日本药品专利期限补偿制度对中国新药研发的启示

Inspiration of the extension of duration of patent right in Japan to new drug research and development in China

由于新药的研究和开发时间较长,未经安全性、有效性严格审查的药品不能上市,审查时间过长从而导致新药研发成本过高。日本实行药品专利期限补偿制度,给予药品一定专利保护期限的延长,有效减少了新药和仿制药的矛盾。本文通过对日本2017—2019年的药品专利期延长申请数据进行分析,结合2020年10月17日第十三届全国人民代表大会常务委员会第二十二次会议通过的全国人民代表大会常务委员会关于修改《中华人民共和国专利法》的决定的相关条款,从中汲取对中国新药研发的启示。

The facts that the research and development of new drugs lasts for long period,drugs without strict examination of safety and effectiveness cannot be put on the market,and the review time is very long,leads to the high cost of new drug research and development.Japan implements the system of extension of the duration of a patent right,which extends the period of patent protection for drugs and effectively reduces the contradiction between new drugs and generic drugs.In this paper,through analysis of the application data of the extension of the duration of a patent right in Japan from 2017 to 2019,combined with the relevant provisions of the amendment to the patent law of the People’s Republic of China(second deliberation draft),we can learn the enlightenment to the new drug research and development in China.