Patents, Data Exclusivity, and the Development of New Drugs
专利、数据独占与新药开发
Abstract Pharmaceutical firms enjoy market exclusivity for new drugs from concurrent patent protection and exclusivity of the clinical trials data submitted for market approval. Patent invalidation during drug development renders data exclusivity the sole source of protection and shifts the period of market exclusivity. In instrumental variables regressions, we quantify the effect of a one-year reduction in expected market exclusivity on the likelihood of drug…