Page:United States Statutes at Large Volume 124.djvu/841

124 STAT. 815 PUBLIC LAW 111–148—MAR. 23, 2010 ‘‘(2) The term ‘biosimilar’ or ‘biosimilarity’, in reference to a biological product that is the subject of an application under subsection (k), means— ‘‘(A) that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components; and ‘‘(B) there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product. ‘‘(3) The term ‘interchangeable’ or ‘interchangeability’, in reference to a biological product that is shown to meet the standards described in subsection (k)(4), means that the biological product may be substituted for the reference product without the intervention of the health care provider who pre- scribed the reference product. ‘‘(4) The term ‘reference product’ means the single biological product licensed under subsection (a) against which a biological product is evaluated in an application submitted under sub- section (k).’’. (c) CONFORMING AMENDMENTS RELATING TO PATENTS.— (1) PATENTS.—Section 271(e) of title 35, United States Code, is amended— (A) in paragraph (2)— (i) in subparagraph (A), by striking ‘‘or’’ at the end; (ii) in subparagraph (B), by adding ‘‘or’’ at the end; and (iii) by inserting after subparagraph (B) the fol- lowing: ‘‘(C)(i) with respect to a patent that is identified in the list of patents described in section 351(l)(3) of the Public Health Service Act (including as provided under section 351(l)(7) of such Act), an application seeking approval of a biological product, or ‘‘(ii) if the applicant for the application fails to provide the application and information required under section 351(l)(2)(A) of such Act, an application seeking approval of a biological product for a patent that could be identified pursu- ant to section 351(l)(3)(A)(i) of such Act,’’; and (iv) in the matter following subparagraph (C) (as added by clause (iii)), by striking ‘‘or veterinary biological product’’ and inserting ‘‘, veterinary biological product, or biological product’’; (B) in paragraph (4)— (i) in subparagraph (B), by— (I) striking ‘‘or veterinary biological product’’ and inserting ‘‘, veterinary biological product, or biological product’’; and (II) striking ‘‘and’’ at the end; (ii) in subparagraph (C), by— (I) striking ‘‘or veterinary biological product’’ and inserting ‘‘, veterinary biological product, or biological product’’; and (II) striking the period and inserting ‘‘, and’’; (iii) by inserting after subparagraph (C) the fol- lowing: