Orange Book Listing Recent Developments

Impact on Prosecution of Pharmaceutical U.S. Patent Applications, Subsequent Orange Book Listings, Hatch Waxman Litigation

A live 90-minute premium CLE video webinar with interactive Q&A

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Tuesday, February 14, 2023

1:00pm-2:30pm EST, 10:00am-11:30am PST

Early Registration Discount Deadline, Friday, January 20, 2023

or call 1-800-926-7926

This CLE course will guide patent counsel on recent Orange Book developments. The panel will discuss Orange Book listing practices and the implications for patent prosecution, listing, and litigation. The panel will examine contemporary thought about Form 3542 and pitfalls to avoid.

Description

The FDA Orange Book lists approved drug products and related patents and regulatory exclusivities. In 2022, the FDA issued final guidance on questions and answers related to the Orange Book. In addition, the FDA submitted a Report to Congress on “The Listing of Patent Information in the Orange Book,” under Section 2(e) of the Orange Book Transparency Act of 2020.

There may be more than meets the eye when complying with the requirements outlined in the Orange Book listing Form 3542. Patent counsel must be up to date on the most recent developments to employ best practices when prosecuting pharmaceutical patents, particularly with an eye to, upon approval of a drug substance, drug product, or method of use, utilizing Form 3542 to list appropriate U.S. patents in the Orange Book and possibly to subsequently enforce in Hatch-Waxman litigation. The Orange Book list is an integral component of the Hatch-Waxman framework, specifically established for pharmaceutical patent litigation.

Listen as our authoritative panel guides patent counsel on recent Orange Book developments, including Orange Book listing practices and the implications for patent prosecution, listing, and litigation. The panel will examine, in particular, contemporary thought about Form 3542 and pitfalls to avoid. The panel will also discuss how listing practices played a role in recent Hatch-Waxman cases such as GSK v. Teva and Almarin v. Hikma.

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Outline

  1. Recent Orange Book developments
    1. Orange Book listing practices
    2. Implications for patent prosecution
    3. Implications for listing
    4. Implications for litigation
  2. Form 3542 and pitfalls to avoid
  3. How listing practices played a role in recent Hatch-Waxman cases

Benefits

The panel will review these and other key issues:

  • What are the changes and anticipated changes to the Orange Book?
  • What strategies should counsel employ when listing pharmaceutical patents in the Orange Book?

Faculty

Burgy, Adriana
Adriana L. Burgy

Partner
Finnegan Henderson Farabow Garrett & Dunner

Ms. Burgy focuses on opinion work, client counseling, patent prosecution and management, and litigation in the...  |  Read More

Feldstein, Mark
Mark J. Feldstein, Ph.D.

Partner
Finnegan Henderson Farabow Garrett & Dunner

Dr. Feldstein focuses on U.S. district court litigation, primarily concerning the enforcement of U.S. patent rights and...  |  Read More

Irving, Thomas
Thomas L. Irving

Partner
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

MacAlpine, Jill
Jill K. MacAlpine, Ph.D.

Partner
Finnegan Henderson Farabow Garrett & Dunner

Dr. MacAlpine practices patent procurement, due diligence investigations, opinion work, and client counseling,...  |  Read More

Hooson, Sarah
Sarah Hooson

Director, Legal
Merck Sharp & Dohme

Ms. Hooson is director in the Intellectual Property Group at Merck in Rahway, NJ. Her present responsibilities include...  |  Read More

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