Biosimilars: Emerging Legal Challenges
Navigating FDA's Pathway to Approval, Patent Issues, and the Exclusivity Period
Recording of a 90-minute CLE webinar with Q&A
This CLE webinar will provide IP attorneys with a review of the complex standards of the FDA's Biosimilar Approval Pathway and address patent and exclusivity concerns around the development and marketing of biosimilars including information exchanges, infringement issues, and sameness and interchangeability questions.
- FDA’s regulation of biosimilars
- 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
- 12-year exclusivity
- Definition of exclusivity
- Criteria for exclusivity
The panel will review these and other key questions:
- 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 is the criteria for the 12-year exclusivity period?
Following the speaker presentations, you'll have an opportunity to get answers to your specific questions during the interactive Q&A.
Anthony J. Fitzpatrick
He co-chairs the firm's Intellectual Property Litigation Practice. He has litigated matters involving diverse... | Read More
He co-chairs the firm's Intellectual Property Litigation Practice. He has litigated matters involving diverse technologies, including factory controls and automation, semiconductors, and water purification, and has gained particular experience in biotechnology, medical devices and other life sciences. He has extensive trial experience and has been lead trial counsel in a number of patent cases.Close
Daniel A. Kracov
Arnold & Porter
He heads the firm's FDA and Healthcare Practice and assists clients in negotiating the challenges relating to the... | Read More
He heads the firm's FDA and Healthcare Practice and assists clients in negotiating the challenges relating to the development, approval and marketing of drugs, biologics, and medical devices. He regularly handles product and compliance-related investigations, the development of regulatory corporate compliance programs, and due diligence in financings, mergers and acquisitions.Close