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H.R. 3709

Protecting Consumer Access to Generic Drugs Act of 2013

Protecting Consumer Access to Generic Drugs Act of 2013 - 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 deem 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.

Referred to the Subcommittee on Courts, Intellectual Property, and the Internet.

Rep. Rush, Bobby L. [D-IL-1](D-IL)Sponsor
5 cosponsors5 D
5cosponsors2committees7actions7subjects
  • Introduced in HouseDec 11, 2013
  1. Committee

    Referred to the Subcommittee on Courts, Intellectual Property, and the Internet.

  2. Committee

    Referred to the Subcommittee on Regulatory Reform, Commercial And Antitrust Law.

  3. Committee

    Referred to the Subcommittee on Health.

  4. IntroReferralH11100

    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.

  5. IntroReferralH11100

    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.

  6. IntroReferralIntro-H

    Introduced in House

  7. IntroReferral1000

    Introduced in House

Protecting Consumer Access to Generic Drugs Act of 2013 — Informed