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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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    References listed on IDEAS

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    1. Hall, B.H., 1999. "Innovation and Market Value," Economics Papers 1999-w3, Economics Group, Nuffield College, University of Oxford.
    2. Bronwyn H. Hall & Adam B. Jaffe & Manuel Trajtenberg, 2001. "The NBER Patent Citation Data File: Lessons, Insights and Methodological Tools," NBER Working Papers 8498, National Bureau of Economic Research, Inc.
    3. Daron Acemoglu & Joshua Linn, 2004. "Market Size in Innovation: Theory and Evidence from the Pharmaceutical Industry," The Quarterly Journal of Economics, Oxford University Press, vol. 119(3), pages 1049-1090.
    4. Rosen, Sherwin, 1974. "Hedonic Prices and Implicit Markets: Product Differentiation in Pure Competition," Journal of Political Economy, University of Chicago Press, vol. 82(1), pages 34-55, Jan.-Feb..
    5. Brown, James N & Rosen, Harvey S, 1982. "On the Estimation of Structural Hedonic Price Models," Econometrica, Econometric Society, vol. 50(3), pages 765-768, May.
    6. Frank R. Lichtenberg & Joel Waldfogel, 2003. "Does Misery Love Company? Evidence from pharmaceutical markets before and after the Orphan Drug Act," NBER Working Papers 9750, National Bureau of Economic Research, Inc.
    7. Amy Finkelstein, 2004. "Static and Dynamic Effects of Health Policy: Evidence from the Vaccine Industry," The Quarterly Journal of Economics, Oxford University Press, vol. 119(2), pages 527-564.
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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 National Bureau of Economic Research, Inc.
    2. 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.

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