Obtaining and Managing REMS Patents: What Patent Prosecutors Need to Know, USPTO and FDA Policies and Rules
Recording of a 90-minute premium CLE video webinar with Q&A
This CLE webinar will guide patent counsel on the issues surrounding Risk Evaluation and Mitigation Strategy (REMS) patents and listing in the Orange Book. The panel will discuss REMS patents and what patent prosecutors need to know. The panel will address the current efforts of the USPTO and FDA to determine what policy or rules will govern the listing of REMS patents. The panel will also discuss other issued patents relating to REMS and will offer best practices for obtaining and managing REMS patents.
Outline
- Current FDA OB Listing Policy
- Future policy direction
- Options for REMS patent holders
- REMS patent litigation
- Issued REMS patents
Benefits
The panel will review these and other high priority issues:
- What are the considerations for patent counsel when deciding whether to list a REMS patent in the Orange Book?
- What is the significance of the FTC intervention in the Jazz case?
- What best practices should counsel employ when obtaining and managing REMS patents?
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.
Mark J. Feldstein, Ph.D.
Partner
Finnegan Henderson Farabow Garrett & Dunner
Dr. Feldstein focuses on U.S. district court litigation, primarily concerning the enforcement of U.S. patent rights and... | Read More
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.
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Thomas L. Irving
Partner
Finnegan Henderson Farabow Garrett & Dunner
Mr. Irving has 35 years of experience in the field of IP law. His practice includes due diligence, patent prosecution,... | Read More
Mr. Irving has 35 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. Mr. Irving has served as lead counsel in many patent interferences.
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Adriana L. Burgy
Partner
Finnegan Henderson Farabow Garrett & Dunner
Ms. Burgy focuses on opinion work, client counseling, patent prosecution and management, and litigation in the... | Read More
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. From a patent prosecution perspective, she has drafted and prosecuted numerous patent applications domestically and internationally, guided and advised clients on complex procedural and legal issues surrounding clients' patent portfolios, developed and implemented strategic prosecution in support of ongoing litigation, generated strategies for maximizing investment in patent portfolios, and facilitated the identification of high-priority applications within patent portfolios.
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