About | HeinOnline Law Journal Library | HeinOnline Law Journal Library | HeinOnline
LOG IN
LOG IN

20 Yale J.L. & Tech. 1 (2018)

handle is hein.journals/yjolt20 and id is 1 raw text is: 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-finding new 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. Particular thanks go to Mark Bartholomew, Jenelle Beavers, Carl Coleman, Paul Gugliuzza, Yaniv Heled, Cynthia Ho, John Jacobi, Kristin Johnson, Dmitry Karshtedt, Aaron Kesselheim, Renee Landers, Peter Lee, Erika Lietzan, Maggie Lewis, Molly McBurney, Michael Meurer, Fran Miller, Emily Michiko Morris, Kevin Outterson, Jordan Paradise, Michael Risinger, Alice Ristroph, Christopher Robertson, William Sage, Brian Shephard, Michael Simkovic, Ashley Stevens, Liza Vertinsky, and Kathy Zeiler. Special thanks go to Katie Spraberry for excellent research assistance.

What Is HeinOnline?

HeinOnline is a subscription-based resource containing thousands of academic and legal journals from inception; complete coverage of government documents such as U.S. Statutes at Large, U.S. Code, Federal Register, Code of Federal Regulations, U.S. Reports, and much more. Documents are image-based, fully searchable PDFs with the authority of print combined with the accessibility of a user-friendly and powerful database. For more information, request a quote or trial for your organization below.



Short-term subscription options include 24 hours, 48 hours, or 1 week to HeinOnline.

Purchase Access

Contact us for annual subscription options:

Contact Us

Already a HeinOnline Subscriber?

Log In

profiles profiles most