PATENT LAW & THEORY: A HANDBOOK OF CONTEMPORARY RESEARCH, Toshiko Takenaka ed., Edward Elgar Publishing Co., 2009
31 Pages Posted: 11 Dec 2007 Last revised: 9 May 2013
Date Written: 2009
This Chapter considers the range of research use exceptions in use around the world in major technology oriented countries. While most of the countries considered have fairly robust R&D and regulatory review research use exceptions, the U.S. has no commercial R&D exception, an extremely limited de jure common law exception for dilettante experiments, and yet arguably the broadest regulatory review exception. At the same time, researchers employed by the federal or state governments, or funded by the federal government, can in many cases enjoy the protection of certain de facto research use exceptions. While some of these have analogues elsewhere - e.g., the 1498 government use clause and the Crown Right in the U.K. - these de facto exceptions may have more potential in the U.S. because of the extraordinary amount of research still conducted by or on behalf of the government. Further, it is not actually clear whether stronger or weaker research use exceptions are better for spurring innovation. The Chapter outlines the policy considerations raised by research use exceptions by focusing on whether the exceptions fairly enable research or instead provide a means for imitators to engage in unfair competition with patent owners and their assignees/licensees.
Keywords: patents, research exceptions, Hatch-Waxman, Bayh-Dole, Bolar Exemptions
JEL Classification: O31, O32, O33, O34, O35, O36, O37, O38
Suggested Citation: Suggested Citation
O'Connor, Sean M., Enabling Research or Unfair Competition? De Jure and De Facto Research Use Exceptions in Major Technology Countries (2009). PATENT LAW & THEORY: A HANDBOOK OF CONTEMPORARY RESEARCH, Toshiko Takenaka ed., Edward Elgar Publishing Co., 2009. Available at SSRN: https://ssrn.com/abstract=1069222