The pharmaceutical labeling carve-out regulations remain a source of complexity in several cases. The Hatch-Waxman Act created a way for the Food and Drug Administration (FDA) to approve generic drugs even if they omit information about protected use to encourage competition among generic products. However, following the Teva v. GSK ruling, businesses must exercise caution and recognize the intricate relationship between Orange Book listed use patents, reference listed drug’s prescribing information, and promotional labeling and other related activities.

Furthermore, as other skinny-labeling-related cases continue to emerge which emphasize the need for legal professionals, businesses and other practitioners to remain up to date with recent developments to successfully navigate this area of law.

Join distinguished experts Jason A. Lief (Windels Marx) and Ha Kung Wong (Venable LLP) for an in-depth discussion on the latest developments impacting Hatch-Waxman litigation. The speakers will share valuable insights, including practical advice and strategies, to help navigate the dynamic legal landscape in this field.

Key topics include:

• Hatch-Waxman Act: Latest Issues and Challenges
• Examining the Pharmaceutical Labeling Carve-Out Regulations
• Analyzing The implications of the Teva v. GSK ruling
• Other Skinny-Labeling-Related Cases
• Practical Tips and Compliance Strategies
• What Lies Ahead