The Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) establishes a specific framework for the resolution of patent disputes that will affect the development of biosimilars. While the regulatory and intellectual property aspects of the biosimilar industry are still evolving, a deeper understanding of patent designations, pre-litigation strategies, and portfolio management, along with clarification of the differences between Hatch-Waxman patent enforcement and the BPCIA patent framework will facilitate better preparation for biosimilar applicants and reference product sponsors. Even if you are confident in your assessment of the relevant patents, are you prepared to adapt to the unique BPCIA patent designation requirements?
Join us for this 90-minute interactive webinar with Dr. Lawrence M. Sung, partner at Dewey & LeBoeuf, to gain insights into the BPCIA patent framework and its effects on biosimilars development, and strategies of how you should prepare for patent disputes. Time will be set aside at the end of the presentation to ask Dr. Sung your questions.
Learning Points:
- Understand the differences between the Hatch-Waxman patent enforcement framework for brand-name, patented versus generic pharmaceuticals, and the BPCIA patent framework for reference product sponsors versus biosimilar applicants
- Study BPCIA’s pre-litigation patent information exchange
- What is the statutory timetable established for the required disclosures by both reference product sponsors and biosimilar applicants?
- Devise a plan how to budget for biosimilars patent litigation
- Enhance your knowledge of the timing and scope of patent designations, infringement and invalidity contentions, and other related disclosures
- What are their respective effects on the reference product sponsors and biosimilars?
- Prepare for a number of patent dispute scenarios
- Strategize how to manage your patent portfolio in view of the BPCIA and to avoid potential problems with enforcement due to claim drafting and licensing practices
Who Should Attend:
- Research Facilities
- In-house counsel
- CEOs
- General counsel and directors
- Pharmaceutical and medtech professionals
- Regulatory affairs professionals
- Consultants
Speaker’s Biography:
Dr. Lawrence M. Sung is a registered patent attorney with a Ph.D. in microbiology and has 18 years of experience in biotechnology, medical device and pharmaceutical patent counseling, litigation and technology transfer. He heads the Dewey & LeBoeuf practice team specializing in biosimilars strategic counseling and litigation.
A former judicial clerk to (now Senior) Circuit Judge Raymond C. Clevenger, III, of the U.S. Court of Appeals for the Federal Circuit, Dr. Sung has also been involved extensively in patent appeals. In addition, Dr. Sung holds the appointment of law school professor and director of the Intellectual Property Law Program at the University of Maryland School of Law. Dr. Sung has served as a consultant to the National Human Genome Research Institute and as a member of the National Academies Standing Committee on Emerging Issues and Data on Environmental Contaminants.
