Hatch-Waxman and BPCIA in the Trenches: Deconstructing and Constructing an Exclusivity Dispute
1:00 – Registration to Workshop C This working group will deconstruct, in a step by-step manner, complex exclusivity disputes, analyze FDA’s and the disputing parties’ various (and sometimes evolving) positions on exclusivity. Relevant court decisions will also be analyzed and their practical and future effects discussed. Working group attendees will have the opportunity to understand how the exclusivity “rules of the road” are applied in a real-world case. After the exclusivity case analyses are completed, attendees will have the opportunity to construct their own exclusivity dispute by choosing from various base facts. Once the case is constructed, the speaker will lead you through the exclusivity analysis. Working group attendees will have the opportunity to apply various Hatch-Waxman concepts learned during the Boot Camp.