3.0.0 54 2023-01-15T21:34:06Z 2023-01-15T21:34:06Z Senate S S 2003-01-07 108 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2003-01-07T21:27:44Z 2003-01-07 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S55-58) IntroReferral 2003-01-07 Introduced in Senate IntroReferral 10000 9 Library of Congress S000148 Sen. Schumer, Charles E. [D-NY] Charles Schumer D NY E. N M000303 Sen. McCain, John [R-AZ] JOHN MCCAIN R AZ SIDNEY 2003-01-07 True E000286 Sen. Edwards, John [D-NC] JOHN EDWARDS D NC 2003-01-07 True C001035 Sen. Collins, Susan M. [R-ME] Susan Collins R ME M. 2003-01-07 True K000105 Sen. Kennedy, Edward M. [D-MA] EDWARD KENNEDY D MA MOORE 2003-01-07 True M001141 Sen. Miller, Zell [D-GA] ZELL MILLER D GA 2003-01-07 True J000177 Sen. Johnson, Tim [D-SD] TIM JOHNSON D SD 2003-01-07 True C001041 Sen. Clinton, Hillary Rodham [D-NY] HILLARY CLINTON D NY R 2003-01-07 True K000305 Sen. Kohl, Herb [D-WI] HERBERT KOHL D WI H. 2003-01-07 True F000061 Sen. Feingold, Russell D. [D-WI] RUSSELL FEINGOLD D WI D. 2003-01-07 True S000770 Sen. Stabenow, Debbie [D-MI] Debbie Stabenow D MI 2003-01-07 True D000064 Sen. Daschle, Thomas A. [D-SD] THOMAS DASCHLE D SD ANDREW 2003-01-07 True N000032 Sen. Nelson, Bill [D-FL] CLARENCE NELSON D FL WILLIAM 2003-01-07 True R000361 Sen. Rockefeller, John D., IV [D-WV] JAY ROCKEFELLER D WV 2003-01-07 True L000174 Sen. Leahy, Patrick J. [D-VT] Patrick Leahy D VT 2003-01-07 True R000122 Sen. Reed, Jack [D-RI] John Reed D RI F. 2003-01-07 True P000590 Sen. Pryor, Mark L. [D-AR] Mark Pryor D AR Lunsford 2003-01-07 True D000563 Sen. Durbin, Richard J. [D-IL] Richard Durbin D IL J. 2003-01-07 True D000432 Sen. Dorgan, Byron L. [D-ND] BYRON DORGAN D ND LESLIE 2003-01-07 True L000550 Sen. Landrieu, Mary L. [D-LA] MARY LANDRIEU D LA 2003-01-21 False B000468 Sen. Bingaman, Jeff [D-NM] JESSE BINGAMAN D NM FRANCIS 2003-02-25 False D000596 Sen. Dayton, Mark [D-MN] MARK DAYTON D MN 2003-03-12 False Health Administrative procedure Administrative remedies Civil actions and liability Commerce Competition Congress Congressional reporting requirements Consent decrees Department of Health and Human Services Drug approvals Drug industry Generic drugs Government Operations and Politics Government paperwork Governmental investigations Intellectual property Judicial opinions Law Patents Pharmaceutical research Prescription pricing Restrictive trade practices Right of petition Science, Technology, Communications Health 00 2003-01-07 Introduced in Senate 2006-11-28T17:35:40Z Requires applicants (pharmaceutical companies) to register their patents with the Food and Drug Administration (FDA) within 30 days of approval (or issuance for subsequently issued patents).

Makes failure to timely register a bar to civil actions for patent infringement.

Requires applications for new drugs (NDA) or abbreviated new drug applications (ANDA) which rely upon investigations not conducted by or for the applicant and which concern a patent that claims both the drug and a method of use or more than one method of use to include a certification on a claim-by-claim basis that the patent is invalid or will not be infringed (known as a Paragraph IV filing/certification) by the new drug's (generic) manufacture and a statement regarding the method(s) of use claim.

Prohibits (for subsequently issued patents) an extension of the 30 month stay of FDA approval for any new drug where an ANDA or NDA contains a Paragraph IV filing/certification and the patent holder indicates an intention to bring a patent infringement suit against the new (generic) drug's manufacturer.

Makes failure to timely file a civil action for infringement a bar to later action.

Requires the first generic applicant with a Paragraph IV filing to forfeit the 180 day marketing exclusivity period to a subsequent generic applicant if the first generic applicant engages in certain behaviors (forfeiture events) which delay or prevent the marketing of the generic drug.

Revises notice requirements for Paragraph IV filings to include and protect certain proposed formulation, composition, or method of use information.

Excludes an applicants's ability to pay damages from a court's consideration of whether or not to provide injunctive relief before the expiration of the 30 month stay of approval period.]]>

Greater Access to Affordable Pharmaceuticals Act of 2003 Display Title Greater Access to Affordable Pharmaceuticals Act of 2003 Official Title as Introduced A bill to amend the Federal Food, Drug, and Cosmetic Act to provide greater access to affordable pharmaceuticals. Introduced in Senate IS Short Titles as Introduced Greater Access to Affordable Pharmaceuticals Act of 2003 Introduced in Senate 2003-01-07T05:00:00Z 2003-01-07 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S55-58) 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.