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.
Drug safety, medical device, and laboratory regulationIntellectual propertyPrescription drugs
REMEDY Act
USA116th CongressS-1209| Senate
| Updated: 4/11/2019
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.