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Do fixed patent terms distort innovation? Evidence from cancer clinical trials

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  • Eric Budish

    (Booth School of Business)

  • Benjamin Roin

    (Harvard Law School)

  • Heidi Williams

    (Massachusetts Institute of Technology)

Abstract

Patents award innovators a fixed period of market exclusivity, e.g., 20 years in the United States. Yet, since in many industries firms file patents at the time of discovery ("invention") rather than first sale ("commercialization"), effective patent terms vary: inventions that commercialize at the time of invention receive a full patent term, whereas inventions that have a long time lag between invention and commercialization receive substantially reduced - or in extreme cases, zero - effective patent terms. We present a simple model formalizing how this variation may distort research and development (R&D). We then explore this distortion empirically in the context of cancer R&D, where clinical trials are shorter - and hence, effective patent terms longer - for drugs targeting late-stage cancer patients, relative to drugs targeting early-stage cancer patients or cancer prevention. Using a newly constructed data set on cancer clinical trial investments, we provide several sources of evidence consistent with fixed patent terms distorting cancer R&D. Back-of-the-envelope calculations suggest that the number of life-years at stake is large. We discuss three specific policy levers that could eliminate this distortion - patent design, targeted R&D subsidies, and surrogate (non-mortality) clinical trial endpoints - and provide empirical evidence that surrogate endpoints can be effective in practice.

Suggested Citation

  • Eric Budish & Benjamin Roin & Heidi Williams, 2013. "Do fixed patent terms distort innovation? Evidence from cancer clinical trials," Discussion Papers 13-001, Stanford Institute for Economic Policy Research.
  • Handle: RePEc:sip:dpaper:13-001
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    Cited by:

    1. Branstetter, Lee & Chatterjee, Chirantan & Higgins, Matthew J., 2022. "Generic competition and the incentives for early-stage pharmaceutical innovation," Research Policy, Elsevier, vol. 51(10).
    2. Stiglitz, Joseph E., 2015. "Leaders and followers: Perspectives on the Nordic model and the economics of innovation," Journal of Public Economics, Elsevier, vol. 127(C), pages 3-16.
    3. Michael Kremer & Christopher M. Snyder, 2015. "Preventives Versus Treatments," The Quarterly Journal of Economics, President and Fellows of Harvard College, vol. 130(3), pages 1167-1239.
    4. Michael Kremer & Christopher M. Snyder, 2018. "Worst-Case Bounds on R&D and Pricing Distortions: Theory with an Application Assuming Consumer Values Follow the World Income Distribution," NBER Working Papers 25119, National Bureau of Economic Research, Inc.
    5. Jeffrey Clemens & Stan Veuger, 2015. "Risks to the Returns to Medical Innovation: The Case of Myriad Genetics," NBER Working Papers 21469, National Bureau of Economic Research, Inc.
    6. David H. Howard & Peter B. Bach & Ernst R. Berndt & Rena M. Conti, 2015. "Pricing in the Market for Anticancer Drugs," NBER Working Papers 20867, National Bureau of Economic Research, Inc.
    7. Jeffrey Clemens & Stan Veuger, 2017. "Risks To The Returns To Medical Innovation: The Case Of Myriad Genetics," Contemporary Economic Policy, Western Economic Association International, vol. 35(2), pages 345-357, April.
    8. Clemens, Jeffrey, 2014. "Implications of Physician Ethics, Billing Norms, and Service Cost Structures for Medicare's Fee Schedule," MPRA Paper 73392, University Library of Munich, Germany.
    9. Matthew Grennan & Robert J. Town, 2020. "Regulating Innovation with Uncertain Quality: Information, Risk, and Access in Medical Devices," American Economic Review, American Economic Association, vol. 110(1), pages 120-161, January.
    10. Jeffrey Clemens & Joshua D. Gottlieb, 2017. "In the Shadow of a Giant: Medicare’s Influence on Private Physician Payments," Journal of Political Economy, University of Chicago Press, vol. 125(1), pages 1-39.
    11. Jeffrey Clemens, 2012. "The Effect of U.S. Health Insurance Expansions on Medical Innovation," Discussion Papers 11-016, Stanford Institute for Economic Policy Research.
    12. Kremer, Michael, 2018. "Worst-Case Bounds on R&D and Pricing Distortions: Theory and Disturbing Conclusions if Consumer Values Follow the World Income," CEPR Discussion Papers 13241, C.E.P.R. Discussion Papers.
    13. Wagner, Stefan & Wakeman, Simon, 2016. "What do patent-based measures tell us about product commercialization? Evidence from the pharmaceutical industry," Research Policy, Elsevier, vol. 45(5), pages 1091-1102.
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