关键词: 仿制药, 专利药, 药品专利链接, 利益平衡, 市场独占期

Abstract: Pharmaceutical patent linkage system is an important tool to protect the interests of patented pharmaceutical companies in the process of promoting production of generic drugs. Since the beginning of the 21st century China has begun its efforts to build a pharmaceutical patent link system. Different from the three stages of the drug patent linking system in the United States,the drug patent linking system in China has defined two stages:drug patent information registration,drug patent linking path selection and implementation, but has not yet defined the third stage of market monopoly. In reforming and improving the drug patent linkage system in China, it is necessary to ensure authentic and accurate drug patent information registration, and to coordinate the interest conflicts between brand manufacturers and generic manufacturers in developing drug patent linkage, so as to complete the compensation for the interests of patented drugs challenged by generic drugs through market exclusivity period mechanism, and to strengthen effect of drug patent linkage system.

Key words: generic drug, patented drug, drug patent linkage, interest balance, market exclusivity period