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    中国药品知识产权法治发展报告

    摘要

    药品是保障健康权实现的必需品,药品创新是提升全民健康水平的根本推动力,知识产权是激励和调整医药产业持续创新的基本制度。本文分析了改革开放以来中国药品知识产权法治发展历程及最新进展。在经历了被动接受、调整适应而后主动选择过程之后,中国已建立起了现代化药品知识产权制度框架,其分为保护药品创新和保障公共健康需求两方面,即以专利权保护、药品专利链接制度、药品专利期限补偿制度、药品试验数据保护制度激励药品创新,通过专利权保护例外、强制许可制度、专利豁免和反垄断制度保障公共健康需求。相关配套制度有待进一步完善,未来需明确国家药品产业定位和基本政策取向,构建适应制药产业发展、以公共健康为根本出发点的药品知识产权法治。 <<
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    Abstract

    As drugs are necessary to safeguard people’s right to health,drug innovation has become the fundamental driving force to improve the health of our people,and intellectual property has become the basic system to stimulate and adjust the sustainable innovation of the pharmaceutical industry. The development and new achievements of the law-based drug intellectual property in China since the reform and opening up are analyzed in this article. After a process of passive acceptance,adjustment and adaptation,and active selection,China has established a modern pharmaceutical intellectual property system framework,which can be divided into two parts,namely protection of pharmaceutical innovation and protection of public health needs. To be specific,we stimulate pharmaceutical innovation through patent protection,pharmaceutical patent linkage system,pharmaceutical patent term compensation system,and pharmaceutical test data protection system,and guarantee public health needs through patent protection exceptions,compulsory licensing system,patent exemption and anti-monopoly system. Relevant supporting systems need to be further improved. In the future,it is necessary to clarify the orientation and basic policy orientation of the pharmaceutical industry in the country,and formulate laws and regulation on pharmaceutical intellectual property rights that adapts to the development of the pharmaceutical industry and takes public health as the fundamental starting point.

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    作者简介
    张浩然:张浩然,中国社会科学院法学研究所助理研究员,中国社会科学院知识产权中心研究员。
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