基因治疗专利制度研究

【作者】 沈其梅；

【导师】 姚荣涛；

【作者基本信息】 复旦大学 ， 法律， 2008， 硕士

【摘要】 随着生物技术的飞速发展,人类基因组测序计划的完成,涌现出越来越多的新的基因工程技术成果,其中基因治疗就是发展较快而争议也较多的一项生物技术。基因治疗给人们带来了新的希望,也给人们带来了诸多问题,基因治疗技术已经开始触动专利法的一些基本概念和原则,引起了世界各国广泛的关注,各国都在不断地根据本国技术发展情况对审查指南和专利法等规定作相应的调整和完善。比如:如何处理社会伦理问题、专利性审查中法律标准与政策的基本考虑、专利权的保护范围、基因资源提供者的知情同意与利益分配的原则等等。本文通过分析比较美国、欧洲和中国基因治疗专利申请或授权的趋势、相关政策和规定,对我国的基因治疗专利制度提出了一些初步的意见和具体策略。我国虽然在基因治疗的某些方面取得了巨大的进展,但是就整体而言,我国与美国、日本等发达国家的差距还很大。笔者建议应该从严掌握实用性审查标准;对于充分公开问题,应该做特别规定,以确保基因资源提供者的知情同意权的行使;为了避免阻碍我国的基因治疗产业的发展,应该适当限制基因治疗专利的授权范围等。总之,我国专利法不能盲目地与世界接轨,向发达国家看齐,而应该根据我国的具体国情,以基因治疗的伦理问题、利益分配问题等为契机,安排适当的专利制度,以促进我国基因治疗技术的迅速发展。更多还原

【Abstract】 The rapid development of biotechnology and accomplishment of Human Genome Project brought more and more new achievements to gene engineering , among which, gene therapy is growing quickly and disputed often. Gene therapy gives people new hopes, and at the meantime it brings a lot of issues. Gene therapy has begun to impact on some basic concept and principles of patent law and aroused the world’s broad attention; every nation is making ceaseless adjustments and consummations to the Manual of Patent Examining Procedure and patent law according to technology development.For example: how to deal with the issue of social ethics, the consideration of juristic criterion and policies in patentability, the protection scope of patent, informed consent of the provider of gene resource and the principle of benefit distribution, etc. The article analyzes the trend of patents and patent applications on gene therapy in U. S. A, Europe and China, do some micromesh comparative research combined with the policy and regulations on their gene therapy patents, and provide some primary opinions and specific policies.Although we are making some great progress in certain aspects in gene therapy, considering the whole situation, we still have large gap with developed countries such as America and Japan. So the author advises to practice relevance strict utility standard in patent examination, As to adequate disclosure, we should make specific provisions , so that we can insure gene resources providers’ exertion of the informed consent; and we should confine the scope of claims of issued gene therapy patents in order to avoid hindering the development of domestic gene therapy research.Above all, our patent law can’t be the same with the world’s developed countries blindly. Based on the situation of our country, appropriate patent systems should be arranged in virtue of the ethics issue and profit distribution etc, which will boost the rapid progress of gene therapy technology in our country.更多还原