ACI’s 6th Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA

The American Conference Institute’s (ACI’s) virtual 6th Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA is scheduled to take place from October 20-29, 2026 (Eastern Standard Time).  Led by an experienced faculty, 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).  And the 2026 program has been refined, condensed, and refreshed to deliver an even more practical and efficient learning experience.

ACI’s Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA is a two-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.

The Two-Week Learning Journey

Build a strong foundation in Hatch-Waxman and BPCIA before diving into practical litigation strategy.

Week 1 – October 20 & 22

• Hatch-Waxman and BPCIA Framework and the Regulatory Foundation
• Hatch-Waxman and BPCIA statutory scheme
• Link between the FDA Approval and the Patent Process
• FDA Pathways, bioequivalence, exclusivities and patent strategy

Week 2 – October 27 & 29

Nuts & Bolts of Hatch-Waxman & BPCIA Case Strategy

• Early case strategy
• Contentions, claim construction and discovery
• Use of experts, expert discovery and technical proof
• Trends and strategic considerations—trial, PTAB, settlements

Hyman, Phelps & McNamara, P.C.’s Sara W. Koblitz will speak during a session, titled “The Ins and Outs of the Orange Book, Labeling, Safe Harbor, PIV Certs, Notice Letters, and the 30-Month Stay.”

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-FDA27.  You can access the conference brochure and sign up for the event here.  We look forward to seeing you at the conference!