Biologics and Biosimilars: FDA Initiatives and Guidance, Approvals and Exclusivity, Patent Prosecution, Litigation
Recording of a 90-minute premium CLE video webinar with Q&A
This CLE course will provide essential updates on FDA practice and patent law relating to biologics and biosimilars. The panel will discuss the current state of and recent changes to FDA initiatives, approvals, and exclusivities, as well as patent prosecution, post-grant proceedings, and litigation.
Outline
- FDA updates
- FDA initiatives for biologics and biosimilars
- Biologic and biosimilar approvals and exclusivity
- Critical differences between biologic and biosimilar approvals and exclusivities vs. small molecule approvals and exclusivities
- Prosecution considerations and FDA guidelines
- Status of biologic and biosimilar approvals and exclusivities
- Patent updates
- Prosecution of biologic patents
- Section 101 patent eligibility guidelines
- Section 103 obviousness trends
- Post-grant reviews and inter partes reviews of biologics patents
- Status and trends in PGR and IPR proceedings
- Federal Circuit appeals from the Patent Trial and Appeal Board
- Biosimilar patent litigation
- Primary differences between biosimilar patent litigation and Hatch-Waxman litigation
- Status and trends in biosimilar patent litigations
- Prosecution of biologic patents
Benefits
The panel will review these and other critical issues:
- What can we learn from FDA's recent guidance on biologics and biosimilars?
- How does FDA's recent guidance impact patent strategy?
- Should your patent strategy for biologics differ from your approach for small molecule drugs?
Faculty
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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Sara W. Koblitz
Director
Hyman Phelps & McNamara
Ms. Koblitz advises FDA-regulated clients on a range of issues with a particular focus on Hatch-Waxman patent and... | Read More
Ms. Koblitz advises FDA-regulated clients on a range of issues with a particular focus on Hatch-Waxman patent and exclusivity, biosimilars, and the Orange Book. She helps drug and device manufacturers in various stages of product development and guides clients through the applicable regulatory requirements with respect to applications and submissions, device classification, potential exclusivities, promotional issues, and post-marketing requirements. She also counsels cosmetics, food, and dietary supplement clients, with experience regarding genetically-modified foods, medical foods, food labeling, and dietary supplement claims and substantiation.
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M. David Weingarten, Ph.D.
Partner
Finnegan Henderson Farabow Garrett & Dunner
Dr. Weingarten has a diverse intellectual property practice focusing on patent litigation before U.S. district courts... | Read More
Dr. Weingarten has a diverse intellectual property practice focusing on patent litigation before U.S. district courts and the U.S. International Trade Commission (ITC), post-grant trial proceedings at the U.S. Patent and Trademark Office (USPTO), prosecution, and strategic portfolio management. He also drafts opinions on patent infringement, validity, and enforceability, and prepares intellectual property agreements, such as those relating to license and supply. In addition, he prepares and prosecutes U.S. patent applications on behalf of domestic and foreign clients.
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