我国药品专利激励与保障制度困境及优化路径  

The Dilemma and Optimization Path of China's Drug Patent Incentive and Protection System

作　　者：饶家宁 罗凯 熊雨飞 Rao Jianing;Luo Kai;Xiong Yufei(East China Jiaotong University Intellectual Property Research Center,Nanchang 330001,China)

机构地区：[1]华东交通大学知识产权研究中心,南昌330001

出　　处：《卫生法学》2025年第1期92-97,共6页Health Law

基　　金：2023年度江西省知识产权保护软科学研究项目“药品知识产权激励与保障制度研究”(2023-16)阶段性成果。

摘　　要：药品兼具制药企业利益追逐与社会公共利益保障的双重属性,两者只有利益均衡才能推动药品市场供给与药品可及性的平衡。检视既有药品专利激励制度与保障制度。激励制度呈现制度失衡,特殊药品、中药等容易游离激励之外。保障制度由于受药品“安全性”和“有效性”的标准制约,无法挣脱技术设置的“藩篱”,且两项制度衔接存在制度空白。鉴此,强化专利药品客体扩张范畴,增加《中药品种保护条例》衔接条款,最大化激励我国药品研发,制度回归到平衡状态。出台中国化“桔皮书”制度,化解原研药与仿制药的冲突,将激励与保障政策体系化,共同推动我国药品领域发展。Drugs have the dual attributes of pursuing the interests of pharmaceutical companies and ensuring social public interests. Only by balancing the interests of the two can the balance between drug market supply and drug accessibility be promoted. Examining the existing incentive and protection systems for drug patents, the incentive system shows an imbalance, with special drugs, traditional Chinese medicine, etc. easily deviating from the incentive system. The protection mechanism, constrained by standards of "safety" and "efficacy", is unable to overcome technological barriers, and there exists a systemic gap in the coordination of these two mechanisms. In view of this, we will strengthen the expansion of the scope of patent drug objects, add connecting clauses in the Regulations on the Protection of Traditional Chinese Medicine Varieties, maximize incentives for drug research and development in China, and return the system to a balanced state. Introducing a Chinese style "orange book" system to resolve the conflict between original research drugs and generic drugs, systematizing incentive and protection policies, and jointly promoting the development of China's pharmaceutical industry.

关 键 词：知识产权 专利激励 优化路径 

分 类 号：D922.16[政治法律—宪法学与行政法学]