Latest News & Updates

Training That Fits Your Workweek
Our new two-week format delivers the same comprehensive program with greater flexibility.

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Special $200 Rate for Law Students
Are you currently enrolled in law school? Attend ACI’s Hatch-Waxman & BPCIA program for just $200 and build your knowledge of this highly specialized area of life sciences law.

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ACI’s intensive learning series on the essentials of the Hatch-Waxman Act & BPCIA is back!

This year’s program has been refined, condensed, and refreshed to deliver an even more practical and efficient learning experience. This two-week crash course will cover the regulatory components and IP considerations for both small and large molecule drugs. Led by an experienced faculty, this course will provide new lawyers and executives with the foundational knowledge needed to go deeper into the dynamics of patent lifecycles, litigation and business development plans.

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Hear from the Conference Co-Chairs
Conference Co-Chairs Chris Bruno and Jenna Rea Deneault share what’s ahead for this year’s Hatch-Waxman and BPCIA Virtual Series. Watch their message to learn more about the timely issues, practical insights and important conversations awaiting attendees.

Your 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
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Join leading IP and regulatory counsel to help you understand:

Interplay of the PTO and FDA in the patenting of drugs and biologics

Essentials of the FDA approval process and its link to biopharma patents ĉ In-depth and practical knowledge of Hatch-Waxman and BPCIA protocols, including:

  • Orange Book vs Purple Book
  • Bioequivalency
  • Exclusivities
  • Differences between NDAs, ANDAs, BLAs, aBLAs
  • The Safe Harbor
  • Paragraph IV litigation and the BPCIA patent dance
  • ‘Ins and outs’ of patent term extension

Who Should Attend

The Hatch-Waxman and BPCIA Proficiency Series is designed for new associates, junior partners, and professionals in the life sciences industry.

Law Firms with Practice Groups

  • Life Sciences, Pharmaceuticals and Biopharmaceuticals
  • Follow-on Biologics and Biosimilars
  • Intellectual Property and Patent Prosecution
  • Patent and IP Litigation
  • Hatch-Waxman and BPCIA Litigation
  • Regulatory and Commercialization
  • Trademark & Copyright
  • Life Sciences IP Antitrust

Pharma and Biopharmeutical Companies

  • C-Suite Executives and Associate Executives
  • In-House Counsel (IP, Regulatory, Corporate, Litigation)
  • Business Development Executives

Why Choose ACI’s Hatch-Waxman and BPCIA Virtual Proficiency Series

Comprehensive IP & Regulatory Training. Substantive Resource Materials for Your Daily Work.

Build a practical understanding of Hatch-Waxman, Biologics Price Competition and Innovation Act (BPCIA), patent linkage, exclusivities, biosimilars, Paragraph IV litigation, and regulatory strategy.

Learn from Industry Leaders.

Learn from leading experts in life sciences IP law and regulatory affairs – including experienced attorneys, industry counsel, and former government officials – who will share actionable insights and real-world strategies drawn from high-stakes litigation and policy developments.

15 Hours of Training Plus On-Demand Access.

Gain 15 hours of interactive instruction across four live sessions, plus access to all class recordings for continued learning and future reference.

Interactive Virtual Experience. Dedicated Q&A Period Each Day.

Participate in dynamic case studies, practical scenarios, and live Q&A sessions designed to translate complex legal frameworks into practical application for IP counsel, regulatory professionals, and business stakeholders.

Flexible Online Format. 2 weeks, 2x weekly.

Access content in convenient modules designed to fit your schedule. Whether attending live or viewing recorded sessions, you’ll gain lasting value from flexible, high-impact learning.

Certificate of Completion and CLE Credits.

Earn CLE credits and professional development hours applicable to your jurisdiction and organization, while enhancing your expertise in this evolving and highly specialized field.

Accreditation

Accreditation will be sought in those jurisdictions requested by the registrants which have continuing education requirements. This course is identified as nontransitional for the purposes of CLE accreditation.

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“Legal and business professionals who work in the life sciences industry must be well versed in the regulatory components and IP issues that play an integral role in the protection of companies’ products. This immersive series explores a variety of patent and regulatory issues, including essentials and intricacies of Hatch-Waxman and BPCIA litigation and regulation. The Series is so comprehensive, it truly stands apart as the best option to train newer lawyers and in-house counsel.”
—Fangli Chen, Ph.D., Partner
Proskauer Rose LLP (2024 Conference Co-Chair)
“Patent litigation continues to generate numerous consequential precedents that impact the strength and scope of patent rights covering pharmaceutical and biopharmaceutical innovations. Further, legislators and regulators continue to increase their oversight of the pharmaceutical and biopharmaceutical industries. This Series covers the essentials of the litigation, regulatory, and business landscape relating to these industries to give attendees a proficiency with the fundamentals of patent prosecution, exclusivities, patent litigation, commercialization, and more. This comprehensive Series is important especially at a time when all attorneys increasingly need to have a holistic and multifaceted understanding of the legal and business aspects of these complex industries.”
—Jason Murata, Partner
Axinn, Veltrop & Harkrider (2024 Conference Co-Chair)
“Recently a large contingent of our patent drafting and prosecution team attended ACI’s virtual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA to ensure they had a solid foundation in such litigation and regulation. While many of our practitioners may have had some exposure to the litigation process in their careers, some have not. It is not possible to design optimal product exclusivity strategies in the life sciences without a thorough understanding of how such patents will be enforced and the intricacies of the relevant regulatory exclusivities and processes. This Passport course helps fill that gap with comprehensive instruction from some of the leading legal practitioners in these areas. This program is unique in its focus and provided a great return on the investment of our team’s time attending the course.”
—Timothy X. Witkowski, R&D IP Global Head, Chemistry/Targeted Oncology, Novartis Biomedical Research

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