Topics of discussion will include:

• Creating and valuing exclusivity and patent term extension forecasts as part of the IP due diligence
• Knowing which questions to ask to determine which patent should ultimately receive the patent term extension
• How to navigate orphan drug exclusivity post Catalyst
• Unpacking Jazz Pharmaceuticals lawsuit against the FDA for granting orphan drug exclusivity to Avadel’s narcolepsy drug on the basis of clinical superiority
• CMS’s guidance on orphan drug exclusivity and the IRA’s price control provisions
• Learning the current landscape for Orange Book listing requirements as applied to REMS or device patents
• Unpacking Jazz Pharmaceuticals lawsuit against Avadel relating to the listability of REMS patents
• Strategies to protect against the risk
• Understanding the role of FDA classifications and designations in triggering price control negotiations under the Inflation Reduction Act
• Navigating compliance challenges and implications for regulatory strategies