3.0.0 369 2023-01-11T13:17:23Z 2023-01-11T13:17:23Z Senate S S 2009-02-03 111 ssju00 Judiciary Committee Senate Standing Reported by 2009-10-15T22:04:59Z Markup by 2009-10-15T16:13:28Z Referred to 2009-02-03T20:41:02Z S. Rept. 111-123 2010-02-02 ssju00 Judiciary Committee Senate By Senator Leahy from Committee on the Judiciary filed written report. Report No. 111-123. Minority views filed. Floor 2010-02-02 By Senator Leahy from Committee on the Judiciary filed written report. Report No. 111-123. Minority views filed. Committee 14900 9 Library of Congress ssju00 Judiciary Committee 2009-10-15 Senate Placed on Senate Legislative Calendar under General Orders. Calendar No. 183. Calendars 2009-10-15 ssju00 Judiciary Committee Senate Committee on the Judiciary. Reported by Senator Leahy with an amendment in the nature of a substitute. Without written report. Committee 2009-10-15 Committee on the Judiciary. Reported by Senator Leahy with an amendment in the nature of a substitute. Without written report. Committee 14000 9 Library of Congress ssju00 Judiciary Committee 2009-10-15 ssju00 Judiciary Committee Senate Committee on the Judiciary. Ordered to be reported with an amendment in the nature of a substitute favorably. Committee 2009-02-03 ssju00 Judiciary Committee Senate Read twice and referred to the Committee on the Judiciary. (text of measure as introduced: CR S1433-1434) IntroReferral 2009-02-03 Sponsor introductory remarks on measure. (CR S1433) IntroReferral B00100 9 Library of Congress 2009-02-03 Introduced in Senate IntroReferral 10000 9 Library of Congress K000305 Sen. Kohl, Herb [D-WI] HERBERT KOHL D WI H. N G000386 Sen. Grassley, Chuck [R-IA] Charles Grassley R IA E. 2009-02-03 True F000061 Sen. Feingold, Russell D. [D-WI] RUSSELL FEINGOLD D WI D. 2009-02-03 True D000563 Sen. Durbin, Richard J. [D-IL] Richard Durbin D IL J. 2009-02-03 True B000944 Sen. Brown, Sherrod [D-OH] Sherrod Brown D OH 2009-02-03 True C001035 Sen. Collins, Susan M. [R-ME] Susan Collins R ME M. 2009-05-12 False K000367 Sen. Klobuchar, Amy [D-MN] Amy Klobuchar D MN 2009-06-01 False N000032 Sen. Nelson, Bill [D-FL] CLARENCE NELSON D FL WILLIAM 2009-06-23 False F000457 Sen. Franken, Al [D-MN] Al Franken D MN 2009-09-09 False D000432 Sen. Dorgan, Byron L. [D-ND] BYRON DORGAN D ND LESLIE 2010-02-24 False J000177 Sen. Johnson, Tim [D-SD] TIM JOHNSON D SD 2010-07-26 False S000033 Sen. Sanders, Bernard [I-VT] Bernard Sanders I VT 2010-08-02 False 2010-01-28T06:00:00Z S. 369, Preserve Access to Affordable Generics Act http://www.cbo.gov/publication/21015 <p>Cost estimate for the bill as reported by the Senate Committee on the Judiciary on October 15, 2009. Note: Numbers updated in <a href="http://www.cbo.gov/ftpdocs/115xx/doc11582/s369_updated_table.pdf">a new table</a> on June 16, 2010.</p> 2010-01-28T06:00:00Z S. 369, Preserve Access to Affordable Generics Act https://www.cbo.gov/publication/21015 Cost estimate for the bill as reported by the Senate Committee on the Judiciary on October 15, 2009. Note: Numbers updated in a new table on June 16, 2010. 2010-06-16T04:00:00Z S. 369, Preserve Access to Affordable Generics Act (Updated table) http://www.cbo.gov/publication/21549 <p>Updated table for the bill as reported by the Senate Committee on the Judiciary on October 15, 2009.</p> 2010-06-16T04:00:00Z S. 369, Preserve Access to Affordable Generics Act (Updated table) https://www.cbo.gov/publication/21549 Updated table for the bill as reported by the Senate Committee on the Judiciary on October 15, 2009. Commerce Administrative law and regulatory procedures Competition and antitrust Contracts and agency Federal Trade Commission (FTC) Intellectual property Marketing and advertising Prescription drugs Commerce 00 2009-02-03 Introduced in Senate 2009-04-24T15:25:21Z Preserve Access to Affordable Generics Act - Amends the Clayton Act to make it unlawful for a person, in connection with the sale of a drug product, to be a party to any agreement resolving or settling a patent infringement claim in which: (1) an abbreviated new drug (generic) application filer receives anything of value; and (2) such filer agrees not to research, develop, manufacture, market, or sell the generic product for any period. Excludes a resolution or settlement that includes no more than the right to market the generic product prior to the expiration of the patent. Authorizes the Federal Trade Commission (FTC) to exempt certain such agreements if they are in furtherance of market competition and for the benefit of consumers.

Amends the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 to set forth additional filing requirements related to agreements between a brand name drug company and a generic drug applicant. Requires the Chief Executive Officer or the company official responsible for negotiating any agreement to file a certification that materials filed with respect to such agreements are complete, final, and exclusive.

Amends the Federal Food, Drug, and Cosmetic Act to provide that forfeiture of the 180-day exclusivity period for the marketing of a generic drug occurs if there is a final decision of the FTC or the court that an agreement has violated this Act.

]]> 01 2009-10-15 Reported to Senate with amendment(s) 2010-02-03T20:07:35Z Preserve Access to Affordable Generics Act - Declares as the purposes of this Act to: (1) enhance competition in the pharmaceutical market by stopping anticompetitive agreements between brand name and generic drug manufacturers; and (2) support the purpose and intent of antitrust laws by prohibiting anticompetitive practices in the pharmaceutical industry that harm consumers.

Amends the Federal Trade Commission Act to authorize the Federal Trade Commission (FTC) to initiate a proceeding against parties to any agreement resolving or settling, on a final or interim basis, a patent infringement claim, in connection with the sale of a drug product. Establishes a presumption that any such agreement has anticompetitive effects and is unlawful if the filer of an abbreviated new drug application receives anything of value and agrees to limit or forego research, development, manufacturing, marketing, or sales of the drug product for any period of time. Allows an exception to such presumption if the parties to the agreement demonstrate by clear and convincing evidence, based on specified competitive factors, that the procompetitive benefits of the agreement outweigh the anticompetitive effects.

Exempts from the restrictions of this Act a resolution or settlement of a patent infringement claim if the only consideration granted by a new drug application holder to a filer of an abbreviated new drug application is the right to market the drug product in the United States prior to the expiration of any patent that is the basis for the patent infringement claim or any patent right that would prevent the marketing of such drug, a payment for reasonable litigation expenses not exceeding $7.5 million, and a covenant not to sue on any claim that the filer infringes a U.S. patent.

Allows review of FTC enforcement orders under this Act in federal court. Imposes civil penalties for violations of this Act.

Amends the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 to set forth additional filing requirements related to agreements between a brand name drug company and a generic drug applicant. Requires the Chief Executive Officer or the company official responsible for negotiating any agreement to file a certification that materials filed with respect to such agreement are complete, final, and exclusive.

Amends the Federal Food, Drug, and Cosmetic Act to provide that forfeiture of the 180-day exclusivity period for the marketing of a generic drug occurs if there is a final decision of the FTC or a court that an agreement has violated this Act.

Grants the FTC exclusive authority to litigate matters relating to anticompetitive practices in connection with the sale of generic brand drugs. Establishes a three-year limitation period for bringing FTC enforcement actions (other than cease and desist requests) under this Act.

]]> Preserve Access to Affordable Generics Act Display Title Preserve Access to Affordable Generics Act Short Titles as Introduced Preserve Access to Affordable Generics Act Short Titles as Reported to Senate Preserve Access to Affordable Generics Act S Senate Official Title as Introduced A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market. Reported to Senate 2009-10-15T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-111s369rs/xml/BILLS-111s369rs.xml Introduced in Senate 2009-02-03T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-111s369is/xml/BILLS-111s369is.xml 2010-02-02 By Senator Leahy from Committee on the Judiciary filed written report. Report No. 111-123. Minority views filed. 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.