DESCRIPTION
Session 7: BPCIA & Hatch-Waxman 101
BCLT-Oregon Start-Up Series
BCLT Life Sciences Law & Policy Center
Wednesday, Novemner 12, 2025 | 1:00 p.m. | B-CLE
1.25 General CLE Credit Available
Series Info | Resources | Speaker Bios & Contact Info
Join the Berkeley Center for Law & Technology for an engaging session that unpacks two of the most important regulatory frameworks shaping the pharmaceutical and biotech industries: the Hatch-Waxman Act and the Biologics Price Competition and Innovation Act (BPCIA). Our expert presenters, Madelyn McCormick and Dexter Whitley, PhD, will guide participants through the complex—but critical—interplay between patents, exclusivities, and regulatory approvals for small-molecule drugs and biologics.
This program offers a practical foundation for understanding how these frameworks balance innovation incentives with market competition, and how they affect litigation, exclusivity rights, and drug pricing.
Speaker(s):
Madelyn McCormick, Fish & Richardson
Dexter Whitley, Fish & Richardson
Program Series:
Are you a scientist, inventor, entrepreneur, or investor thinking about launching or working with a start-up company? Do you have questions about patents and trade secrets, regulatory requirements, consulting agreements, privacy considerations, and/or IP licensing? The Berkeley Center for Law & Technology and the University of Oregon School of Law have partnered on a new Start-Up Signature Series of virtual legal education programs, designed specifically for start-up companies and their investors. The Start-Up Signature Series will give you the education you need to successfully push your start-up forward!
All programs are free to access.