摘要
罕见病及其治疗药物(即孤儿药)的研发面临市场失灵困境,患者群体小、研发成本高导致企业缺乏研发动力,知识产权制度在激励创新的同时也因专利垄断加剧了药品可及性问题。本文以知识产权为切入点,分析孤儿药研发的现状与挑战,探讨专利制度的双重作用,并结合国际经验与中国实践,提出优化专利保护、完善强制许可、推动开放许可与平行进口等对策,以平衡创新激励与公共健康的需求。研究发现,孤儿药市场的可持续性依赖于政策干预与法治工具的创新,我国可通过本土化路径构建兼顾效率与公平的治理体系,实现创新效率与社会公平的共赢。
The research and development of orphan drugs for rare diseases face a market failure due to the small patient population and high costs,which discourages pharmaceutical investment.While intellectual property rights incentivize the innovation,patent monopolies exacerbate drug accessibility challenges.This paper examines dual role of patent systems in orphan drug research and development,analyzes global practices and proposes policy recommendations for China,including optimizing patent protection,enhancing compulsory licensing mechanisms,and promoting open licensing.The study concludes that balancing innovation incentives and public health requires systemic governance reforms,integrating global lessons with localized strategies.
作者
原静
YUAN Jing(Patent Examination Cooperation Jiangsu Center of the Patent Office,China National Intellectual Property Administration,Suzhou 215163,China)
出处
《中国新药杂志》
北大核心
2025年第21期2247-2252,共6页
Chinese Journal of New Drugs
关键词
孤儿药
罕见病
知识产权
专利垄断
药品可及性
orphan drugs
rare diseases
intellectual property
patent monopoly
drugaccessibility
