Critical Issues in Hatch-Waxman Litigation
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 [...]