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 webinar with interactive Q&A


Tuesday, November 17, 2020

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

Early Registration Discount Deadline, Friday, October 23, 2020

or call 1-800-926-7926

This CLE webinar will provide guidance to patent counsel on 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 Food and Drug Administration (FDA) changes Form 3542.

Description

In a year in which the FDA’s Orange Book, which lists approved drug products and related patents and regulatory exclusivities, celebrates its 40th anniversary, the Food and Drug Administration (FDA) is working to modernize the Orange Book. In May 2020, the FDA issued draft guidance on questions and answers related to the Orange Book. On June 1, the FDA announced it was establishing a public docket to receive public comments regarding the types of patent information published in the Orange Book. A great many comments were filed by the Aug. 31, 2020 deadline.

There may be more than meets the eye when it comes to complying with the requirements set forth in Orange Book listing Form 3542. Recently, the trade association, IPO, responding to the June 1, FDA public docket, submitted comments to FDA about how to improve listing Form 3542. The IPO report included an Appendix of comprehensive, proposed Form 3542 improvements principally authored by two of the presenters on this program and their firm. Many other organizations and individuals also offered comments to FDA.

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. Listing in the Orange Book 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.

READ MORE

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 Hatch Waxman litigation resulting therefrom

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

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

Rudolph, Barbara
Barbara R. Rudolph, Ph.D.

Partner
Finnegan Henderson Farabow Garrett & Dunner

Dr. Rudolph has successfully litigated complex Hatch-Waxman Paragraph IV Abbreviated New Drug Application and...  |  Read More

Live Webinar

Buy Live Webinar
Early Discount (through 10/23/20)

Live Webinar

$297

Buy Live Webinar & Recording
Includes special savings of $300 (through 10/23/20)

Live Webinar & Download

$394

Live Webinar & DVD

$394 + $24.45 S&H

Other Formats
— Anytime, Anywhere

Early Discount (through 10/23/20)

Strafford will process CLE credit for one person on each recording. All formats include program handouts. To find out which recorded format will provide the best CLE option, select your state:

CLE On-Demand Video

48 hours after event

$297

Download

48 hours after event

$297

DVD

10 business days after event

$297 + $24.45 S&H