Ask AI
H.R. 3812

REMEDY Act

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.

Referred to the Subcommittee on Health.

Rep. McKinley, David B. [R-WV-1](R-WV)Sponsor
1 cosponsor1 D
1cosponsors1committees4actions1related bills3subjects
  1. Committee

    Referred to the Subcommittee on Health.

    Health Subcommittee
  2. IntroReferralH11100

    Referred to the House Committee on Energy and Commerce.

    Energy and Commerce Committee
  3. IntroReferralIntro-H

    Introduced in House

  4. IntroReferral1000

    Introduced in House

REMEDY Act — Informed