[Webinar] 3rd Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA

October 10th - 26th, 1:00 pm EST
American Conference Institute (ACI)
October 10th - 26th, 2023
1:00 PM EST

Or call 888-224-2480 for fastest service.

You can save extra 10% off the current rate by using code D10-999-JDS24.

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

Attend ACI’s Hatch-Waxman and BPCIA Proficiency Series from October 10-26, 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.



Li Feng, Ph.D.


Rachel Pernic Waldron
RMMS Legal

A thorough understanding of Hatch-Waxman and the BPCIA is essential to anyone working in the biopharmaceutical area. This series will provide an in-depth review of Hatch-Waxman and the BPCIA along with 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.

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

Download the Brochure to see the full program including speaker faculty.

Save 10% off the current registration fee by using code D10-999-JDS24.

*Discount is valid for new registrations only and it’s not applicable for workshops.


American Conference Institute (ACI)

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