S 1209 116th Congress Senate Health Drug safety, medical device, and laboratory regulation Intellectual property Prescription drugs

REMEDY Act

Introduced: April 11, 2019 Introduced by: Cassidy, Bill Republican · Louisiana See on congress.gov

Everywhere this bill has been 2 steps

Introduced

In committee

Reported out

Passed House

Passed Senate

To President

Became law

Apr 11, 2019

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Apr 11, 2019

Introduced in Senate

Plain-English summary Congressional Research Service

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.

What's happening now April 11, 2019

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Committees of jurisdiction 1