中国药品专利纠纷早期解决机制初探

Preliminary Analysis of the Early-stage ResolutionMechanism for Drug Patent Disputes in China

经过30余年的发展,我国药品专利链接制度实现了从无到有的跨越,并通过借鉴国际经验、落地现实国情不断完善,最终形成了一套具有中国特色的药品专利纠纷早期解决机制。本文通过7个板块系统分析这一机制的特点与作用,介绍药品专利链接制度在中国进行的本土化构建。这一机制旨在实现公平与效率的动态平衡,其建立推动了司法程序和行政程序的有效衔接。但作为纠纷早期解决机制,在施行之初,不应苛责以该机制解决所有药品专利纠纷问题,还应当与专利诉讼等途径形成多元化纠纷解决矩阵,高效而有序地解决药品专利纠纷,提高药品可及性。

After more than 30 years of development,China's pharmaceutical patent linkage system has made significant strides from its inception,continuously refining itself by learning from international experience and adapting to domestic conditions.This has ultimately resulted in the establishment of an early-stage resolution mechanism for drug patent disputes with Chinese characteristics.Through a systematic analysis of seven sections,this paper systematically analyzes the characteristics and functions of this mechanism,and introduces the localization of the pharmaceutical patent linkage system in China.The mechanism aims to achieve a dynamic balance between fairness and efficiency,and its establishment has facilitated an effective integration of judicial and administrative procedures.However,as an early-stage dispute resolution mechanism,it should not be expected to single-handedly address all drug patent disputes at its outset.Instead,diversified dispute resolution channels,including patent litigation,should be established to efficiently and systematically solve drug patent disputes,ultimately enhancing drug accessibility.