S. 27 (112th): Preserve Access to Affordable Generics Act

Jan 25, 2011 (112th Congress, 2011–2013)
Died (Reported by Committee)
Herbert “Herb” Kohl
Senator from Wisconsin
Read Text »
Last Updated
Jul 22, 2011
18 pages
Related Bills
S. 369 (111th) was a previous version of this bill.

Reported by Committee
Last Action: Oct 15, 2009


This bill was introduced on July 21, 2011, in a previous session of Congress, but was not enacted.

Introduced Jan 25, 2011
Referred to Committee Jan 25, 2011
Reported by Committee Jul 21, 2011
Full Title

A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market.


No summaries available.

9 cosponsors (6D, 2R, 1I) (show)

Senate Judiciary

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Primary Source

THOMAS.gov (The Library of Congress)

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GovTrack’s Bill Summary

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Library of Congress Summary

The summary below was written by the Congressional Research Service, which is a nonpartisan division of the Library of Congress.

7/22/2011--Reported to Senate without amendment.
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.

House Republican Conference Summary

The summary below was written by the House Republican Conference, which is the caucus of Republicans in the House of Representatives.

No summary available.

House Democratic Caucus Summary

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