基于行政和司法视角浅析医药领域补交实验数据审理与考量

Analysis of the judgement and consideration application of rules for supplementary experimental data in pharmaceutical field from administrative and judicial perspectives

摘要

随着中美贸易谈判的推进和《专利审查指南》中补交实验数据相关章节的修改,近年来以补交实验数据为争议焦点的行政和司法案件数量呈显著上升趋势。但与此同时,个案的审理过程亦反映出一定的争议特性。本文通过全面梳理《专利审查指南》中相关规定与司法领域典型裁判规则,归纳补交实验数据审理中“三项事实”和“三对关系”的判断思路与方法,之后对近年来具有代表性的行政决定和司法判决进行深入剖析,并在此基础上结合审理实务工作特点对补交实验数据审理中的关键环节提出建议,以期在国内补交实验数据的制度框架下客观、合理地评价补交实验数据相关问题,持续提升补交实验数据审理的一致性和可预期性,从而为推动我国医药行业创新高质量发展提供助力。

Abstract

With the advancement of Sino-US trade negotiations and the revision of relevant chapters on supplementary experimental data in the Patent Examination Guidelines, the number of administrative and judicial cases in which supplementary experimental data are the focus of dispute has shown a significant upward trend in recent years. At the same time, however, the trial processes of individual cases have also revealed certain controversial characteristics. This article comprehensively reviews the relevant provisions of the Patent Examination Guidelines and typical adjudication rules in the judicial field, and summarizes the approaches and methods for judging the “three facts” and the “three pairs of relationships” in the trial of supplementary experimental data. It then provides an in-depth analysis of representative administrative decisions and judicial judgments in recent years. On this basis and taking into account the characteristics of the trial practice, suggestions are put forward for the key steps in the trial of supplementary experimental data, so as to objectively and reasonably evaluate the issues related to supplementary experimental data under China's institutional framework for supplementary experimental data, continuously enhance the consistency and predictability of trials involving supplementary experimental data, and thereby help promote the innovative and high-quality development of China's pharmaceutical industry.

关键词

医药领域 / 专利 / 补交实验数据 / 能够得到 / 采信标准

Key words

pharmaceutical field / patent / supplementary experimental data / can be obtained / acceptance criteria

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