; and (B) would have bought the follow-on product solely because of the significant health improvement that those individuals would experience. (14) Ultimate parent entity The term ultimate parent entity has the meaning given the term in section 801.1 of title 16, Code of Federal Regulations, or any successor regulation. (15) Underlying composition of matter patent The term underlying composition of matter patent means a patent with respect to the molecules, compounds, or new formulations of the active ingredient of a drug or biological product. (b) Prohibitions (1) Patent thicketing (A) Prima facie Except as provided in subparagraph (B), an action by a drug manufacturer that constitutes patent thicketing shall be considered to be an unfair method of competition in or affecting commerce in violation of section 5(a). (B) Rebuttal (i) In general Subject to subparagraph (C), an action that constitutes patent thicketing shall not be considered to be an unfair method of competition in or affecting commerce in violation of section 5(a) if the manufacturer described in that paragraph demonstrates to the Commission or a district court of the United States, as applicable, by a preponderance of the evidence in a proceeding initiated by the Commission under subsection (c)(1)(A), or in a suit brought under subparagraph (B) or (C) of subsection (c)(1), that the anticompetitive effects of the action do not outweigh the pro-competitive effects of the action. (ii) Evidence In making a demonstration under clause (i) that the anticompetitive effects of patent thicketing do not outweigh the pro-competitive effects of that behavior, a manufacturer described in subparagraph (A)— (I) may present evidence that— (aa) the inventions claimed in the additional patents described in subclauses (I) and (II) of subsection (a)(11)(A)(i) resulted in— (AA) clinically meaningful and significant therapeutic or safety benefits; (BB) significantly improved product purity or potency; (CC) significant gained efficiencies in manufacturing