For Hatch-Waxman litigators, staying up to date with new FDA regulations is crucial. By monitoring these developments, Hatch-Waxman litigators can adapt their strategies, assess the potential impact on patent validity and infringement disputes, and navigate the evolving landscape of pharmaceutical patent litigation effectively. During this session, our panelists will help you understand the nuances of new regulations and initiatives, empowering you to provide valuable insights, and advocate for your clients’ interests.

Topics of discussion will include:

• Exploring the progress of the FDA/USPTO collaboration
• Dissecting FDORA and 2023 FY legislative priorities
• Proposed GDUFA riders included in FDORA
• GDUFA II user fees, guidances and MAPPs
• Exploring how FDORA is influencing pharmaceutical patent litigation
• Detailing the impact of recent FDA and related litigation on brands and generics
• Melinta v. FDA
• Avadel v. FDA
• Sandoz v. Becerra
• Vanda v. FDA
• Avadel v. Jazz