中國大陸藥品專利鏈接制度的相關研究

Abstract

本論文將探討中國大陸藥品專利糾紛早期解決機制之施行內涵，並研析其未來可能的修法方向。首先，剖析中國大陸歷年醫療改革的重點與方針，釐清社會對藥品專利糾紛早期解決機制之期許。其次，梳理中國大陸藥品專利鏈接制度之形成基礎，並結合藥品流通行業的相關統計數據，說明藥品專利糾紛早期解決機制的施行背景。接著，介紹藥品專利鏈接制度的具體內容，探討其施行以來面臨的問題與因應策略。而後，透過對中國大陸藥品專利鏈接訴訟實務的相關研究，比對其與台灣西藥專利連結制度之設計差異，藉以闡明藥品專利鏈接制度之特點與立法意旨。最後，研析中國大陸藥品專利糾紛早期解決機制在未來可能的修法方向。

This paper explores the implementation of Early Resolution Mechanism of Drug Patent Disputes in mainland China and analyzes its potential future legislative amendments. First, it examines the priorities and policies of healthcare reform in Mainland China over the years to clarify societal expectations regarding Early Resolution Mechanism of Drug Patent Disputes. Second, it outlines the formation of the Drug Patent Linkage System in Mainland China and incorporates relevant statistical data from the pharmaceutical distribution industry to illustrate the implementation background of the early resolution mechanism. Next, it introduces the specific content of the Drug Patent Linkage System and discusses the challenges encountered since its implementation, along with corresponding countermeasures. Subsequently, through research on litigation practices related to Drug Patent Linkage in Mainland China and a comparison of design differences with the Drug Patent Linkage System in Taiwan, it elucidates the characteristics and legislative intent of the Drug Patent Linkage System. Finally, it analyzes possible directions for future legislative amendments to Early Resolution Mechanism of Drug Patent Disputes in Mainland China.