Gain a comprehensive understanding of Hatch-Waxman and BPCIA essentials, a critical competency for legal and business professionals in the biopharmaceutical arena.

Welcome to ACI’s Hatch-Waxman and BPCIA Proficiency Series, a virtual three-week program designed to provide new lawyers and executives for the life sciences industry with a solid foundation for understanding the essentials as well as the intricacies of Hatch-Waxman and BPCIA litigation and regulation.

Everyone who works in the life sciences industry must be well versed in the regulatory components and IP subtleties that play such an integral role in the patenting of its products.

A thorough understanding of Hatch-Waxman and the BPCIA is essential to anyone working in the biopharmaceutical area. This series, presenting virtually on our new state of the art interactive platform, will provide an in-depth review of Hatch-Waxman and the BPCIA as well as other IP basics relative to small molecules and biologics. This program will lay the necessary foundation to understand the dynamics of the applicable patent life cycles for biopharmaceutical products and business development plans.

Week One
Oct. 8 & 10

Regulatory Foundation:

  • Interplay of the FDA and PTO
  • Pre-Commercialization Concerns
  • Link between the FDA Approval and the Patent Process
  • The Orange Book

Week Two
Oct. 15 & 17

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 Three
Oct. 22 & 24

Focus on Bioequivalence, Exclusivity, Extensions, and Exceptions:

  • Bioequivalence & Interchangeability
  • 180-Day Exclusivity
  • Non-Patent/ Regulatory Exclusivity
  • Exploring the Safe Harbor
  • Examining Patent Extensions

Fangli Chen, Ph.D.

Proskauer Rose LLP

“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. I am excited to be a part of this immersive series, which 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 and I look forward to overseeing the Series as Co-Chair this October.”


Jason Murata

Axinn, Veltrop & Harkrider

“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 promises to cover 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. I’m proud to co-chair such a comprehensive Series, especially at a time where all attorneys increasingly need to have a holistic and multifaceted understanding of the legal and business aspects of these complex industries.”

What you can expect
  • 3 weeks of 2x weekly in-depth instruction
  • 18 hours of interactive learning for professional development
  • Dedicated questions and answer period each day
  • 6 class recordings for future reference
  • Substantive resource materials for your daily work
  • Certificate of completion and CLE credits
Practical Benefits to Attending
  • UNDERSTAND the interplay of the PTO and FDA in the patenting of drugs and biologics
  • LEARN about the approval process for drugs and biologics and their connection to the patent process
  • DEVELOP an in-depth and practical knowledge of Hatch-Waxman protocols, including:
    • Differences between NDAs, ANDAs, BLAs, aBLAs
    • The Orange Book vs. The Purple Book
    • 180 Exclusivity
    • Bioequivalency
    • The Safe Harbor
  • COMPREHEND the framework of Hatch-Waxman Paragraph IV litigation and BPCIA patent dance
  • MAKE SENSE of the relationship between patent and non-patent exclusivity
  • EXAMINE patent extensions including restorations and adjustments
  • NAVIGATE the rules and exceptions of the safe harbor
Who Should Attend

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


  • 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


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