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Course Details

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.

Faculty

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 In May 2020, the FDA issued draft guidance on questions and answers related to the Orange Book.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.

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 FDA draft guidance on questions and answers related to the Orange Book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?