Koichi Sumikura

Redefining the concept of standardisation for pluripotent stem cells

In this report we review the concept of standardization and propose an exhaustive framework for the proper management of technology on pluripotent stem cells based on studies of global and regional initiatives. We demonstrated detailed observational analysis on global initiatives for the standardization of related technologies as well as regional attempts with particular interest in the cases of the UK, the US and Japan. Consequently, we came up two fundamental issues: first, these initiatives and attempts tend to be limited to each of currently existing categories of pluripotent stem cells, whereas the technological opportunity to enable clinical/commercial application is equally open to all stem cell types. Second, the subject to be examined for standardization is set to a quite narrow range compared to precedent practices in other industrial sectors. To address these issues, we propose a strategic framework for standardization with an emphasis on comprehensiveness covering various technological opportunities and consistency to learning in the management science. By utilizing this framework development of intellectual property rights not only through patents but through taking leadership in standardization can be considered as means for improving research and development competence. Of particular concerns is the formation of quality standards for final products/services and core elemental technology, especially specific pluripotent stem cell lines. Furthermore, we inferred two stages of the standardization process, individualization where a particular product/service is qualified by the market, then standardization where the elemental technology is subsequently established as compatibility standards.

Analysing knowledge capture mechanisms: Methods and a stylised bioventure case

Knowledge transfer between science and technology has been studied at micro- and macro-levels of analysis. This has contributed to the understanding of the mechanisms and drivers, but actual transfer mechanism and process, be they through codified or tacit sources, have very rarely been mapped and measured to completeness and remain, to a large extent, a black box. We develop a novel method for mapping science–technology flows and introduce ‘concept clusters’ as an instrument to do so. Using patent and publication data, we quantitatively and visually demonstrate the flows of knowledge between academia and industry. We examine the roles of exogenous and endogenous knowledge sources, and of co-inventors and co-authors in the application of university-generated knowledge. When applied to a stylised case, we show that the method is able to trace the linkages between base knowledge and skill sets and their application to a technology, which in some instances span over twenty-five years.

An Empirical Analysis on Absorptive Capacity Based on Linkage with Academia

In this paper, we empirically explain how scientific knowledge assimilated from academia affects corporate performance, particularly in the pharmaceutical industry of Japan. We use balanced panel data on 46 pharmaceutical firms in Japan for the period 1992–2005. Then, we introduce a new concept, propensity to capture basic research (PCBR), to index how much scientific knowledge firms have assimilated from universities and public research institutes. We use this index to verify whether absorption of such knowledge influences corporate performance. According to econometric analysis, PCBR is positively significant for patent applications and patent efficiency but not for number of approved drugs. This obviously implies that scientific knowledge assimilated from academia is effective for technological performance in firms. Moreover, the results suggest how R&D is structured in the organizational setup of Japanese pharmaceutical firms.

How enterprise strategies are related to innovation and productivity change: an empirical study of Japanese manufacturing firms

This study analyzes the total factor productivity of 1067 Japanese manufacturing firms. In production estimation, we employ the directional distance function and Luenberger productivity indicator. Research and development strategy survey data are used to analyze the determinant factors related to improvements in innovation and productivity. Our results indicate that increasing technology and knowledge through a ‘black box’ process is related to an increase in productivity. Furthermore, the protection and management of production knowledge and expertise is a valid method of increasing global technical change.

Patent protection and access to genetic resources

Developing countries and patent offices have shown differing approaches to patent specification disclosure requirements and benefit sharing.

The patentability of medicinal inventions related to personalized medicine in Japan.

Several amendments of the examination guidelines for medicinal inventions may be good news for pharmaceutical companies.

Patent protection for protein structure analysis

Three national patent offices have consulted on patents that cover protein three-dimensional structural data and pharmacophores, with significant implications for the biotechnology industry.

How can we promote development of new drugs from academic knowledge?: Focusing on corporate perspective on contribution of basic research to innovation

It is well understood that academic knowledge generated from basic research at university contribute to innovation in industrial sector. In order to demonstrate the degree to which academic knowledge contributes to innovation, we conducted multiple surveys on private corporations. Based on the results of our surveys, we have found the existence of a recognition gap between inventors and business managers with respect to contribution of academic knowledge to innovation. The reason for this gap is the potential disconnect in information between inventors and business managers concerning the application of academic knowledge.

The Issues Surrounding Patent Protection for Human-Embryonic Stem Cells and Therapeutic Cloning in Japan

In 2003, the Intellectual Property Strategy Headquarter was established within the Japanese government,1 and an Intellectual Property Strategic Program has since been released every year.2 The Government of Japan (GOJ) has been seeking to be an “intellectual property-based nation”.

A Consortium for Enhanced Access to Patented Research Tools: Japanese Policy and Proposal of a Novel Scheme

Currently, in Japan and other developed countries, massive amounts of research funds, including government funds, are being poured into basic research conducted by universities and public research institutions in the area of life science. From such academic research, a number of innovations ultimately leading to the development of new medicines are attained. However, the existence of patents for research tools can result in impeding the promotion of academic research, making it necessary to form a proper measure. As such a measure, this paper considers the establishment of a patent distribution mechanism whereby patented inventions are gathered and managed by a single organization to facilitate the conclusion of license agreements for individual technologies. The results of our survey of life science researchers show that there is a substantial need among these researchers for such a mechanism. The same survey also found that many researchers hope for a mechanism based on the principle of reciprocity. Under this mechanism, a researcher offering his or her own patented invention for free would be entitled to use patented inventions of other researchers for free. Using the results of this survey as a reference, this paper considers specific aspects of a research tool consortium.