Date/Time
Date(s) - 23 Jul 2013
9:00 AM - 10:00 AM
Preparing for Biosimilars:
Key Points for Participating in the U.S. Regulatory Framework
WEBINAR
In view of the U.S. approval process for biosimilars, companies are gearing up to either produce their own biosimilar products, or to defend against their entry onto the market. While the Biologics Price Competition and Innovation Act (BPCIA) spells out many of the requirements, the pathway for approval is complicated. Our panel of experts will discuss the features of the BPCIA and how it operates for both approved biologics as well as biosimilar entrants. They will also make some predictions on its impact for life science companies.
When: Tuesday, July 23, 2013
9:00 am PST | 12:00 noon EST
60 minutes, complete with Q&A
One hour of California CLE credit available for attorneys.
Washington CLE credit pending.
What We Will Cover:
- Overview of the BPCIA
- Preparing for the Patent Exchange
- Strategic Use of AIA Post-Grant Procedures
Panel of Attorneys:
Michael Fuller
J.D. University of San Diego
M.S. Biology, University of California, Los Angeles
B.S. Biology, University of California, Los Angeles
Sheila Swaroop
J.D. University of California, Berkeley School of Law
B.A. Biology, Harvard University
Carol Pitzel Cruz
J.D. The George Washington University Law School
B.S. Chemistry, University of Washington
Eli Loots
J.D. University of California, Berkeley School of Law
Ph.D. Molecular and Cell Biology, University of California, Berkeley
B.S. Chemistry and Biochemistry, University of Arkansas
About Knobbe Martens
Knobbe Martens has one of the largest and most experienced biotechnology groups in IP law, with more than 75 attorneys and scientists representing clients in all stages of their business and technology development. We maintain a talented litigation group adept in all aspects of biotechnology IP law. Our extensive Hatch-Waxman litigation practice combined with our deep technical expertise in biotechnology uniquely position Knobbe Martens to develop and implement effective IP strategies for biosimilars.