Pharmaceutical Reverse Payment Settlements: Presumptions, Procedural Burdens, And Covenants Not To Sue Generic Drug Manufacturers

This Article analyzes recent developments in antitrust law, focusing on agreements between pharmaceutical patent holders and generic drug manufacturers that require a generic manufacturer to delay its market entry in exchange for a payment or other consideration from the patent holder.A predictable consequence of settlements that delay the marketing of a generic drug is that prices for the patented drug will remain higher than if the generic competitor had prevailed in its challenge to the patent's validity or the patent holder had failed to show that the generic infringed on its patent.Analysis of the legality of these settlements has huge consequences for drug competition, health care costs, the average American family budget, the law, and public policy. I.