
  2. Strategies and tactics regarding use codes in both Orange Book listings and Hatch Waxman counterclaim challenges
  3. Will there be enhanced antitrust and FTC scrutiny of use codes
  4. Will Congress and/or the FDA, through its regulations, pick up the Use Code gauntlet hurled down by Justice Sotomayor in her concurring opinion


The panel will review these and other key questions:

  • What impact will the Caraco decision have for method-of-use patents?
  • What steps can counsel for brand manufacturers take to tailor their use codes?
  • What can generic manufacturers do to limit the scope of use codes?

Following the speaker presentations, you'll have an opportunity to get answers to your specific questions during the interactive Q&A.


Irving, Thomas
Thomas L. Irving

Finnegan Henderson Farabow Garrett & Dunner

Mr. Irving has 35 years of experience in the field of IP law. His practice includes due diligence, patent prosecution,...  |  Read More

Bloch, David
David S. Bloch

Winston & Strawn

Mr. Bloch focuses on intellectual property litigation. His experience also includes intellectual property matters that...  |  Read More

Donna M. Meuth
Donna M. Meuth
Associate General Counsel - Intellectual Property

Ms. Meuth has diverse experience in intellectual property law, including patent portfolio management, patent...  |  Read More

Deborah M. Herzfeld
Deborah M. Herzfeld

Of Counsel
Finnegan Henderson Farabow Garrett & Dunner

Ms. Herzfeld focuses her practice on patent prosecution and counseling work, with an emphasis on chemical subject...  |  Read More

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