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中国科技论坛  2022, Issue (1): 131-138    
  研究与探讨 本期目录 | 过刊浏览 | 高级检索 |
论新《专利法》中药品专利链接制度的确立及完善
李晓秋, 余晨
重庆大学法学院科技法治研究中心,重庆 400030
On the Establishment and Improvement of the Drug Patent Linkage System in the New “Patent Law”
Li Xiaoqiu, Yu Chen
Research Center for the Rule of Law in Science and Technology in School of Law,Chongqing University,Chongqing 400030,China
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摘要 当前,中国正从制药大国迈向制药强国,鼓励药品创新创造和推动仿制药生产,形成药品专利共治大格局已成为重要论题。新《专利法》确立了药品专利纠纷早期解决机制,同时也确立了药品专利有效期补偿制度作为药品专利链接制度的配套制度,充分体现了该项制度的价值取向:确保创新药企、仿制药企和社会公众的利益平衡以及提高效率并避免资源浪费。新《专利法》中确立的药品专利链接制度还存在一些不足,如“相关的专利权”范围有待明确、“异议期”和“等待期”仍存争议、首仿药的独占期制度不够完善、药品专利有效期限补偿机制不够健全。在推动药品专利链接制度的实施过程中,建议明确专利权范围、进一步完善专利信息公示、规范药品专利声明申报程序、合理设置化学药品的等待遏制期和完善首仿药的独占期制度。
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李晓秋
余晨
关键词 新《专利法》专利链接药品创新知识产权共治    
Abstract:China is currently moving from a major pharmaceutical country towards a pharmaceutical powerhouse.In this period,it has become a significant issue to encourage drug innovation and the generic drugs production,so as to form a large joint governance of drug patents.The new Chinese Patent Law has established an early settlement mechanism for drug patent disputes,and also a drug patent validity period compensation system as a supporting system for the drug patent linkage system.This fully reflects the value orientation of the system:to ensure the balance of interests among innovative pharmaceutical companies,generic pharmaceutical companies and the public,as well as the value orientation to improve efficiency and avoid resources waste.There are still several deficiencies in the drug patent linkage system established in the new Patent Law,such as unspecified scope of the“relevant patent rights”,controversial“opposition period”and“waiting period”,inadequate exclusivity period system of the first generic drug,and the incomplete compensation mechanism for the effective period of drug patents.In promoting the implementation of the drug patent linkage system,it is recommended to define the scope of patent rights,further improve the disclosure of patent information,standardize the declaration procedures for drug patent declarations,reasonably set the waiting period for chemical drugs,and improve the exclusive period system for the first generic drug.
Key wordsNew“Patent Law”    Patent linkage    Drug innovation    Joint governance of intellectual property
收稿日期: 2020-11-03     
PACS:  D923.42  
基金资助:国家社科基金一般项目“‘互联网+’产业形态下的专利权保护规则适应性研究”(18XFX013)。
作者简介: 李晓秋(1972-),女,重庆人,重庆大学法学院教授、博士生导师,研究方向为创新与知识产权法、互联网法律、科技法治。
引用本文:   
李晓秋, 余晨. 论新《专利法》中药品专利链接制度的确立及完善[J]. 中国科技论坛, 2022(1): 131-138.
Li Xiaoqiu, Yu Chen. On the Establishment and Improvement of the Drug Patent Linkage System in the New “Patent Law”. , 2022(1): 131-138.
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