Paragraph IV Disputes Master Symposium

Partner Maarika Kimbrell will present during the 9th annual Paragraph IV Disputes Master Symposium. Her panel, Brand and Generic Insights on FDA Programs Impacting Pharmaceutical Patents, will cover current developments around the Hatch-Waxman Act.

For Hatch-Waxman litigators, staying up to date with new US Food and Drug Administration (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, Maarika and the other panelists will help attendees understand the nuances of the new regulations and initiatives.

Topics will include:

• Exploring the FDA/US Patent and Trademark Office collaboration
• Dissecting Food and Drug Omnibus Reform Act of 2022 (FDORA) and 2023 FY legislative priorities
  • Proposed Generic Drug User Fee Act (GDUFA) riders included in FDORA
  • GDUFA II user fees, guidance, and Manuals of Policies and Procedures
• Exploring how FDORA is influencing pharmaceutical patent litigation
• Detailing the impact of recent FDA cases and related litigation on brands and generics
  • Melinta Therapeutics, LLC, et al v. FDA et al
  • Avadel Pharmaceuticals v. FDA
  • Sandoz Inc. v. Xavier Becerra
  • Vanda Pharmaceuticals, Inc. v. FDA
  • Jazz Pharms., Inc., v. Avadel CNS