Preserve Access to Affordable Generics Act

Summary

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.

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Documents

6 official files

• Reported to Senate (text)

  Reported to Senate · EN · 15 October 2009

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• Reported to Senate (PDF)

  Reported to Senate · EN · 15 October 2009

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• Reported to Senate with amendment(s)

  summary · EN · 15 October 2009

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• Introduced in Senate (text)

  Introduced in Senate · EN · 3 February 2009

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• Introduced in Senate (PDF)

  Introduced in Senate · EN · 3 February 2009

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• Introduced in Senate

  summary · EN · 3 February 2009

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