The Drug Repurposing Ecosystem

70 Pages Posted: 21 Apr 2017 Last revised: 7 Dec 2017

Sam Halabi

University of Missouri School of Law

Date Written: April 20, 2017

Abstract

The pharmaceutical industry is in a state of fundamental transition. New drug approvals have slowed, patents on blockbuster drugs are expiring, and costs associated with developing new drugs are escalating and yielding fewer viable drug candidates. As a result, pharmaceutical firms have turned to a number of alternative strategies for growth. One of these strategies is “drug repurposing” – finding new ways to deploy approved drugs or abandoned clinical candidates in new disease areas. Despite the efficiency advantages repurposed drugs show, there is broad agreement that there is insufficient repurposing activity because of numerous intellectual property protection and market failures. This article examines the system that surrounds drug repurposing including serendipitous discovery, the application of “big data” methods to prioritize promising repurposing candidates, the unorthodoxly regulated off-label prescription practices of providers and related prohibitions on pharmaceutical firms’ off-label marketing. The article argues that there is a complex ecosystem in place and that additional or disruptive IP or market exclusivity incentives may harm as much as help in promoting repurposing activity. To illustrate this threat, the article traces the trajectory of metformin, a common diabetes drug that shows promise for conditions ranging from polycystic ovary syndrome to breast cancer. From the initial reasons for Bristol Myers Squibb to refuse to invest in promising alternative uses to the institutions, researchers, and regulators who identified possibilities for metformin treatment, this article aims to map the role of intellectual property protection, market exclusivity, and search for capital that led to metformin’s ascent as a repurposed drug. The article contributes a concrete understanding to a problem for which scholars have quickly suggested more powerful patent and market exclusivity protection when doing so may undermine the very processes now leading to effective alternative uses for existing drugs.

Suggested Citation

Halabi, Sam, The Drug Repurposing Ecosystem (April 20, 2017). 20 Yale J. L. & Tech. (2017); University of Missouri School of Law Legal Studies Research Paper No. 2017-29. Available at SSRN: https://ssrn.com/abstract=2955873

Sam Halabi (Contact Author)

University of Missouri School of Law ( email )

332 Cornell Hall
Columbia, MO Columbia 65211
United States

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