Implementation and outcomes of China's drug patent linkage system: lessons from international experience.

Abstract

Introduction: The drug patent linkage system plays a crucial role in achieving a balance between protecting drug innovation and ensuring the accessibility of generic drugs. Currently, this system has been implemented in many countries. This review aims to provide policy guidance and a reference basis for relevant stakeholders, while also offering valuable insights to other countries considering the implementation of the patent linkage system globally.

Areas covered: This review provides a comprehensive summary and comparative analysis of the patent linkage systems in the United States, Canada, South Korea, Singapore, and China, with a focus on China's recently implemented system and its outcomes. The data presented are derived from the official websites of the China NIPA, the IPC, and the NMPA's Drug Patent Information Registration Platform.

Expert opinion: This main goal of this system is to balance the interests of both parties through an efficient dispute resolution mechanism, while policy formulation is only the initial stage of the reform process and requires continuous improvement throughout the implementation phase. The author employed descriptive statistical methods to systematically analyze relevant data, providing valuable insights to colleagues in the field both domestically and internationally.