Biosimilars: Navigating FDA's Evolving Approval Pathway, Protecting Patents and Trade Secrets
Recording of a 90-minute premium CLE webinar with Q&A
This CLE course will provide a drill-down for IP counsel on the FDA's draft guidances and considerations raised in public meetings to navigate the complex standards of the FDA's Biosimilar Approval Pathway. The panel will also address the challenging issues concerning complying with the patent information exchanges required by the BPCIA, and discuss emerging legal challenges, including potential ethical considerations.
FDA regulation of biosimilars
- The new guidance
- The approval pathway
- Definitions and problems of "highly similar" and "interchangeability"
- Production issues and concerns of safety and efficacy
Patent issues regarding the development and marketing of biosimilars
- The patent exchange procedures
- Disclosure of biosimilars application
- Infringement issues
- Definition of exclusivity
- Criteria for exclusivity
Best practices for protecting the technology
- Trade secrets
The panel will review these and other key questions:
- How will the draft guidances impact protection for biosimilars?
- What are the FDA's definitions for "highly similar" and "interchangeability"?
- What are the market protection issues raised by patent exchange procedures for biopharmaceuticals?
- What are the ethical and strategic challenges arising from the different rounds of litigation that may occur as a result of the statute?
Following the speaker presentations, you'll have an opportunity to get answers to your specific questions during the interactive Q&A.
Howard W. Levine
Finnegan Henderson Farabow Garrett & Dunner
Mr. Levine has over 20 years of experience in patent litigation, primarily in the areas of biotechnology and... | Read More
Mr. Levine has over 20 years of experience in patent litigation, primarily in the areas of biotechnology and pharmaceuticals and has extensive experience in cases arising from the filing of Abbreviated New Drug Applications (ANDA). He has conducted all aspects of pre-trial, trial, and post-trial proceedings, including appeals to the U.S. Court of Appeals for the Federal Circuit and the U.S. Supreme Court. Mr. Levine lectures widely on patent law, including such topics as the written description and the patentability of different crystalline forms of drug substances.Close
Kevin E. Noonan, Ph.D.
McDonnell Boehnen Hulbert & Berghoff
Dr. Noonan's practice involves all aspects of patent prosecution, interferences, and litigation. He represents... | Read More
Dr. Noonan's practice involves all aspects of patent prosecution, interferences, and litigation. He represents pharmaceutical companies both large and small on a myriad of issues, as well as several universities in both patenting and licensing to outside investors. Dr. Noonan also has over 20 years of experience as a molecular biologist, and is a founding author of the Patent Docs weblog, which focuses on biotechnology and pharmaceutical patent law. He has also filed amicus briefs to district courts, the Federal Circuit and the Supreme Court involving patenting issues relevant to biotechnology.Close