associated with implementing the knowledge into commercialization and because life science has been one of the top four prioritized areas (along with information and communications, environmental science, and nanotechnologies & materials) in Japanese science and technology policy since the late 1990s.³

Section 2 explains legislative measures facilitating public-private linkage and public funding scheme in Japan. Traditionally, the Japanese government gave top priority to energy-related research such as nuclear fusion. But The Basic Plan for Science and Technology, which has been introduced every five year period since 1996, has gradually reallocated research expenditures to other technology fields, putting more weight on life science. Since the introduction of the Basic Plan, more than 400 billion yen has been allocated to life science every year.⁴ The establishment of the Council for Science and Technology Policy (CSTP) attached to the Cabinet office in 2001 is one of the watershed events that facilitated more flexible allocation of the research budget. Unfortunately, however, there are still a lot of defects in the public funding scheme. For instance, the share of competitive research grants is still small, and the grant is very rigid to use.

Section 3 examines the Japanese pro-patent policy. Since the latter half of 1990s, the Japanese government has actively promoted pro-patent policy in order to advance research collaboration among industry, university, and government and to facilitate commercialization of their research findings. These initiatives reflected considerable interest among Japanese policymakers in emulating the U.S. Bayh-Dole Act of 1980, which is widely credited with stimulating significant growth in university-industry technology transfer and research collaboration. We depict the trends in government and university patenting by assignee types in biomedical fields and discuss possible effects of the Japanese version of the Bayh-Dole policy on biomedical research. We believe that the Japanese version seems to be just beginning to have some impact on the patenting activity of government research institutes. On the other hand, it does not appear to dictate the patenting behavior of university researchers. Institutional and organizational features of government research institutes and universities are keys to elucidate their differential responses.

Section 4 discusses institutional constraints on clinical trials. The clinical trial is an important institutional infrastructure for promoting translational research, which is the combination of basic and applied research producing clinically effective biomedical products or gene therapy/diagnoses. Inventing biomedical products is one of the ultimate goals of biomedical research. Therefore, if institutional 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