definiens: means those Products for which an ANDA ( Abbreviat ed New Drug Application ) underSection 505(j ) ( 21 USC 355 et . seq . ) or an NDA ( New Drug Application ) under Section 5 05 ( b ) ( 2 ) of the Federal Food, Drugand Cosmetic Act has been filed with the FDA and fo r which certification has been provided under Secti on 505(j)(2)(A)(vii)(IV ) or Section 505 ( B)(2)(A)(iv ) to the effect that some or all Orange Book listed pate nts are invalid or will not beinfringed by the manufacture, use, or sale of the n ew drug for which the application is submitted and which may become thesubject of litigation for patent infringement under Section 505 ( 21 USC 355 et . seq . ) filed by the owner of the Orange Booklisted patents