Hatch-Waxman and BPCIA

The conference is organized by American Conference Institute (ACI). For more than 40 years, ACI and C5 have brought together business leaders, legal professionals and international experts for conferences focused on timely business intelligence, networking and professional development.

The Hatch-Waxman and BPCIA Proficiency Series is an intensive two-week virtual program focused on the legal and regulatory frameworks governing small-molecule drugs, biologics, generics, and biosimilars. It combines foundational instruction on FDA and USPTO processes with practical coverage of patent strategy, exclusivities, Hatch-Waxman and BPCIA litigation, and case strategy.

The 6th Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA will take place virtually from October 20-29, 2026, in Eastern Standard Time. Live sessions are scheduled for October 20, 22, 27, and 29.

The series is designed for new associates, junior partners, in-house counsel, executives, and other professionals working in the life sciences industry. It is especially relevant to professionals focused on intellectual property, patent prosecution, patent litigation, regulatory matters, commercialization, corporate legal issues, and business development.

The program is centered on the pharmaceutical, biopharmaceutical, biotechnology, biologics, biosimilars, and generic drug sectors. Participants also include law firms and organizations supporting life sciences intellectual property, regulatory, litigation, policy, and commercialization work.

Topics include the Hatch-Waxman Act and BPCIA statutory frameworks; FDA and USPTO roles; NDA, ANDA, BLA, aBLA, and 505(b)(2) pathways; Orange Book and Purple Book issues; bioequivalence and interchangeability; regulatory and patent exclusivities; the safe harbor; Paragraph IV certifications and litigation; the BPCIA patent dance; patent term extension; labeling and carve-outs; case management; claim construction; discovery; experts; PTAB proceedings; trial strategy; and settlements.

Attendees will build a practical understanding of how FDA approval pathways, patent prosecution, patent listings, exclusivities, and launch timing interact under Hatch-Waxman and the BPCIA. The series also develops practical litigation skills, including early case strategy, contentions, claim construction, discovery, expert practice, technical proofs, dispositive motions, trial planning, PTAB coordination, and settlement considerations.

Faculty typically includes experienced life sciences intellectual property and regulatory attorneys, industry counsel, and former government officials. The program is structured to bring practical perspectives on regulatory strategy, patent protection, litigation, and commercialization.

The 2026 faculty includes professionals from Upadhye Tang LLP; Groombridge, Wu, Baughman & Stone LLP; Covington & Burling LLP; Gemini Law LLP; Loeb & Loeb LLP; Crowell & Moring LLP; Hyman, Phelps & McNamara P.C.; Rakoczy Molino Mazzochi Siwik LLP; Kirkland & Ellis LLP; Orrick; Katten Muchin Rosenman LLP; Fox Rothschild LLP; Saul Ewing LLP; Haug Partners LLP; Young Conaway Stargatt & Taylor, LLP; and Jones Day LLP.

The virtual format is designed to support interaction with attendees and speakers through a dynamic online platform. The program also includes dedicated question-and-answer (Q&A) periods, practical scenarios, and other interactive elements that help participants engage with faculty and peers.

Yes. Groups of 4-8 attendees from the same organization receive a 10% discount, while groups of 9-12 receive a 15% discount. Groups of more than 12 should contact ACI for available rates; team members must be from the same organization or firm and register together in one transaction.

Registrants who register and pay are eligible for a full refund until October 15, 2026. If unable to attend, registrants may request either a full refund or a full credit note for themselves or a colleague to attend another event; all cancellations and changes must be submitted to ACI’s Customer Experience Team by October 15.

CLE credits are available for the Proficiency Series. Credit eligibility and requirements may vary by jurisdiction or professional body. Learn more about CPE on our CPE Accreditation Page or reach out to our Continuing Education team at [email protected] with your specific inquiry.