Orange Book Listing Recent Developments
Impact on Prosecution of Pharmaceutical U.S. Patent Applications, Subsequent Orange Book Listings, Hatch Waxman Litigation
Recording of a 90-minute premium CLE video webinar with Q&A
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.
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- FDA draft guidance on questions and answers related to the Orange Book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?
Faculty
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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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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Sarah Hooson
Director, Legal
Merck Sharp & Dohme
Ms. Hooson is director in the Intellectual Property Group at Merck in Rahway, NJ. Her present responsibilities include... | Read More
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.
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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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Jill K. MacAlpine, Ph.D.
Partner
Finnegan Henderson Farabow Garrett & Dunner
Dr. MacAlpine practices patent procurement, due diligence investigations, opinion work, and client counseling,... | Read More
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.
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