2022年版欧专局审查指南生物领域专利适格性与我国相关规定的比较研究

Comparative study on patentability of biotechnological inventions between 2020 edition of Guidelines for Examination in the European Patent Office and corresponding regulations in China

基因与生物技术的发展日新月异,对专利制度、道德伦理和公共政策提出了一系列严峻的挑战。在新技术、新产业、新业态、新模式下如何评判专利的适格性需要现行法律法规及时地作出回应和调整。2022年3月1日,欧洲专利局(以下简称欧专局)最新版审查指南生效,该版审查指南对以违反公共秩序和道德为由而被排除在专利适格性之外的发明的相关规定进行了重要修改,阐明了对转基因动物是否符合“公共秩序”和道德评估时应采用的标准。就欧专局审查指南的上述修改内容以及其对生物技术领域专利适格性的相关规定进行了梳理,并与我国现行《专利法》《专利法实施细则》及《专利审查指南》的相关规定进行了比较分析,以期为我国专利政策研究和我国创新主体在欧专局申请专利提供借鉴和参考。

The rapid development of gene and biotechnology has posed a series of serious challenges to the patent system,ethics,and public policy.It requires rapid responses and adjustments from existing laws and regulations that how to judge the patent eligibility in the context of new technologies,industries,business forms,and models.On March 1,2022,the latest version of Guidelines for Examination in the European Patent Office(EPC Guidelines)came into force.This version of EPC Guidelines made significant modifications to the relevant regulations of exceptions to patentability on the grounds of violating"ordre public"and morality,clarifying the standards to be adopted when assessing whether genetically modified animals meet the"ordre public"and morality.This article reviews the above amendments to the EPC Guidelines and relevant regulations on patentability in the field of biotechnology,and compares them with the relevant provisions of the Patent Law,the Rules for the Implementation of the Patent Law,and the Guidelines for Examination in China,in hopes of providing reference for research of patent policy and for innovation subject in applications for patents in the European Patent Office.