仿制药替换创新药的排他权壁垒与美国实践突破研究  

Exclusionary barriers of generic drugs replacing innovative drugs and american breakthrough in practice

作　　者：金春阳[1] JIN Chun-yang(School of Law,Xi’an Jiaotong University,Xi’an 710049,China)

机构地区：[1]西安交通大学法学院,西安710049

出　　处：《中国新药杂志》2021年第14期1249-1254,共6页Chinese Journal of New Drugs

基　　金：2020年教育部项目(留金美[2020]1509);西安交通大学2020年课程思政专项研究重点项目。

摘　　要：创新药公司对于新药、其初始用途以及后续研发出的新用途都可取得专利权及药物试验数据专有权保护,这2种权利皆为排他权,旨在保障创新药公司在市场上拥有独占性营销地位。创新药的初始排他权和后续排他权构成仿制药上市的制度壁垒。但在美国的实践中,一旦初始排他权到期,仿制药将被鼓励上市,后续排他权实际上无法阻止仿制药替换创新药的进程。本研究从行政监管、医药实践及司法救济3个方面,解析美国社会突破制度壁垒的实践举措,发现利益相关方在行政监管和医药实践中规避后续排他权是制度壁垒得以突破的主要原因,而后续排他权本身侵权易、维权难的特点是制度壁垒得以突破的次要原因。Innovative drug companies can obtain patent rights and exclusive rights for drug trial data for new drugs, their initial uses and new uses developed in the future. Both rights are exclusive rights, which are designed to protect innovative drug companies in their predominant position in the market. The initial exclusivity and subsequent exclusivity of innovative drugs constitute institutional barriers to the marketing of generic drugs. However, in the practice of the United States, once the initial exclusivity expires, generic drugs will be encouraged to enter the market. Actually, subsequent exclusivity cannot prevent the process of the replacement of innovative drugs by generic drugs. This article analyzes the practical measures of American society to break through institutional barriers from three aspects of administrative supervision, medical practice and judicial relief, and finds that the evasion of subsequent exclusive rights by stakeholders in administrative supervision. Furthermore, medical practice is the main reason for the breakthrough of institutional barriers. The difficulty of asserting the subsequent exclusivity is the secondary reason for the breakthrough of institutional barriers.

关 键 词：方法专利 药品专利 专利链接 创新药 仿制药 

分 类 号：R95[医药卫生—药学]