我国肿瘤基因治疗的专利分析及相应发展对策研究
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摘要
背景：随着生物技术行业的快速发展，现代生物技术的分支之一——基因治疗领域逐渐被各国所重视，成为人们攻克癌症的希望。近年来，我国生物制药行业不断发展，在肿瘤基因治疗领域也取得了一定成绩。由于肿瘤基因治疗领域高新技术的特点决定了它需要有专门的分析方法来对其进行技术分析与预测。专利分析是竞争情报中一种独特的分析方法，将专利数据转化为竞争情报，有利于分析行业现状及所处竞争环境，预测技术发展趋势，并为行业的发展及技术的潜在竞争提供决策参与。本文即是将专利分析方法具体运用于分析我国肿瘤基因治疗领域的现状及发展趋势之中，并进行国内外对比研究。
目的：本课题旨在通过收集国内外肿瘤基因治疗专利数据并运用专利分析指标及相应分析方法，了解国内肿瘤基因治疗领域的整体现状及技术发展趋势，把握其研究热点及机构研发现状，并与国外肿瘤基因治疗的发展进行对比分析，找出自身发展中存在的不足，提出相应的发展对策。
方法：通过对国内外生物制药行业发展现状的总体分析，及针对国内外肿瘤基因治疗领域运用专利历年数量、技术生命周期、地区分布情况、专利技术内容、机构竞争力等专利分析指标与方法来进行对比分析，将分析结果结合运用SWOT分析法，提出相应发展对策。
结果：通过专利分析发现世界肿瘤基因治疗领域正处研发阶段，尚无药品正式上市，在经过狂热期后已逐渐进入稳步发展期。我国目前该领域也处于研发初期阶段，在基础研究和临床试验等方面均与发达国家有明显差距。
硕士学位论文 中文摘要
对策：根据SWOT分析结果，本论文就如何加强基础研究、鼓励
临床试验和推动产业化提出了一系列发展我国肿瘤基因治疗技术的
对策。概括起来，即推动国际国内科研机构、制药企业之间的广泛合
作，充分运用政府影响力，为肿瘤基因治疗的专利申请和临床试验提
供必要的便利条件。
Background: As a new branch of modern biotechnology, gene therapy studies have been highly thought all over the world in company with the development of modern biotechnology and have brought great hope to the therapy of cancers. Biopharmaceutical industry in china has made rapid progress in the last 10 years. To date, gene therapy for cancers in china has also been studied. Due to the features of new technologies of modem biotechnology and gene therapy for cancers, expert methods should be used to analyse the industry and related developing technologies. As a unique analytical technique, patent analysis can translate patent data into competitive intelligence which benefits the analysis of the current status and the competitive environment, forecasts technological trends, estimates the competitive ability of the area, and helps to make decisions for it. In this paper patent analysis is used to analyse the current status and the trends. Comparative studies of china and the world in the area of gene therapy are
also conducted.
Objects: After patent data of gene therapy for cancers in china and abroad collected, indicators and techniques of patent analysis are used to acquire the current status and the technological trends in the area of gene therapy for cancers. By this means we can find out the hotspots and estimate the current researches and development of facilities. Compared the situation about gene therapy for cancers in china with that of the
whole world, the developmental countermeasures are put forward correspondingly after disadvantages of the area in china being pointed out.
Methods: Current status of biopharmaceutical industry in china and abroad is analysed first as a whole. Then using the technique of patent analysis and the following indicators such as patent numbers of past years, technology life circle, patent technology area, the competitive ability of facilities and so on. We analysed the patents in the area of gene therapy for cancers. SWOT method is also used to analyse the results from patent analysis, and then the developmental countermeasures are put forward.
Results: Gene therapy for cancers in the whole world is under the stage of R&D recently, but still no drugs come into market. After zealously pursued for several years, gene therapy for cancers has gone into a stable developing stage gradually. But in china it is also still in initial research stage and there is a great distance between china and some developed countries in these aspects such as fundamental researches, clinical trials, et al.
Countermeasures: According to the results of SWOT analysis, a series of developmental countermeasures on gene therapy for cancers in china are put forward in such aspects as how to enhance fundamental researches, encourage clinical trials, and push forward its industrialization. In short, the countermeasures are to promote collaborate widely between scientific & technological facilities and pharmaceutical enterprises in China and abroad, and offer more convenient conditions for applications of patents and clinical trials making full use of government policy.
目的：本课题旨在通过收集国内外肿瘤基因治疗专利数据并运用专利分析指标及相应分析方法，了解国内肿瘤基因治疗领域的整体现状及技术发展趋势，把握其研究热点及机构研发现状，并与国外肿瘤基因治疗的发展进行对比分析，找出自身发展中存在的不足，提出相应的发展对策。
方法：通过对国内外生物制药行业发展现状的总体分析，及针对国内外肿瘤基因治疗领域运用专利历年数量、技术生命周期、地区分布情况、专利技术内容、机构竞争力等专利分析指标与方法来进行对比分析，将分析结果结合运用SWOT分析法，提出相应发展对策。
结果：通过专利分析发现世界肿瘤基因治疗领域正处研发阶段，尚无药品正式上市，在经过狂热期后已逐渐进入稳步发展期。我国目前该领域也处于研发初期阶段，在基础研究和临床试验等方面均与发达国家有明显差距。
硕士学位论文 中文摘要
对策：根据SWOT分析结果，本论文就如何加强基础研究、鼓励
临床试验和推动产业化提出了一系列发展我国肿瘤基因治疗技术的
对策。概括起来，即推动国际国内科研机构、制药企业之间的广泛合
作，充分运用政府影响力，为肿瘤基因治疗的专利申请和临床试验提
供必要的便利条件。
Background: As a new branch of modern biotechnology, gene therapy studies have been highly thought all over the world in company with the development of modern biotechnology and have brought great hope to the therapy of cancers. Biopharmaceutical industry in china has made rapid progress in the last 10 years. To date, gene therapy for cancers in china has also been studied. Due to the features of new technologies of modem biotechnology and gene therapy for cancers, expert methods should be used to analyse the industry and related developing technologies. As a unique analytical technique, patent analysis can translate patent data into competitive intelligence which benefits the analysis of the current status and the competitive environment, forecasts technological trends, estimates the competitive ability of the area, and helps to make decisions for it. In this paper patent analysis is used to analyse the current status and the trends. Comparative studies of china and the world in the area of gene therapy are
also conducted.
Objects: After patent data of gene therapy for cancers in china and abroad collected, indicators and techniques of patent analysis are used to acquire the current status and the technological trends in the area of gene therapy for cancers. By this means we can find out the hotspots and estimate the current researches and development of facilities. Compared the situation about gene therapy for cancers in china with that of the
whole world, the developmental countermeasures are put forward correspondingly after disadvantages of the area in china being pointed out.
Methods: Current status of biopharmaceutical industry in china and abroad is analysed first as a whole. Then using the technique of patent analysis and the following indicators such as patent numbers of past years, technology life circle, patent technology area, the competitive ability of facilities and so on. We analysed the patents in the area of gene therapy for cancers. SWOT method is also used to analyse the results from patent analysis, and then the developmental countermeasures are put forward.
Results: Gene therapy for cancers in the whole world is under the stage of R&D recently, but still no drugs come into market. After zealously pursued for several years, gene therapy for cancers has gone into a stable developing stage gradually. But in china it is also still in initial research stage and there is a great distance between china and some developed countries in these aspects such as fundamental researches, clinical trials, et al.
Countermeasures: According to the results of SWOT analysis, a series of developmental countermeasures on gene therapy for cancers in china are put forward in such aspects as how to enhance fundamental researches, encourage clinical trials, and push forward its industrialization. In short, the countermeasures are to promote collaborate widely between scientific & technological facilities and pharmaceutical enterprises in China and abroad, and offer more convenient conditions for applications of patents and clinical trials making full use of government policy.
引文
[1]樊松林．关于竞争情报研究深入开展的几个问题．上海大学学报(社科版)，2002．9(1)：105～108
[2]陈若韵．企业竞争情报的搜集与研究．情报杂志，2000(6)：15～17
[3]新井 喜美雄(日本)．专利情报分析．医学工程师，1995(1)：19～35
[4]刘焕成．专利信息在分析竞争对手中的作用．情报科学，2001(4)：422～424
[5]Mogee, M.E. Using Patent data for technology analysis and planning. Research Technology Management, 1991, 34(4)
[6]吴燕敏．专利情报分析的意义．情报学刊，1993(6)：449～453
[7]Craigs. Fleisher, Babetle Bensoussan. Strategic and competitive analysis: methods and techniques for analyzing business competition. Prentice Hall PTR, 2002.3:347～363
[8]胡维新．医学分子生物学．湖南：中南工业大学出版社，2001．270～286
[9]Merritt McKinney. Gene therapy said promising despite side effects. Gene Therapy, 2001(8)
[10]基因治疗与基因工程药物(http://www.sy.dq.hl.cn/biology/chapter101.htm)
[11]医药中国网站．癌症的预防和治疗(http://www.echinaherbs.com/theme3.asp?themeid=11&aid=1730)
[12]吴祖泽．肿瘤基因治疗进展．世界科技研究与发展，1999，21(1)．9～10
[13]马飞．肿瘤基因治疗仍在探索阶段．(http://www.37c.com.cn/info/message/200112/200112685.html)
[14]Peter Steele. Competitive Intelligence from patent. Bussiness Brief: Pharmatech 2002:1～3
[15]陈传宏，苏之仪，吴玉瑞．生物医药产业发展的信息支持．医学与哲学，1998，19(1)：24～26
[16]国家“863”计划生物技术领域发展述评．(http://www.cnsp.org.cn/tbtj/863b.htm)
[17]郭勇．生物制药技术．北京：中国轻工业出版社，2000：6～10
[18]生物技术制药工业发展动态．(http://www.medboo.com/business/message/100823483.htm)
[19]卫件波．我国生物制药行业的现状与发展．(http://sjzjh.gtja.com/yjbg/y4.htm)
[20]吴梧桐．下一个10年的生物技术与生物制药．中国药学杂志，1999，34(1)：3～6
[21]孙燕玲．因特网上查专利．北京：知识产权出版社，2002：86～90
[22]李伟，温彦果．我国现代生物技术专利统计分析及其发展趋势和态势研究．科学学与科学技术管理，2002(4)：5～7
[23]Drug Patent 2001. Current Patent Inc. ( http://www. current-patents.com/drug_patents/)
[24]北方恒和企业技术创新实例—生物芯片技术的专利情报分析(北方恒和顿数据有限公司)(http://www.all-patent.com/mall/home/eid-biology.asp)
[25]CHI Technology Indicators. (http://www. chiresearch.com/about/data/tech/indicator. php3)
[26]同12
[27]W.B. Ashton and R.A. Klavans. Technical intelligence for business: keeping abreast of science & technology, Battelle Press, 1997
[28]董文军．专利统计信息分析及其应用．科技情报开发与经济，2000，10(5)：29～30
[29]李虎军．我国基因治疗初上临床试验．科学时报．1999．6．16
[30]强伯勤．我国生物技术蓬勃发展十五年．(http://www.agri.ac.cn/agri_net/02/2-05/0107wg.htm)
[31]国家食品药品监督管理局．(http://www.sda.gov.cn)
[32]孔为民，孙建衡，林晨肿．肿瘤基因治疗研究进展(下)．(http://www.medonline.com.cn/medonline/01/200303/06/111236.asp)
[33]医药中国网站．癌症的预防和治疗(http://www.echinaherbs.com/theme3.asp?themeid=11&aid=1730)
[34]中国癌症信息库．(http://www.bufotanine.com/drugs/hwjs.php)
[35]华拓医药．(http://www.huamodrug.com/zycp/rub.htm)
[36]张学全，张建松．我国抢占基因市场缘何受阻．(http://database.cpst.net.cn/popul/focus/artic/10712105452.html)
[2]陈若韵．企业竞争情报的搜集与研究．情报杂志，2000(6)：15～17
[3]新井 喜美雄(日本)．专利情报分析．医学工程师，1995(1)：19～35
[4]刘焕成．专利信息在分析竞争对手中的作用．情报科学，2001(4)：422～424
[5]Mogee, M.E. Using Patent data for technology analysis and planning. Research Technology Management, 1991, 34(4)
[6]吴燕敏．专利情报分析的意义．情报学刊，1993(6)：449～453
[7]Craigs. Fleisher, Babetle Bensoussan. Strategic and competitive analysis: methods and techniques for analyzing business competition. Prentice Hall PTR, 2002.3:347～363
[8]胡维新．医学分子生物学．湖南：中南工业大学出版社，2001．270～286
[9]Merritt McKinney. Gene therapy said promising despite side effects. Gene Therapy, 2001(8)
[10]基因治疗与基因工程药物(http://www.sy.dq.hl.cn/biology/chapter101.htm)
[11]医药中国网站．癌症的预防和治疗(http://www.echinaherbs.com/theme3.asp?themeid=11&aid=1730)
[12]吴祖泽．肿瘤基因治疗进展．世界科技研究与发展，1999，21(1)．9～10
[13]马飞．肿瘤基因治疗仍在探索阶段．(http://www.37c.com.cn/info/message/200112/200112685.html)
[14]Peter Steele. Competitive Intelligence from patent. Bussiness Brief: Pharmatech 2002:1～3
[15]陈传宏，苏之仪，吴玉瑞．生物医药产业发展的信息支持．医学与哲学，1998，19(1)：24～26
[16]国家“863”计划生物技术领域发展述评．(http://www.cnsp.org.cn/tbtj/863b.htm)
[17]郭勇．生物制药技术．北京：中国轻工业出版社，2000：6～10
[18]生物技术制药工业发展动态．(http://www.medboo.com/business/message/100823483.htm)
[19]卫件波．我国生物制药行业的现状与发展．(http://sjzjh.gtja.com/yjbg/y4.htm)
[20]吴梧桐．下一个10年的生物技术与生物制药．中国药学杂志，1999，34(1)：3～6
[21]孙燕玲．因特网上查专利．北京：知识产权出版社，2002：86～90
[22]李伟，温彦果．我国现代生物技术专利统计分析及其发展趋势和态势研究．科学学与科学技术管理，2002(4)：5～7
[23]Drug Patent 2001. Current Patent Inc. ( http://www. current-patents.com/drug_patents/)
[24]北方恒和企业技术创新实例—生物芯片技术的专利情报分析(北方恒和顿数据有限公司)(http://www.all-patent.com/mall/home/eid-biology.asp)
[25]CHI Technology Indicators. (http://www. chiresearch.com/about/data/tech/indicator. php3)
[26]同12
[27]W.B. Ashton and R.A. Klavans. Technical intelligence for business: keeping abreast of science & technology, Battelle Press, 1997
[28]董文军．专利统计信息分析及其应用．科技情报开发与经济，2000，10(5)：29～30
[29]李虎军．我国基因治疗初上临床试验．科学时报．1999．6．16
[30]强伯勤．我国生物技术蓬勃发展十五年．(http://www.agri.ac.cn/agri_net/02/2-05/0107wg.htm)
[31]国家食品药品监督管理局．(http://www.sda.gov.cn)
[32]孔为民，孙建衡，林晨肿．肿瘤基因治疗研究进展(下)．(http://www.medonline.com.cn/medonline/01/200303/06/111236.asp)
[33]医药中国网站．癌症的预防和治疗(http://www.echinaherbs.com/theme3.asp?themeid=11&aid=1730)
[34]中国癌症信息库．(http://www.bufotanine.com/drugs/hwjs.php)
[35]华拓医药．(http://www.huamodrug.com/zycp/rub.htm)
[36]张学全，张建松．我国抢占基因市场缘何受阻．(http://database.cpst.net.cn/popul/focus/artic/10712105452.html)