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, November 16, 2021
- 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, 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

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- FDA draft guidance on questions and answers related to the Orange Book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