WATCH: Navigating the regulatory-IP nexus—maximizing exclusivity in an evolving policy landscape

Rolando Medina, Partner at Choate, leads a panel featuring MJ Edwards, Senior Associate General Counsel at Gilead Sciences; Manja Epping, Partner at Heuking; and Lillian Hiett, IP Therapeutic Area Head at Takeda Pharmaceuticals.The discussion addresses how recent FDA guidance and shifting regulatory priorities are reshaping patent prosecution and claim drafting. The panel explores strategies for securing and maximizing patent term extensions and regulatory exclusivity periods, alongside leveraging orphan drug and pediatric designations for a competitive edge.The session also evaluates the biosimilar litigation landscape, identifying emerging patent challenge trends and defensive strategies. Emphasis is placed on adapting overarching IP strategies to mitigate regulatory uncertainty and maintain long-term exclusivity.