遗传资源利用中的知识产权国际保护
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摘要
在生物科技高速发展的背景下,遗传资源的利用已经广泛涉及到医学、化妆品、现代农业、药品、食品等行业。知识产权制度加速了遗传资源的商业化利用,保障生物科技的研发收回投资。二十世纪90年代以来,生物剽窃的现象时有发生,给遗传资源所在国造成了巨大损失,发达国家依仗技术和资金优势,利用发展中国家的遗传资源进行研究,获得技术成果后申请专利,然后高价向发展中国家转让专利,获得高额利润。《生物多样性公约》签订后,为了贯彻事先知情同意和惠益分享原则的实施,防止越演越烈的生物剽窃,发展中国家提出了在专利申请中披露遗传资源的来源,并将此与专利的有效性相联的主张,同时,发展中国家积极在WIPO,WTO推动这一提议,力求形成具有约束力的国际规则。虽然,在国际层面上无重大进展,但很多国家的专利法已经增加了披露遗传资源来源的要求,在细节上有所区别。中国在新修改的专利法中加入了遗传资源披露要求,体现了我国作为生物资源大国和发展中的生物技术强国的立场,有着重大的意义。但这仍然需要其他法律法规的配套,才能发挥其应有的作用。基于上述研究的目的和意义,本文分五章展开分析。
     第一章详细介绍了遗传资源的概念,列举了国际层面上遗传资源的定义,各国立法中对遗传资源的定义,分析了遗传资源和传统知识以及生物多样性之间的关系,以及遗传资源的法律地位。第二章探讨了遗传资源的利用。遗传资源的利用涉及很多产业,如医药、农业、化妆品等,而专利权和植物新品种权是对遗传资源利用成果的主要保护方式,文章分析了遗传资源利用中所出现的生物剽窃现象,介绍了目前国际上遗传资源利用的双边体系和多边体系。第三章介绍了遗传资源来源披露要求的提出,以及在WIPO、WTO下的进展,涉及专利合作条约、专利法条约、专利实体法条约草案、TRIPS协议第二十七条第三款(b)项和第二十九条,概要地分析了有关国家的立场。第四章对现有遗传资源来源披露立法的现状做一归纳介绍和梳理,解释了典型的加强披露,适中披露以及弱式披露模式的具体立法。第五章立足于中国的情况,介绍了目前中国遗传资源管理的具体机构,评析现有涉及遗传资源的立法,对新修改的专利法和专利法实施条例草案做了简述。
With the rapid development of technology, human being has more power to utilize the genetic resource, nowadays; the utilization of genetic resource is common in many industries, such as the pharmaceuticals, the botanical medicines, personal health care and cosmetic products and so on. Currently, the intellectual property is the main mechanism for the commercial utilization of genetic resources. However, the problem is that the developed countries use genetic resources mainly from developing countries, and gain enormous economic benefits through intellectual property right. With the conclusion of the CBD, the principle of prior informs consent and fair and equitable sharing of benefits is established. The developing courtiers argued that the current intellectual property system facilitates the so called bio-piracy, which is detrimental to the developing country. The developing countries are pushing the proposal that the patent applicants should be required to disclose the origin of genetic resources and traditional knowledge on which their inventions were based. They proposal of this kind (with different version) are wildly discusses at different international forum such as the WIPO and the WTO, and some courtiers have already amended their patent laws. The newly amendment of the Patent Law in China also follows this trend. With these purposes, this thesis includes five chapters.
     Chapter 1 begins with the definition of the genetic resources, and then discusses the relationship between the genetic resource and traditional knowledge, the relationship between the genetic resource and biodiversity, and the legal status of the genetic resources. Chapter 2 discusses the utilization of the genetic resources, introduced the concept of bio-piracy and typical cases. Chapter 3 analyzes the bilateral system under Convention on Biodiversity and the multilateral system under International Treaty on Plant Genetic Resources for Food and Agriculture. Chapter 4 describes how the proposal, which argues that patent applicants should be required to disclose the origin of genetic resources and traditional knowledge on which their inventions were based, is being discussed in the WIPO and WTO. The national legislation of this kind is also analyzed. Chapter 5 gives the comments on the newly amended Patent Law of China, and calls for further support of other genetic resource management law.
引文
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    2该公约于1992年6月5日在7联合国所召开的里约热内卢世界环境与发展大会上通过的正式通过,并于1993年12月29日起生效(因此每年的12月29日被定为国际生物多样性日)。到目前为止,已有100多个国家加入了这个公约。该公约的秘书处设在瑞士的日内瓦,最高管理机构为缔约方会议(CoP)。CoP由各国政府代表组成。其职责为:按照公约所规定的程序通过生物多样性公约的修正案、附件及议定书等。
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    59 对此案的介绍可以参见网站http://www.etcgroup.org/en/materials/publications.html?pub id=683 2009-1-5
    60 以下是关于此案的时间表
    02 December 2003:USPTO's reexamination results in "Non Final" Rejection of Patent
    02 June 2004:Proctor submits 400+ page amendment to "Non Final" Rejection
    14 April 2005:USPTO issues "Final Rejection" of Patent
    14 October 2005:Proctor submits Request for Continued Examination of Patent
    21 December 2005:and issues another "Final Rejection" of Patent
    61 Legal Elements of the "Ayahuasca" Patent Case http://www.grain.org/bio-ipr/?id=1672009-1-26
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    66 见生物多样性公约原文http://www.cbd.int/convention/articles.shtml?a=cbd-02 2009-01-03
    67 见条约导言
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    69 见条约第12条3(a)
    70 见条约11.3
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    72 Shawn N.Sullivan Plant Genetic Resources and the Law.Past,Present,and Future,Plant Physiology,Vol.135,No.1(May,2004),pp.10-15
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    74 http://biodiv.coi.gov.cn/fg/gy/xx0401a.htm 2009-2-22
    75 英文原文为 Recipients shall not claim any intellectual property or other rights that limit the facilitatedaccess to the plant genetic resources for food and agriculture,or their genetic parts or components,in the form received from the Multilateral System;
    76 英国知识产权委员会.知识产权与发展战略相结合[R]第69页
    77 The status of public and proprietary germplasm and information.IP Strategy Today 7-2003.http://www.biodevelopments.org/ip/ipst7.pdf 2009-2-22
    78 12(f)Access to plant genetic resources for food and agriculture protected by intellectual and other property rights shall be consistent with relevant international agreements,and with relevant national laws;13.2 The Contracting Parties agree that benefits arising from the use,including commercial,ofplant genetic resources for food and agriculture under the Multilateral System shall be sharedfairly and equitably through the following mechanisms:the exchange of information,access toand transfer of technology,capacity-building,and the sharing of the benefits arising fromcommercialization,taking into account the priority (b) Access to and transfer of technology
    (ⅰ) The Contracting Parties undertake to provide and/or facilitate access totechnologies for the conservation,characterization,evaluation and use of plantgenetic resources for food and agriculture which are under the Multilateral System.Recognizing that some technologies can only be transferred through genetic material,the Contracting Parties shall provide and/or facilitate access tosuch technologies and genetic material which is under the Multilateral System and to improved varieties and genetic material developed through the use of plant genetic resources for food and agriculture under the Multilateral System,in conformity with the provisions of Article 12.Access to these technologies,improved varieties and genetic material shall be provided and/or facilitated,whilerespecting applicable property rights and access laws,and in accordance withnational capabilities.
    (ⅱ) Access to and transfer of technology to countries,especially to developing countries and countries with economies in transition,shall be carried out through a set of measures,such as the establishment and maintenance of,and participation in,crop-based thematic groups on utilization of plant genetic resources for food and agriculture,all types of partnership in research and development and in commercial joint ventures relating to the material received,human resource development,and effective access to research facilities.
    (ⅲ) Access to and transfer of technology as referred to in(ⅰ) and(ⅱ) above,including that protected by intellectual property rights,to developing countries that are Contracting Parties,in particular least developed countries,and countries with economies in transition, shall be provided and/or facilitated under fair and most favourable terms,in particular in the case of technologies for use in conservation as well as technologies for the benefit of farmers in developing countries,especially in least developed countries,and countries with economies in transition,including on concessional and preferential terms where mutually agreed,inter alia,through partnerships in research and development under theMultilateral System.Such access and transfer shall be provided on terms whichrecognize and are consistent with the adequate and effective protection ofintellectual property rights.
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    80 文件号UNEP/CBD/COP/6/20
    81 杨红菊.专利申请中遗传资源来源公开问题系列研究——问题的提出及国际讨论进展综述[J]贵州师范大学学报(社会科学版)2006(02)
    82 http://www.peoole.com.cn/GB/channel2/17/20000603/87781.html
    83 WIPO Document SCP/3/10
    84 原文为 "All industrial property protection shall guarantee the protection of the country's biological and genetic heritage.Consequently,the grant of patents or registrations that relate to elements of that heritage shall be subject to their having been acquired legally."
    85 原文为"Every document shall specify the registration number of the contract affording access to genetic resources and a copy thereof where the goods or services for which protection is sought have been manufactured or developed from genetic resources,or products thereof,of which one of the member countries is the country of origin."
    86 WIPO Document WIPO/TKGRF/IC/1/3
    87 见 WIPO Documents WIPO/IP/GR/01 and WIPO/IP/GR/02.
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    89 见WIPO会议文件SCP/4/2
    90 WIPO Document SCP/9/2 at 10."Nothing in this Treaty and the Regulations shall limit the freedom of a Contracting Party to take any action it deems necessary for the preservation of essential security interests or to comply with international obligations,including those relating to the protection of genetic resources,biological diversities,traditional knowledge and the environment"
    91 Dominic Keating,Access To Genetic Resources And Equitable Benefit Sharing Through A New Disclosure Requirement In The Patent System:An Issue In Search Of A Forum,87 J.Pat.&Trademark Off.Soc'y 525
    92 见WIPO会议文件SCP/10/11
    93 见WIPO会议文件SCP/10/11
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    102 WIPO Doc.PCT/R/WG/4/14,和 PCT/R/WG/5/13
    103 Swiss proposal was re-submitted as WIPO Doc.PCT/R/WG/5/11 Rev. Additional Comments by Switzerland on its Proposal Regarding the Declaration of Source of Genetic Resources and Traditional Knowledge in Patent Applications,WIPO Doc.PCT/R/WG/6/11
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    105 世界贸易组织WT/CTE/W/66文件
    106 世界贸易组织WT/CTE/W/65文件
    107 世界贸易组织IP/C/W/356文件
    108 世界贸易组织IP/C/W/403文件
    109 世界贸易组织IP/C/W/474文件
    110 世界贸易组织IP/C/W/383文件
    111 世界贸易组织IP/C/W/433文件
    112 世界贸易组织IP/C/W/393文件
    113 世界贸易组织IP/C/W/434文件
    114 BRAZIL,INDIA CIRCULATE DRAFT TRIPS AMENDMENT ON PATENT DISCLOSURE,Inside Washington Publishers,Inside U.S.Trade,Vol.24 No.22
    115 UPOV Council,Reply of UPOV to the Notification of June 26,2003 from the Executive Secretary of the Convention on Biological Diversity,UPOV Document C/37/21
    116 见上文中生物剽窃案件介绍部分
    117 国家知识产权局条法司编.专利法研究2005[M],知识产权出版社2006,第213页
    118 英国知识产权委员会.知识产权与发展政策相结合[R],第86页
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    120 牟萍.论专利申请中生物遗传资源来源的披露[A],见国家知识产权局条法司编,专利法研究2005[M],知识产权出版社2006,第119页
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    124 http://www.sipo.gov.cn/sipo/ztxx/yczyhctzsbh/zlk/gglf/t20050324 43276.htm 2009-1-5
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    129 https://www.aippi.org/download/comitees/166/SR166English.pdf 2009-3-1
    130 http://www.nbaindia.org/docs/agro-whitepaper.pdf 2009-3-1
    131 http://www.mep.gov.cn/natu/swdyx/swwzzybh/2OO708/t20070806 107580.htm 2009-2-10
    132 李立.传统知识遗传资源民间文艺等立法不够缺乏保护国家知识产权局局长解析中国优势领域知识产权立法如何提速[N],法制日报,2008,07(01):08.
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    134 例如,我国的生物多样性公约履约小组设立在环保部下
    135 《保护知识产权行动纲要(2006-2007年)》第五、建立长效机制(十四)完善法律法规体系。要针对当前保护知识产权工作中的突出问题,完善有关法律法规,增强可操作性,加大打击力度。要研究解决侵权违法所得数额计算标准、约束滥用知识产权行为以及企业名称、商标和标志模仿知名度高的商标等问题,推动遗传资源、传统知识、民间文学艺术等领域的知识产权保护法律法规建设。
    136 《国家中长期科学和技术发展规划纲要(2006—2020年)》九、科技投入与科技基础条件平台项下包括“自然科技资源服务平台。建立完备的植物、动物种质资源,微生物菌种和人类遗传资源,以及实验材料,标本、岩矿化石等自然科技资源保护与利用体系。”
    137 修改后的专利法http://www.sczw.gov.cn/scweb/show.jsp?id=7756&child type=60 2009-1-10
    138 http://www.chinacourt.org/html/article/200808/31/319504.shtml 2009-3-1
    139 http://www.sipo.gov.cn/sipo2008/tz/gz/200811/P020081105600019958913.pdf2009-3-15
    140 例如,2001年,《瞭望》周刊曾发表文章,对哈佛大学公共卫生学院等机构在我国安徽农村进行的有关哮喘病、高血压、肥胖症、糖尿病、骨质疏松等多种疾病的基因调查行为提出质疑:这些项目是否让实验参与者充分了解研究目的及参与研究的利弊情况,收集他们的血样或基因样本,是否尊重了参与者的知情同意权;对这些涉及数以万计的人体基因样本的使用是否会造成我国基因遗传资源的流失。2002年3月28日,中国卫生部下设的“人体研究保护办公室”分别致函支持这些研究项目的哈佛大学公共卫生学院等机构,通报其调查结果:这些机构在中国进行的15个人类基因研究项目,在生命伦理、监督管理和确保参与者的安全等多方面存在问题,属违规操作。2002年3月29日,美国《洛杉矶时报》披露:美国联邦政府官员发出了数封措辞严厉的斥责信,指责哈佛大学的科研做法,质疑哈佛大学在对世界上最令人垂涎的“遗传信息宝库”——中国人类遗传资源进行科研时的道义问题。对此可以参见:http://www.biotech.org.cn/news/news/show.php?id=22359
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