浅谈《药品注册管理办法》中的知识产权保护

目的在药品注册过程中提高知识产权保护的力度。方法详细分析了《药品注册管理办法》中有关知识产权内容的条款,并结合相关的法律法规,对目前我国药品注册过程中的专利保护问题进行了阐述。结果新修订的《药品注册管理办法》加大了药品知识产权的保护力度,但尚存在一些不够完善的地方。结论在对比借鉴美国药品注册中保护专利做法的基础上,提出了相应的改进方案,对推动我国药品知识产权保护有一定的参考作用。

Discussion on the Intellectual Property Protection in the Drug Registration Regulations

Objective To improve the ability of medical intellectual property rights effectively during drug registration. Methods Combining with corresponding laws and regulations, the related issues of the Drug Registration Regulation on intellectual property were entirely analyzed, and the problems of patent protection on the process of drug registration in our country were put forword. Results The protection intensity of drug intellectual patents has been enhanced by the new revised Drug Registration Regulation, whereas need some modifications to be more perfect. Conclusions The countermeasures were put forword by comparing the practice of patent protection of drug registration in the USA, which facilitate the protection of drug intellectual property.