推动专利到期药物仿制上市的专利制度优化研究  

On the Optimization of the Patent System to Promote the Marketing of Generic Drugs with Expired Patents

作　　者：胡潇潇[1] Hu Xiaoxiao

机构地区：[1]中南林业科技大学政法学院

出　　处：《知识产权》2022年第9期70-89,共20页Intellectual Property

基　　金：国家社科基金项目“专利到期药物仿制上市法律保障机制研究”(18BFX168);湖南省社科基金项目“推动专利到期药物仿制上市法律对策研究”(17YBA427)。

摘　　要：原研药专利到期后仿制药尽快上市参与竞争可以有效降低药品价格、提升药品可及性。我国《专利法》《专利审查指南》等专利制度修改后,药品专利补充实验数据制度、药品专利纠纷早期解决机制、药品专利期限补偿制度将对专利到期后仿制药及时上市带来新的影响。就推动专利到期药物仿制上市而言,目前我国专利制度存在药品专利补充实验数据审查制度不健全、药品专利纠纷早期解决机制不完善、药品专利期限补偿规则不清晰三大问题。在利益平衡原则指导下,应当建立健全药品专利补充实验数据的接受和审查制度,优化药品专利纠纷早期解决机制,严格药品专利期限补偿条件,以推动专利到期药物仿制及时上市。When the patents of original drugs expired, generic drugs can be listed as soon as possible to participate in the competition, which can effectively reduce the price and improve the accessibility of drugs. With the last revisions of the Chinese Patent Law and the Guidelines and so on for Patent Examination, the system of drug patent supplementary experimental data, the early resolution mechanism for drug patent disputes, and the pharmaceutical patent term extension system will bring new impact on the timely listing of generic drugs with expired patents. In terms of promoting the generic listing of drugs with expired patents, there are three major problems in China’s patent system at present: irregularity of drug patent supplementary experimental data review system,shortage of early resolution mechanisms for drug patent disputes, and unclear rules for the drug patent term extension. The marketing of generic drugs with expired patents can be promoted if the measures have been taken, under the principle of balance of interests, to establish the system on acceptance and review of supplementary experimental data for drug patents, improve the early resolution mechanism for drug patent disputes, and strictly implement the compensatory conditions for drug patent terms.

关 键 词：原研药 仿制药 药品专利补充实验数据 药品专利链接 药品专利期限补偿 

分 类 号：D923.42[政治法律—民商法学]