生技新藥產業是指使用於人類及動植物用之新藥及高風險醫療器材之產業。而生技新藥產業與醫藥產業，在目的上均與人類及動植物用藥或醫療儀器相關；差異之處在於目前的生技醫藥產業相較於20餘年前的醫藥產業，多了生物技術的應用，產業結構由大型藥廠垂直整合演變為非營利組織、生物技術公司、大型藥廠分工的形態。總結來說，生物技術是生技新藥產業的重要組成要素，而生物技術的興起，則改變了過去醫藥產業產品與技術的組成，也改變了產業結構。 生物技術產業或醫藥產業是全球各國競相發展的產業類別，我國亦不例外；其中，美國無論於生物技術或醫藥產業的發展，均居於全球領先的地位，其成功必然有可以提供我們討論或學習之處。而在知識價值鏈的體系中，美國大學更扮演著提供創新以及產學合作的重要角色，對於全球生技新藥產業的進步有重要的貢獻。從而本研究以美國為標的，研究產業的發展歷程，並進一步以產業之觀點，探討大學產學合作的模式以及智慧財產管理，希望能供我國大學與產業實務發展的參考。 從美國生物技術與醫藥產業發展的歷史與經驗，本研究歸納出生物技術產業興起的因素，與1980年代發生的基礎科學上的突破性發展、拜杜法案的通過、專利法將生物技術的發明納入保護範圍，三項因素有關。另外，由大學所提供的創新，透過密切的產學合作、授權與技術移轉、企業間的策略聯盟等方式，於知識的價值鏈中流動並增加價值，而大學提供創新的人才，往往也是創業者和重要的經營者。 本研究認為，美國大學對生物技術發展具有重要性的貢獻，其中，大學內部創業與大學智慧財產的管理特別值得討論。在大學內部創業方面，美國大學不但鼓勵創業，並制定股權政策，允許新創公司以股權取代部分的授權報酬，給予新創公司實際的協助。透過限制大學持股比例與禁止大學擔任董事或參與董事投票活動之原則，則可兼顧大學避免利益衝突與公司專業經營的需求。 在大學智慧財產管理的部份，本研究認為加州大學系統的智慧財產管理方式，採用網路式的授權與技術移轉組織，將各校區共同的需求如政策、法務、資訊技術與通訊等活動統籌處理，而將需與發明人和企業密切交流的活動如授權與技術移轉的活動交由各校區的授權與技術移轉中心負責。透過此種統籌與分工管理的方式，能夠兼顧減少營運成本與增加授權效率的功能。 經由本研究節果，建議我國的大學可採用網路式的授權與技術移轉組織之概念，除各校之授權與技轉中心外，聯合設一統籌政策、法務、智慧財產資料庫之管理機構，並對大學持有公司股份、鼓勵創業、避免利益迴避等議題制定一致的政策，方能有效利用資源並發揮大學創新的價值。 / Biotech and new drug development industry are targeted toward the development of drugs for human, animal, or plant use. This also includes the high-risk industry in medical devices. Although the pharmaceutical industry shares common objectives, the biotech and new drug industry emphasizes on applications in biotechnology and its industrial structure is composed by non-profit organizations and biotech dedicated firms. While biotechnology forms the basis to the biotech and new drug industry, the improvement of biotechnology also changed the interaction between the pharmaceutical products and technologies as well as its industrial structure. Biotechnology and pharmaceutical industry have received considerable attention around the world, including Taiwan. Since U.S. has been the leading country in the development of biotechnology and pharmaceutical industry, we can surely learn from its success. In particular, universities in the U.S. have played a crucial role in providing innovation and promoting university-industry cooperation and resulted in significant contributions to the progress of global biotech and new drug industry. Thus, this study will investigate the development of the industry within the U.S. by dissecting the various university-industry cooperation models and the management of intellectual property rights. Results from this study will hopefully shed some light on bridging our university with industry for further practice operation. By examining the U.S. biotech and pharmaceutical industry, this study has concluded that breakthroughs in fundamental, the passage of Bayh-Dole Act, and the inclusion of biotechnology into patent law science in 1980s are responsible for the rise of biotechnology industry. In addition, active university-industry cooperation along with licensing, technology transfer, strategic alliance among enterprises and information flowing in the knowledge value chain added the value of the innovation provided by universities. In many cases, the university has not only provided innovation, but also a source for future leaders that would take on role of the founders or head of project management. The U.S. universities have made significant contributions to the development of biotechnology by establishing entrepreneurship programs, intellectual property rights management, and often providing substantial assistance in business start-up. One type of assistance is rendered through regulating policies on equity that allows start-up companies to provide equity in place of part of license fee. In order to avoid a “conflict of interest”, universities should be limited of their possession of industry equity, which can prevents them from taking part in the company as the board director or members. In terms of the management of intellectual property rights, the measures of management of the University of California system can help diminish operation cost and enhance licensing efficiency. University of California system resorts to Technology transfer in a distributed institutional network that feed the common needs from each campus such as patent policies, general counsel, and information technology and communications. A licensing and technology transfer center (OTT) on each campus will follow a system wide license and technology transfer process between the inventor and the enterprise. In conclusion, it is recommended that our university could adopt the concept of network licensing and technology transfer. Through an overall arrangement, a management institute can be established to regulate the planning of policies, provide general counseling, and build a database of intellectual property rights aside from the existing licensing and technology center of each university. In the best interest of the developing biotech and new drug industry, universities should initiate policies with regard to equity holding limitation, encouragement of start-up business, and the avoidance in the “conflict of interest” so the industry may effectively utilize university resources and demonstrate its innovative values.

Esta tese analisa as características e as condições do desenvolvimento industrial e tecnológico do setor de máquinas-ferramenta no Brasil. O trabalho parte do pressuposto de que há uma relação entre trajetória tecnológica, regime tecnológico e desenvolvimento econômico e considera que o arcabouço sobre Sistema Setorial de Inovação pode trazer importantes contribuições para o desenvolvimento tecnológico entre os setores industriais. A revisão teórica da tese aplicou a discussão sobre trajetória tecnológica, regime tecnológico e Sistema Setorial de Inovação ao caso do setor de máquinas-ferramenta mundial, destacando as características do desenvolvimento das tecnologias do setor na Inglaterra, EUA e Japão. A metodologia de pesquisa abrangeu uma análise sobre o setor de máquinas-ferramenta no Brasil. Esta análise considerou as características do desempenho industrial e tecnológico e as interações realizadas entre empresas de máquinas-ferramenta e grupos de pesquisa sediados no Estado de São Paulo. A partir da análise empírica e setorial, a tese constatou que o regime tecnológico do setor de máquinas-ferramenta do Brasil apresenta características distintas, relativamente ao setor de máquinas-ferramenta dos países analisados na revisão teórica. O Sistema Setorial de Inovação de máquinas-ferramenta no Brasil também apresenta algumas diferenças em relação ao Sistema Setorial de máquinas-ferramenta da Alemanha, Japão, EUA e Itália. A conclusão é que a escolha das empresas por trajetórias tecnológicas no passado pode repercutir um ambiente tecnológico distinto para um mesmo setor através dos países. Considera-se que as características do ambiente tecnológico de cada setor podem apresentar alguns efeitos positivos para a sua competitividade. Entretanto, no longo prazo, a dinâmica industrial e tecnológica do setor de máquinas-ferramenta nacional pode ser afetada pela escolha entre trajetórias tecnológicas. / This thesis analyzes the characteristics and conditions of the industrial and technological development of the machine tools industry in Brazil. The work assumes that there is a relationship between technological trajectory, technological regime and economic development and considers the framework of the Sectoral System of Innovation can make important contributions to technological development among industries. A theoretical review of the thesis applied the discussion on technological trajectory, technological regime and Sectoral System of Innovation in the case of machine tools industry, highlighting the features of the technology development sector in England, USA and Japan. The research methodology includes an analysis of the machine tools industry in Brazil. This analysis considered the performance characteristics of industrial and technological interactions between companies of machine tools and research groups based in São Paulo. From the empirical analysis and sector, the thesis found that the technological regime of the machine tools industry in Brazil has distinct characteristics to the machine tools industry of the countries analyzed in the theoretical review. The machine tools Sectoral System of Innovation in Brazil also have some differences from the System Sector machine tools from Germany, Japan, USA and Italy. The conclusion is that the choice of enterprises by technological trajectories in the past can influence a distinct technological environment for the same sector across countries. It is considered that the characteristics of the technological environment of each sector may have some positive effects on their competitiveness. However, in the long term, the dynamic industrial and technological sector of machine tools can be affected by national choice between technological trajectories.

Esta tese analisa as características e as condições do desenvolvimento industrial e tecnológico do setor de máquinas-ferramenta no Brasil. O trabalho parte do pressuposto de que há uma relação entre trajetória tecnológica, regime tecnológico e desenvolvimento econômico e considera que o arcabouço sobre Sistema Setorial de Inovação pode trazer importantes contribuições para o desenvolvimento tecnológico entre os setores industriais. A revisão teórica da tese aplicou a discussão sobre trajetória tecnológica, regime tecnológico e Sistema Setorial de Inovação ao caso do setor de máquinas-ferramenta mundial, destacando as características do desenvolvimento das tecnologias do setor na Inglaterra, EUA e Japão. A metodologia de pesquisa abrangeu uma análise sobre o setor de máquinas-ferramenta no Brasil. Esta análise considerou as características do desempenho industrial e tecnológico e as interações realizadas entre empresas de máquinas-ferramenta e grupos de pesquisa sediados no Estado de São Paulo. A partir da análise empírica e setorial, a tese constatou que o regime tecnológico do setor de máquinas-ferramenta do Brasil apresenta características distintas, relativamente ao setor de máquinas-ferramenta dos países analisados na revisão teórica. O Sistema Setorial de Inovação de máquinas-ferramenta no Brasil também apresenta algumas diferenças em relação ao Sistema Setorial de máquinas-ferramenta da Alemanha, Japão, EUA e Itália. A conclusão é que a escolha das empresas por trajetórias tecnológicas no passado pode repercutir um ambiente tecnológico distinto para um mesmo setor através dos países. Considera-se que as características do ambiente tecnológico de cada setor podem apresentar alguns efeitos positivos para a sua competitividade. Entretanto, no longo prazo, a dinâmica industrial e tecnológica do setor de máquinas-ferramenta nacional pode ser afetada pela escolha entre trajetórias tecnológicas. / This thesis analyzes the characteristics and conditions of the industrial and technological development of the machine tools industry in Brazil. The work assumes that there is a relationship between technological trajectory, technological regime and economic development and considers the framework of the Sectoral System of Innovation can make important contributions to technological development among industries. A theoretical review of the thesis applied the discussion on technological trajectory, technological regime and Sectoral System of Innovation in the case of machine tools industry, highlighting the features of the technology development sector in England, USA and Japan. The research methodology includes an analysis of the machine tools industry in Brazil. This analysis considered the performance characteristics of industrial and technological interactions between companies of machine tools and research groups based in São Paulo. From the empirical analysis and sector, the thesis found that the technological regime of the machine tools industry in Brazil has distinct characteristics to the machine tools industry of the countries analyzed in the theoretical review. The machine tools Sectoral System of Innovation in Brazil also have some differences from the System Sector machine tools from Germany, Japan, USA and Italy. The conclusion is that the choice of enterprises by technological trajectories in the past can influence a distinct technological environment for the same sector across countries. It is considered that the characteristics of the technological environment of each sector may have some positive effects on their competitiveness. However, in the long term, the dynamic industrial and technological sector of machine tools can be affected by national choice between technological trajectories.

CoordenaÃÃo de AperfeiÃoamento de Pessoal de NÃvel Superior / O atual debate sobre a funÃÃo social da universidade tem evoluÃdo em torno do seu papel empreendedor, entendido como uma atuaÃÃo mais direta e participativa, voltada ao desenvolvimento social e econÃmico por meio do incentivo à interaÃÃo com o setor industrial e da produÃÃo e comercializaÃÃo de tecnologias. Neste sentido, a cooperaÃÃo entre universidade e indÃstria para pesquisa e inovaÃÃo assume papel fundamental, e à o objeto de estudo desta pesquisa. A despeito da extensa literatura nacional e internacional dedicada ao tema, nÃo foram identificados estudos que se destinassem a mapear a percepÃÃo dos gestores acadÃmicos de pesquisa acerca do fenÃmeno, o que se mostra oportuno pelo nÃvel estratÃgico em que eles atuam e pela relevÃncia das decisÃes que tomam. Destarte, o objetivo geral do trabalho foi verificar a relaÃÃo entre os fatores antecedentes da cooperaÃÃo universidade-indÃstria e a propensÃo da universidade a cooperar, a partir da perspectiva dos gestores acadÃmicos de pesquisa. Primeiramente foram desenvolvidas escalas de mensuraÃÃo para cada determinante identificado na revisÃo de literatura. Em seguida, foi realizada uma survey com uma amostra de 125 gestores acadÃmicos de pesquisa, de 109 universidades e institutos federais brasileiros, em que apenas duas unidades da federaÃÃo nÃo estiveram representadas. Por meio de anÃlises fatoriais exploratÃria e confirmatÃria, as escalas foram validadas, viabilizando o teste de um modelo estrutural explicativo da propensÃo à cooperaÃÃo com uso de modelagem de equaÃÃes estruturais. Os resultados confirmaram (i) a influÃncia positiva dos benefÃcios da cooperaÃÃo â incorporaÃÃo de novas informaÃÃes aos processos de ensino e pesquisa, obtenÃÃo de recursos financeiros adicionais e aumento do prestÃgio dos pesquisadores e suas instituiÃÃes â sobre a propensÃo da universidade à cooperaÃÃo com a indÃstria; (ii) a influÃncia positiva da solidez da parceria, medida em funÃÃo do comprometimento dos pesquisadores, da confianÃa no parceiro industrial e de adequados processos de comunicaÃÃo; e (iii) a influÃncia negativa das diferenÃas culturais e institucionais entre universidade e indÃstria sobre esta propensÃo. NÃo foi validada a influÃncia positiva (iv) da reputaÃÃo em pesquisa e transferÃncia de tecnologia e (v) da captaÃÃo de recursos para pesquisa aplicada sobre a propensÃo à cooperaÃÃo. Adicionalmente, atravÃs de uma anÃlise de regressÃo linear mÃltipla, verificou-se que (vi) o acompanhamento do desempenho das parcerias pelos gestores acadÃmicos, (vii) a confianÃa no parceiro da indÃstria, e (viii) o prestÃgio do pesquisador sÃo variÃveis explicativas da propensÃo da universidade à cooperaÃÃo com a indÃstria. Considerando a distribuiÃÃo geogrÃfica da pesquisa acadÃmica brasileira, o estudo traz à tona um abrangente panorama da percepÃÃo dos gestores de pesquisa das principais instituiÃÃes de ensino superior do Brasil acerca das parcerias com a indÃstria, o que lhe conferiu carÃter inovador e permitiu a proposiÃÃo de uma agenda de pesquisas no campo / The current debate on the social function of the university has evolved around its entrepreneurial role, seen as a more direct and participative action, focused on social and economic development by encouraging the interaction with the industrial sector and the production and commercialization of technologies. In this regard, cooperation between universities and industry for research and innovation assumes a fundamental role, and it is the study object of this research. Despite the extensive national and international literature devoted to the topic, studies intended to map the perception of the academic research managers about the phenomenon had not been identified, which seems opportune given the strategic level at which they work and the relevance of the decisions they make. Hence, the general purpose of the study was to investigate the relationship between the university-industry cooperation antecedents and the university propensity to cooperate, from the academic research managersâ perspective. Firstly, measurement scales have been developed for each determinant identified in the literature review. Then, a survey was conducted by addressing a sample with 125 academic research managers, from 109 Brazilian universities and federal institutes, in which only two Brazilian states were not represented. Through exploratory and confirmatory factor analysis, the scales were validated, enabling to test an explanatory structural model for the propensity to cooperation, by using structural equation modeling. The results confirmed (i) the positive influence of the cooperation benefits â like incorporating new information to the teaching and research processes, obtaining additional funds and increasing the prestige of the researchers and their institutions â on the university propensity to cooperation with industry; (ii) the positive influence of the partnership solidity, measured by the commitment of researchers, trust in the industrial partner, and appropriate communication processes; and (iii) the negative influence of the cultural and institutional differences between university and industry on such propensity. The positive influences (iv) of reputation in research and technology transfer on the propensity to cooperation has not been validated, as well as (v) that of the fundraising for applied research. In addition, through a multiple linear regression analysis, it was found that (vi) the partnerships performance monitoring by academic managers, (vii) the trust in industry partner, and (viii) the prestige of researcher are explanatory variables for the university propensity to cooperation with industry. Considering the geographic distribution of the Brazilian academic research, the study brings up a comprehensive overview of the perception of research managers from the main higher education institutions in Brazil about the partnerships with industry, which conferred to it innovative character and allowed to propose a research agenda in the field.

Made available in DSpace on 2016-03-15T19:26:46Z (GMT). No. of bitstreams: 1 Natali Vanali Alves Moreira.pdf: 1953655 bytes, checksum: 05250fd934621ed2bbe388e01d3de89f (MD5) Previous issue date: 2009-09-01 / Fundo Mackenzie de Pesquisa / This thesis attempts to study and to examine how the interface structures contribute to the cooperation between university and industry. The aim of this work is to verify the major contributions of these interface structures created in the State and Federal universities in Brazil, when it comes to the managers. It means the technology transfer and licensing offices or the named centers of innovation technology, according to the Brazilian Law of Innovation, sanctioned in 2004 (number 10.193/04). The relevance of this study is reinforced by the rising valuation of the interface structure as a way to become the university-industry cooperation feasible. This sort of collaboration appears in the literature as a great opportunity to generate innovations, mainly the technological ones. Despite the importance of this cooperation, this liaison is not so simple to be established. Surveys showed the existence of different barriers that make more difficult to respond to the needs of the companies and to the objectives of the university. One alternative to minimize these obstacles is called interface structure. It means the institutional mechanisms designed to promote and to facilitate the cooperation. It was established by the Law of Innovation, created in Brazil in 2004. According to this law, all the Brazilian institutes of science and technology must have a center of innovation technology. Before the law, these centers were known as the technology transfer offices and as patent management firms, which were responsible to the interface between academy and industry. The research combined exploratory and qualitative approaches. Due to this reason, the corpus is composed by four cases, as follows: Inova Agency at Unicamp (State University of Campinas), Agency of Innovation at USP (University of São Paulo), Innovation Agency at UFSCar (Federal University of São Carlos), and Center of Technology Innovation at Unesp (São Paulo State University). The data were collected by interviews and document s reviews. We applied the methodology of analysing content and comparative cases. The results were remarkable. The four cases were essentially linked to the intellectual property. The university-industry cooperation has become much more important to the Brazilian government. The most part of the innovations leaded by the interface structures is a technological product or process. Besides, these interface structures work in a sort of activities that, allied with other components, contribute in many ways to the university-industry cooperation. The final analysis reveals some conclusions, suggestions and paths, related to the specific challenges proposed. It also presents in details some contributions to the interface structures to the cooperation between Academy and industry. / Este estudo busca analisar como as estruturas de interface contribuem para a cooperação entre universidade e empresa. O objetivo principal é verificar as mais relevantes contribuições das estruturas de interface das universidades públicas brasileiras para a cooperação universidade-empresa (U-E), do ponto de vista de seus gestores: os escritórios de transferência e de licenciamento de tecnologia (ETLT) ou os chamados núcleos de inovação tecnológica (NIT), de acordo com a Lei de Inovação de 2004 (Lei 10.193/04). A relevância deste estudo está relacionada à crescente valorização da estrutura de interface como uma forma de tornar a cooperação U-E mais factível. A cooperação universidade-empresa aparece na literatura como uma importante oportunidade de geração de inovações, principalmente tecnológicas. Apesar da importância da cooperação, essa aproximação não aparece como uma tarefa fácil. Estudos demonstraram a existência de diversas barreiras que dificultam a compatibilização das necessidades da empresa com os objetivos da universidade. Uma alternativa para minimizar esses entraves são as chamadas estruturas de interface, ou seja, mecanismos institucionais desenhados para promover e facilitar a cooperação. Seguindo essa linha, no Brasil, em 2004, foi sancionada a Lei de Inovação, que regulamenta que toda Instituição de Ciência e Tecnologia deve ter um Núcleo de Inovação Tecnológica (NIT), conhecido anteriormente por escritório de transferência e licenciamento de tecnologia, responsável pela interface U-E. Este estudo foi realizado por meio de uma pesquisa exploratória e qualitativa. Para isso, foram conduzidos quatro estudos de casos, a saber: a Agência Inova da Unicamp, a Agência USP de Inovação, a Agência de Inovação da UFSCar e o Núcleo de Inovação Tecnológica da Unesp. A coleta de dados foi feita por meio de entrevistas e documentos. Como técnicas de análise, foram utilizadas as análises de conteúdo e de comparação dos casos. Os resultados chamaram a atenção. Os quatro casos estão essencialmente envolvidos com instrumentos relacionados à propriedade intelectual; a cooperação U-E tem se tornado cada vez mais importante para o governo brasileiro; a maioria das inovações intermediadas pelas estruturas de interface é tecnológica de produto ou de processo. Além disso, as estruturas de interface estudadas realizam uma série de atividades que, aliadas a outros fatores, contribuem de diversas formas à cooperação U-E. Por fim, o trabalho comenta os resultados das análises à luz dos objetivos específicos e destaca, em detalhes, as contribuições das estruturas de interface à cooperação U-E.