Generic Drugs and Innovative Drug Incentives: Early Dispute Resolution Mechanism in China

Abstract

The early dispute resolution mechanism created a new foundation for pharmaceutical innovation and expanding access to generics in China. This article examines the evolution of pharmaceutical regulation, explores the structure of early dispute resolution provisions, and analyzes the implications for generics and innovators through a comparative approach. It concludes that the early dispute resolution will encourage generic companies to challenge patents early and often. For example, the long exclusivity, the short waiting period, and the bifurcated adjudication system provide legal incentives to early generic entry. The unclarified and unlimited notification system set legal impediments to disincentive innovators asserting their right. Moreover, an increase in filing of weak generic claims motivated by the prospect of a future long exclusivity might bring little consumer benefit.