Technology, R&D management
Patent, pharmaceuticals, drug development
Firms in the pharmaceutical industry typically rely on a period of market exclusivity derived from patent protection and data exclusivity to recoup their investments in R&D. The invalidation of patent rights during drug development renders data exclusivity the sole source of protection and shifts the period of market exclusivity at the project level. Invalidation therefore constitutes a natural experiment that allows us to identify how the duration of market exclusivity affects firms' incentives to innovate. Our analysis is based on a novel data set that links the development histories of drug candidates with underlying patent data. We identify causal effects relying on an instrument for the potentially endogenous patent invalidation. Our findings highlight that shorter durations of market exclusivity reduce the hazards of successful drug commercialization.
With permission of the Academy of Management