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H.R.3995 - Protecting Consumer Access to Generic Drugs Act of 2012
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.
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Mr. RUSH (for himself and Mr. WAXMAN) introduced the following bill; which was 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 concernedCommentsClose CommentsPermalink
SECTION 1. SHORT TITLE.
SEC. 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--CommentsClose CommentsPermalink
(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.CommentsClose CommentsPermalink
(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--CommentsClose CommentsPermalink
(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 (
(2) AGREEMENT RESOLVING OR SETTLING- The term ‘agreement resolving or settling’, in reference to a patent infringement claim, includes any agreement that is contingent upon, provides a contingent condition for, or is otherwise related to the resolution or settlement of the claim.CommentsClose CommentsPermalink
(3) ANDA- The term ‘ANDA’ means an abbreviated new drug application for the approval of a new drug under section 505(j) of the Federal Food, Drug, and Cosmetic Act (
(5) PATENT INFRINGEMENT- The term ‘patent infringement’ means infringement of any patent or of any filed patent application, extension, reissuance, renewal, division, continuation, continuation in part, reexamination, patent term restoration, patent of addition, or extension thereof.CommentsClose CommentsPermalink
(6) PATENT INFRINGEMENT CLAIM- The term ‘patent infringement claim’ means any allegation made to an ANDA filer, whether or not included in a complaint filed with a court of law, that its ANDA or drug to be manufactured under such ANDA may infringe any patent.CommentsClose CommentsPermalink
SEC. 3. FTC RULEMAKING.
The Federal Trade Commission may, by rule promulgated under
SEC. 4. FORFEITURE OF 180-DAY EXCLUSIVITY PERIOD UNDER THE FFDCA.
Section 505(j)(5)(D)(i) of the Federal Food, Drug, and Cosmetic Act (
SEC. 5. NOTICE AND CERTIFICATION OF AGREEMENTS.
(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)’.CommentsClose CommentsPermalink
‘(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.’.’.CommentsClose CommentsPermalink
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