高致病性传染病疫苗专利申请中生物材料保藏问题

Biological material preservation issues in patent applications for highly pathogenic infectious disease vaccines

目的为高致病性传染病疫苗专利确权问题提供解决方案。方法通过对比研究《专利法》《专利法实施细则》《专利审查指南》及中华人民共和国农业农村部和国务院卫生健康委员会等部门的相关法规中对高致病性病原微生物保藏程序的相关规定,并对国外相关案例进行研究,分析得出我国高致病性传染病疫苗专利申请中生物材料保藏问题的成因,尝试提出解决高致病性传染病疫苗专利确权问题的可实施路径。结果《专利审查指南》中规定的不需要保藏生物材料的情形和国外处理相关问题的经验不适用于解决我国高致病性传染病疫苗专利的确权问题。结论建议修改《专利法》、《专利审查指南》中的相关条款,助力上述问题的解决。

Objective To provide solutions for highly pathogenic infectious disease vaccines patent confirmation.Methods By deeply analyzed the regulatory documents from Patent Law,Implementing Regulations of the Patent Law,Guidelines for Patent Examination,regulations made by Ministry of Agriculture and Rural Affairs of the People′s Republic of China and National Health Commission of the People′s Republic of China and foreign cases for microbiological deposit procedures,we summarized the causes of biomaterial deposition of highly pathogenic infectious disease vaccine patent application in China,and attempted to propose implementation paths to solve the issue.Results The situation stipulated in the Guidelines for Patent Examination that there was no need to deposit biomaterials and foreign experience were not applicable to solve the problem of patent confirmation for highly pathogenic infectious disease vaccines in China.Conclusion It is suggested to amend the relevant provisions in the Patent Law and the Guidelines for Patent Examination to solve the issue.