跨国医药公司在华专利战略分析及对中药产业的启示研究
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摘要
中药产业作为新近走入工业化的传统医药产业,由于物质基础的复杂和技术手段的不足,知识产权保护体系建设还很薄弱。近年跨国公司由于研发压力纷纷将开发目标转向具有药用价值的天然产物,尤其中医药以其悠久的医学传统和丰富的医药知识吸引了跨国公司的研发投入。跨国公司作为现代知识产权制度的重要推动者,知识产权制度在跨国公司的经营战略中已经远远超出原有的法律意义。跨国公司的专利战略具有哪些特点?跨国公司对于中药知识产权保护都有哪些威胁?面对跨国公司的大举进入,中药产业该如何面对?现有研究对这些问题还没有作出明确回应,从而这些问题成为本课题的研究目标。
本课题主要通过调查研究、统计分析、案例研究、比较分析等方法对主要跨国医药公司在华专利数据和国外申请人在华中药领域专利数据的分析,结合相关专利诉讼、经营案例的调研,总结出跨国医药公司的知识产权战略,提出完善我国中药知识产权保护体系的意见和建议,具体研究内容如下:
第1章回顾分析了跨国医药公司在华发展概况,根据跨国医药公司在华投资深度将其发展历程分为起步、发展、调整与提高三个阶段。从全球战略、市场环境、成本因素、资源供给、政策制度等角度探讨了跨国公司在华投资的决策因素。
第2章以跨国医药公司在华行业协会——“药品研制和开发行业委员会”会员公司为样本,对跨国医药公司在华专利布局及相关诉讼案例进行了统计、分析、总结,揭示了跨国公司专利布局的特点和专利诉讼的运用技巧。
第3章对国外在华中药领域专利数据进行了全面的检索统计和技术分析,纳入分析专利申请794件,其中290件为授权专利。国外中药专利申请主要来自日本、美国、韩国、德国,中药材在药材原料并没有占到绝对份额,很多国外申请是基于本国或其他地区天然产物提出的申请。对于企业申请人分别选取意大利因迪纳有限公司、日本株式会社资生堂、雀巢产品有限公司作为植物药、日用品、饮食品三类企业代表进行分析,并对日、美、韩、德、印五国的申请进行了重点分析。
第4章选取近年积极投身中药资源开发的诺华公司进行案例分析,总结出跨国公司获取中药专利的三种路径——自主创新、研发联盟、专利许可。同时,通过对银杏叶提取物专利和标准状况的介绍与分析,指出专利型标准化战略不符合中药技术特点和属性,中药产业的当务之急是提高中药技术标准,占领中药产业发展的标准高地。
第5章通过对相关数据与案例总结,归纳出跨国医药公司专利战略的特点和常见专利战略类型。专利战略作为跨国公司的核心战略与其商业战略和技术战略密不可分。跨国公司常用专利战略包括基本专利战略、专利网战略、专利许可战略、专利诉讼战略及研发联盟战略。
第6章对于跨国公司专利战略给中药产业带来的影响进行了归纳总结,主要影响是:①跨国公司利用我国中医药资源法律监管制度缺失,无偿开发我国中药关键技术和药材资源;②跨国公司导致中药研发人才流失,中药企业创新能力被削弱;③国内机构中药专利成果议价能力不足,致使专利成果转让、许可遭遇不公正补偿。
第7章针对跨国公司带给中药产业的现实威胁和远期影响,结合跨国公司的专利战略从政府层面和企业层面提出了国内中药产业的应对措施。
通过上述分析,本研究得出以下结论:
跨国公司的专利战略具有全局性,实施策略多样化,擅长利用各种法律、行政手段达到其战略目的。跨国医药公司在华专利活动主要特点:①专利意识强;②研发活动国际化趋势明显;③善于利用专利制度。针对跨国公司中药领域投资的主要环节,应加强中药材原料种植、炮制、提取物加工和中药国际交流合作涉及的知识产权保护。跨国医药公司在西药领域的专利布局和诉讼案例充分体现了跨国公司对于专利制度的工具化应用,为维护中药知识产权安全在借鉴跨国公司专利战略的基础上,国内中药产业应从政府层面和企业层面分别采取措施防范未然。在政府层面,应该:①调整创建法律法规,构建中药法律保护体系;②健全现行法律体系,完善创新激励转化机制;③完善市场转化机制,促进医药企业技术创新;④加强专业人才培养,提高专利法规执行能力;⑤构建行业预警系统,加强知识产权安全监管。在企业层面,应该:①加大研发投入,增强企业技术创新能力;②结成战略联盟,积极利用外部研发资源;③提高质量标准,拓展中药国际发展空间;④制订专利战略,增强企业专利运用能力;⑤集聚高端人才,构建国际水平运营能力。
The intellectual property rights protection system of tradition Chinese medicine industry is still weak as it begins industrialized recently and has a complicated material basis and hasn't enough technique measurement. In these years, many transnational corporations turn their study purposes to natural products with officinal value for the research and development pressure. Traditional Chinese medicine is attracting a lot of research and development devotion of transnational corporation because it has a long medical tradition and ample medical knowledge. Transnational corporations have become important propellents of modern intellectual property rights system. To transnational corporations, intellectual property system in management strategy aspect is not only original law interesting, but also a significant strategic instrument to invest and exploit. How many characteristics have the transnational corporations in patent strategy? How do transnational corporations bring threats to the traditional Chinese medicine industry about intellectual property of the traditional Chinese medicine and for traditional Chinese medicine how to face those threats from the transnational corporations? By far the present studies have no definite answer to those questions, so we take those questions for our study object.
In this study, the patent data of major transnational pharmaceutical corporations in China and the applicants overseas in traditional Chinese medicine field were analyzed through many methods including close research, statistical analysis, case by case research and comparison analysis and so on. Combined those data with the investigation of relative patent lawsuit and management case, intellectual property strategy of transnational corporations was summed up and the suggestion of how to enhance intellectual property protection system of traditional Chinese medicine was provided as the followings.
In Chapter 1, the development survey of transnational corporations in China was analyzed retrospectively. According to the investment depth of transnational corporations in China, the development course was divided into three stages, i.e. start, development, and adjustment and improvement. We explored the decision-making factors from the global strategy, market condition, cost factors, resource supply, policy system aspects etc.
In Chapter 2, we took the member corporations of the R&D-based pharmaceutical association committee, guild of transnational pharmaceutical corporations in China, as samples to do some statistics, analysis and sum up about the patent portfolio of transnational pharmaceutical corporations in China and some related lawsuit cases. The year distribution, applicants' condition, country distribution, PCT general condition, patent cooperation and indications indexes of the patent data were gathered and analyzed. The lawsuit case part included some cases in recent years.
In Chapter 3, we comprehensively searched and analyzed the patent data of transnational corporations in China, and 794 patent applications were included in the analysis, 290 of which were authorized patent. The year, applicants, country, medicinal materials producing area, technique type, indicates were taken as analyzed indexes, we found most of the overseas patent applications came from Japan, America, Korea, German, and Chinese herbs weren't the raw materials of those applications, many overseas patent applicants put forward their applications based on the natural products of their own countries or other countries. Indena Inc, Shiseido Co Ltd , Nestle Ltd were analyzed as botanical materials, commodity and food representatives respectively, and at the same time, the patent applications of Japan, American, Korea, German, India five countries were analyzed as important parts.
In Chapter 4, Novartis, a company actively involving in the traditional Chinese medicine resource research and development in recent years, was selected as a key case analyzed, and the results suggested that independent innovation, R&D ally, patent permission were three ways to get the Chinese medicine patent of transnational corporations. The introduction and analysis of patent and standards of Ginkgo Biloba Extract condition indicated patent standardization strategy didn't accord with the technique characteristics and property of Chinese medicine, the major urgent of Chinese pharmaceutical industry was to improve the technique standards, and to occupy the national height of Chinese medicine industry development.
In Chapter 5, through the analysis of the related data and case, the patent strategy characteristics of transnational pharmaceutical corporations and common patent strategy types were summed up.
In Chapter 6, we concluded what patent strategy of transnational corporations do on the Chinese pharmaceutical industry, that is①the loss of key technology and resources of traditional Chinese medicine;②the innovative capability of Chinese pharmaceutical corporations being weakened;③patents of traditional Chinese medicine from China being devaluated.
In Chapter 7, according to the realistic threats and long term effects on Chinese medicine industry that transnational corporations brought, the facing methods of domestic medical industry were provided combined with the patent strategy of transnational corporation from the government and company aspects.
Through the above analysis, the conclusions were as followed.
They had a full-scale and various patent strategies, and did well in using the law and administrated means to get the purpose. The patent strategy as the core strategy of transnational corporations, connected closely with business strategy and technique strategy. The general patent strategy included basic patent strategy, patent net strategy, patent permission strategy, patent lawsuit strategy and R&D ally strategy.
In the Chinese medicine intellectual property protection field, about the plant, the making, the process technique of extract and R&D cooperation with overseas agents aspects, the corresponding intellectual property methods should be brought forward. In addition, Chinese medicine quality standards levels should be improved and should not become the patent typed standardized strategy which is not correspond to the technique characteristics and property of Chinese medicine.
The patent portfolio and lawsuit cases show that transnational corporations applied patent system proficiently, and we should take some measures to guard against transnational corporations. Those measures should be designed from government and corporations.
本课题主要通过调查研究、统计分析、案例研究、比较分析等方法对主要跨国医药公司在华专利数据和国外申请人在华中药领域专利数据的分析,结合相关专利诉讼、经营案例的调研,总结出跨国医药公司的知识产权战略,提出完善我国中药知识产权保护体系的意见和建议,具体研究内容如下:
第1章回顾分析了跨国医药公司在华发展概况,根据跨国医药公司在华投资深度将其发展历程分为起步、发展、调整与提高三个阶段。从全球战略、市场环境、成本因素、资源供给、政策制度等角度探讨了跨国公司在华投资的决策因素。
第2章以跨国医药公司在华行业协会——“药品研制和开发行业委员会”会员公司为样本,对跨国医药公司在华专利布局及相关诉讼案例进行了统计、分析、总结,揭示了跨国公司专利布局的特点和专利诉讼的运用技巧。
第3章对国外在华中药领域专利数据进行了全面的检索统计和技术分析,纳入分析专利申请794件,其中290件为授权专利。国外中药专利申请主要来自日本、美国、韩国、德国,中药材在药材原料并没有占到绝对份额,很多国外申请是基于本国或其他地区天然产物提出的申请。对于企业申请人分别选取意大利因迪纳有限公司、日本株式会社资生堂、雀巢产品有限公司作为植物药、日用品、饮食品三类企业代表进行分析,并对日、美、韩、德、印五国的申请进行了重点分析。
第4章选取近年积极投身中药资源开发的诺华公司进行案例分析,总结出跨国公司获取中药专利的三种路径——自主创新、研发联盟、专利许可。同时,通过对银杏叶提取物专利和标准状况的介绍与分析,指出专利型标准化战略不符合中药技术特点和属性,中药产业的当务之急是提高中药技术标准,占领中药产业发展的标准高地。
第5章通过对相关数据与案例总结,归纳出跨国医药公司专利战略的特点和常见专利战略类型。专利战略作为跨国公司的核心战略与其商业战略和技术战略密不可分。跨国公司常用专利战略包括基本专利战略、专利网战略、专利许可战略、专利诉讼战略及研发联盟战略。
第6章对于跨国公司专利战略给中药产业带来的影响进行了归纳总结,主要影响是:①跨国公司利用我国中医药资源法律监管制度缺失,无偿开发我国中药关键技术和药材资源;②跨国公司导致中药研发人才流失,中药企业创新能力被削弱;③国内机构中药专利成果议价能力不足,致使专利成果转让、许可遭遇不公正补偿。
第7章针对跨国公司带给中药产业的现实威胁和远期影响,结合跨国公司的专利战略从政府层面和企业层面提出了国内中药产业的应对措施。
通过上述分析,本研究得出以下结论:
跨国公司的专利战略具有全局性,实施策略多样化,擅长利用各种法律、行政手段达到其战略目的。跨国医药公司在华专利活动主要特点:①专利意识强;②研发活动国际化趋势明显;③善于利用专利制度。针对跨国公司中药领域投资的主要环节,应加强中药材原料种植、炮制、提取物加工和中药国际交流合作涉及的知识产权保护。跨国医药公司在西药领域的专利布局和诉讼案例充分体现了跨国公司对于专利制度的工具化应用,为维护中药知识产权安全在借鉴跨国公司专利战略的基础上,国内中药产业应从政府层面和企业层面分别采取措施防范未然。在政府层面,应该:①调整创建法律法规,构建中药法律保护体系;②健全现行法律体系,完善创新激励转化机制;③完善市场转化机制,促进医药企业技术创新;④加强专业人才培养,提高专利法规执行能力;⑤构建行业预警系统,加强知识产权安全监管。在企业层面,应该:①加大研发投入,增强企业技术创新能力;②结成战略联盟,积极利用外部研发资源;③提高质量标准,拓展中药国际发展空间;④制订专利战略,增强企业专利运用能力;⑤集聚高端人才,构建国际水平运营能力。
The intellectual property rights protection system of tradition Chinese medicine industry is still weak as it begins industrialized recently and has a complicated material basis and hasn't enough technique measurement. In these years, many transnational corporations turn their study purposes to natural products with officinal value for the research and development pressure. Traditional Chinese medicine is attracting a lot of research and development devotion of transnational corporation because it has a long medical tradition and ample medical knowledge. Transnational corporations have become important propellents of modern intellectual property rights system. To transnational corporations, intellectual property system in management strategy aspect is not only original law interesting, but also a significant strategic instrument to invest and exploit. How many characteristics have the transnational corporations in patent strategy? How do transnational corporations bring threats to the traditional Chinese medicine industry about intellectual property of the traditional Chinese medicine and for traditional Chinese medicine how to face those threats from the transnational corporations? By far the present studies have no definite answer to those questions, so we take those questions for our study object.
In this study, the patent data of major transnational pharmaceutical corporations in China and the applicants overseas in traditional Chinese medicine field were analyzed through many methods including close research, statistical analysis, case by case research and comparison analysis and so on. Combined those data with the investigation of relative patent lawsuit and management case, intellectual property strategy of transnational corporations was summed up and the suggestion of how to enhance intellectual property protection system of traditional Chinese medicine was provided as the followings.
In Chapter 1, the development survey of transnational corporations in China was analyzed retrospectively. According to the investment depth of transnational corporations in China, the development course was divided into three stages, i.e. start, development, and adjustment and improvement. We explored the decision-making factors from the global strategy, market condition, cost factors, resource supply, policy system aspects etc.
In Chapter 2, we took the member corporations of the R&D-based pharmaceutical association committee, guild of transnational pharmaceutical corporations in China, as samples to do some statistics, analysis and sum up about the patent portfolio of transnational pharmaceutical corporations in China and some related lawsuit cases. The year distribution, applicants' condition, country distribution, PCT general condition, patent cooperation and indications indexes of the patent data were gathered and analyzed. The lawsuit case part included some cases in recent years.
In Chapter 3, we comprehensively searched and analyzed the patent data of transnational corporations in China, and 794 patent applications were included in the analysis, 290 of which were authorized patent. The year, applicants, country, medicinal materials producing area, technique type, indicates were taken as analyzed indexes, we found most of the overseas patent applications came from Japan, America, Korea, German, and Chinese herbs weren't the raw materials of those applications, many overseas patent applicants put forward their applications based on the natural products of their own countries or other countries. Indena Inc, Shiseido Co Ltd , Nestle Ltd were analyzed as botanical materials, commodity and food representatives respectively, and at the same time, the patent applications of Japan, American, Korea, German, India five countries were analyzed as important parts.
In Chapter 4, Novartis, a company actively involving in the traditional Chinese medicine resource research and development in recent years, was selected as a key case analyzed, and the results suggested that independent innovation, R&D ally, patent permission were three ways to get the Chinese medicine patent of transnational corporations. The introduction and analysis of patent and standards of Ginkgo Biloba Extract condition indicated patent standardization strategy didn't accord with the technique characteristics and property of Chinese medicine, the major urgent of Chinese pharmaceutical industry was to improve the technique standards, and to occupy the national height of Chinese medicine industry development.
In Chapter 5, through the analysis of the related data and case, the patent strategy characteristics of transnational pharmaceutical corporations and common patent strategy types were summed up.
In Chapter 6, we concluded what patent strategy of transnational corporations do on the Chinese pharmaceutical industry, that is①the loss of key technology and resources of traditional Chinese medicine;②the innovative capability of Chinese pharmaceutical corporations being weakened;③patents of traditional Chinese medicine from China being devaluated.
In Chapter 7, according to the realistic threats and long term effects on Chinese medicine industry that transnational corporations brought, the facing methods of domestic medical industry were provided combined with the patent strategy of transnational corporation from the government and company aspects.
Through the above analysis, the conclusions were as followed.
They had a full-scale and various patent strategies, and did well in using the law and administrated means to get the purpose. The patent strategy as the core strategy of transnational corporations, connected closely with business strategy and technique strategy. The general patent strategy included basic patent strategy, patent net strategy, patent permission strategy, patent lawsuit strategy and R&D ally strategy.
In the Chinese medicine intellectual property protection field, about the plant, the making, the process technique of extract and R&D cooperation with overseas agents aspects, the corresponding intellectual property methods should be brought forward. In addition, Chinese medicine quality standards levels should be improved and should not become the patent typed standardized strategy which is not correspond to the technique characteristics and property of Chinese medicine.
The patent portfolio and lawsuit cases show that transnational corporations applied patent system proficiently, and we should take some measures to guard against transnational corporations. Those measures should be designed from government and corporations.
引文
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5 韦晓云.中药品种知识产权保护实质探析.科技与法律,2005,(4):60-66.
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7 袁志明,张永祥.试析现行知识产权制度对我国中药的保护.世界科学技术——中医药现代化,2002,5(2):8-10,75.
8 郑永锋.中药专利申请的现状分析及审查标准.中国新药杂志,2000,9(1):61-64.
9 宋彬,张平川,王明旭.陕西省中医药知识产权保护存在的问题及其对策分析.中国卫生事业管理,2003,(11):699-700.
10 万仁甫,严桂平,李晓东,等.构建中药知识产权保护体系的新思考.中医药管理杂志,2006,14(2):9-12.
11 张韬.现行中药知识产权保护中存在的问题及其解决途径.世界科学技术——中药现代化,2002,4(1):59-60.
12 黄佑,冯国忠.中药品种保护制度亟待引入淘汰机制.中国药业,2003,12(6):8-9.
13 张韬.中药知识产权行政保护与法律保护并存的影响.世界科学技术——中药现代化,2001,3(2):41-42.
14 张建平.中药品种保护制度的关键问题.时珍国医国药,2007,18(4):1001-1003.
15 莫瑶江.加强知识产权保护推动中药现代化进程.世界科学技术——中药现代化,2001,3(3):50-53,91.
16 沈朝斌,成肇炎,顾瑁.中医药发展及其知识产权防卫策略探讨.上海中医药杂志,2001,(8):4-6.
17 吴小璐,肖诗鹰.我国中药专利保护存在的误区及问题分析.中国中药杂志,2004,29(6):603-604.
1 Pharmaceutical Research and Manufacturers of America,Pharmaceutical Industry Profile 2007(Washington,DC:PhRMA,March 2007)
2[澳]彼得·达沃豪斯/约翰·布雷斯韦特著;刘雪涛译.信息封建主义.北京:知识产权出版社,2005:103.
3 David F Horrobin BM DPhil.Innovation in the pharmaceutical industry.Journal of the royal society of medicine 2000,93(6):341-345.
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1 张伟波.中药专利保护的现状及其研究.世界科学技术——中药现代化,2001,3(1):40-46.
2 车明凤.中药的七种保护方式与有关法律法规简介.中国药事,2004,18(9):540-545.
3 王兵,陈维国.我国中草药知识产权保护的几个问题.知识产权研究,2005,(1):64-69.
4 梅智胜.现行法律制度下的我国中药知识产权保护.中国中医药信息杂志,2006,13(1):9-11.
5 韦晓云.中药品种知识产权保护实质探析.科技与法律,2005,(4):60-66.
6 李贞,邵蓉.关于《中药品种保护条例》修订的探讨.上海医药,2007,28(1):33-36.
7 袁志明,张永祥.试析现行知识产权制度对我国中药的保护.世界科学技术——中医药现代化,2002,5(2):8-10,75.
8 郑永锋.中药专利申请的现状分析及审查标准.中国新药杂志,2000,9(1):61-64.
9 宋彬,张平川,王明旭.陕西省中医药知识产权保护存在的问题及其对策分析.中国卫生事业管理,2003,(11):699-700.
10 万仁甫,严桂平,李晓东,等.构建中药知识产权保护体系的新思考.中医药管理杂志,2006,14(2):9-12.
11 张韬.现行中药知识产权保护中存在的问题及其解决途径.世界科学技术——中药现代化,2002,4(1):59-60.
12 黄佑,冯国忠.中药品种保护制度亟待引入淘汰机制.中国药业,2003,12(6):8-9.
13 张韬.中药知识产权行政保护与法律保护并存的影响.世界科学技术——中药现代化,2001,3(2):41-42.
14 张建平.中药品种保护制度的关键问题.时珍国医国药,2007,18(4):1001-1003.
15 莫瑶江.加强知识产权保护推动中药现代化进程.世界科学技术——中药现代化,2001,3(3):50-53,91.
16 沈朝斌,成肇炎,顾瑁.中医药发展及其知识产权防卫策略探讨.上海中医药杂志,2001,(8):4-6.
17 吴小璐,肖诗鹰.我国中药专利保护存在的误区及问题分析.中国中药杂志,2004,29(6):603-604.
1 Pharmaceutical Research and Manufacturers of America,Pharmaceutical Industry Profile 2007(Washington,DC:PhRMA,March 2007)
2[澳]彼得·达沃豪斯/约翰·布雷斯韦特著;刘雪涛译.信息封建主义.北京:知识产权出版社,2005:103.
3 David F Horrobin BM DPhil.Innovation in the pharmaceutical industry.Journal of the royal society of medicine 2000,93(6):341-345.
4 施维亚中国.http://www.servier.com.cn/Monde/ServierChina.asp.访问时间:2007-5-12.
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6 搜狐健康频道.http://health.sohu.com/20061107/n246244350.shtml.访问时间:2007-6-3.
7 Novartis.http://www.novartis.com/research/research-centers/nibr-shanghai.shtml.访问时间:2007-5-18.
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