REMEDY Act

The REMEDY Act amends the Federal Food, Drug, and Cosmetic Act to change how patents are handled when approving generic drugs (abbreviated new drug applications). For drugs approved on or after the bill's enactment, the brand-name drug holder must select one patent (called the "covered patent") when first filing patent information, and that selection cannot be changed. This limits the 30-month stay on generic approval to that single covered patent.

Sec. 2, Amendments to ANDA approval provisions: The bill modifies section 505 of the FD&C Act. For drugs approved before the enactment date, the existing rules for patent infringement lawsuits and 30-month stays continue. For drugs approved on or after the enactment date, only the "covered patent" (the one selected by the holder) can be used to trigger a 30-month stay when a generic applicant challenges it. The bill updates several subsections to distinguish between old and new drugs, ensuring that for new drugs, only the covered patent is eligible for the stay, and court decisions on patent validity apply to that covered patent.