论我国药品专利链接制度的完善

在促进仿制药上市的过程中，药品专利链接制度是保护专利药厂利益的重要工具。21世纪伊始，我国开始尝试构建本土化的药品专利链接制度，目前正逐步从松散走向紧密、从形式走向实质。与美国药品专利链接制度的三个阶段相比，我国药品专利链接制度明确了药品专利信息登记、药品专利链接路径选择与实施两个阶段，但是对第三阶段市场独占期尚未确定。在改革和完善我国药品专利链接制度的过程中，既应保障药品专利信息登记的完整性、真实性与准确性，也应协调好药品专利链接路径设置与展开过程中专利药厂和仿制药厂的利益冲突，最终通过实施市场独占期机制来完成仿制药挑战专利药的利益补偿，不断强化药品专利链接制度的实施效果。

On the Perfection of China's Pharmaceutical Patent Linkage System

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.