Sec. 4. Unlawful compensation for delay
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/bill/115/hr/4117/ih/section-4A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
The Federal Trade Commission Act ( 15 U.S.C. 44 et seq.) is amended by inserting after section 26 ( 15 U.S.C. 57c–2 ) the following: The Commission may initiate a proceeding to enforce the provisions of this section against the 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 product. Subject to subparagraph (B), in such a proceeding, an agreement shall be an unfair method of competition in or affecting commerce and be a violation of section 5 if pursuant to the agreement— an ANDA filer receives anything of value, including an exclusive or non-exclusive license, an agreement regarding the marketing of a product, or any other commercial opportunity or benefit; and the ANDA filer agrees to limit or forgo research, development, manufacturing, marketing, or sales of the ANDA product for any period of time.
Subparagraph
(A)shall not apply if the parties to such agreement demonstrate by clear and convincing evidence that— the value described in subparagraph (A)(i) is compensation solely for other goods or services that the ANDA filer has promised to provide; or the procompetitive benefits of the agreement outweigh the anticompetitive effects of the agreement. In determining whether the settling parties have met their burden under subsection (a)(2)(B), the fact finder may not presume— that entry of the ANDA product into interstate commerce would not have occurred until the expiration of the relevant patent or statutory exclusivity; or that the agreement’s provision for entry of the ANDA product into interstate commerce prior to the expiration of the relevant patent or statutory exclusivity means that the agreement is procompetitive. Nothing in this section shall prohibit a resolution or settlement of a patent infringement claim in which the consideration granted to the ANDA filer as part of the resolution or settlement includes one or more of the following and nothing else: The right to market the ANDA product 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. A payment, not to exceed $7,500,000, if based on reasonable litigation expenses. A covenant not to sue (including any agreement to dismiss) on any claim that the ANDA product infringes a United States patent. Any party that is subject to a final order of the Commission, issued in an administrative adjudicative proceeding under the authority of subsection (a)(1), may, within 30 days after the issuance of such order, petition for review of such order in— the United States Court of Appeals for the District of Columbia Circuit; or the United States Court of Appeals for the circuit in which any party subject to such final order is incorporated on the date that the petition for review is filed. In a proceeding for judicial review of a final order of the Commission, the findings of the Commission as to the facts, if supported by evidence, shall be conclusive. Nothing in this section shall be construed to modify, impair, or supersede the operation of— the antitrust laws as defined in subsection
(a)of the first section of the Clayton Act ( 15 U.S.C. 12(a) ), or any State law substantially similar to any of such antitrust laws; or section 5 of this Act or any substantially similar State law. Nothing in this section shall modify, impair, or supersede the right of an ANDA filer to assert a claim or counterclaim against any person under any law referred to in paragraph (1). Each party that violates subsection (a)(2)(A) shall forfeit and pay to the United States a civil penalty sufficient to deter such violation, but in no event greater than 3 times the value received by the party that is reasonably attributable to such violation. Such penalty shall accrue to the United States and may be recovered in a civil action brought by the Commission, in its own name by any of its attorneys designated by it for such purpose, in a district court of the United States against any party that commits such violation. In such actions, the United States district courts are empowered to grant mandatory injunctions and such other and further equitable relief as the courts determine to be appropriate. If the Commission has issued a cease and desist order with respect to a party in an administrative adjudicative proceeding under the authority of subsection (a)(1), an action brought pursuant to paragraph
(1)may be commenced against such party at any time before the expiration of 1 year after such order becomes final pursuant to section 5(g). In an action under subparagraph (A), the findings of the Commission as to the material facts in the administrative adjudicative proceeding with respect to a violation described in subsection (a)(2)(A) by a party shall be conclusive unless— the terms of such cease and desist order expressly provide that the Commission’s findings shall not be conclusive; or the order became final by reason of section 5(g)(1), in which case such finding shall be conclusive if supported by evidence. In determining the amount of the civil penalty described in this section, the court shall take into account— the nature, circumstances, extent, and gravity of the violation, including the amount of commerce affected; with respect to the violator, in addition to the value received, the degree of culpability, any history of violations, the ability to pay, and any effect on the ability to continue doing business; and other matters that justice requires. Remedies provided in this subsection are in addition to any other remedy provided by Federal or State law. Nothing in this paragraph shall be construed to affect any authority of the Commission under any other provision of law. In this section: The term agreement resolving or settling a patent infringement claim includes any agreement that is entered into within 30 days before or after the resolution or the settlement of a patent infringement claim, or any other agreement that can be shown to be contingent upon, to provide a contingent condition for, or to be otherwise related to the resolution or settlement of the claim. The term ANDA means an abbreviated new drug application filed under section 505(j) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j) ) or a new drug application filed under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(b)(2) ). The term ANDA filer means a party that owns or controls an ANDA filed with the Commissioner of Food and Drugs or has the exclusive rights under such ANDA to distribute the ANDA product. The term ANDA product means the product to be manufactured under the ANDA that is the subject of the patent infringement claim. The term drug product has the meaning given such term in section 314.3(b) of title 21, Code of Federal Regulations (or any successor regulation). The term NDA means a new drug application filed under section 505(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(b) ). The term patent infringement claim means any allegation made to an ANDA filer, whether or not included in a complaint filed with a court, that the ANDA filer’s ANDA or ANDA product may infringe any of the following held by, or exclusively licensed to, the NDA holder of the drug product: Any patent. Any filed patent application. Any extension, reissue, renewal, division, continuation, continuation in part, or reexamination of a patent. Any patent term restoration, patents of addition, or extensions thereof. Any other patent interest. The term statutory exclusivity means those prohibitions on the approval of drug applications under clauses
(ii)through
(iv)of section 505(c)(3)(E) (5- and 3-year data exclusivity), section 527 (orphan drug exclusivity), section 505A (pediatric exclusivity), or section 505E (qualified infectious disease product exclusivity) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(c)(3)(E) , 360cc, 355a, 355f). . Section 27 of the Federal Trade Commission Act, as added by this section, shall apply to any agreement described in section 27(a)(2)(A) of that Act entered into after June 17, 2013. Section 27(f) of the Federal Trade Commission Act, as added by this section, shall apply to agreements entered into on or after the date of enactment of this Act.
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- 15 USC 57c–2
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