药品专利审查引入新药注册审查思路的可行性研究

The Feasibility of the Connection between the Drug Patents Examination and the New Drug Registration

目的证成药品专利审查引入新药注册审查思路的可行性,构建药品专利审查与新药注册审查的衔接模式,以促进专利药品的上市、增加社会公众用药选择。方法对专利授权之"新颖性"、"创造性"、"实用性"审查标准与新药注册之"安全性"、"有效性"、"质量可控性"审查标准进行比较研究,寻找药品专利审查与新药注册审查的衔接点。结果与结论 "实用性"审查标准与新药注册之"安全性"、"有效性"、"质量可控性"标准之间存有较大的衔接空间。药品专利的实用性审查标准可以合理参照药品注册审查标准,综合药品产业发展情况、专利权人利益、社会公众利益等因素进行动态调整。

OBJECTIVE To improve the feasibility of the connection between the drug patents examination and the new drug reg- istration and design the connecting pattern between them, which will enhance the appearance on the market for the patent drugs, even- tually increase the drug choice for the public. METHODS To find the connecting space between drug patents examination and the e- valuation standards for drug registration by comparing the ＂novelty＂, ＂inventiveness＂, ＂practical applicability＂ standards for a patent with the ＂safety＂, ＂efficacy＂ and ＂quality＂ standards for drug registration. RESULTS AND CONCLUSION A large connecting space between the practical applicability standard for a patent and the evaluation standards for drug registration is found in this paper. The practical applicability standard for a patent can be adjusted dynamically according to the evaluation standards for drug registration based on the development level of the pharmaceutical industry, interests of patent holders and the public, etc.