ACI’s FDA Boot Camp returns for its 35th iteration, in a fully virtual format, with the continued intent of providing an essential working knowledge of core FDA concepts and real world examples to help life sciences attorneys and executives excel in their practices.
WilmerHale Partner Emily Whelan will present at the “Hatch-Waxman and BPCIA in the Trenches: Exclusivity and Bioequivalency Working Group” workshop from 2–5:30 p.m. ET on September 24. 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.