Regulatory policy, value of knowledge assets and innovation strategy: The case of the Orphan Drug Act

The U.S. Orphan Drug Act provides R&D incentives to drug-makers that go beyond statutory patent protection. The study explores the act's effect on financial returns to innovation and on the strategy of orphan drug development. Results indicate that the financial return to orphan drug development is positive. The findings suggest that when market size is small and cumulative innovation is an important phenomenon the policy that extends effective patent duration or subsidizes R&D activity improves incentives to innovate.