REMEDY Act

The REMEDY Act would reform how the FDA handles patent certifications and the 30-month stay during Abbreviated New Drug Application (ANDA) approvals under the Federal Food, Drug, and Cosmetic Act. The core idea is to curb “evergreening” tactics by requiring a single, defined “covered patent” that determines whether the 30-month stay may apply, and by tightening when and which patents can trigger infringement actions. For drugs approved after the bill’s enactment, the sponsor-selected “covered patent” (one patent among those listed for a drug) would be the sole patent eligible for the 30-month stay, and that choice could not be changed. The bill also adjusts the timing and scope of patent-infringement actions, differentiating between drugs approved before versus after enactment. Overall, the measure aims to reduce manipulation of patent litigation to extend drug years beyond the original protections.