我国药品专利期补偿制度的构建与完善研究

Research on the Construction and Improvement of Drug Patent Term Compensation System in China

药品的需求特性和研发成本较高,使其专利保护期延长成为必要。本文论证了我国构建药品专利补偿期制度的正当性基础,由分析国情而认为构建药品专利期限补偿制度符合我国潜在的公共政策目标、能够平衡相关主体的利益,并建议采用“专利法+特别法+专利审查指南”的立法模式、将“新药”解释为“药品”、将适用对象限定为人用药品、对激活标准进行扩大解释、明确补偿期限及计算方法、规定补偿程序。

Due to the demand characteristics of drugs and high r&d costs,it is necessary to extend the patent protection term.This paper demonstrates the legitimacy of China's construction of drug patent compensation term sys⁃tem,analyzes China's national conditions,and thinks that the construction of drug patent compensation term system is in line with China's potential public policy goals,and can balance the interests of relevant subjects.It is suggested that the legislative model of"patent law+special law+patent examination guide"should be adopted to interpret"in⁃novative drug"as"medicine",limit the applicable object to drugs for human use,expand the interpretation of activa⁃tion standard,clarify the compensation period and calculation method,and stipulate the compensation procedure.