Introduction
Since 2000, more than 500 new medicines have been approved by the US Food and Drug Administration (FDA). Those drugs have extended and enhanced millions of people’s lives. Globally, there are more than 7000 medicines in development to treat and cure a vast array of diseases and afflictions. And 74% of those experimental drugs are potentially first-in-class, meaning they treat disease in an entirely novel way (PhRMA 2015). Of the medicines in development, the lion’s share – more than 5000 – come from labs in the United States (PhRMA 2015). This is not coincidental. The research takes place in the United States, because it is incentivized and rewarded in the United States through robust intellectual property protections, including patents.
Both theoretical and empirical work consistently finds that patents play an important role in maintaining competitive advantage, and that in the biopharmaceutical industry they are more important than any other factor. Scherer (2005)...
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Further Reading
Cockburn, I. M., Lanjouw, J. O., & Schankerman, M. (2016). Patents and the global diffusion of new drugs. American Economic Review, 106(1), 136–164 Available at: https://www.aeaweb.org/articles?id=10.1257/aer.20141482.
DiMasi, J. A., Grabowski, H. G., & Hanson, R. W. (2016). Innovation in the pharmaceutical industry: New estimates of R&D costs. Journal of Health Economics, 47, 20–33 Available at: https://www.sciencedirect.com/science/article/abs/pii/S0167629616000291.
Lietzan, E. (2020). The ‘evergreening’ metaphor in intellectual property scholarship. Akron Law Review, forthcoming. Available at: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3537035
Lietzan, E., & Acri Née Lybecker, K. M. L. (2020). Distorted drug patents. Washington Law Review, forthcoming, 2020. Available at: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3458588
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Scherer, F. M. (2005). Patents: Economics, policy and measurement. Cheltenham, UK/Northampton: Elgar.
Wertheimer, A., Levy, R., & O’Connor, T. (2001). Too many drugs? The clinical and economic value of incremental innovations. In Investing in health: The social and economic benefits of health care innovation (Vol. 14, pp. 77–188). Bingley: Emerald Group Publishing.
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Acri née Lybecker, K.M.L. (2023). Pharmaceutical Patent Protection: Key Issues and Dilemmas. In: Romaniuk, S.N., Marton, P.N. (eds) The Palgrave Encyclopedia of Global Security Studies. Palgrave Macmillan, Cham. https://doi.org/10.1007/978-3-319-74319-6_635
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