FDA Data Exclusivity Guidance: Emerging Patent Challenges and Opportunities
Navigating Complexities of Exclusivity, New Developments, and the Implications for ANDAs and Hatch-Waxman Litigation
Recording of a 90-minute premium CLE webinar with Q&A
This CLE course will provide patent counsel with a review of the new FDA draft guidance and examine the impact of the FDA's wholly revised interpretation of the new chemical entity (NCE) exclusivity provisions and will offer strategies to maximize data exclusivity.
- FDA data exclusivity and how it relates to Hatch-Waxman
- Five-year data exclusivity
- Three-year data exclusivity
FDA’s new draft guidelines and denial of citizen petitions: prospective five-year data exclusivity for some combo drug products
- Qualifying subject matter
- Limitations on ANDA filing and relation to Hatch-Waxman
- Applicability to prospective NDAs
- Patent and business strategies to maximize data exclusivity in light of both the new and old landscape
The panel will review these and other key questions:
- How does the new FDA draft guidance change the landscape of NCE exclusivity?
- What are the implications of the FDA's new interpretation of NCE exclusivity for Hatch-Waxman litigation?
- What strategies should companies and counsel employ to maximize data exclusivity?
Following the speaker presentations, you'll have an opportunity to get answers to your specific questions during the interactive Q&A.
Thomas L. Irving
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. He has served as lead counsel in many patent interferences.Close
Donna M. Meuth
Associate General Counsel
Ms. Meuth has diverse experience in intellectual property law, including patent portfolio management, patent... | Read More
Ms. Meuth has diverse experience in intellectual property law, including patent portfolio management, patent prosecution and litigation. Her technical focus is in the pharmaceutical, chemical and biotechnology arts. She has significant interference experience and litigation experience, in particular ANDA litigation for branded pharmaceuticals.Close
Lauren L. Stevens, Esq.
Global Patent Group
Ms. Stevens practices strategic client counseling and patent procurement in the pharmaceutical area, including the... | Read More
Ms. Stevens practices strategic client counseling and patent procurement in the pharmaceutical area, including the preparation of validity, infringement, and freedom-to-operate opinions regarding chemical and pharmaceutical patents. She advises clients on intellectual property matters related to a wide range of technologies.Close