Patent Listings in the Orange Book: FTC Guidance, Policy, and Enforcement; the Recent Teva v. Amneal Delisting Case
Practical Steps for NDA Holders and Applicants
A live 90-minute premium CLE video webinar with interactive Q&A
This CLE webinar will guide patent counsel on patent listings in the Orange Book and the U.S. Federal Trade Commission's (FTC) recent actions. The panel will examine the FTC's policy on Orange Book listings, its recent enforcement, and the options it is considering. The panel will discuss what holders and applicants can do with both existing listings and future listings.
Outline
- Review of Orange Book listings
- Improperly listed patents; delisting
- FTC's recent guidance, policy statements
- FTC enforcement
- Input from politicians, such as Sen. Klobuchar
- Practical steps for NDA holders and applicants to take with past listed Orange Book patents, as well as future listings
Benefits
The panel will review these and other key issues:
- What key considerations should pharma organizations and counsel weigh when determining whether or not to Orange Book list a patent?
- Pros and cons of whether to list particular patents
- Value from not listing certain patents, particularly in view of the recent Lundbeck Federal Circuit case
- What steps could patentees have taken during prosecution or in, e.g., reissue, in the Orange Book listed patents challenged by the FTC?
- What steps are involved in delisting a patent and what ramifications might flow therefrom?
Faculty
Joanna T. Brougher, Esq., MPH
Owner & Principal
BioPharma Law Group
Ms. Brougher is a patent attorney who focuses on all aspects of services related to patents in the areas of... | Read More
Ms. Brougher is a patent attorney who focuses on all aspects of services related to patents in the areas of biotechnology, pharmaceuticals and medical devices, including patentability opinions, due diligence, patent drafting, domestic and foreign patent prosecution, development and management of patent portfolios, and general client counseling during all phases of a product’s lifecycle, from concept to commercialization.
Her patent experience covers a variety of complex and innovative inventions involving small molecule drugs, biologics, cell-based technologies, compositions, drug formulations and drug delivery systems, immunotherapeutics, medical devices, diagnostic tests, nanotechnology, and immunology, particularly vaccines and antibodies. Ms. Brougher also has experience counseling clients on the Hatch-Waxman Act and is monitoring developments involving biosimilars under the Biologics Price Competition and Innovation Act.
Thomas L. Irving
Partner
The Marbury Law Group
Mr. Irving has 47 years of experience in the field of IP law. His practice includes due diligence, patent prosecution,... | Read More
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.
Close
Michelle E. O'Brien
Partner, Head of Life Sciences
The Marbury Law Group
Ms. O’Brien has more than 20 years of experience representing domestic and foreign clients of all sizes in... | Read More
Ms. O’Brien has more than 20 years of experience representing domestic and foreign clients of all sizes in patent procurement, litigation, and client counseling, with a particular emphasis on chemical, biochemical, and pharmaceutical technologies. Exemplary areas of her technical expertise include polymer chemistry; ceramics; glass; food chemistry; cosmetics; paper products; adhesives; and pharmaceutical products, including new chemical entities and formulations and novel solid forms, including polymorphs, cocrystals, and amorphous forms of compounds.
Close
Serena Farquharson-Torres, Ph.D., J.D.
Executive Director & Assistant General Counsel in Intellectual Property Law
Bristol Myers Squibb
Ms. Farquharson-Torres works in all aspects of pharmaceutical patent law and has held various roles of increasing... | Read More
Ms. Farquharson-Torres works in all aspects of pharmaceutical patent law and has held various roles of increasing responsibility since joining the company in 2016 and serves on the IP leadership team. She is a leader in the advancement of inclusion in innovation and the practice of IP law. Prior to joining Bristol Myers Squibb, Ms. Farquharson-Torres started her career as a patent lawyer in private practice and moved on to Schering-Plough/Merck and then Sanofi. She received her J.D. from the University of North Carolina, her Ph.D. in Biological Chemistry from University of Minnesota, and her B.S. in Chemistry from Howard University
CloseEarly Discount (through 01/17/25)