我国“Bolar例外”条款困境与出路分析

Analysis of the Dilemma and the Outlet of China's "Bolar Exception" Clause

我国《专利法》引入"Bolar例外"条款意义深远,现有17万个药品批准文号中属于化学药品的约有10.7万个,其中95%以上是仿制药。"Bolar例外"条款是专利权人、仿制药厂商与社会公共利益平衡的产物,美国等国家在"Bolar例外"条款的适用范围、配套制度等方面积累了有益的经验。我国可针对现行"Bolar例外"条款的缺失,结合当前仿制药品产业发展的实际,本着立法本意借鉴有益经验,进一步完善"Bolar例外"的相关规定与配套制度。

As there are about 107,000 chemical drugs in the 170,000 drug approval documents, of which more than 95% are generic drugs, the introduction of the ＂Bolar Exception＂ clause in China＇s patent law is far-reaching. In general, the ＂Bolar Exception＂ clause is a production of the balance among patentees, generic drug manufacturers and the public interest. Moreover, the United States and other countries have accumulated advanced experienced from the clause＇s application scope, supporting system and so on. In view of the lack of the current ＂Bolar Exception＂ clause and actual development of the present generic drug industry, China can improve the relevant provisions and the supporting system of the clause by learning from the benefi cial experience with positive legislative intents.