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.

Sessions will take place each Tuesday and Thursday afternoon in October for 3 weeks. Take a look at the 2022 Agenda and Speakers

Week One
Oct. 11 & 13

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. 18 & 20

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. 25 & 27

Focus on Bioequivalence, Exclusivity, Extensions, and Exceptions:

  • Bioequivalence & Interchangeability
  • 180-Day Exclusivity
  • Non-Patent/ Regulatory Exclusivity
  • Exploring the Safe Harbor
  • Examining Patent Extensions
2022 Co-Chairs

Vishal Gupta

Steptoe & Johnson LLP


Elizabeth Holland

IP Litigation Partner
Allen & Overy

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
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Very solid, excellent conference. Touched on critical subject matter.

Consultant, Prince Pines LLC
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It was very good.

Counsel, Bachem Americas, Inc.
Who Should Attend

The Hatch-Waxman and BPCIA Essentials Proficiency Series is designed for new Associates and business executives for the life sciences industry.

Attorneys assigned to the following practice groups:

  • Life Sciences, Pharmaceuticals, and Biopharmaceuticals
  • Intellectual Property and Patents
  • Patent and IP Litigation
  • Hatch-Waxman and BPCIA litigation
  • Patents, Trademark & Copyright


  • In-House Counsel
  • Business Development Executives
  • C-Suite Executives
  • Associate Executives