3.0.0 1617 2022-11-01T05:47:42Z 2022-11-01T05:47:42Z Senate S 2019-05-22 116 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2019-05-22T21:22:54Z Second Look at Drug Patents Act of 2020 116 4253 S 2020-07-21 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Related bill CRS 2019-05-22 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2019-05-22 Introduced in Senate IntroReferral 10000 9 Library of Congress M001111 Sen. Murray, Patty [D-WA] Patty Murray D WA N C001056 Sen. Cornyn, John [R-TX] John Cornyn R TX 2019-05-22 True Health Administrative remedies Drug safety, medical device, and laboratory regulation Government information and archives Intellectual property Prescription drugs Health 00 2019-05-22 Introduced in Senate 2021-09-13T15:55:56Z Second Look at Drug Patents Act of 2019

This bill addresses the publication of drug patent information.

Drug manufacturers must submit patent information to the U.S. Patent and Trademark Office (USPTO) within 30 days following approval of a new drug application or an abbreviated new drug application. For patents issued after approval of an application, a drug manufacturer must submit the required patent information within 30 days of issuance. The USPTO must publish the patent information and invite requests for patent validity challenges.

The Food and Drug Administration must provisionally list in the Approved Drug Products with Therapeutic Equivalence Evaluations publication (commonly known as the Orange Book) a drug patent submitted to the USPTO in accordance with this bill until the Patent Trial and Appeal Board confirms the patent to be patentable or the patent is not challenged within a specific time frame.

]]> Second Look at Drug Patents Act of 2019 Display Title Second Look at Drug Patents Act of 2019 Short Title(s) as Introduced Second Look at Drug Patents Act of 2019 Introduced in Senate IS Official Title as Introduced A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the listing of patents in the Orange Book. Introduced in Senate IS Introduced in Senate 2019-05-22T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-116s1617is/xml/BILLS-116s1617is.xml 2019-05-22 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.