Patents, Innovation, and Competition in Pharmaceuticals: The Hatch-Waxman Act After 40 Years
回顾美国哈奇-韦克斯曼法案40年来的影响，分析其对药品竞争与创新的平衡效果，揭示品牌药企积累专利、仿制药企挑战专利的僵局，以及专利延期条款的缺陷。
A central policy issue in pharmaceuticals is how to balance the dynamic benefits of new drugs against the static benefits of low prices for existing drugs. In the United States, that balance is set by the Hatch-Waxman Act. We review the Act's origins and key features, then present evidence on its effects on competition and innovation. On the competition side, we show how the Act creates incentives for brands to accumulate patents and generics to challenge them, with the result being a rough stalemate. We also discuss strategies deployed by brands to delay generic entry. On the innovation side, we show that the Act's patent extension provisions — which aim to allow branded firms to make up for time lost during clinical trials and regulatory review — are incomplete, resulting in potential distortions. The net result is a convoluted and expensive approach to balancing innovation and competition.