Page:United States Statutes at Large Volume 124.djvu/833

 124 STAT. 807 PUBLIC LAW 111–148—MAR. 23, 2010 such authority applies to biological products licensed under subsection (a). ‘‘(6) EXCLUSIVITY FOR FIRST INTERCHANGEABLE BIOLOGICAL PRODUCT.—Upon review of an application submitted under this subsection relying on the same reference product for which a prior biological product has received a determination of inter- changeability for any condition of use, the Secretary shall not make a determination under paragraph (4) that the second or subsequent biological product is interchangeable for any condition of use until the earlier of— ‘‘(A) 1 year after the first commercial marketing of the first interchangeable biosimilar biological product to be approved as interchangeable for that reference product; ‘‘(B) 18 months after— ‘‘(i) a final court decision on all patents in suit in an action instituted under subsection (l)(6) against the applicant that submitted the application for the first approved interchangeable biosimilar biological product; or ‘‘(ii) the dismissal with or without prejudice of an action instituted under subsection (l)(6) against the applicant that submitted the application for the first approved interchangeable biosimilar biological product; or ‘‘(C)(i) 42 months after approval of the first inter- changeable biosimilar biological product if the applicant that submitted such application has been sued under sub- section (l)(6) and such litigation is still ongoing within such 42-month period; or ‘‘(ii) 18 months after approval of the first interchange- able biosimilar biological product if the applicant that sub- mitted such application has not been sued under subsection (l)(6). For purposes of this paragraph, the term ‘final court decision’ means a final decision of a court from which no appeal (other than a petition to the United States Supreme Court for a writ of certiorari) has been or can be taken. ‘‘(7) EXCLUSIVITY FOR REFERENCE PRODUCT.— ‘‘(A) EFFECTIVE DATE OF BIOSIMILAR APPLICATION APPROVAL.—Approval of an application under this sub- section may not be made effective by the Secretary until the date that is 12 years after the date on which the reference product was first licensed under subsection (a). ‘‘(B) FILING PERIOD.—An application under this sub- section may not be submitted to the Secretary until the date that is 4 years after the date on which the reference product was first licensed under subsection (a). ‘‘(C) FIRST LICENSURE.—Subparagraphs (A) and (B) shall not apply to a license for or approval of— ‘‘(i) a supplement for the biological product that is the reference product; or ‘‘(ii) a subsequent application filed by the same sponsor or manufacturer of the biological product that is the reference product (or a licensor, predecessor in interest, or other related entity) for— ‘‘(I) a change (not including a modification to the structure of the biological product) that results Definition.