Page:United States Statutes at Large Volume 124.djvu/836

 124 STAT. 810 PUBLIC LAW 111–148—MAR. 23, 2010 or exclusively licensed by the reference product sponsor, whether a claim of patent infringement could reasonably be asserted if the subsection (k) applicant engaged in the manufacture, use, offering for sale, sale, or importation into the United States of the biological product that is the subject of the application under subsection (k). ‘‘(E) OWNERSHIP OF CONFIDENTIAL INFORMATION.—The confidential information disclosed under this paragraph is, and shall remain, the property of the subsection (k) applicant. By providing the confidential information pursu- ant to this paragraph, the subsection (k) applicant does not provide the reference product sponsor or the outside counsel any interest in or license to use the confidential information, for purposes other than those specified in subparagraph (D). ‘‘(F) EFFECT OF INFRINGEMENT ACTION.—In the event that the reference product sponsor files a patent infringe- ment suit, the use of confidential information shall continue to be governed by the terms of this paragraph until such time as a court enters a protective order regarding the information. Upon entry of such order, the subsection (k) applicant may redesignate confidential information in accordance with the terms of that order. No confidential information shall be included in any publicly-available com- plaint or other pleading. In the event that the reference product sponsor does not file an infringement action by the date specified in paragraph (6), the reference product sponsor shall return or destroy all confidential information received under this paragraph, provided that if the ref- erence product sponsor opts to destroy such information, it will confirm destruction in writing to the subsection (k) applicant. ‘‘(G) RULE OF CONSTRUCTION.—Nothing in this para- graph shall be construed— ‘‘(i) as an admission by the subsection (k) applicant regarding the validity, enforceability, or infringement of any patent; or ‘‘(ii) as an agreement or admission by the sub- section (k) applicant with respect to the competency, relevance, or materiality of any confidential informa- tion. ‘‘(H) EFFECT OF VIOLATION.—The disclosure of any con- fidential information in violation of this paragraph shall be deemed to cause the subsection (k) applicant to suffer irreparable harm for which there is no adequate legal remedy and the court shall consider immediate injunctive relief to be an appropriate and necessary remedy for any violation or threatened violation of this paragraph. ‘‘(2) SUBSECTION (k) APPLICATION INFORMATION.—Not later than 20 days after the Secretary notifies the subsection (k) applicant that the application has been accepted for review, the subsection (k) applicant— ‘‘(A) shall provide to the reference product sponsor a copy of the application submitted to the Secretary under subsection (k), and such other information that describes the process or processes used to manufacture the biological product that is the subject of such application; and Deadline. Notification.