The American Conference Institute’s (ACI’s) virtual 5th Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA is scheduled to take place from October 14-30, 2025 (Eastern Standard Time). The virtual training series is specifically designed for attorneys, regulatory affairs professionals, and industry executives working at the intersection of FDA law, IP strategy, and biopharmaceutical innovation to provide advanced training on the 1984 Hatch-Waxman and the 2010 Biologics Price Competition and Innovation Act (BPCIA).
ACI’s Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA is a three-week virtual intensive—part of ACI’s Proficiency Series—that provides a structured, expert-led examination of the regulatory, litigation, and exclusivity frameworks governing both small molecules and biologics. With a focus on the FDA–PTO interplay, patent lifecycle management, and the litigation pathways that shape market entry, this program offers actionable insights to strengthen your practice or in-house strategy.
Key Modules Include:
Week 1 – Regulatory Foundation
- Interplay of the FDA and PTO
- Pre-Commercialization Concerns
- Link between the FDA Approval and the Patent Process
- The Orange Book
Week 2 – Hatch-Waxman and BPCIA Framework
- The Hatch-Waxman Landscape
- Paragraph IV Disputes and Litigation
- Biosimilars: BPCIA and aBLA Overview
- Participating in the Patent Dance
- The Purple Book
Week 3 – Bioequivalence, Exclusivity, Extensions, and Exceptions
- Bioequivalence & Interchangeability
- 180-Day Exclusivity
- Non-Patent/ Regulatory Exclusivity
- Exploring the Safe Harbor
- Examining Patent Extensions
Why Attend:
- Gain practical, case-driven insights from top litigators and regulatory counsel.
- Understand how FDA regulatory actions shape IP enforcement and market exclusivity.
- Build the legal and regulatory fluency necessary to advise on product development, litigation readiness, and lifecycle management.
- Learn in a flexible virtual format with live Q&A and on-demand access.
Hyman, Phelps & McNamara, P.C.’s Sara W. Koblitz and Andrew Wasson from Haug Partners will speak during a session, titled “The Orange Book: Listings, De- Listings and Other Matters of Interest.”
FDA Law Blog is a conference media partner. As such, we can offer our readers a special 10% discount. The discount code is: D10-999-FDA26. You can access the conference brochure and sign up for the event here. We look forward to seeing you at the conference!
