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

Course Details
- smart_display Format
On-Demand
- signal_cellular_alt Difficulty Level
- work Practice Area
Patent
- event Date
Tuesday, February 14, 2023
- schedule Time
1:00 p.m. ET./10:00 a.m. PT
- timer Program Length
90 minutes
-
This 90-minute webinar is eligible in most states for 1.5 CLE credits.
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.
Faculty

Dr. Feldstein focuses on U.S. district court litigation, primarily concerning the enforcement of U.S. patent rights and trade secret issues, and post-grant trial proceedings at the USPTO, including inter partes review (IPR) and post grant review (PGR). He maintains an active patent prosecution practice, preparing and prosecuting U.S. patent applications on behalf of domestic and foreign clients. He also provides opinions and strategic guidance to clients on infringement, validity, enforceability, and clearance matters. His practice encompasses a range of technologies, including pharmaceuticals, biochemistry, polymers, small molecule chemistry, optics, and medical and analytic devices.

Dr. MacAlpine practices patent procurement, due diligence investigations, opinion work, and client counseling, primarily in the chemical and pharmaceutical areas. She has extensive experience in handling patent matters before the U.S. Patent and Trademark Office (USPTO), including post-grant proceedings specifically IPRs, appeals, and oral hearings at the PTAB; drafting and prosecution of patent applications; reissue and reexamination proceedings; and interferences.

Ms. Burgy focuses on opinion work, client counseling, patent prosecution and management, and litigation in the chemical, pharmaceutical, and biotechnology arts. She counsels her clients on a diverse range of patent issues. She assists clients on single-patent issues as well as complex matters involving multiple patents and applications requiring ongoing advice on patent portfolio strategy and development, with an eye towards litigation. She has assisted clients in the early stages of development through due diligence and patent portfolio analysis.

Mr. Irving has 47 years of experience in the field of IP law. His practice includes due diligence, patent prosecution, reissue and reexamination, patent interferences, and counseling, including prelitigation, Orange Book listings of patents covering FDA-approved drugs, and infringement and validity analysis in the chemical fields, as well as litigation. He has served as lead counsel in many patent interferences.

Ms. Hooson is director in the Intellectual Property Group at Merck in Rahway, NJ. Her present responsibilities include patent preparation, prosecution, and due diligence support for small molecule, vaccine, and antibody programs in human and animal health. She gained her initial legal patent experience while working at GlaxoSmithKline (GSK). She received her bachelor’s degree in Biomedical Engineering from Georgia Institute of Technology, and her J.D. from Delaware Law School - Widener University. She gained considerable bio-pharmaceutical research and development and vaccine process development experience while working as an engineer at Merck, GSK, and MedImmune.
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.
Outline
- Recent Orange Book developments
- Orange Book listing practices
- Implications for patent prosecution
- Implications for listing
- Implications for litigation
- Form 3542 and pitfalls to avoid
- 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?
Unlimited access to premium CLE courses:
- Annual access
- Available live and on-demand
- Best for attorneys and legal professionals
Unlimited access to premium CPE courses.:
- Annual access
- Available live and on-demand
- Best for CPAs and tax professionals
Unlimited access to premium CLE, CPE, Professional Skills and Practice-Ready courses.:
- Annual access
- Available live and on-demand
- Best for legal, accounting, and tax professionals
Related Courses

Patent Design Arounds: Minimizing Risk of Infringement and Reducing Likelihood of Competitor Design Arounds
Monday, May 19, 2025
1:00 p.m. ET./10:00 a.m. PT

Patent Infringement: Structuring Opinions of Counsel
Wednesday, May 7, 2025
1:00 p.m. ET./10:00 a.m. PT

Means-Plus-Function Patent Claims Following Xencor: Preamble, Written Description, and More
Thursday, May 15, 2025
1:00 p.m. ET./10:00 a.m. PT