Orange Book Listing Recent Developments

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.