Recent Developments Affecting the Enforcement, Procurement, and Licensing of Research Tool Patents

Abstract

A vigorous discussion exists regarding the need to provide exclusive patent rights as incentives to invent and to disclose so-called “research tools,” whether such exclusive rights should apply to all uses and users of patented research tools, and whether exclusive rights to prohibit all uses of research tools would unduly discourage sequential invention. This article summarizes recent developments under U.S. patent laws of particular relevance to the debate over the patenting of research tools, and provides some insights into the practices of various academic sciences, industries, and government agencies regarding the treatment of these important inventions. The article provides a brief history of the experimental use and regulatory approval exceptions to patent infringement liability and summarizes recent cases interpreting the regulatory approval exception and its application to research tool patents subsequent to the Supreme Court's 2005 Merck v. Integra decision. It then surveys empirical studies that examine the practices of scientific researchers and patent holders, and describes recent changes to patenting and licensing policies and behaviors in the public and private sectors. The article reviews and explains recent and proposed changes to the patent system that may affect patents for and use of research tools. Finally, it discusses a variety of alternatives to the experimental use and regulatory approval exceptions that could facilitate access and continued use of patented technologies in scientific research and commercial development. * This article was originally prepared for inclusion by IFTECH in an internal report for the Japanese Patent Office on the worldwide state of research tool patents.