人类基因序列专利的审查标准研究

发布时间：2018-03-15 20:04

本文选题：人类基因序列专利　切入点：审查标准　出处：《湘潭大学》2015年硕士论文　论文类型：学位论文

【摘要】：作为二十一世纪生物及生命科学技术领域中最为活跃的技术之一,人类基因相关技术在专利保护的问题上因其具有特殊性而争议颇多。目前人类基因序列的专利审查方面主要面临如下问题:人类基因序列的可专利性尚未明确界定,专利审查的实用性标准模糊,实用性审查没有稳定而一致的高度;现有的人类基因序列专利审查的标准,因为没有全面考虑人类基因序列的物质、生物医药以及化学发明客体的特点,导致了利益失衡从而争议颇多;同时人类基因序列具有特殊的人伦意义,故而授予人类基因序列专利权保护是否违背人伦道德也颇具争议。各国对人类基因序列的可专利性、审查标准等方面均有立法规定,其具体侧重点根据各国自身的具体国情各有不同。在人类基因序列的可专利性问题上,美国将其作为工业产品、物质组分纳入可专利主题,日本则是将其作为化学物质发明纳入可专利客体,而欧盟则将其作为生物材料纳入专利保护范围。同时,日、欧立法都认为未说明功能的单纯基因序列不具有可专利性。而欧盟规定须由特定组织评价其伦理问题,还提出了基因提供者的知情同意权。在人类基因序列的专利审查标准的问题上,美国通过一系列判例确立了具有一定高度和复杂性的审查标准,而欧盟则特别强调技术性特征,日本则特别强调权利要求需要规范书写以把握权利要求范围。针对我国人类基因序列专利审查标准现状,即人类基因序列的可专利性不明确,实用性标准太低,以及没有充分考虑人类基因序列的人伦特性,我们应从以下方面来完善我国的审查标准:以工业应用性高度区分可专利的人类基因序列来明确人类基因序列保护客体;适当提高实用性审查标准;引入基因材料提供者的知情同意权以及建立基因材料提供者的数据库,来规范人类基因序列的权利合法化来源以及平衡人类基因序列专利带来的巨大经济利益。
[Abstract]:In 21th century, as one of the most active technologies in biology and life science and technology, Human gene-related technology is controversial because of its particularity. At present, the patent examination of human gene sequence is mainly faced with the following problems: the patentability of human gene sequence has not been clearly defined. The criteria for the utility of patent reviews are vague, and there is no stable and consistent level of examination of utility; existing standards for patent review of human gene sequences are not fully considered for substances of human genetic sequences, The characteristics of biopharmaceutical and chemical inventions lead to the imbalance of interests, which is controversial, and the human gene sequence has special significance of human relations. Therefore, it is controversial whether the patent right of human gene sequence protection is contrary to the ethics of human relations. Countries have legislation on the patentability of human gene sequence and the standards of examination, etc. Its specific focus varies according to the specific conditions of each country. On the issue of patentability of human gene sequences, the United States regards it as an industrial product, and the substance component is included in the patentable theme, Japan included the invention as a chemical substance in the patentable object, while the European Union included it as a biological material in the scope of patent protection. European legislation holds that simple gene sequences with unspecified functions are not patentable. The EU requires specific organizations to evaluate their ethical issues. The right of informed consent of gene providers is also raised. On the question of patent examination criteria for human gene sequences, the United States has established, through a series of jurisprudence, standards of review with a certain degree of complexity, while the European Union has placed particular emphasis on technical characteristics. Japan, in particular, emphasizes the need to standardize the writing of claims in order to grasp the scope of claims. In view of the current situation of patent examination standards for human gene sequences in China, that is, the patentability of human gene sequences is not clear, and the practical standards are too low. As well as not fully considering the human nature of human gene sequence, we should perfect our review standard from the following aspects: to distinguish patentable human gene sequence from industrial application to make clear the object of human gene sequence protection; Appropriate enhancement of practical review standards; introduction of informed consent rights for providers of genetic materials; and establishment of databases for providers of genetic materials, To regulate the right to legalize the source of human gene sequence and to balance the huge economic benefits of human gene sequence patent.
【学位授予单位】：湘潭大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：D913

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