The innovation paradox: pharmaceutical marketing exclusivity and incentives for drug development

摘要

Abstract Objectives Biopharmaceutical innovation is highly dependent on a period of exclusive marketing after approval, to cover the costs of research and development programs. Longer R&D programs are not, however, associated with longer periods of exclusive marketing. Instead exclusivity dwindles with each additional month of pre‐commercialization research — an innovation paradox. Methods Drawing on the length of premarket programs from 1984 to 2016 using a dataset of regulatory milestones made public through FDA's implementation of the patent term restoration provisions of the 1984 Hatch‐Waxman statute, this article explores the impact of the innovation paradox on drug research and development decisions. Key Findings Lengthy clinical testing periods can lead to shortened effective patent life. Conclusions If the length of the pre‐market process correlates with particular drug types, disease targets, or studied outcomes, we may be offering an inadequate incentive in entire areas of medicine where we have a critical need for new treatments.