H.R. 3812 · 116th Congress
Reforming Evergreening and Manipulation that Extends Drug Years Act
- Stage
- In committee
- Sponsor
- David McKinley
- Introduced
- 2019-07-17
- Latest action
- 2019-07-18 · Referred to the Subcommittee on Health.
Summary
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.