Preserve Access to Affordable Generics Act

Bill: 110-s-316
Sponsor: Sen. Kohl, Herb [D-WI]
Introduced: 2007-01-17 in the Senate
Policy area: Commerce
Subjects: Antitrust law
Competition
Congress
Congressional reporting requirements
Crime and Law Enforcement
Criminal investigation
Drug industry
Generic drugs
Governmental investigations
Health
Intellectual property
Marketing
Patent infringement
Pharmaceutical research
Restrictive trade practices
Science, Technology, Communications

Summary:
action_date: 2007-01-17
text: 
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.
 
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 Federal Trade Commission (FTC) or the court that an agreement has violated this Act.
 
Requires the FTC to study the prevalence of anticompetitive agreements in the pharmaceutical industry and their impact. Requires the Attorney General or FTC to consider whether any additional enforcement action is necessary.

action_date: 2007-02-27
text: 

(This measure has not been amended since it was introduced. The summary has been expanded because action occurred on the measure.)

 
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.
 
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: (1) are complete, final, and exclusive; (2) include any ancillary agreements that are contingent upon, provide a contingent condition for, or are otherwise related to, the agreement; and (3) include written descriptions of any relevant oral agreements, representations, commitments, or promises between the parties that have not been reduced to writing.
 
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 Federal Trade Commission (FTC) or the court that an agreement has violated this Act.
 
Requires the FTC to study the prevalence of anticompetitive agreements in the pharmaceutical industry and their impact. Requires the Attorney General or FTC to consider whether any additional enforcement action is necessary.
 
Authorizes appropriations.


Legislative actions:
action_date: 2007-03-07
text: Committee on the Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights. Hearings held.
action_date: 2007-02-27
text: Placed on Senate Legislative Calendar under General Orders. Calendar No. 59.
action_date: 2007-02-27
text: Committee on the Judiciary. Reported by Senator Leahy without amendment. Without written report.
action_date: 2007-02-27
text: Committee on the Judiciary. Reported by Senator Leahy without amendment. Without written report.
action_date: 2007-02-15
text: Committee on the Judiciary. Approved for reporting without amendment favorably.
action_date: 2007-01-17
text: Committee on the Judiciary. Hearings held.
action_date: 2007-01-17
text: Read twice and referred to the Committee on the Judiciary. (text of measure as introduced: CR S679-680)
action_date: 2007-01-17
text: Sponsor introductory remarks on measure. (CR S679)
action_date: 2007-01-17
text: Introduced in Senate