Reforming Evergreening and Manipulation that Extends Drug Years Act or the REMEDY Act
This bill addresses drug patents with respect to Food and Drug Administration (FDA) approval of a drug application.
Currently, when the owner of a brand-name drug approval sues a generic drug company for patent infringement based on the generic company's application for FDA approval of a generic version of the brand-name drug, there is generally a 30-month stay on the approval of the generic version. Under this bill, the stay goes into effect only if the lawsuit alleges infringement of a patent that claims the drug compound.
When the U.S. Patent and Trademark Office invalidates a patent for a drug, the FDA must update its list of relevant patents for the drug.