Garner the Hatch-Waxman and BPCIA winning edge—boost your life sciences IP and regulatory IQ.

Welcome to ACI’s Hatch-Waxman and BPCIA Passport to 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.

This intensive three-week training program, presented 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. 5 & 7

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. 12 & 14

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. 19 & 21

Focus on Bioequivalence, Exclusivity, Extensions, and Exceptions:

  • Bioequivalence & Interchangeability
  • 180-Day Exclusivity
  • Non-Patent/ Regulatory Exclusivity
  • Exploring the Safe Harbor
  • Examining Patent Extensions
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
Key Highlights
  • The interplay for the FDA and PTO in the patenting of drugs and biologics
  • How the Hatch-Waxman Act established the paradigm for market entry of generic small molecule drugs — and how the BPCIA framework for biosimilar product entry is evolving
  • Differences between NDAs, ANDAs, BLAs, aBLAs
  • The Orange Book vs. The Purple Book
  • The framework for Hatch-Waxman Paragraph IV litigation and the BPCIA patent dance
  • The relationship between patent and non-patent exclusivity
  • The importance of patenting bioequivalence characteristics in certain drug products
  • The ‘ins and outs’ of patent term extension
  • The rules and exceptions of the safe harbor
Who Should Attend

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

LAW FIRMS
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

PHARMACEUTICAL COMPANIES

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