S. 27 Preserve Access to Affordable Generics Act 2011
LEGISLATIVE INFORMATION PAGE
Bill Number: S. 27
Title: Preserve Access to Affordable Generics Act
Primary Sponsor: Kohl (D- Wisconsin)
Introduced: 1/25/11; referred to Judiciary Committee
The purpose of this Act is to enhance competition in the pharmaceutical market by stopping anticompetitive agreements between brand name and generic drug manufacturers.
Federal Trade Commission- Antitrust Laws Amendments:
- Establishes presumption that any agreement to settle a patent infringement claim in exchange for anything of value or in agreement to limit research, development, manufacturing, marketing, or sales of the product, has anticompetitive effects. Exception available if the parties to the agreement demonstrate by clear and convincing evidence, that procompetitive benefits outweigh the anticompetitive effects.
- Exempts some specific settlements involving the right to market the drug product in the US prior to the expiration of any patent that is the basis for the patent infringement claim.
- Amends the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 change filing requirements related to agreements between a brand name drug company and a generic drug applicant. Requires CEO or company official responsible for negotiating any agreement to file a certification that materials filed with respect to such agreement are complete, final, and exclusive.
- Provides for forfeiture of the 180-day exclusive marketing period if FTC or a court finds a violation of 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. Imposes civil penalties for violations of this Act.
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No California Delegation Co-sponsors