Protecting Consumer Access to Generic Drugs Act of 2007

Bill: 110-hr-1902
Sponsor: Rep. Rush, Bobby L. [D-IL-1]
Introduced: 2007-04-17 in the House
Policy area: Health
Subjects: Claims
Commerce
Competition
Consumer protection
Contracts
Drug industry
Drugs
Generic drugs
Government Operations and Politics
Government paperwork
Intellectual property
Marketing
Patent infringement
Patents
Pharmaceutical research
Prescription pricing
Restrictive trade practices
Science, Technology, Communications

Summary:
action_date: 2007-04-17
text: 
Protecting Consumer Access to Generic Drugs Act of 2007 - Prohibits, as an unfair and deceptive act or practice and an unfair method of competition in or affecting interstate commerce, any person from being 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 drug. Excludes a resolution or settlement that includes no more than: (1) the right to market the generic drug before the expiration of the patent or other exclusivity period; or (2) the waiver of a patent infringement claim for damages. 
 
Authorizes the Federal Trade Commission (FTC) to exempt agreements in furtherance of market competition and for the benefit of consumers.
 
Amends the Federal Food, Drug, and Cosmetic Act to provide that a generic drug applicant forfeits market exclusivity for failing to market the drug 75 days after: (1) a court dismisses a declaratory judgment action for lack of subject matter jurisdiction; or (2) the applicant files with the Secretary of Health and Human Services a covenant that the patent owner will not sue the applicant for patent infringement. Deems an applicant to have forfeited market exclusivity if the applicant enters into an agreement that violates this Act.
 
Amends the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 to revise reporting requirements related to agreements between a generic drug applicant and a brand name drug company to include: (1) a description of the subject matter of other agreements between the parties; and (2) a certification that the materials filed represent the complete, final, and exclusive agreement between the parties.


Legislative actions:
action_date: 2007-05-04
text: Referred to the Subcommittee on Courts, the Internet, and Intellectual Property.
action_date: 2007-05-02
text: Subcommittee Hearings Held.
action_date: 2007-04-18
text: Referred to the Subcommittee on Commerce, Trade and Consumer Protection.
action_date: 2007-04-17
text: Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
action_date: 2007-04-17
text: Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
action_date: 2007-04-17
text: Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
action_date: 2007-04-17
text: Introduced in House
action_date: 2007-04-17
text: Introduced in House