Access problem to research tool patents as seen in Japan: Access problem to research tool patents as seen in Japan Sadao Nagaoka* Institute of Innovation Research, Hitotsubashi University February 2005 At Fifth Meeting of the Committee on Intellectual Property Rights in Genomic and Protein-Related Inventions, A Joint Committee of The National Academies Science, Technology and Economic Policy Board And Science, Technology, and Law Program The National Academies *The following is my personal view.


Interests in this issue in Japan: Interests in this issue in Japan Strong concerns by the pharmaceutical and bio-related companies over the recent patenting of research tools. -often no substitute -high and reach-through royalty despite of unclear patent scope -danger of royalty stacking One former national university being sued for using a “patented” mouse for research (Tokyo high court 2002)


Slide3: The government Strategic Program for the Creation, Protection and Exploitation of Intellectual Property in 2003 and 2004 called for the clarification of the limits of patent right for the purpose of experiment or research and the study of the use of compulsory license and other measures to ensure smooth conclusion of license contracts. Working group established by the JPO to address these issues


Japanese patent law on research exemption: Japanese patent law on research exemption There are two relevant provisions: Section 68 (Scope of patent right) A patentee shall have an exclusive right to work the patented invention “as business”. Section 69(1) (Limits of patent right ) The effects of the patent right shall not extend to the working of the patent right for the purpose of experiment or research


No precedents in fully clarifying the exact scope of these provisions: No precedents in fully clarifying the exact scope of these provisions Section 68 (Scope of patent right) Prevailing view (including that of the Working group) It includes the use by non-profit business, such as a university or a government agency. It excludes only private and home use.


Slide6: Section 69(1) (Limits of patent right ) Prevailing view (including that of working group) Experiment or research exemption covers only those on the subject matter for the purpose of technical progress.


Thus, : Using the patented invention for the research other than that on the subject matter itself is infringement, even if such research is done by a university. Madey v. Duke would have led to the same ruling in Japan. Thus,


The objective of experiment and research of the subject matter may not be strictly for technical progress: Testing the subject matter for the purpose of regulatory approval might be considered an infringement, since it does not contribute to technical progress. However, the supreme court ruled in 1999 that testing a patented chemical product for the regulatory approval is protected by the exemption from the general public interest perspective. The objective of experiment and research of the subject matter may not be strictly for technical progress


Government use: Government use No general law authorizing the government use, as 28 U.S.C. §1498 for sovereign immunity Section 30 of the law on the Special Measures for Revitalizing the Industry allows the patent generated from the government funded research to be held by a contractor including a university. The government can obtain the royalty-free license to use the patent, when it demonstratively serves the public interest. The march-in right (compulsory license to a third party) in the case where the patent is not worked without a good reason


Compulsory license for public interest : Compulsory license for public interest The Japanese patent law has a provision on compulsory license for public interest (Section 93). Any interested party, including the government agency, can apply for this. However, it has never been used. The guideline for this section requires high level of public interest.


Slide11: The conclusion of the working group: More investigations are necessary to evaluate the necessity and desirability of amending the law and/or the guideline for a compulsory license. How serious is the problem of access, especially for academic research? Would the measures such as the development of a licensing guideline for the patents from the public fund and competition policy-based interventions address the legitimate concerns?