新形势下中国药品专利链接制度的建立与监管

发布时间：2018-04-26 21:20

本文选题：药品 + 注册审批　；参考：《重庆医科大学》2014年硕士论文

【摘要】：药品作为一种与人体健康和生命直接相关的特殊商品，其技术创新和研发投资回报可以通过专利制度来获得保障，而其安全性、有效性和质量可控性则由严格的行政审批管理来规制。随着我国医药产业国际化进程的加快以及药品注册管理法规体系的不断完善和规范，药品注册过程中的专利侵权纠纷案日益增多，药品专利保护问题越发成为药品注册审批中的焦点问题。药品专利链接制度的建立则是将药品注册与专利保护有效链接，注册过程中应充分考虑药品的专利问题，同时鼓励仿制药的发展以增加公众用药的可及性，旨在平衡促进创新与保护公众健康之间的关系。我国《药品注册管理办法》2002年以来以药品专利链接制度为主题进行了两次修改，但制度尚处于尝试和完善阶段，其科学性、合理性和可操作性存在诸多问题，药品“注册中的专利问题”依然十分突出。因此新时代下如何建立完善我国药品专利链接制度，进一步完善政府的监管职能将是未来我国药品注册管理部门所要关注的重要课题。本文通过解析药品注册管理法规体系的形成与发展以及我国医药产业当前的发展现状深入剖析我国药品专利链接制度形成的制度背景和现实背景。并通过恒瑞-赛诺菲专利纠纷一案分析我国药品专利链接制度存在的不足，，目前我国药品专利链接制度存在专利权属状态说明不清晰，专利申明可信度低、专利纠纷缺乏有效的救济途径、“专利期届满前2年”规定无实际意义、未建立药品专利期延长制度、数据保护独占期缺乏针对性等问题，因此借鉴美国专利链接制度的成功经验，本文分别从实体和操作两个层面提出了完善建议。
[Abstract]:As a special commodity directly related to human health and life, the return on investment in technology innovation and R & D can be guaranteed through the patent system, and its safety. Effectiveness and quality controllability are regulated by strict administrative examination and approval management. With the acceleration of the internationalization of the pharmaceutical industry in China and the continuous improvement and standardization of the regulatory system of drug registration, the number of patent infringement disputes in the process of drug registration is increasing day by day. Drug patent protection has become the focus of drug registration and approval. The establishment of drug patent link system is to link drug registration with patent protection. In the process of registration, the patent problem of drugs should be fully considered, and the development of generic drugs should be encouraged in order to increase the accessibility of drug use to the public. The aim is to balance the relationship between promoting innovation and protecting public health. The measures for Drug Registration Administration in China have been revised twice since 2002 on the subject of drug patent link system, but the system is still in the stage of trial and perfection, and there are many problems in its scientific, rational and operational aspects. The patent problem in drug registration is still very prominent. Therefore, how to establish and perfect the drug patent link system under the new era, and how to further perfect the government's supervisory function will be an important subject that our drug registration administration departments should pay close attention to in the future. By analyzing the formation and development of the regulatory system of drug registration and the current development situation of the pharmaceutical industry in China, this paper deeply analyzes the institutional background and the realistic background of the formation of the pharmaceutical patent link system in China. And through the case of Hengru-Sanofei patent dispute, this paper analyzes the shortcomings of the drug patent link system in China. At present, the patent ownership status of the drug patent link system in our country is not clear, and the patent declaration credibility is low. Patent disputes lack effective remedies, the "2 years before the expiration of patent period" has no practical significance, the system of prolonging the patent period of drugs has not been established, and the exclusive period of data protection is short of pertinence, etc. Therefore, using the successful experience of the patent link system in the United States for reference, this paper puts forward some suggestions from two aspects: entity and operation.
【学位授予单位】：重庆医科大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：R951

【参考文献】