Page:United States Statutes at Large Volume 124.djvu/840

124 STAT. 814 PUBLIC LAW 111–148—MAR. 23, 2010 engaging in the commercial manufacture or sale of such biological product until the court decides the issue of patent validity, enforcement, and infringement with respect to any patent that is— ‘‘(i) included in the list provided by the reference product sponsor under paragraph (3)(A) or in the list provided by the subsection (k) applicant under para- graph (3)(B); and ‘‘(ii) not included, as applicable, on— ‘‘(I) the list of patents described in paragraph (4); or ‘‘(II) the lists of patents described in paragraph (5)(B). ‘‘(C) REASONABLE COOPERATION.—If the reference product sponsor has sought a preliminary injunction under subparagraph (B), the reference product sponsor and the subsection (k) applicant shall reasonably cooperate to expe- dite such further discovery as is needed in connection with the preliminary injunction motion. ‘‘(9) LIMITATION ON DECLARATORY JUDGMENT ACTION.— ‘‘(A) SUBSECTION (k) APPLICATION PROVIDED.—If a sub- section (k) applicant provides the application and informa- tion required under paragraph (2)(A), neither the reference product sponsor nor the subsection (k) applicant may, prior to the date notice is received under paragraph (8)(A), bring any action under section 2201 of title 28, United States Code, for a declaration of infringement, validity, or enforce- ability of any patent that is described in clauses (i) and (ii) of paragraph (8)(B). ‘‘(B) SUBSEQUENT FAILURE TO ACT BY SUBSECTION (k) APPLICANT.—If a subsection (k) applicant fails to complete an action required of the subsection (k) applicant under paragraph (3)(B)(ii), paragraph (5), paragraph (6)(C)(i), paragraph (7), or paragraph (8)(A), the reference product sponsor, but not the subsection (k) applicant, may bring an action under section 2201 of title 28, United States Code, for a declaration of infringement, validity, or enforce- ability of any patent included in the list described in para- graph (3)(A), including as provided under paragraph (7). ‘‘(C) SUBSECTION (k) APPLICATION NOT PROVIDED.—If a subsection (k) applicant fails to provide the application and information required under paragraph (2)(A), the ref- erence product sponsor, but not the subsection (k) applicant, may bring an action under section 2201 of title 28, United States Code, for a declaration of infringement, validity, or enforceability of any patent that claims the biological product or a use of the biological product.’’. (b) DEFINITIONS.—Section 351(i) of the Public Health Service Act (42 U.S.C. 262(i)) is amended— (1) by striking ‘‘In this section, the term ‘biological product’ means’’ and inserting the following: ‘‘In this section: ‘‘(1) The term ‘biological product’ means’’; (2) in paragraph (1), as so designated, by inserting ‘‘protein (except any chemically synthesized polypeptide),’’ after ‘‘aller- genic product,’’; and (3) by adding at the end the following: