3.0.0 3991 2022-11-01T13:50:21Z 2022-11-01T13:50:21Z House HR 2019-07-25 116 [Congressional Record Volume 165, Number 126 (Thursday, July 25, 2019)][House][Pages H7468-H7469]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. JOHNSON of Georgia:H.R. 3991.Congress has the power to enact this legislation pursuantto the following:[[Page H7469]]U.S. Constitution, Article I, Section 8.]]> hsju00 Judiciary Committee House Standing hsju03 Courts, Intellectual Property, and the Internet Subcommittee Discharged from 2019-11-19T22:13:38Z Referred to 2019-08-28T19:47:24Z Markup by 2019-11-21T21:19:51Z Referred to 2019-07-25T14:13:10Z Affordable Prescriptions for Patients Act of 2019 116 1416 S 2019-06-28 Placed on Senate Legislative Calendar under General Orders. Calendar No. 132. Related bill CRS Fostering Undergraduate Talent by Unlocking Resources for Education Act 116 2486 HR 2020-07-23 Message on House action received in Senate and at desk: House amendments to Senate amendment. Related bill CRS 2019-11-21 hsju00 Judiciary Committee 1 House committee actions Ordered to be Reported (Amended). Committee 2019-11-21 hsju00 Judiciary Committee 1 House committee actions Committee Consideration and Mark-up Session Held. Committee 2019-11-19 hsju00 Judiciary Committee 1 House committee actions Subcommittee on Courts, Intellectual Property, and the Internet Discharged. Committee 2019-08-28 hsju03 Courts, Intellectual Property, and the Internet Subcommittee 1 House committee actions Referred to the Subcommittee on Courts, Intellectual Property, and the Internet. Committee 2019-07-25 Referred to the House Committee on the Judiciary. IntroReferral H11100 2 House floor actions hsju00 Judiciary Committee 2019-07-25 Introduced in House IntroReferral Intro-H 9 Library of Congress 2019-07-25 Introduced in House IntroReferral 1000 9 Library of Congress J000288 Rep. Johnson, Henry C. "Hank," Jr. [D-GA-4] Henry Johnson D GA C. "Hank" 4 N R000591 Rep. Roby, Martha [R-AL-2] Martha Roby R AL 2 2019-07-25 True Commerce Competition and antitrust Health care costs and insurance Inflation and prices Intellectual property Judicial review and appeals Prescription drugs Commerce 00 2019-07-25 Introduced in House 2020-10-15T14:41:28Z Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019

This bill limits in certain instances the number of patents that the manufacturer of a biologic drug can assert in a lawsuit against a company seeking to sell a biosimilar version of that drug. (A biologic drug is produced through natural processes or isolated from natural sources. A biosimilar version is substantially similar to the original biologic, which is the reference product, and is often marketed as a less expensive alternative.)

The bill's provisions apply to an existing framework that gives the biosimilar manufacturer an abbreviated path to Food and Drug Administration approval to sell the biosimilar. Specifically, if the biosimilar manufacturer completes certain actions under the framework, such as sharing certain information about its product with the reference product manufacturer, the bill limits the number of certain patents that the reference product manufacturer may assert in a lawsuit, such as patents that were filed more than four years after the reference product received market approval. The limit shall not apply to patents claiming certain methods for using the biologic drug.

The court in which the infringement lawsuit is filed may increase the limit if justice so requires or if there is good cause for the increase.

]]> Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 Display Title Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 Official Title as Introduced To amend title 35, United States Code, to clarify and improve the process for subsection (k) applicants to resolve patent infringement claims for biological products (commonly known as the "patent dance"), and for other purposes. Introduced in House IH Short Title(s) as Introduced Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 Introduced in House IH Introduced in House 2019-07-25T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-116hr3991ih/xml/BILLS-116hr3991ih.xml 2019-11-21 Ordered to be Reported (Amended). 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.