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

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  • Rzakhanov, Zaur

Abstract

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.

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  • Rzakhanov, Zaur, 2008. "Regulatory policy, value of knowledge assets and innovation strategy: The case of the Orphan Drug Act," Research Policy, Elsevier, vol. 37(4), pages 673-689, May.
    • Handle: RePEc:eee:respol:v:37:y:2008:i:4:p:673-689
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    Cited by:

    1. Philippe Gorry & Diego Useche, 2018. "Orphan Drug Designations as Valuable Intangible Assets for IPO Investors in Pharma-Biotech Companies," NBER Chapters, in: Economic Dimensions of Personalized and Precision Medicine, pages 305-334, National Bureau of Economic Research, Inc.
    2. Angelo Kenneth S. Romasanta & Peter Sijde & Jacqueline Muijlwijk-Koezen, 2020. "Innovation in pharmaceutical R&D: mapping the research landscape," Scientometrics, Springer;Akadémiai Kiadó, vol. 125(3), pages 1801-1832, December.
    3. Olga Bruyaka & Hanko Zeitzmann & Isabelle Chalamon & Richard Wokutch & Pooja Thakur, 2013. "Strategic Corporate Social Responsibility and Orphan Drug Development: Insights from the US and the EU Biopharmaceutical Industry," Journal of Business Ethics, Springer, vol. 117(1), pages 45-65, September.
    4. Koh, Yumi & Lee, Gea M., 2023. "R&D subsidies in permissive and restrictive environment: Evidence from Korea," Research Policy, Elsevier, vol. 52(1).

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