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Jon Roses will lead a workshop with Emily Whelan of WilmerHale titled “Hatch-Waxman and BPCIA in the Trenches: Exclusivity and Bioequivalency Working Group” at the 41st annual FCA Boot Camp presented by ACI. This workshop will build upon the content covered during the FDA Boot Camp main conference on the regulatory and IP interplay in the Hatch-Waxman and BPCIA schematics. The workshop will be led in a step by-step manner to:
- 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.
To receive 10% off registration, use code: S10-806-806L24.S