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面向生物医药企业技术创新的专利信息服务模式研究
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摘要
随着我国生物医药行业的发展,建立以企业为主体的自主创新体系是目前亟待解决的问题,在这一体系建设中,信息支持是体系建设的基础[1]。生物医药产业的特点是产业的高度专利依赖性和专利药品发达国家的高度垄断性,以专利为主的知识产权是生物技术和现代生物医药公司竞争优势的基础。我国目前生物药品品种较少,大部分都不具有自主知识产权,长期以来以仿制外国药品为主。加入WTO后,我国要履行对100多个成员国实行知识产权保护的承诺,这将给我国生物制药业带来巨大的冲击。我国生物医药企业必须高度重视国内外生物医药专利及相关法律法规的保护与利用研究,因此生物医药产业与其他产业比较,专利信息分析相关性较强,研究更具代表性、更有价值。
     可以说生物医药技术创新过程是一个专利信息利用的过程,因为在生物医药技术创新流程中,其高技术含量的显著特征主要体现在三点:其一,涉及到的学科领域非常之广泛;其二,多个学科领域交叉明显,关系复杂;其三需要的信息往往是每个学科最前沿的,要求有很高的前沿科技含量。而从事生物医药领域技术创新的人员不可能具备所需的如此海量的信息资源储备,同其他科技文献资源相比较,专利信息资源是最为满足以上三点要求的信息资源。可见生物医药产业的技术创新与其他产业相比较,对专利信息分析的需求更加强烈,主要表现在:需要专利信息分析支持的流程环节多,需要分析的专利信息涉及到的学科领域较多,而且专利信息分析的难度较大。而目前我国的专利信息服务大多还停留在检索层面,对专利信息分析服务开展很少,而且多为被动服务,对生物医药企业技术创新提供信息支持的力度相对不足,因此为生物医药企业提供更高质量专利服务,可以有效提升生物医药企业技术创新能力。在这一研究中涉及两个研究领域:医药信息利用与技术创新管理,这两个领域都有国内外学者展开了大量的研究,但鲜有学者将两者相互结合。
     本文研究旨在通过为生物医药企业提供专利信息服务的实践过程,探讨建立一种专业化的生物医药专利信息分析服务模式,这种专利信息服务模式的特点是:将专利分析与生物医药企业的技术创新过程中的风险控制与流程优化管理有机结合,通过将生物医药信息服务与管理学两个领域的理论和研究方法相互融合,从一种多学科理论方法结合新的角度探讨建立一种新型的专利分析与生物医药企业技术创新管理结合的模式,在验证这一新的模式可行性和有效性的同时,为提高医药专利信息资源利用效率提供新的方法和思路。本论文由八个部分构成。
     绪论部分,在分析我国生物医药企业技术创新管理对专利信息需求特点基础上,分别从医药信息研究和技术创新管理两个领域,回顾和介绍了相关研究的现状和背景,由此明确了本文研究目的和意义,并确立了本文研究框架和研究方法及技术路线。
     第二部分,为确定本研究的理论及方法依据,对相关理论和方法进行了系统的梳理。首先,对专利信息分析方法进行总结,分析各种方法的利弊。其次,对管理学领域与技术创新管理相关理论进行总结和概括。
     第三部分,通过对生物医药产业特点和其技术创新流程的核心环节进行深入调查研究与分析,得到生物医药对专利信息服务的专业化要求,为达到建立一种专利信息服务的和专业化模式的目的,专利信息分析服务必须满足生物医药技术创新对风险控制和流程管理的要求。
     第四部分,结合已有的常规专利信息分析指标体系与需求调查分析结果,建立一个具有生物医药技术创新管理特点的专利信息分析指标体系。由于这个指标体系结合了与生物医药技术创新风险源相关的专利信息分析指标项,因此相对现有的专利信息分析指标来说更体现了本研究专利信息分析与技术创新专利需求紧密相关的特点。
     第五部分,建立生物医药企业专利信息服务模式并验证其有效性。首先,以前一部分研究得到的指标体系为依据,结合生物医药技术创新参与者的需求调查结果,提供专利分析报告;在此基础上,通过比较分析服务提供前后的调查数据,评价专利信息分析服务对生物医药企业技术创新管理的干预作用。结果表明:专利信息分析对生物医药企业技术创新管理的干预,可以帮助创新人员控制创新中存在的风险,但是对于不同类别的风险其干预作用是不同的。通过对干预前后流程优化可控系数统计分析,以及对干预前后系数差数据分析都可以看出,专利信息分析服务生物医药企业对于技术创新管理流程的优化有明显的促进作用;另外,这种促进作用与专利信息分析对生物医药企业技术创新风险控制的干预作用是成正相关的,这说明对于生物医药企业来说,控制技术创新过程中的各项风险与整个创新流程的优化是相互促进,相互交融的两个方面,这两种管理学的手段共同应用,并且通过专利信息支持起作用,是本研究通过具体的实践过程得以验证的有效模式。
     第六部分,在实践研究的基础上,梳理出将专利信息分析服务结合于生物医药技术创新管理的模式的确立原则、组成、框架。
     第七部分,同时通过对以上模式的深入分析,从信息利用角度,给出对信息服务机构提高专利信息服务效率的建议。
     第八部分,结论及展望部分。主要介绍研究的主要成果并分析研究的局限性同时提出对未来相关研究的展望。
In the wake of the development of biomedical industry in our country, it’s an urgent problem that establish an independent innovation system in which enterprises is the mainstay, the information support is the foundation of this system. Bio-pharmaceutical industry is characterized by a high degree of patent-dependent industries, and patent medicines developed a high degree of monopoly, the patent-based intellectual property to biotechnology and pharmaceutical companies a competitive advantage of modern biological basis. China current biological drugs are less species, most of them do not have independent intellectual property rights, has long been dominated by generic drugs overseas. After joining the WTO, China must fulfill more than 100 members committed to the implementation of intellectual property protection, which will give our country a huge impact on the biopharmaceutical industry. China biomedical enterprises must attach great importance to international bio-pharmaceutical patents and related laws and regulations, protection and utilization of research, so the bio-pharmaceutical industry compared with other industries, a strong correlation analysis of patent information, study more representative, more valuable.
     So we can say the process of biomedical innovation is a process of using patent information, as in biomedical technology innovation process, its salient feature is high-tech which is mainly reflected to three points: First, the involved disciplines is very wide; Second, numbers of significant cross-disciplinary fields, and the complex relationship; Third, the information is often needed for the most cutting-edge of each subject, the technology demands a high level. And the technological staff of biomedical innovation in the R&D field could not have the necessary resources so vast reserves of information, the patent information is the information resources that is the mos satisfied with these three requirements comparing to other scientific resources. Above that, in technological innovation, the biomedical industry shows the demand for patent information analysis is more intense compared with other industries, mainly in: many links process need of patent information analysis to support; there are many subject area related to the patent analyze; and patent information analysis are technically difficult. There are two research areas involves in this study: the medical information use and the management of technological innovation, domestic and foreign scholars in these two areas havestarted a lot of research, but few scholars have combined both of them.
     This study is designed to establish a personalized,professional services, biomedical patent information analysis mode by the patent analysis services practice which providing to the bio-pharmaceutical companies, this patent information service model is characterized by combining the patent analysis with the risk control and process optimization of biological pharmaceutical companies in the process of technology innovation. By consulting the theoris and research methods of two areas which are the biomedical information and the management. From a new perspective, through the graftting and the integration of both of the two above areas to establish a new model which combined the patent analysis service with the biomedical technological innovation management .At the sametime we want to prove the validation of the feasibility and effectiveness of this new model, while, to provide the new methods and ideas which could be used to improve the efficiency of using the patent information resource to of medical. This thesis is constitued with eight parts.
     Introduction section, at the first, we analysis the features of the patent information needs by the biomedical enterprise technology innovation management, then give the idea of this study; the same time,we review and describes the status of research and background concern both areas of the medical information and the management of technological innovation, on these research basis, we defined the purpose and significance of this study, and describes the system framework and research methods and technical route of this paper.
     As the second part, because of that we integrat and graft the theory and methods of two areas in this study, so at the first, we make systematic sort of the theories and methods of this research. First, at the aim of determine the method of the patent analysis we do the comparative study of the case analysis of medical patent information. Secondly, we analysis of the theory according to the field of management and technical innovation management in order, determine the basic theory of technology innovation management by which we use to essay this thesis. Finally, we analysis the mode of foreign pharmaceutical consulting services and find the experience we can learn to use in this study.
     The third part, as it is bio-pharmaceutical companies that of the main setting in the research of the technological innovation management, so it is necessary to find the characteristics of the biomedical industry and the core aspects of its technical innovation ,then we make a process-depth study and exploration,at the aim to find the entry point,through it we can achieve the effective model which is the combination of a personality and professional patent information service and management of biomedical of technological innovation.
     The fourth part, we combine the existing indicator system with the actual surveys to the bio-pharmaceutical companies, then we establish the patent information analysis indicators with the features of biomedical innovation management, this indicator system as a combination of biomedical technology innovation and risk-source-related analysis of key indicators of patent information, patent information available so the relative analysis of indicators is more a reflection of the research analysis of patent information personalized features.
     The fifth part is the core part of the practice of research in this section.First of all, through the survey the needs of the participants of biomedical technology innovative to get their personalized needs of patent information; to satisfied these needs,we provide patent analysis services based on the indicators from the previous chapter study as the framework, for the bio-pharmaceutical companies involved in technology innovation to; in the two time periods before and after services were paid survey, through data analysis, evaluation of patent information analysis services in the biomedical enterprise technology innovation management intervention effect, through the analysis of the survey questionnaire can be considered, patent information analysis in the biomedical intervention in the management of technological innovation can help to control innovation and innovation risks, but for different types of risk the intervention is different. Respectively before and after intervention by the control coefficient of statistical analysis process optimization, as well as data analysis before and after intervention coefficient difference can be seen, analysis of patent information services company for biomedical technology innovation management processes have significant role in promoting optimal; In addition, this role in promoting and patent information analysis in the biomedical risk control technological innovation is the intervention of a positive correlation, indicating that the bio-pharmaceutical companies, control of the process of technological innovation, risk and optimize the innovation process are mutually reinforcing, two aspects of interacting with each other, these two means of co-management applications, and patent information support through work, through this study to verify the specific practice an effective model.
     On the base of the practice above charpter, in the sixth part of the study, we make a systematic analysis of the practice research of results, to tease out the combination of patent information analysis services in the biomedical establishment of technological innovation management principles, composition, framework, and further through in-depth analysis of research conclusion and further expand the application of recommendations. Part VII is the conclusion of the study. Section VIII summarizes the main results of the study and analysis of the limitations of the study also raised the prospects for future research.
     This sort of domestic and international information services and technology in the medical field of study related to innovation management theory, on this basis, the new study point to a combination of both, for specific biomedical technological innovation management process in practice intervention study. By a large number of biomedical technology innovators in interviews, surveys to get personalized analysis of indicators of patent information and patent information analysis service needs, this study highlights the personalized, professional characteristics, the analysis of patent information has been based on biomedical enterprise technology innovation management mode. And through practical investigation of this model to evaluate the role, then this basis, given the use of patent information to improve the efficiency of medical recommendations, this theory and method in research on management of medical information and a combination of two subject areas, more of the previous studies a definite breakthrough, more important is it from the perspective of biomedical information services, the use of medical information system for our research provides some practical and theoretical basis.
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