【作者】 张正；

【导师】 俞风雷；

【作者基本信息】 天津大学 ， 法学， 2019， 硕士

【摘要】 我国的原研药数量少且价格较高,仿制药则以低价占据大部分的药品市场,但仿制药的上市有可能侵犯原研药企业的专利权。需要在仿制药上市审批与原研药专利保护之间创建有效链接,即药品专利链接制度。其目的是平衡原研药企业与仿制药企业之间的利益,以达到既可能保护原研药企业的利益,促进药品的研发和创新,又能够加速仿制药的上市,使药品的价格降低,福利大众。2007年,我国的《药品注册管理办法》,其中有些条款与药品专利链接制度有一定的联系,但是与美国相比,还不是完整的药品专利链接制度。2017年5月,原国家食品药品监督管理总局(CFDA)(现为国家药品监督管理局)的《关于鼓励药品医疗器械创新保护创新者权益的相关政策(征求意见稿)》,提出了要在我国建立药品专利链接制度。其后上线的《中国上市药品目录集》,国家药品监督管理局(以下简称国家药监局)公开征求《药品试验数据保护实施办法(暂行)》意见,以及2019年1月全国人大常委会发布的《专利法修正案(草案)》中增加的“创新药品发明专利期限补偿制度”都是在对药品专利链接制度进行的探索。因此在研究国内外药品专利链接制度的基础上,提出以立法的形式明确建立药品专利链接制度,并完善仿制药申请简化制度、健全专利期延长和试验数据保护制度、建立药品监管部门、知识产权局和法院之间的有效链接等建议,以促进我国药品专利链接制度的建立。更多还原

【Abstract】 China’s original research drugs are small in quantity and high in price,while generic drugs occupy most of the pharmaceutical market at low prices,but the listing of generic drugs may infringe the patent rights of the original research drug companies.It is necessary to create an effective link between the approval of the generic drug and the patent protection of the original drug,that is,the drug patent link system.The purpose is to balance the interests between the original drug companies and generic drugs companies in order to protect the interests of the original drug companies and promote drug research and development.It can also speed up the listing of generic drugs,reduce the price of medicines,and benefit the public.In 2007,China’s State Food and Drug Administration(CFDA)promulgated the"Administrative Measures for Drug Registration",some of which have certain links with the patent linking system,but compared with the United States,it is not a complete drug patent linking system.In May 2017,the CFDA issued the "Policy on Encouraging the Rights and Interests of Innovative Protection of Innovative Drugs for Medical Devices(Consultation Draft)",and proposed to establish a drug patent link system in China.The "China Listed Drugs Catalogue",and the "Implementation Measures for the Protection of Drug Test Data(Provisional Draft)issued by the State Drug Administration(hereinafter referred to as the State Food and Drug Administration)and the fourth revision of the Patent Law The "Innovative Medicine Invention Patent Term Compensation System" added in the draft is an exploration of the drug patent link system.Therefore,on the basis of studying the drug patent linking system at home and abroad,it is proposed to establish a drug patent linking system in the form of legislation,improve the generic drug application simplification system,improve the patent period extension and test data protection system,establish drug regulatory authorities,and intellectual property rights.Suggestions such as effective links between the bureau and the court to promote the establishment of a drug patent linking system in China.更多还原