药品专利链接制度研究

Research on Pharmaceutical Patent Linkage System

药品专利制度与药品行政管理制度的有效链接对于理顺药品专利权人和仿制药厂的关系,平衡原研药商与公众利益,促进仿制药的及时上市具有重要意义。我国专利法2008年修订后,已为推动专利药仿制提供了有利条件,但由于药品行政管理制度与专利制度未达到有效链接,尚未能对专利药仿制打开具有操作性的通路,也未能提供足够激励。我国作为仿制药大国,对药品的专利链接制度亟需进行修改和细化。本文阐释了美国的相关制度和我国实践中存在的诸多问题,探讨了我国药品专利链接制度改进的路径。

An effective linkage system between pharmaceutical patent system and drug administration system is important for balancing the interest between Originator Company and the public. It would improve the generic manufacturers, and eventually increase the drug approval. China＇s Patent Law revised in 2008 has included the Bolar provision which is aimed at speeding up generic entry into the market and availability of low cost drugs to the consumer. However, the current patent linkage system of China fails to provide sufficient incentives to the generic drug manufacturers. This article introduces the patent linkage system of U.S, analyzes the current status of patent linkage system of China, and provides some recommendations for improvement.