Teva v Crawford: Authorising 'authorised generics'?

摘要

In Teva Pharmaceuticals Industries Ltd v Crawford, 410 F.3d 51 (DC Cir. 2005), flu-US Court of Appeals for the District of Columbia (DC Circuit) ruled that 21 USC §355(j)(5)(13)(iv) - the section of the Hatch-Waxman Amendments that created the 180-day exclusivity period - did not prohibit the marketing of 'authorised generic drugs' before expiiy of that period. As the lower court decision explained, 'authorised generic drugs' are defined as 'generic drugs that are put on the market by the holder of a new drug application (NDA) as opposed to an 'ANDA generic drug', which is put on the market by the holder of an abbreviated new drug application (ANDA)' (355 F. Supn. 2d 111, 112, n.1 (DDC 2004)).