3.0.0 1209 2022-11-01T19:47:17Z 2022-11-05T19:24:48Z Senate S 2019-04-11 116 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2019-04-11T20:02:12Z REMEDY Act 116 3812 HR 2019-07-18 Referred to the Subcommittee on Health. Identical bill CRS 2019-04-11 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2019-04-11 Introduced in Senate IntroReferral 10000 9 Library of Congress C001075 Sen. Cassidy, Bill [R-LA] Bill Cassidy R LA N D000563 Sen. Durbin, Richard J. [D-IL] Richard Durbin D IL J. 2019-04-11 True M001153 Sen. Murkowski, Lisa [R-AK] Lisa Murkowski R AK 2019-05-15 False C001096 Sen. Cramer, Kevin [R-ND] Kevin Cramer R ND 2019-05-16 False S001203 Sen. Smith, Tina [D-MN] Tina Smith D MN 2019-05-22 False S001181 Sen. Shaheen, Jeanne [D-NH] Jeanne Shaheen D NH 2019-06-05 False M001176 Sen. Merkley, Jeff [D-OR] Jeff Merkley D OR 2019-07-30 False P000595 Sen. Peters, Gary C. [D-MI] Gary Peters D MI 2019-09-25 False Health Drug safety, medical device, and laboratory regulation Intellectual property Prescription drugs Health 00 2019-04-11 Introduced in Senate 2021-09-13T15:42:50Z 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 Short Title(s) as Introduced REMEDY Act Introduced in Senate IS Short Title(s) as Introduced Reforming Evergreening and Manipulation that Extends Drug Years Act Introduced in Senate IS Official Title as Introduced A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to approval of abbreviated new drug applications. Introduced in Senate IS Introduced in Senate 2019-04-11T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-116s1209is/xml/BILLS-116s1209is.xml 2019-04-11 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. 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.