药品原研企业化合物创造性审查标准及政策研究

Standards and Policies for Creative Review of Compounds in Pharmaceutical Original Research Enterprises

当前我国将药品的知识产权政策提升到了前所未有的高度。药品原研企业是整个药品专利创新链条的核心,也是我国药品摆脱国际依赖并进而推动仿制药上市的根本。在此形势下,制药企业药品专利保护的困难应当在国家政策中加以明确和解决。药品原研企业在专利申请中面临的困难集中表现为动机、意想不到的技术效果和补充实验数据三者关系的衔接上。因此,改进药品专利审查是当务之急。

In recent years,China has paid much more attention to its pharmaceutical policy than ever.The pharmaceutical original research enterprise is the core of the whole pharmaceutical patent innovation chain,and it is also the foundation for China s pharmaceuticals to get rid of international dependence and the promotion of generic drug marketing channels.Under this situation,the difficulty of pharmaceutical patent protection for pharmaceutical original research enterprises should be clarified in national policies.The difficulties faced by pharmaceutical original research enterprises in patent applications are mainly manifested in the connection of motivation,technical personnel in the field and unexpected technical effects.Therefore,it is urgent to improve pharmaceutical patent examination.