药品专利保护期补偿制度的中国路径——《专利法修改草案（2019）》之完善

China’s Approach to Building a Compensation System for Pharmaceutical Industries within Patent Term:The Improvement of Draft Amendment to the Patent Law of the People’s Republic of China (2019)

2019年1月公布的专利法第四次修订草案拟增设药品专利保护期补偿制度以鼓励药品创新,但它与公共健康密切相关,因此有必要审慎对待其具体规则的构建。专利法(草案)的规定过于原则,该制度的基本构成要件不宜由专利法实施细则来补充规定。专利法(草案)的条文存在两方面的缺陷:第一,缺乏审查程序,没有规定保护期延长法律效力以及批准上市的药品与药品专利权之间的关系等基本原则,因此应该予以增补。第二,部分法律规则的表述不科学,如仅限于“创新药品”导致保护范围过窄,“在中国境内与境外同步申请上市”的条件过于严格,不利于激励中国原研药的自主开发,应该予以修订。

In order to promote pharmaceutical innovations,The Fourth Draft Amendment to the Patent Law of the People’s Republic of China published in January,2019 intends to add a compensation system for pharmaceutical industries,the patents of whose products are still in force.However,great prudence should be in order in formulating the specific provisions due to their close relation with the public health.In this paper,we argue that there is still some room for improvement in the current draft patent law,whose provisions are too general.This inadequacy cannot be overcome by Rules for the Implementation of the Patent Law of the People’s Republic of China.Specifically,there are two types of problems with the articles of the daft amendment to the patent law.Firstly,it fails to contain the necessary basic principles concerning the reviewing procedure,the patent term extension,and the relationship between the drugs allowed to enter the market and their patent rights,which should thus be included therein.Secondly,some articles are not scientific enough in wording:e.g.,limiting the patent protection to the newly-developed drugs makes the scope of protection too narrow;and it is too strict to require that the producers apply for the license for their products to enter the market at home and abroad simultaneously,which will have a negative effect on China’s own original development of drugs and thus should be revised.