The Drug Repurposing Ecosystem: Intellectual Property Incentives
Halabi: The Drug Repurposing Ecosystem: Intellectual Property Incentives, The Drug Repurposing Ecosystem: Intellectual Property Incentives, Market Exclusivity, and the Future of "New" Medicines Sam F. Halabil 20 YALE J. L. & TECH. 1 (2018) 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 rep urposing"-findingnew ways to deploy approved drugs or abandoned clinical candidates in new disease areas. Despite the efficiency advantages of repurposing drugs, 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 Fulbright Canada Research Chair in Health Law, Policy, and Ethics, University of Ottawa and Associate Professor, University of Missouri School of Law.; J.D. Harvard; M.Phil. The University of Oxford (St. Antony's College); B.A., B.S. Kansas State University. The author is grateful for comments and helpful suggestions given at faculty workshops at Arizona State University's Sandra Day O'Connor School of Law, Boston University's biolP Faculty Workshop, and Seton Hall University School of Law, as well as the American Society of Law, Medicine, and Ethics' Annual Health Law Professors Conference.
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