Orange Book Patent Listing: The Rationale and Economic Impact of the New Rule

Listing a patent in the US Food and Drug Administration's (FDA) ‘Orange Book’ of approved pharmaceuticals brings some significant advantages to the patent owner. The FDA has recently changed its requirements for listing patents in the Orange Book. The rule's significant economic impact creates a unique opportunity to build valuable new pharmaceutical product lines. In this paper, the rationale for the new rule will be reviewed and its significant economic impact — expected, over the next decade, to add $19bn in revenues to generic drug manufacturers and to take away $52bn in innovator manufacturer revenues — measured. Moreover, the legal advantages of listing patents in the Orange Book, potential obstacles to listing a patent and the way in which the rule applies to patents on polymorphic forms of approved therapeutic products will be examined.