Page:United States Statutes at Large Volume 124.djvu/837

 124 STAT. 811 PUBLIC LAW 111–148—MAR. 23, 2010 ‘‘(B) may provide to the reference product sponsor addi- tional information requested by or on behalf of the reference product sponsor. ‘‘(3) LIST AND DESCRIPTION OF PATENTS.— ‘‘(A) LIST BY REFERENCE PRODUCT SPONSOR.—Not later than 60 days after the receipt of the application and information under paragraph (2), the reference product sponsor shall provide to the subsection (k) applicant— ‘‘(i) a list of patents for which the reference product sponsor believes a claim of patent infringement could reasonably be asserted by the reference product sponsor, or by a patent owner that has granted an exclusive license to the reference product sponsor with respect to the reference product, if a person not licensed by the reference product sponsor engaged in the making, using, offering to sell, selling, or importing into the United States of the biological product that is the subject of the subsection (k) application; and ‘‘(ii) an identification of the patents on such list that the reference product sponsor would be prepared to license to the subsection (k) applicant. ‘‘(B) LIST AND DESCRIPTION BY SUBSECTION (k) APPLICANT.—Not later than 60 days after receipt of the list under subparagraph (A), the subsection (k) applicant— ‘‘(i) may provide to the reference product sponsor a list of patents to which the subsection (k) applicant believes a claim of patent infringement could reason- ably be asserted by the reference product sponsor if a person not licensed by the reference product sponsor engaged in the making, using, offering to sell, selling, or importing into the United States of the biological product that is the subject of the subsection (k) applica- tion; ‘‘(ii) shall provide to the reference product sponsor, with respect to each patent listed by the reference product sponsor under subparagraph (A) or listed by the subsection (k) applicant under clause (i)— ‘‘(I) a detailed statement that describes, on a claim by claim basis, the factual and legal basis of the opinion of the subsection (k) applicant that such patent is invalid, unenforceable, or will not be infringed by the commercial marketing of the biological product that is the subject of the sub- section (k) application; or ‘‘(II) a statement that the subsection (k) applicant does not intend to begin commercial mar- keting of the biological product before the date that such patent expires; and ‘‘(iii) shall provide to the reference product sponsor a response regarding each patent identified by the reference product sponsor under subparagraph (A)(ii). ‘‘(C) DESCRIPTION BY REFERENCE PRODUCT SPONSOR.— Not later than 60 days after receipt of the list and state- ment under subparagraph (B), the reference product sponsor shall provide to the subsection (k) applicant a detailed statement that describes, with respect to each patent described in subparagraph (B)(ii)(I), on a claim by Deadlines.