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


Tuesday, November 16, 2021

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

Early Registration Discount Deadline, Friday, October 22, 2021

or call 1-800-926-7926

This CLE course will guide patent counsel on recent Orange Book developments, including recent cases related to 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 unless and until the FDA changes Form 3542.

Description

The FDA Orange Book lists approved drug products and related patents and regulatory exclusivities. In May 2020, the FDA issued draft guidance on questions and answers related to the Orange Book. The FDA then received public comments regarding the types of patent information published in the Orange Book.

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, either in present form or as it may be changed, 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 of patent attorneys examines the recent Orange Book developments and the implications for patent prosecution, listing, and litigation. The panel will examine, in particular, contemporary thought about Form 3542 and pitfalls to avoid unless and until the FDA changes Form 3542.

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Outline

  1. Recent Orange Book developments
    1. FDA draft guidance on questions and answers related to the Orange Book
    2. Modernizing the Orange Book, particularly FDA's recent public docket for the receipt of public comments regarding the types of patent information published in the Orange Book and related issues, and responses by life science interested parties
  2. Best practices for good faith Orange Book listing and resulting Hatch-Waxman litigation

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

Hooson, Sarah
Sarah Hooson

Director, Legal
Merck

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

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Early Discount (through 10/22/21)

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Early Discount (through 10/22/21)

You may pre-order a recording to listen at your convenience. Recordings are available 48 hours after the webinar. Strafford will process CLE credit for one person on each recording. All formats include course handouts.

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