Patents, Data Exclusivity, and the Development of New Drugs
研究了专利无效后数据独占权如何影响新药上市概率，发现早期专利失效和大药企的反应是主要驱动因素，并估算了研发投资对市场独占期预期的敏感度。
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 commercialization. The effect is largely driven by patent invalidations early in the drug development process and by the responses of large originators. We provide estimates of the responsiveness of R&D investments to market exclusivity expectations.