REMEDY Act
- Last Action
- 4/11/2019
Actions
- 2019-04-11Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- 2019-04-11Introduced in Senate
CRS Summary
As of 2019-04-11 (00)
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.
Cosponsors (7)
- Richard Durbin (D-IL)
- Lisa Murkowski (R-AK)
- Kevin Cramer (R-ND)
- Tina Smith (D-MN)
- Jeanne Shaheen (D-NH)
- Jeff Merkley (D-OR)
- Gary Peters (D-MI)
Subjects
- Drug safety, medical device, and laboratory regulation
- Intellectual property
- Prescription drugs
Sourced from Congress.gov (public domain).
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.