3.0.0 3812 2022-11-01T13:50:34Z 2022-11-01T13:50:34Z House HR 2019-07-17 116 [Congressional Record Volume 165, Number 120 (Wednesday, July 17, 2019)][House]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. McKINLEY:H.R. 3812.Congress has the power to enact this legislation pursuantto the following:Article 1 Section 8Section 8--Powers of Congress. To make all Laws which shallbe necessary and proper for carrying into Execution theforegoing Powers, and all other Powers vested by thisConstitution in the Government of the United States, or inany Department or Officer thereof.[Page H6000]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2019-07-18T18:11:44Z Referred to 2019-07-17T14:00:46Z REMEDY Act 116 1209 S 2019-04-11 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Identical bill CRS 2019-07-18 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2019-07-17 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2019-07-17 Introduced in House IntroReferral Intro-H 9 Library of Congress 2019-07-17 Introduced in House IntroReferral 1000 9 Library of Congress M001180 Rep. McKinley, David B. [R-WV-1] David McKinley R WV B. 1 N W000800 Rep. Welch, Peter [D-VT-At Large] Peter Welch D VT 0 2019-07-17 True Health Drug safety, medical device, and laboratory regulation Intellectual property Prescription drugs Health 00 2019-07-17 Introduced in House 2021-09-13T16:47:48Z 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.

]]> REMEDY Act Display Title REMEDY Act Official Title as Introduced To amend the Federal Food, Drug, and Cosmetic Act with respect to approval of abbreviated new drug applications. Introduced in House IH Short Title(s) as Introduced REMEDY Act Introduced in House IH Short Title(s) as Introduced Reforming Ever­green­ing and Manipulation that Extends Drug Years Act Introduced in House IH Introduced in House 2019-07-17T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-116hr3812ih/xml/BILLS-116hr3812ih.xml 2019-07-18 Referred to the Subcommittee on Health. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.