Protecting Consumer Access to Generic Drugs Act of 2013

To prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and for other purposes. 1. Short title This Act may be cited as the Protecting Consumer Access to Generic Drugs Act of 2013 2. Unfair and deceptive acts and practices related to new drug applications (a) Conduct prohibited It shall be unlawful for any person to directly or indirectly be a party to any agreement resolving or settling a patent infringement claim in which— (1) an ANDA filer receives anything of value; and (2) the ANDA filer agrees not to research, develop, manufacture, market, or sell, for any period of time, the drug that is to be manufactured under the ANDA involved and is the subject of the patent infringement claim. (b) Exceptions Notwithstanding subsection (a)(1), subsection (a) does not prohibit a resolution or settlement of a patent infringement claim in which the value received by the ANDA filer includes no more than— (1) the right to market the drug that is to be manufactured under the ANDA involved and is the subject of the patent infringement claim, before the expiration of— (A) the patent that is the basis for the patent infringement claim; or (B) any other statutory exclusivity that would prevent the marketing of such drug; and (2) the waiver of a patent infringement claim for damages based on prior marketing of such drug. (c) Enforcement A violation of subsection (a) shall be treated as an unfair and deceptive act or practice and an unfair method of competition in or affecting interstate commerce prohibited under section 5 of the Federal Trade Commission Act ( 15 U.S.C. 45 (d) Definitions In this section: (1) Agreement The term agreement 15 U.S.C. 45 (2) Agreement resolving or settling The term agreement resolving or settling (3) ANDA The term ANDA 21 U.S.C. 355(j) (4) ANDA filer The term ANDA filer (5) Patent infringement The term patent infringement (6) Patent infringement claim The term patent infringement claim 3. FTC Rulemaking The Federal Trade Commission may, by rule promulgated under section 553 4. Forfeiture of 180-day exclusivity period under the FFDCA Section 505(j)(5)(D)(i) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j)(5)(D)(i) section 2 of the Protecting Consumer Access to Generic Drugs Act of 2013 or that the agreement has violated 5. Notice and certification of agreements (a) Notice of all agreements Section 1112(c)(2) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 ( 21 U.S.C. 3155 (1) striking the Commission the the Commission (1) the (2) inserting before the period at the end the following: ; and (2) a description of the subject matter of any other agreement the parties enter into within 30 days of an entering into an agreement covered by subsection (a) or (b) (b) Certification of agreements Section 1112 of such Act is amended by adding at the end the following: (d) Certification The Chief Executive Officer or the company official responsible for negotiating any agreement required to be filed under subsection (a), (b), or (c) shall execute and file with the Assistant Attorney General and the Commission a certification as follows: I declare under penalty of perjury that the following is true and correct: The materials filed with the Federal Trade Commission and the Department of Justice under section 1112 of subtitle B of title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, with respect to the agreement referenced in this certification: (1) represent the complete, final, and exclusive agreement between the parties; (2) include any ancillary agreements that are contingent upon, provide a contingent condition for, or are otherwise related to, the referenced agreement; and (3) include written descriptions of any oral agreements, representations, commitments, or promises between the parties that are responsive to subsection (a) or (b) of such section 1112 and have not been reduced to writing. .

Summary: 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.