3.0.0 1416 2022-11-01T13:50:47Z 2022-11-01T13:50:47Z Senate S 2019-05-09 116 ssju00 Judiciary Committee Senate Standing Reported by 2019-06-28T17:22:39Z Markup by 2019-06-27T14:00:38Z Referred to 2019-05-09T19:47:33Z 116 3991 HR 2019-11-21 Ordered to be Reported (Amended). Related bill CRS 116 4398 HR 2019-10-02 Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law. Related bill CRS 116 5133 HR 2020-12-24 Placed on the Union Calendar, Calendar No. 578. Related bill CRS 2019-06-28 Senate Placed on Senate Legislative Calendar under General Orders. Calendar No. 132. Calendars 2019-06-28 ssju00 Judiciary Committee Senate Committee on the Judiciary. Reported by Senator Graham with an amendment in the nature of a substitute. Without written report. Committee 2019-06-28 Committee on the Judiciary. Reported by Senator Graham with an amendment in the nature of a substitute. Without written report. Committee 14000 9 Library of Congress ssju00 Judiciary Committee 2019-06-27 ssju00 Judiciary Committee Senate Committee on the Judiciary. Ordered to be reported with an amendment in the nature of a substitute favorably. Committee 2019-05-09 ssju00 Judiciary Committee Senate Read twice and referred to the Committee on the Judiciary. IntroReferral 2019-05-09 Introduced in Senate IntroReferral 10000 9 Library of Congress C001056 Sen. Cornyn, John [R-TX] John Cornyn R TX N B001277 Sen. Blumenthal, Richard [D-CT] Richard Blumenthal D CT 2019-05-09 True C001047 Sen. Capito, Shelley Moore [R-WV] Shelley Capito R WV Moore 2019-05-15 False M001111 Sen. Murray, Patty [D-WA] Patty Murray D WA 2019-05-22 False S001217 Sen. Scott, Rick [R-FL] Rick Scott R FL 2019-06-03 False K000393 Sen. Kennedy, John [R-LA] John Kennedy R LA Neely 2019-06-03 False H001089 Sen. Hawley, Josh [R-MO] Josh Hawley R MO 2019-06-04 False D000563 Sen. Durbin, Richard J. [D-IL] Richard Durbin D IL J. 2019-06-26 False K000383 Sen. King, Angus S., Jr. [I-ME] Angus King I ME S. 2019-07-24 False S001203 Sen. Smith, Tina [D-MN] Tina Smith D MN 2019-09-12 False P000595 Sen. Peters, Gary C. [D-MI] Gary Peters D MI 2019-09-25 False M001197 Sen. McSally, Martha [R-AZ] Martha McSally R AZ 2019-11-13 False F000463 Sen. Fischer, Deb [R-NE] Deb Fischer R NE 2019-11-13 False T000461 Sen. Toomey, Patrick [R-PA] Patrick Toomey R PA J. 2019-11-21 False 2019-07-19T16:45:00Z https://www.cbo.gov/publication/55472 As reported by the Senate Committee on the Judiciary on June 28, 2019 Commerce Administrative remedies Civil actions and liability Competition and antitrust Consumer affairs Drug safety, medical device, and laboratory regulation Federal Trade Commission (FTC) Health care costs and insurance Inflation and prices Intellectual property Judicial review and appeals Manufacturing Prescription drugs Commerce

00 2019-05-09 Introduced in Senate 2020-08-11T15:26:00Z Affordable Prescriptions for Patients Act of 2019

This bill prohibits patent thicketing and product hopping by drug manufacturers. In general, patent thicketing occurs when a drug manufacturer obtains new patents related to a previously-patented drug, biological product, or underlying chemical composition that extends the manufacturer’s market exclusivity for that drug without demonstrating that the new patents serve a meaningful purpose other than limiting competition from generic drug manufacturers.

Product hopping is presumed when a drug manufacturer obtains removal of a drug from the Food and Drug Administration’s approved drug list, discontinues a drug, or markets a reformulation of an already-approved drug during a certain period after which the manufacturer has been notified that a competing drug manufacturer has applied for generic drug approval. These practices are not considered product hopping if the manufacturer demonstrates that the drug was removed from the approved-drug list for safety reasons. Or, in the case of a drug reformulation, the manufacturer shows that the modified product provides a significant health benefit, is the option least likely to reduce competition, and is based on substantial financial considerations unrelated to limiting competition.

The Federal Trade Commission may penalize violating manufacturers and bring claims in federal court to prohibit the conduct and provide restitution.

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25 2019-06-28 Reported to Senate 2021-03-17T17:44:02Z Affordable Prescriptions for Patients Act of 2019

This bill prohibits product hopping by drug manufacturers. Product hopping is presumed when a drug manufacturer engages is a hard switch or a soft switch. A hard switch occurs when, after a manufacturer receives notice of an application for a generic drugs, either, (1) the manufacturer obtains removal of a drug from the Food and Drug Administration’s approved drug list or the drug is moved to the discontinued products list, and the manufacturer markets or sells a follow-on product; or (2) a manufacturer announces the withdrawal or discontinuance of a listed drug, or the manufacturer destroys the inventory of a listed drug in a manner that impedes generic drug competitors, and the manufacturer markets or sells a follow-on product. A follow-on product is a changed, modified, or reformulated version of a manufacturer’s already-approved drug or biological product that still treats the same medical condition.

A soft switch occurs when a manufacturer receives notice of an application for a generic drugs, takes other actions that impede generic drug competitors, and the manufacturer markets or sells a follow-on product.

A drug manufacturer may rebut a presumption of product hopping by demonstrating that its conduct was not intended to limit competition.

This bill also limits the number of patents that may be included in infringement claims brought by approved biological product license holders against applicants for a biosimilar product license.

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Display Title Short Title(s) as Introduced Introduced in Senate IS Short Title(s) as Reported to Senate S Senate Reported to Senate RS Official Title as Introduced Introduced in Senate IS Reported to Senate 2019-06-28T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-116s1416rs/xml/BILLS-116s1416rs.xml Introduced in Senate 2019-05-09T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-116s1416is/xml/BILLS-116s1416is.xml 2019-06-28 Placed on Senate Legislative Calendar under General Orders. Calendar No. 132. 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.