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H.R. 3812

BillFederalHouseIn Committee
REMEDY Act
About This Bill
Committee
Latest Action · July 18, 2019
Referred to the Subcommittee on Health.
Congress
116th (2019–2021)
Introduced
July 17, 2019
Cosponsors (1)
1D 0R
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Summary

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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.

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