Pre-Conference Interactive Workshop, Monday 19th October 2009
Understanding the developing biosimilars framework in the United States and European Union
Led by: Daniel A. Kracov, Partner and, Chair, FDA and Healthcare Practice, Arnold & Porter LLP, Washington D.C.
David R. Marsh, Ph.D., Partner and Co-Chair, Intellectual Property Practice, Arnold & Porter LLP, Washington, D.C.
Lincoln Tsang, Ph.D., Partner, Arnold & Porter LLP, London
Timings: 09:30 - 10:00 Coffee & Registration
10:00 - 15:00 Workshop
Timing includes lunch and refreshment breaks
Agenda:
Session 1 by Daniel A. Kracov : Overview of U.S. biosimilars legislation: FDA standards, processes and exclusivity
This session will look at the standards and mechanisms for biosimilar licensure under pending legislation (or statute if enacted).
• Biosimilars application review processes
• Requirements for FDA guidance
• Standards for biosimilar and interchangeability determinations
• Data requirements and FDA waiver authorities
• Exclusivity for innovator biologics
• Exclusivity for interchangeable biosimilars
• Nomenclature for biosimilars
• Potential innovator and biosimilar strategies
Session 2 by David R. Marsh: Biosimilar patent issues
This session will examine the mechanisms for handling patent disputes in pending legislation (or statute if enacted), and the impact on biotech patent litigation.
• Processes for handling biosimilar patent disputes
• Impact on strategies for innovator biologic product patenting, patent disputes and resolution
• Potential biosimilar patent strategies
• Potential changes in the biologic product patent litigation dynamic
Session 3 by Lincoln Tsang: Comparing the developing US framework to biosimilars in the EU
This session will provide an overview of the EU framework for biosimilars, including:
• Key differences in the developing US and EU biosimilar framework and pathways
• Biosimilars exclusivity and patent issues in the EU
• Applications and data requirements for EU biosimilars
• Experience to date under the EU biosimilars framework
• Developing global innovator and biosimilar strategies
About your workshop leaders:
Daniel A. Kracov
Dan Kracov heads the FDA and healthcare practice. He assists clients, including start-up companies, trade associations, and large manufacturing companies, in negotiating the challenges relating to the development, approval and marketing of drugs, biologics, and medical devices. His experience in US Food and Drug Administration (FDA) strategic advice and crisis management won him a spot on the Fall 2005 Legal Times list of “Leading Lawyers in Food & Drug Law.”
Mr. Kracov regularly handles product and compliance-related investigations, the development of regulatory corporate compliance programs, and due diligence in financings, mergers and acquisitions. He has a widely-recognized experience in biomedical product-related public policy matters, including Congressional investigations and FDA-related legislative strategies.
David R. Marsh
Dr. David Marsh is co-chair of Arnold & Porter’s intellectual property practice. He focuses extensively on intellectual property counseling, interferences and patent procurement, predominantly in the chemical, pharmaceutical, and biotechnology areas. He has argued multiple matters before the United States Patent and Trademark Office’s Board of Patent Appeals and Interferences. He also manages multiple European Opposition proceedings, and represents clients in patent and other intellectual property litigation or dispute resolution proceedings. Dr. Marsh is also an American Arbitration Association and World Intellectual Property Organization neutral arbitrator. As an adjunct professor at Georgetown Law School, Dr. Marsh teaches “Biotechnology and Patent Law.” He has also written numerous articles on patent law, is a frequent speaker at conferences in the US and Europe, and is an editor of BioScience Law Review. The Legal Timesrecognized Mr. Marsh as a “Leading Life Sciences Lawyer in Washington, DC” for 2006. He was ranked by Practical Law Companies Cross-border Life Sciences Handbook 2006/2007 as “Highly Recommended in Patent Counselling” and “Recommend in Intellectual Property” in both Washington, DC and in the USA. He is also a Fellow of the Royal Society for the encouragement of Arts, Manufactures and Commerce.
Dr. Marsh carried out his graduate work in molecular biology at Cambridge, England and his post-doctoral work at Yale University. His research experience includes molecular biology, immunology, biochemistry, and mammalian and plant genetics.
Lincoln Tsang
Dr Lincoln Tsang is a partner in the firm’s London office. He is both a lawyer and a registered pharmacist with post-graduate qualifications in toxicology and biochemistry. His practice relates to life sciences industry including pharmaceuticals, biotechnology, medical devices, in vitro diagnostic devices, cosmetics and food with particular emphasis on the intersection of the law and public policy relating to life sciences. He assists clients in developing strategies for research and development including product life cycle management, product acquisition, risk and crisis management.
In addition to advising industry, Dr Tsang also advises foreign governments, various trade associations and not-for-profit and/or charity organizations. He maintains an active pro bono practice. He presents and writes widely on regulatory law and public policy.
About: Arnold & Porter LLP
Arnold & Porter LLP is an international law firm with nearly 700 attorneys practicing worldwide in more than 25 practice areas spanning a broad spectrum of the law, with a primary focus on litigation, transactional matters, and regulatory issues. Our attorneys, many of whom have previous government agency experience, routinely counsel pharmaceutical, biotechnology, medical device, and diagnostic companies, as well as other healthcare entities, in responding to complex legal challenges in the US and Europe. Arnold & Porter professionals work together to provide our clients with seamless, comprehensive, and sophisticated analyses, and strong and zealous advocacy.
For further information, please visit: www.arnoldporter.com