21st Century Innovation Systems for Japan and the United States Lessons from a Decade of Change: Report of a Symposium (2009) / Chapter Skim
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Pages 238-252
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Japanese pro-patent policy for the public sector, (iii) institu tional constraint on clinical trials, and (iv)
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Therefore, if insti tutional constraints on clinical trials are severely binding, it may be all the more difficult to obtain an approval for commercialization of a new biomedical product 3The present study mentions "public sector" as indicating both government and university. It should be noted, however, that university researchers and government researchers may be very different from each other in propensity to patent, to the extent of their affinity to open science culture, and the resulting values of their patents.
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Furthermore, Japanese public sector researchers at government research institutes and national universities were burdened with rigid office regulations as well as restrictive dualemployment rules until quite recently. Accordingly, the low mobility of researchers has possibly hindered mutual understanding regarding institutional missions, mutual understanding organizational features, and researchers' incentives among industry, government, university.
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In addition, the number of patent applications that were filed jointly by private and public sector researchers also increased since 1998. In biomedical research, there is an increased trend of patenting by the public sector.12 The share of patents that were filed by the public sector almost trebled in the late 1990s and reached almost 30 percent of total patents in 2002 if we include co-applications with industry.13 10See Odagiri (1999)
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These studies provide, to a greater or lesser degree, a cautious view of pro-patent policy and of Bayh-Dole-like measures in particular. PRePublication coPy
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The organizational structure of the clinical trials is now shifting from the outside-oriented to inside-oriented expert panels, but the number of in-house experts remains quite small in Japan.19 The Ministry of Health, Labor and Welfare itself suggests that the main reason for the hollowing out would be a poor clinical trials infrastructure.20 Implementation structure and incentives for clinical researchers and clinical study participants are not good enough in terms of funding as well as contracting system. The number of clinical research coordinators is also quite low in many national hospitals and national universities, which are the main implementing agencies in Japan.
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organizational Reforms for Public-Sector Research The low mobility of researchers has possibly hindered mutual understand mutual understanding regarding institutional missions, organizational cultures, and researchers' , incentives among government, industry, and universities. Furthermore, Japanese public sector researchers are burdened with rigid office regulations and restrictive dual-employment rules.
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Conse quently, public support for research and pro-patent policy measures in particular must be designed with sufficient attention to the characteristics of institutional and organizational features of the public sector on a case-by-case basis. We think that flexible funding schemes and higher mobility of researchers are keys to improve public-private linkage in Japan.
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IV APPENDIXES PRePublication coPy
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