Page:United States Statutes at Large Volume 124.djvu/839

124 STAT. 813 PUBLIC LAW 111–148—MAR. 23, 2010 ‘‘(A) ACTION IF AGREEMENT ON PATENT LIST.—If the subsection (k) applicant and the reference product sponsor agree on patents as described in paragraph (4), not later than 30 days after such agreement, the reference product sponsor shall bring an action for patent infringement with respect to each such patent. ‘‘(B) ACTION IF NO AGREEMENT ON PATENT LIST.—If the provisions of paragraph (5) apply to the parties as described in paragraph (4)(B), not later than 30 days after the exchange of lists under paragraph (5)(B), the reference product sponsor shall bring an action for patent infringe- ment with respect to each patent that is included on such lists. ‘‘(C) NOTIFICATION AND PUBLICATION OF COMPLAINT.— ‘‘(i) NOTIFICATION TO SECRETARY.—Not later than 30 days after a complaint is served to a subsection (k) applicant in an action for patent infringement described under this paragraph, the subsection (k) applicant shall provide the Secretary with notice and a copy of such complaint. ‘‘(ii) PUBLICATION BY SECRETARY.—The Secretary shall publish in the Federal Register notice of a com- plaint received under clause (i). ‘‘(7) NEWLY ISSUED OR LICENSED PATENTS.—In the case of a patent that— ‘‘(A) is issued to, or exclusively licensed by, the ref- erence product sponsor after the date that the reference product sponsor provided the list to the subsection (k) applicant under paragraph (3)(A); and ‘‘(B) the reference product sponsor reasonably believes that, due to the issuance of such patent, a claim of patent infringement could reasonably 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) application, not later than 30 days after such issuance or licensing, the reference product sponsor shall provide to the subsection (k) applicant a supplement to the list provided by the reference product sponsor under paragraph (3)(A) that includes such patent, not later than 30 days after such supplement is pro- vided, the subsection (k) applicant shall provide a statement to the reference product sponsor in accordance with paragraph (3)(B), and such patent shall be subject to paragraph (8). ‘‘(8) NOTICE OF COMMERCIAL MARKETING AND PRELIMINARY INJUNCTION.— ‘‘(A) NOTICE OF COMMERCIAL MARKETING.—The sub- section (k) applicant shall provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the biological product licensed under subsection (k). ‘‘(B) PRELIMINARY INJUNCTION.—After receiving the notice under subparagraph (A) and before such date of the first commercial marketing of such biological product, the reference product sponsor may seek a preliminary injunction prohibiting the subsection (k) applicant from Deadline. Deadlines. Federal Register, publication. Notice.