The international competitiveness of Japan according to the IMD ranking has, after having topped the list in 1991, been steadily declining down to the 26th position in the 2011 edition. After Japan marked the same 26th position in 2002, many raised voices that the country lacks management skill to exploit its excellent technology. Ten years since then, however, the IMD ranking of Japan for "entrepreneurship", a traditional weak point of the country, is still almost the lowest among the countries surveyed, while its score for "customer satisfaction-oriented management," another parameter in the survey, remains at the top. This suggests that no specific measures or techniques could actually improve Japan's competitiveness without change of the country's economic culture. The problem lies in the fact that the nation takes high precision and quality for granted and obsessively demands risk-free solutions, which has eroded the country's competitiveness by high costs and uselessly high quality. The recent earthquake and nuclear power plant accident were sufficient to break the dream of a risk-free fantasy world. It is now high time for the Japanese to accept the existence of risk for the pursuit of real values.

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Life science is one of the important fields where development of the future innovation is expected. The 21st century is called "a century of the life". "4th Science and Technology Basic Plan" (Council for Science and Technology Policy) was established in August 2011. In this Basic Plan, "the promotion of the life innovation" is shown as one of the urgent issues. Now is the tenth year since "Basic Law for Intellectual Property" was introduced. For past ten years, the importance of the intellectual property strategy has been widely recognized in the technology management. However, there are still some unsolved issues in the intellectual property policy. This special edition is discussed mainly from a viewpoint of the intellectual property under the theme of "New Trend of Life Science Research". Five articles are included in this special edition. First three articles are discussed mainly from the viewpoint of the governmental policy such as the Science and Technology Policy (by Fukushi), the Industrial Policy (by Takehiro), the Intellectual Property Policy (by Kato). Next article is discussed mainly from the viewpoint of the intellectual property strategy in the industry (by Fujii), and final article is discussed mainly from the viewpoint of the life ethics (by Sumikura). Five articles are also discussed from a global viewpoint because the intellectual property has become global by some international frameworks such as TRIPS (Agreement on Trade-Related Aspects of Intellectual Property Rights), ACTA (Anti-Counterfeiting Trade Agreement), and TPP (Trans-Pacific Partnership). It is expected that this special edition is helpful when "the promotion of the life innovation" is discussed for the future direction.

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In the new millennium, life science research has entered a new stage to control and manipulate biological/vital phenomenon and then strategically develop the research achievement to practical application, in addition to the achievement of understanding and investigating mechanisms of our life phenomenon. There is also urgent issue for the stakeholders to establish appropriate management systems for storage, sharing, and protection of various biological data collected by human and other animate beings. In the current article, the author introduce recent trends in top-down strategy for research and development as well as the research data management as intellectual property in the United States and European Commission and then discuss how Japanese stakeholders should progress the strategy of life science research and development.

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This paper introduces basic trend of innovation in healthcare industry and discusses general aims and targets of life-innovation policy of METI.

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Life science is one of the most important fields that should promote innovation, and the patent policy plays an important role for the promotion of life science research. In late years while the patent applications related to the life science research increase globally, the promotion of the protection of the intellectual property rights is internationally discussed, which is expected to improve the incentive to life science research. Specifically, ACTA (Anti-Counterfeiting Trade Agreement) was agreed in October, 2010, and Japan signed to ACTA in October, 2011. There is also the argument about the intellectual property system in TPP (Trans-Pacific Partnership). The international harmonization of the patent examination is also discussed, and comparative studies related to Examination Guidelines are discussed among Japan, the United States, Europe and other countries. Also, member countries of the Patent Prosecution Highway (PPH) are increasing, and the international harmonization of the patent examination is advanced rapidly. It is expected that these trends improve the incentive to a life science research through an adequate protection of the results of the research. As for the effect of the patent rights, the interpretation of the research tool patent was discussed. Examination Guidelines about an extension of the patent terms was revised, which is also important for the incentive to life science research. As future issues, the compulsory license in TRIPS (the Agreement on Trade-Related Aspects of Intellectual Property Rights) and the benefit sharing on CBD (the Biodiversity Convention) are under discussion, which are important issues for life science research.

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Research and development (R&D) for medicines are extremely high risk. On the other hand, the R&D for blockbusters, which used be a main target for R&D of a pharmaceutical company, become difficult. The pharmaceutical company has to change R&D strategy from blockbusters to a lot of products. Therefore, the pharmaceutical company needs various technologies and it becomes almost impossible for it to own all technologies. The use of an open innovation, typically the industry-university cooperation, must be necessary for the solution of this problem, and the pharmaceutical company has to think about the appropriate IP strategy for the open innovation. And the government must make the industrial policy, which can make the pharmaceutical company to use an open innovation, including the proper IP protection for an invention relating a basic technology and the maintenance of the infrastructure promoting the industrial use of such a basic technology. Moreover, the emerging and developing markets, where the growth rate of the market for medicines are much higher than the developed country, becomes attractive. The pharmaceutical company should positively develop the business in these countries. However, the intellectual property system is not high level in these countries. The intellectual property, especially the patent, is very important for the business of the pharmaceutical company. The global harmonization of IP systems at a high level is desirable. It is necessary for global business of the pharmaceutical company to establish the IP system globally harmonized at a high level by the economic partnership agreement using the bilateral or multilateral negotiation.

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At present making an innovation system based on life science is focused as one of the policy issues in Japan. Proper patent protection and its exploitation are considered factors required for making an innovation system successfully. Each country has guideline for patent examination to maximize promotion of, and minimize inhibition for, innovation. Such a guideline has a function to determine what innovation should be promoted by setting standard on statutory subject matter or ethical consideration. This article describes the issues surrounding relationship between intellectual property and ethical consideration by focusing on stem cell research and considers what we should pay attention to for our system construction. In Europe the inventions not eligible for patent subject matter owing to ethical consideration are stipulated in EU directive for biotechnological inventions and the European Patent Convention and the judicial interpretation of such stipulations were shown. In US, ethical consideration is focused on validity of research funding, outside of patent law. At present in Japan the interpretation of the Article 32 of the Patent Act, patents are not issued on the inventions liable to injure public order, morality or public health, is not clear. It is possible that even the inventions actually permitted to work are judged as against the stipulation of the Article 32. From now it is desirable that the range of ethical consideration against the Article 32 would be clear, by setting a guideline for patent examination not inhibitory to innovation in frontier fields including stem cells research.

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インドの製薬産業は1970年代から急速に発展を遂げ,現在では製薬生産量で世界第4位にまで成長した。ところが,この「製薬製造大国」とも言えるインドでは,2005年まで物質特許保護がなかった。本来産業育成を後押しすることを目的に導入される(物質)特許制度がない環境の下で,インドの製薬企業は,海外では特許保護の下にあるオンパテントの先発医薬品を,リバースエンジニアリングし,新たな製造方法を産み出し,インド国内で「ジェネリック医薬品」として製造し,インド内外で販売して,大きく成長を遂げた。ところが,1995年のTRIPS協定を受けてインドは,自国の特許法をTRIPS準拠の法律に改正する義務を負い,2005年に物質特許を導入した。インド大手の製薬企業は1990年代中葉から,2005年までの物質特許導入を見据えて,ビジネスモデルを大きく変えて,それまでのリバースエンジニアリング専業から,新薬開発も行う統合型ビジネスモデルに変更した。先行研究などから途上国に物質特許が導入されると,当該の国の産業育成が阻まれるとの指摘がある。しかし,インド大手の製薬企業の財務諸表などから,インドの大手企業の業績は2005年の物質特許導入を挟んで成長を続けており,インドの製薬企業では,ビジネスモデルの変更により,物質特許導入から受けることが見込まれた負のインパクトを回避して,成長を続けていることが示された。

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1980年代以降,米国を始め世界各国において生じた大学資本主義(Academic Capitalism)と呼ばれる潮流が研究者間の協力関係を阻害している可能性が指摘されてきた。本研究では,自然科学分野における主要な協力形態の1つであるマテリアル・トランスファー(研究試料の共有)に焦点を当てて,日本の科学者コミュニティにおける研究者間協力の現状を調査・分析した。生命・材料科学の各分野の研究者838人から得たサーベイ・データを用いた分析の結果,研究者1人あたり年平均2.8回の依頼を受け,そのうち4.6%の依頼は拒絶される(試料が提供されない)ことが判明した。また,研究者が試料提供を行うか否かの判断には,本人にとってのメリット(例えば共著者の権利),依頼者との過去の協力関係,競合関係などが影響することが示された。米国における類似の研究では,商業活動や産学連携への関与が研究者間の協力関係を阻害するとの報告がなされているが,我々のデータではそのような影響は限定的であった。また,研究試料を広範に共有するための試料バンクの活用状況についても分析したところ,現状での活用度はかなり限定的なものに留まることが示唆された。

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