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HR 3812 116th Congress House Health Drug safety, medical device, and laboratory regulation Intellectual property Prescription drugs

REMEDY Act

Introduced: July 17, 2019 See on congress.gov
 Everywhere this bill has been 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Jul 18, 2019
Referred to the Subcommittee on Health.
Jul 17, 2019
Referred to the House Committee on Energy and Commerce.
Jul 17, 2019
Introduced in House
 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 July 18, 2019

Referred to the Subcommittee on Health.

 Committees of jurisdiction 2