Directive 98／44／EC of the European Parliament and of the Council of 6 June 1998 on the legal protection of biotechnological inventions | | 欧洲议会与欧洲联盟理事会关于生物技术发明的法律保护指令（98／44／EC） |
| （of 6 July 1998） | | （1998年7月6日通过 1998年7月30日生效） |
The European Parliament and the Council of the European Union，
Having regard to the Treaty establishing the European Community，and in particular Article 100a thereof， | | 考虑到《建立欧洲共同体条约》，尤其是其中的第100a条 |
| Having regard to the proposal from the Commission， | | 考虑到委员会的建议①（注①：《官方公报C类（OJC第296号》，1996年10月8日，第4页和《官方公报C类（OJC）第311号》，1997年10月11日，第12页。） |
| Having regard to the opinion of the Economic and Social Committee， | | 考虑到经济和社会委员会的观点②（注②：《官方公报C类（OJC）第295号》，1996年10月7日，第11页。） |
| Acting in accordance with the procedure laid down in Article 189b of the Treaty， | | 按照条约第189b条设定之程序③（注③：1997年7月16日《欧洲议会的观点》（《官方公报C类（OJC）第286号》，1997年9月22日，第87页）；1998年2月26日《理事会共同立场》（《官方公报C类（OJC）第110号》，1998年4月8日，第17页）和1998年5月12日的《欧洲议会的决定》（《官方公报C类（OJC）第167号》，1998年6月1日）；1998年6月16日《理事会决定》。） |
| （1）Whereas biotechnology and genetic engineering are playing an increasingly important role in a broad range of industries and the protection of biotechnological inventions will certainly be of fundamental importance for the Community's industrial development； | | （1）鉴于生物技术和基因工程在广泛的产业领域正发挥着日益增长的重要作用，而且生物技术发明的保护对共同体的产业发展将理所当然地具有根本性的重要意义； |
| （2）Whereas，in particular in the field of genetic engineering，research and development require a considerable amount of high—risk investment and therefore only adequate legal protection can make them profitable； | | （2）鉴于，尤其是在基因工程领域，R&D需要相当数额的高风险投资，并且因此只有充分的法律保护才能使他们赢利； |
| （3）Whereas effective and harmonised protection throughout the Member States is essential in order to maintain and encourage investment in the field of biotechnology； | | （3）鉴于在全体成员国内有效和一致的保护对维持和鼓励生物技术领域的投资非常重要； |
| （4）Whereas following the European Parliaments rejection of the joint text，approved by the Conciliation Committee，for a European Parliament and Council Directive on the legal protection of biotechnological inventions，the European Parliament and the Council have determined that the legal protection of biotechnological inventions requires clarification； | | （4）鉴于根据欧洲议会对由协调委员会批准的欧洲议会和理事会关于生物技术发明的法律保护指令的共同文本④（注④：《官方公报C类（OJC）第68号》，1995年3月20日，第26页。）的否决，欧洲议会和理事会认为生物技术发明的法律保护问题需要明晰； |
| （5）Whereas differences exist in the legal protection of biotechnological inventions offered by the laws and practices of the different Member States；whereas such differences could create barriers to trade and hence impede the proper functioning of the internal market； | | （5）鉴于由不同成员国的法律和惯例提供的对生物技术发明的法律保护存在差异；鉴于此差异可能产生贸易障碍，并且因此阻碍国内市场正常发挥其功能； |
| （6）Whereas such differences could well become greater as Member States adopt new and different legislation and administrative practices，or whereas national case—law interpreting such legislation develops differently； | | （6）鉴于该差异可能因各成员国采取新的不同的立法和行政惯例而进一步扩大，或者鉴于各国对这些立法的解释导致判例法的发展不一致； |
| （7）Whereas uncoordinated development of national laws on the legal protection of biotechnological inventions in the Community could lead to further disincentives to trade．to the detriment of the industrial development of such inventions and of the smooth operation of the internal market； | | （7）鉴于在共同体内各国国家法关于生物技术发明的法律保护的不协调发展可能导致对贸易的进一步阻碍，以及损害这些发明的产业发展和国内市场的平稳运行； |
| （8）Whereas legal protection of biotechnological inventions does not necessitate the creation of a separate body of law in place of the rules of national patent law：whereas the rules of national patent law remain the essential basis for the legal protection of biotechnologicalinventions given that they must be adapted or added to in certain specific respects in order to take adequate account of technological developments involving biological material which also fulfil the requirements for patentability； | | （8）鉴于对生物技术发明的法律保护并不需要创设单独法律以代替国家专利法的规定；鉴于为充分考虑满足专利性要求的有关生物材料的技术发展，生物技术发明的某些特别方面需要调整到或加入专利法中，国家专利法的规定仍然是对生物技术发明给予法律保护的主要基础； |
| （9）Whereas in certain cases，such as the exclusion from patentability of plant and animal varieties and of essentially biological processes for the production of plants and animals，certain concepts in national laws based upon international patent and plant variety conventions have created uncertainty regarding the protection of biotechnological and certain microbiological inventions；whereas harmonisation is necessary to clarify the said uncertainty； | | （9）鉴于在某些情况下，比如排除植物和动物品种以及生产动植物产品的主要是生物学的方法的可专利性，建立在以关于专利和植物新品种的国际公约基础上的一些国家法的概念，对于生物技术和一些微生物发明的保护产生了不确定性；鉴于统一澄清这些不确定性是必要的； |
| （10）Whereas regard should be had to the potential of the development of biotechnology for the environment and in particular the utility of this technology for the development of methods of cultivation which are less polluting and more economical in their use of ground；whereas the patent system should he used to encourage research into，and the application of，such processes； | | （10）鉴于应该考虑到生物技术的发展对环境，尤其是这些技术的应用对发展能减少污染和更经济地使用土地的种植方法的潜在影响；鉴于专利制度应该用于鼓励这些方法的研究和利用； |
| （11）Whereas the development of biotechnology is important to developing countries，both in the field of health and combating major epidemics and endemic diseases and in that of combating hunger in the world；whereas the patent system should likewise be used to encourage research in these fields；whereas international procedures for the dissemination of such technology in the Third World and to the benefit of the population groups concerned should be promoted； | | （11）鉴于生物技术的发展无论是在健康方面和与传染性、地方性疾病作斗争方面以及在世界范围内与饥饿作斗争方面对发展中国家的重要性；鉴于专利制度也应该用于鼓励这些方面的研究；鉴于这些技术在第三世界传播和有利于有关群体的国际程序应予以增强； |
| （12）Whereas the Agreement on Trade—Related Aspects of Intellectual Property Rights（TRIPs）signed by the European Community and the Member States，has entered into force and provides that patent protection must be guaranteed for products and processes in all areas of technology； | | （12）鉴于欧洲共同体及其成员国已签字的《TRIPS协议》①（注①：《官方公报L类（OJL）第336号》，1994年12月23日，第213页。）已生效，该协议规定专利权应当授予一切技术领域的产品和方法； |
| （13）Whereas the Community's legal framework for the protection of biotechnological inventions can be limited to laying down certain principles as they apply to the patentability of biological material as such，such principles being intended in particular to determine the difference between inventions and discoveries with regard to the patentability of certain elements of human origin，to the scope of protection conferred by a patent on a biotechnological invention，to the right to use a deposit mechanism in addition to written descriptions and lastly to the option of obtaining non—exclusive compulsory licences in respect of interdependence between plant varieties and inventions，and conversely； | | （13）鉴于共同体保护生物技术发明的法律框架，当适用于生物材料本身的专利性时可限于设定一些原则，这些原则特别旨在确定有关人体某个部分的专利性时发明和发现的区别，生物技术发明专利所提供的保护范围，除书面公开外采用一种保存机制，及选择对相互依存的植物品种和发明（或者反之）颁发非排他的强制许可； |
| （14）Whereas a patent for invention does not authorise the holder to implement that invention，but merely entitles him to prohibit third parties from exploiting it for industrial and commercial purposes；whereas，consequently，substantive patent law cannot serve to replace or render superfluous national．European or international law which may impose restrictions or prohibitions or which concerns the monitoring of research and of the use or commercialisation of its results，notably from the point of view of the requirements of public health，safety，environmental protection，animal welfare，the preservation of genetic diversity and compliance with certain ethical standards； | | （14）鉴于一项发明专利未授权持有者实施该发明，而仅授权其禁止第三方为工业或商业的目的而利用该发明；鉴于，实体专利法因此不能用于取代国家法、欧洲法或国际法或导致它们的多余，因为它们可以增加限制或禁止的规定，或者对研究进行管理和对该结果进行使用或商业化等，并尤其从公共健康、安全、环境保护、动物的生存、基因多样性的保存以及遵循一定的道德标准等的要求的角度来考虑是这样； |
| （15）Whereas no prohibition or exclusion exists in national or European patent law（Munich Convention）which precludes a priori the patentability of biological matter； | | （15）鉴于各国专利法或欧洲专利法（《慕尼黑公约》）中都没有一律排除生物材料专利性的排除性或禁止性规定； |
| （16）Whereas patent law must be applied so as to respect the fundamental principles safeguarding the dignity and integrity of the person；whereas it is important to assert the principle that the human body，at any stage in its formation or development，including germ ceils，and the simple discovery of one of its elements or one of its products，including the sequence or partial sequence of a human gene，can not be patented；whereas these principles are in line with the criteria of patentability proper to patent law，whereby a mere discovery cannot be patented； | | （16）鉴于专利法必须同时尊重捍卫人的尊严和完美这一基本原则；鉴于声明包括生殖细胞在内的、在形成和发展的任何阶段的人体，以及关于其某个部分或某种产品，包括人类基因序列或部分基因序列的任何简单发现，都不能被授予专利这一原则是很重要的；鉴于这些原则与专利法中的可专利性标准是一致的，即单纯发现不能被授予专利； |
| （17）Whereas significant progress in the treatment of diseases has already been made thanks to the existence of medicinal products derived from elements isolated from the human body and／or otherwise produced，such medicinal products resulting from technical processes aimed at obtaining elements similar in structure to those existing naturally in the human body and whereas，consequently，research aimed at obtaining and isolating such elements valuable to medicinal production should be encouraged by means of the patent system； | | （17）鉴于有从人体中分离或用其他方法取得的药品的存在，它们在疾病处理方面已取得重大进展，并且这些药品所用的技术方法的目的在于获得同人体中自然存在的结构相同的元素；鉴于基于此，旨在得到或分离出对这些药品的生产有重要价值的这些元素的研究工作应通过专利制度予以鼓励； |
| （18）Whereas，since the patent system provides insufficient incentive for encouraging research into and production of biotechnological medicines which are needed to combat rare or orphan diseases，the Community and the Mere ber States have a duty to respond adequately to this problem； | | （18）鉴于，由于专利制度未能提供充分刺激以鼓励对与罕见或“孤儿”疾病作斗争的生物技术药品的研究和生产，共同体和成员国有义务对这些问题作充分的反应； |
| （19）Whereas account has been taken of Opinion No．8 of the Group of Advisers on the Ethical Implications of Biotechnology to the European Commission； | | （19）鉴于已考虑了“生物技术伦理影响咨询组”对欧洲委员会的第八号意见的观点； |
| （20）Whereas，therefore，it should be made clear that an invention based on an element isolated from the human body or otherwise produced by means of a technical process，which is susceptible of industrial application，is not excluded from patentability，even where the structure of that element is identical to that of a natural element，given that the rights conferred by the patent do not extend to the human body and its elements in their natural environment； | | （20）鉴于，由此应明确，基于一个从人体分离出来的元素或通过其它技术方法获得的发明，只要有工业实用性，就未被排除可专利性，即使该元素的结构与自然元素的结构相同，条件是专利授予的权利不延及人体和处在自然环境中的组成元素； |
| （21）Whereas such an element isolated from the human body or otherwise produced is nor excluded from patentability since it is，for example，the result of technical processes used to identify，purify and classify it and to reproduce it outside the human body，techniques which human beings alone are capable of putting into practice and which nature is incapable of accomplishing by itself； | | （21）鉴于从人体中分离的或用其他方式产生的元素未被排除可专利性，因为该元素是用例如技术手段进行区分、提纯、分类或在人体之外复制而产生，并且这是一些人类自己能独立付诸实施但自然界自身不能完成的技术； |
| （22）Whereas the discussion on the patentability of sequences or partial sequences of genes is controversial；whereas，according to this Directive，the granting of a patent for inventions which concern such sequences or partial sequences should be subject to the same criteria of patentability asin all other areas of technology；novelty，inventive step and industrial application；whereas the industrial application of a sequence or partial sequence must be disclosed in the patent application as filed； | | （22）鉴于对基因序列或部分基因序列的可专利性问题一直争论不休；鉴于根据本指令，对涉及基因序列或部分基因序列的发明授予专利应与其他所有技术领域的可专利性适用同样的标准：新颖性、创造性和工业实用性；鉴于基因序列或部分基因序列的工业实用性必须在专利申请中公开； |
| （23）Whereas a mere DNA sequence without indication of a function does not contain any technical information and is therefore not a patentable invention； | | （23）鉴于未说明功能的单纯DNA序列不包含任何技术信息，因此属于不具有可专利性的发明； |
| （24）Whereas，in order to comply with the industrial application criterion it is necessary in cases where a sequence or partial sequence of a gene is used to produce a protein or pan of a protein，to specify which protein or part of a protein is produced or what function it performs； | | （24）鉴于，为符合工业实用性标准，当基因序列或部分基因序列用于生产蛋白质或其中某部分时，有时有必要指明生产了哪种蛋白质或某种蛋白质的哪个部分或指明其可实现什么功能； |
| （25）Whereas，for the purposes of interpreting rights conferred by a patent，when sequences overlap only in parts which are not essential to the invention，each sequence will be considered as an independent sequence in patent law terms； | | （25）鉴于，为解释专利授予的权利之目的，当序列的重叠仅涉及发明的非实质性部分时，每个序列应视为专利法中所说的独立序列； |
| （26）Whereas if an invention is based on biological material of human origin or if it uses such material，where a patent application is med，the person from whose body the material is taken must have had an opportunity of expressing free find informed consent thereto，in accordance with national law； | | （26）鉴于，如果一项发明是基于人体的生物材料或使用了这些材料，在提交专利申请时，该材料从其身体中被提取的人应有机会根据国家法律表示自由的和被告知的同意； |
| （27）Whereas if an invention is based on biological material of plant or animal origin or if it uses such material，the patent application should where appropriate，include information on the geographical origin of such material，if known；whereas this is without prejudice to the processing of patent applications or the validity of rights arising from granted Patents： | | （27）鉴于如果一项发明是基于植物或动物的生物材料或者是对这些材料的使用，在适当的情况下，专利申请应包含，如果知道时，这些材料的地理来源的信息；并鉴于这些不应影响专利申请的处理或授予的专利权利的有效性； |
| （28）Whereas this Directive does not in any way affect the basis of current patent law，according to which a patent may be granted for any new application of a patented product； | | （28）鉴于本指令在任何情况下都不影响现有专利法的基础，即对一项专利产品的新应用可授予一项专利； |
| （29）Whereas this Directive is without prejudice to the exclusion of plant and animal varieties from patentability；whereas on the other hand inventions which concern plants or animals are patentable provided that the application of the invention is not technically confined to a single plant or animal variety； | | （29）鉴于本指令不应影响排除植物和动物品种的可专利性；鉴于，在另一方面，有关植物或动物的发明具有可专利性的前提是此发明的应用在技术上未限于单个植物或动物品种； |
| （30）Whereas the concept plant variety is defined by the legislation protecting new varieties，pursuant to which a variety is defined by its whole genome and therefore possesses individuality and is clearly distinguishable from other varieties； | | （30）鉴于“植物品种”的概念已由保护植物品种的立法进行了定义，即类别由其染色体决定，并因此而具有个性特征并明显区别于其他品种； |
| （31）Whereas a plant grouping which is characterised by a particular gene（and not its whole genome）is not covered by the protection of new varieties and is therefore not excluded from patentability even if it comprises new varieties of plants； | | （31）鉴于以一个特别的基因（但不是整个染色体）为特征的某一植物群不受植物新品种保护，并且因此即使它构成植物新品种也不能排除其可专利性； |
| （32）Whereas，however，if an invention consists only in genetically modifying a particular plant variety，and if a new plant variety is bred，it will still be excluded from patentability even if the genetic modification is the result not of an essentially biological process but of a biotechnological process； | | （32）鉴于，但是，如果一项发明仅为对某种特殊植物品种进行基因修饰，并且如果一个新品种是繁殖的，即使该基因修饰并非主要是由于生物学的方法而是生物技术方法的结果，它将同样被排除可专利性： |
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