Workshop C — Hatch-Waxman and BPCIA in the Trenches: Exclusivity and Bioequivalency Working Group

Sep 15, 2022 2:30pm – 5:30pm

Brian Malkin
McDermott Will & Emery LLP (Washington, DVC)

Jonathan B. Roses
Wolf, Greenfield & Sacks, P.C. (Boston, MA)

Emily R. Whelan
WilmerHale (Boston, MA)

This workshop will build upon the content covered during the main conference on the regulatory and IP interplay in the Hatch-Waxman and BPCIA schematics. Our workshop leaders will in a step by-step manner:

  • Deconstruct complex exclusivity disputes
  • Analyze FDA’s and the disputing parties’ various (and sometimes evolving) positions on exclusivity
  • Explore bioequivalency conundrums

Relevant court decisions will also be analyzed and their practical and future effects discussed. Workshop attendees will have the opportunity to understand how the exclusivity “rules of the road” are applied in a real-world case.