REMEDY Act

S 4878, the REMEDY Act, changes how brand-name drug companies must handle patent challenges when generic drugs seek FDA approval. It requires drug sponsors to select one specific patent (called the "covered patent") for potential 30-month market exclusivity when first filing patent information with the FDA for drugs approved after the law takes effect. This selection cannot be changed later, and the law updates legal language to distinguish between patents for drugs approved before or after the Act's enactment. The bill directly affects brand-name drug companies and generic manufacturers involved in patent litigation over drug approvals. It modifies the timing for filing patent infringement lawsuits related to generic drug applications.