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crisis has brought the optimal design of pharmaceutical patent policy to the fore. In this paper we evaluate patent policy in … the US pharmaceutical industry. We estimate the effect of patent length and scope on generic entry prior to the expiration … of new drug patents using two quasi-experimental approaches: one based on changes in patent laws and another on the …
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This paper introduces a newly digitized, open-access version of the Food and Drug Administration's "Orange Book"--a linkage between approved small-molecule drugs and the patents that protect them. The Orange Book also reports any applicable regulatory exclusivity that prevents competitive entry....
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