3.0.0 27 2023-01-11T13:20:45Z 2023-01-11T13:20:45Z Senate S S 2011-01-25 112 ssju00 Judiciary Committee Senate Standing Reported by 2011-07-22T18:26:45Z Markup by 2011-07-21T16:21:15Z Referred to 2011-01-25T19:38:48Z 2011-07-22 Senate Placed on Senate Legislative Calendar under General Orders. Calendar No. 110. Calendars 2011-07-22 ssju00 Judiciary Committee Senate Committee on the Judiciary. Reported by Senator Leahy without amendment. Without written report. Committee 2011-07-22 Committee on the Judiciary. Reported by Senator Leahy without amendment. Without written report. Committee 14000 9 Library of Congress ssju00 Judiciary Committee 2011-07-21 ssju00 Judiciary Committee Senate Committee on the Judiciary. Ordered to be reported without amendment favorably. Committee 2011-01-25 ssju00 Judiciary Committee Senate Read twice and referred to the Committee on the Judiciary. (text of measure as introduced: CR S144-146) IntroReferral 2011-01-25 Sponsor introductory remarks on measure. (CR S143-144) IntroReferral B00100 9 Library of Congress 2011-01-25 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. 2011-01-25 True D000563 Sen. Durbin, Richard J. [D-IL] Richard Durbin D IL J. 2011-01-25 True C001035 Sen. Collins, Susan M. [R-ME] Susan Collins R ME M. 2011-01-25 True K000367 Sen. Klobuchar, Amy [D-MN] Amy Klobuchar D MN 2011-01-25 True F000457 Sen. Franken, Al [D-MN] Al Franken D MN 2011-01-25 True B000944 Sen. Brown, Sherrod [D-OH] Sherrod Brown D OH 2011-01-25 True S000033 Sen. Sanders, Bernard [I-VT] Bernard Sanders I VT 2011-01-25 True J000177 Sen. Johnson, Tim [D-SD] TIM JOHNSON D SD 2011-02-01 False B000468 Sen. Bingaman, Jeff [D-NM] JESSE BINGAMAN D NM FRANCIS 2012-02-01 False 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 2011-01-25 Introduced in Senate 2011-09-15T17:57:27Z Preserve Access to Affordable Generics Act - 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. Establishes a presumption that any such agreement has anticompetitive effects and is unlawful if the filer of an abbreviated new drug (generic) application receives anything of value and agrees to limit or forego research, development, manufacturing, marketing, or sales of the generic drug 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 pro-competitive 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 the brand name manufacturer to the generic manufacturer is: (1) the right to market the generic drug in the United States prior to the expiration of any patent that is the basis for the patent infringement claim or any patent right or other statutory exclusivity that would prevent the marketing of such drug, (2) a payment for reasonable litigation expenses not exceeding $7.5 million, and (3) a covenant not to sue on any claim that the generic drug 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 require a brand name manufacturer and generic manufacturer to submit to the FTC any other agreements the parties enter into within 30 days of entering into an agreement related to the manufacturing, marketing, or sale of the brand name or generic drug or the exclusivity period. Requires the Chief Executive Officer or the company official responsible for negotiating any such 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 forfeit the 180-day exclusivity period for the marketing of a generic drug 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.

]]> 80 2011-07-22 Reported to Senate without amendment 2011-09-15T17:55:35Z (This measure has not been amended since it was introduced. The summary of that version is repeated here.)

Preserve Access to Affordable Generics Act - 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. Establishes a presumption that any such agreement has anticompetitive effects and is unlawful if the filer of an abbreviated new drug (generic) application receives anything of value and agrees to limit or forego research, development, manufacturing, marketing, or sales of the generic drug 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 pro-competitive 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 the brand name manufacturer to the generic manufacturer is: (1) the right to market the generic drug in the United States prior to the expiration of any patent that is the basis for the patent infringement claim or any patent right or other statutory exclusivity that would prevent the marketing of such drug, (2) a payment for reasonable litigation expenses not exceeding $7.5 million, and (3) a covenant not to sue on any claim that the generic drug 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 require a brand name manufacturer and generic manufacturer to submit to the FTC any other agreements the parties enter into within 30 days of entering into an agreement related to the manufacturing, marketing, or sale of the brand name or generic drug or the exclusivity period. Requires the Chief Executive Officer or the company official responsible for negotiating any such 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 forfeit the 180-day exclusivity period for the marketing of a generic drug 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 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. Introduced in Senate IS Short Titles as Introduced Preserve Access to Affordable Generics Act Short Titles as Reported to Senate Preserve Access to Affordable Generics Act S Senate Reported to Senate 2011-07-22T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-112s27rs/xml/BILLS-112s27rs.xml Introduced in Senate 2011-01-25T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-112s27is/xml/BILLS-112s27is.xml 2011-07-22 Placed on Senate Legislative Calendar under General Orders. Calendar No. 110. 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.