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 and interchangeable conundrums, including the elimination of switching study requirements
• Address the complications that arise when sponsors seek to seek to modify products, production processes, or quality controls for approved biologics license application (BLA) biosimilar and interchangeable products under the change notification process outlined in 21 C.F.R. Part 601.12

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.