Page:United States Statutes at Large Volume 117.djvu/2473

 117 STAT. 2454

(II) by striking clause (i) and inserting the following: ‘‘(i) if before the expiration of such period the district court decides that the patent is invalid or not infringed (including any substantive determination that there is no cause of action for patent infringement or invalidity), the approval shall be made effective on— ‘‘(I) the date on which the court enters judgment reflecting the decision; or ‘‘(II) the date of a settlement order or consent decree signed and entered by the court stating that the patent that is the subject of the certification is invalid or not infringed;’’; (III) by striking clause (ii) and inserting the following: ‘‘(ii) if before the expiration of such period the district court decides that the patent has been infringed— ‘‘(I) if the judgment of the district court is appealed, the approval shall be made effective on— ‘‘(aa) the date on which the court of appeals decides that the patent is invalid or not infringed (including any substantive determination that there is no cause of action for patent infringement or invalidity); or ‘‘(bb) the date of a settlement order or consent decree signed and entered by the court of appeals stating that the patent that is the subject of the certification is invalid or not infringed; or ‘‘(II) if the judgment of the district court is not appealed or is affirmed, the approval shall be made effective on the date specified by the district court in a court order under section 271(e)(4)(A) of title 35, United States Code;’’; (IV) in clause (iii), by striking ‘‘on the date of such court decision.’’ and inserting ‘‘as provided in clause (i); or’’; (V) by inserting after clause (iii), the following: ‘‘(iv) if before the expiration of such period the court grants a preliminary injunction prohibiting the applicant from engaging in the commercial manufacture or sale of the drug until the court decides the issues of patent validity and infringement and if the court decides that such patent has been infringed, the approval shall be made effective as provided in clause (ii).’’; and (VI) in the matter after and below clause (iv) (as added by subclause (V)), by striking ‘‘Until the expiration’’ and all that follows; and (iii) in the third sentence, by striking ‘‘paragraph (3)(B)’’ and inserting ‘‘subsection (b)(3)’’; (C) by redesignating subparagraph (D) as subparagraph (E); and (D) by inserting after subparagraph (C) the following: ‘‘(D) CIVIL ACTION TO OBTAIN PATENT CERTAINTY.— ‘‘(i) DECLARATORY JUDGMENT ABSENT INFRINGEMENT ACTION.— ‘‘(I) IN GENERAL.—No action may be brought under section 2201 of title 28, United States Code,

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13:59 Aug 30, 2004

PUBLIC LAW 108–173—DEC. 8, 2003

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