美国和加拿大药品专利链接体系要素的选择及其对中国的启示  

Choice of the Elements of Drug Patent Linkage System in U. S. and Canada and Its Inspiration to China

作　　者：刘立春[1] 朱雪忠[2] 

机构地区：[1]华中科技大学知识产权战略研究院,湖北武汉430074 [2]同济大学知识产权学院,上海200092

出　　处：《中国科技论坛》2014年第1期147-154,共8页Forum on Science and Technology in China

基　　金：国家自然科学基金项目"基于审查行为影响下的专利倾向及其政策含义研究"(71003037);教育部人文社会科学研究一般项目"中国企业国际化经营中知识产权风险评价和控制研究"(11YJA630224)

摘　　要：药品专利链接是药品注册审批过程中,考察待审批仿制药与已批准新药的有效专利之间关系的程序。国内学者对中国专利链接体系的研究主要集中在宏观层面,很少涉及具体要素和实际操作模式的研究。在现有宏观政策研究基础上,从专利链接审查涉及的药品范围、公示专利类型和部门之间的链接模式等微观层面归纳出中国药品专利链接体系中存在的不足,参考发达国家专利链接体系具体的运行机制并结合我国国情,在具体操作层面上提出完善建议。Drug patent linkage is a review procedure that investigates the relationship between the generic drug and the effective pa- tent of the registered drug during the drug registration and approval process. The domestic scholars mainly researched on the macro- level of China drug patent linkage system, however, few scholars studied on the specific elements and operation mode of patent linkage. Based on the existing macroscopic policy research, from micro-level such as the drug classifications involved in patent link- age examination procedure, types of displayed patent and linkage mode among departments, we induce the existent insufficiency of China drug patent linkage system, and put forward some improving suggestions about concrete operation by referring to the advanced operation mechanism of patent linkage system of developed countries and combining with China＇s national conditions.

关 键 词：药品专利链接 药品审批 专利审查 

分 类 号：G306.3[文化科学]