124 STAT. 812 PUBLIC LAW 111–148—MAR. 23, 2010 claim basis, the factual and legal basis of the opinion of the reference product sponsor that such patent will be infringed by the commercial marketing of the biological product that is the subject of the subsection (k) application and a response to the statement concerning validity and enforceability provided under subparagraph (B)(ii)(I). ‘‘(4) PATENT RESOLUTION NEGOTIATIONS.— ‘‘(A) IN GENERAL.—After receipt by the subsection (k) applicant of the statement under paragraph (3)(C), the reference product sponsor and the subsection (k) applicant shall engage in good faith negotiations to agree on which, if any, patents listed under paragraph (3) by the subsection (k) applicant or the reference product sponsor shall be the subject of an action for patent infringement under paragraph (6). ‘‘(B) FAILURE TO REACH AGREEMENT.—If, within 15 days of beginning negotiations under subparagraph (A), the sub- section (k) applicant and the reference product sponsor fail to agree on a final and complete list of which, if any, patents listed under paragraph (3) by the subsection (k) applicant or the reference product sponsor shall be the subject of an action for patent infringement under paragraph (6), the provisions of paragraph (5) shall apply to the parties. ‘‘(5) PATENT RESOLUTION IF NO AGREEMENT.— ‘‘(A) NUMBER OF PATENTS.—The subsection (k) applicant shall notify the reference product sponsor of the number of patents that such applicant will provide to the reference product sponsor under subparagraph (B)(i)(I). ‘‘(B) EXCHANGE OF PATENT LISTS.— ‘‘(i) IN GENERAL.—On a date agreed to by the sub- section (k) applicant and the reference product sponsor, but in no case later than 5 days after the subsection (k) applicant notifies the reference product sponsor under subparagraph (A), the subsection (k) applicant and the reference product sponsor shall simultaneously exchange— ‘‘(I) the list of patents that the subsection (k) applicant believes should be the subject of an action for patent infringement under paragraph (6); and ‘‘(II) the list of patents, in accordance with clause (ii), that the reference product sponsor believes should be the subject of an action for patent infringement under paragraph (6). ‘‘(ii) NUMBER OF PATENTS LISTED BY REFERENCE PRODUCT SPONSOR.— ‘‘(I) IN GENERAL.—Subject to subclause (II), the number of patents listed by the reference product sponsor under clause (i)(II) may not exceed the number of patents listed by the subsection (k) applicant under clause (i)(I). ‘‘(II) EXCEPTION.—If a subsection (k) applicant does not list any patent under clause (i)(I), the reference product sponsor may list 1 patent under clause (i)(II). ‘‘(6) IMMEDIATE PATENT INFRINGEMENT ACTION.— Deadlines. Deadline. Notification. Time period. Applicability.
