Abstract

There are conflicting opinions on whether the existing US legal and economic environment for pharmaceutical research is conducive for the repurposing of patent-protected drugs. This article therefore addresses the following innovation policy questions: Does US patent law and regulatory policy assign sufficient value to new use patents in the pharmaceutical industry? If present law and regulatory policy does assign sufficient value, what evidence is there that the pharmaceutical industry is actively involved in technology strategies to repurpose existing pharmaceuticals? Based on an evaluation of the extant legal literature, US pharmaceutical firms are generally successful at legally enforcing their new use patents against infringement. Furthermore, the truncating of the time and resources dedicated to the drug discovery, development, and regulatory review process provide sufficient economic "value" on both the front end of the pharmaceutical regulatory approval process, and the back end of the drug patent term for encouraging pharmaceutical industry repurposing.

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