McManis, Charles R.; Yagi, Brian --- "Early stage patenting, the US Bayh-Dole Act and the anti-commons hypothesis" [2017] ELECD 816; in Matthews, Duncan; Zech, Herbert (eds), "Research Handbook on Intellectual Property and the Life Sciences" (Edward Elgar Publishing, 2017) 256

Book Title: Research Handbook on Intellectual Property and the Life Sciences

Editor(s): Matthews, Duncan; Zech, Herbert

Publisher: Edward Elgar Publishing

ISBN (hard cover): 9781783479443

Section: Chapter 15

Section Title: Early stage patenting, the US Bayh-Dole Act and the anti-commons hypothesis

Author(s): McManis, Charles R.; Yagi, Brian

Number of pages: 37

Abstract/Description:

Over the past 15 years a debate has raged in the United States over the impact of the Bayh- Dole Acton genetic research and development. The Bayh-Dole Act, enacted in 1980, was designed to promote technology transfer by allowing universities, small businesses and other research institutions, in the absence of special circumstances, to retain ownership of the patent rights resulting from federally funded research, subject to a number of limitations and obligations, including an obligation on the part of universities and other non-profit institutions to share royalties with the actual inventor and to provide a royaltyfree non-exclusive license to the US government.Although the Bayh-Dole Act governs the patenting of federally-funded research in all fields of technology, university patenting and licensing pursuant to the Act have thus far overwhelmingly involved the life sciences.At the heart of the debate over the Bayh-Dole Act’s impact on genetic research and development have been two interrelated questions: (1) whether granting patents to universities on the results of ‘upstream’ genetic researchundermines the norms of the biological research community; and (2) whether such patenting promotes or retards biomedical innovation, technology transfer, and/or the development of downstream commercial products or processes. A specific thesis of critics of the Bayh-Dole Act can be traced back to a 1998 article in which Heller and Eisenberg posed what has come to be called the ‘tragedy of the anti-commons’ or ‘anti-commons hypothesis’ – namely, that too many intellectual property rights in ‘upstream’ research results could paradoxically restrict ‘downstream’ research and product development by making it too costly and burdensome to collect all the necessary licenses.A contemporaneous and related concern in this debate is that the use of patents in such areas as basic biological science could undermine the basic sharing norms of ‘open science’ in the academic research community and that the failure of US patent law to distinguish between downstream innovations that lead directly to commercial products and fundamental research discoveries that broadly enable further scientific investigation could hinder rather than accelerate biomedical research.