新颖性推定方式及举证责任分配原则的探讨新颖性推定方式及举证 .pdf

PROGRESS IN PHARMACEUTICAL SCIENCES 2015,39 8 :577-581 ( ) 577 新颖性推定方式及举证责任分配原则的探讨 ——医药生物领域专利新颖性评判热点问题分析 魏聪* （国家知识产权局专利复审委员会医药生物申诉二处，北京 100190） [ 摘要 ] 结合具体案例分析医药生物领域专利新颖性评判的热点问题之一 —— 新颖性推定的审查方式的主要类型和基本思路，并探讨相 应的举证责任分配原则。在此基础上提出，新颖性推定方式作为一种事实推定，实际上体现了高度盖然性的评判标准，应当在推定基础、 推定主体、推定过程、考量因素以及推定结论把握等方面加以规范，同时合理分配举证责任，避免主观性的干扰。 [ 关键词 ] 医药生物领域专利；新颖性；盖然性；举证责任 [ 中图分类号 ] G306 [ 文献标志码 ] A [ 文章编号 ] 1001-5094（2015）08-0577-05 A Probe into the Review Mode of Novelty Presumption and the Principles of the Allocation of Burden of Proof ——Analysis of a Hot Issue on the Novelty Judgement of Pharmaceutical and Biotechnology Patents WEI Cong (The Second Pharmacy and Biotech Appeal Division, The Patent Reexamination Board of the State Intellectual Property Office of the P.R.China, Beijing 100190, China) [Abstract] In this paper, the main types and basic ideas of the review mode of novelty presumption as a hot issue on the novelty judgement of pharmaceutical and biotechnology patents were analyzed based on several concrete cases, and the corresponding principles of the allocation of burden of proof were also discussed. On this basis, it was put forward that the novelty presumption, as a fact inference, actually represents the standard of proof with high degree of probability. Therefore, the base of presumption, judgment subject, process of presumption, consideration factors and conclusion grasp should be standardized, and the burden of proof should be allocated reasonably in order to avoid the interference of subjectivity. [Key words] pharmaceutical and biotechnology patent; novelty; probability; burden of proof 根据《专利法》第 22 条第 2 款的规定，除了抵触