论药品专利期限补偿制度的改革

The Reform of the Pharmaceutical Patent Term Extension System

药品专利期限补偿制度的理论基础在于制药行业的特殊性导致专利保护期价值取向的偏离。由于制度本身的局限性,再加上我国医药产业与发达国家的差异性,导致了一些制度困境。文章意在探究如何明确我国药品专利期限延长制度的适用范围,丰富以临床价值为导向的医药创新激励措施,落实药品专利期限补偿的监督机制,规制扰乱市场竞争秩序的专利策略,建立宽严并济的可专利性审查标准,以期从制度本身和外围层面探寻改革方案。

The theoretical basis of the pharmaceutical patent term extension system is that the particularity of the pharmaceutical industry leads to value deviation of the patent protection period.However,the limitations of the system itself,combined with the differences between the pharmaceutical industry in China and that in developed countries,have caused a number of institutional difficulties.This paper intends to explore how to clarify the application scope of the pharmaceutical patent term extension system,to enrich the incentives to encourage pharmaceutical innovation oriented by clinical value,to strengthen the supervision mechanism of the pharmaceutical patent term compensation system,to regulate those patent strategies that disrupt market competition,and to establish a proper patentability review standard.The purpose is to explore reform initiatives based on the system itself and other relevant information.