Preserve Access to Affordable Generics Act

Bill: 113-s-214
Sponsor: Sen. Klobuchar, Amy [D-MN]
Introduced: 2013-02-04 in the Senate
Policy area: Commerce
Subjects: Administrative law and regulatory procedures
Competition and antitrust
Contracts and agency
Federal Trade Commission (FTC)
Intellectual property
Marketing and advertising
Prescription drugs

Summary:
action_date: 2013-02-04
text: 
Preserve Access to Affordable Generics Act - Amends the Federal Trade Commission Act to authorize the Federal Trade Commission (FTC) to initiate a proceeding against parties to any agreement resolving or settling, on a final or interim basis, a patent infringement claim, in connection with the sale of a drug. Establishes a presumption that any such agreement has anticompetitive effects and is unlawful if the filer of an abbreviated new drug (generic) application receives anything of value and agrees to limit or forego research, development, manufacturing, marketing, or sales of the generic drug for any period of time. Allows an exception to such presumption if the parties to the agreement demonstrate by clear and convincing evidence, based on specified competitive factors, that the pro-competitive benefits of the agreement outweigh the anticompetitive effects. 
 
Exempts from the restrictions of this Act a resolution or settlement of a patent infringement claim if the only consideration granted by the brand name manufacturer to the generic manufacturer is: (1) the right to market the generic drug in the United States prior to the expiration of any patent that is the basis for the patent infringement claim or any patent right or other statutory exclusivity that would prevent the marketing of such drug, (2) a payment for reasonable litigation expenses not exceeding $7.5 million, and (3) a covenant not to sue on any claim that the generic drug infringes a U.S. patent. 
 
Allows review of FTC enforcement orders under this Act in federal court. Imposes civil penalties for violations of this Act.
 
Amends the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 to require a brand name manufacturer and generic manufacturer to submit to the FTC any other agreements the parties enter into within 30 days of entering into an agreement related to the manufacturing, marketing, or sale of the brand name or generic drug or the exclusivity period. Requires the Chief Executive Officer or the company official responsible for negotiating any such agreement to file a certification that materials filed with respect to such agreement are complete, final, and exclusive.
 
Amends the Federal Food, Drug, and Cosmetic Act to forfeit the 180-day exclusivity period for the marketing of a generic drug if there is a final decision of the FTC or a court that an agreement has violated 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 for bringing FTC enforcement actions (other than cease and desist requests) under this Act. 
 


Legislative actions:
action_date: 2013-07-23
text: Committee on the Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights. Hearings held.
action_date: 2013-02-04
text: Read twice and referred to the Committee on the Judiciary.
action_date: 2013-02-04
text: Introduced in Senate