我国应对药品专利常青化策略研究

Research on China’s Strategies to Deal with the Evergreening of Drug Patent

药品自古以来与人类健康息息相关,同时作为一种特殊商品能给制药企业带来巨大收益,故制药领域的健康发展对我国原研药企、仿制药企的发展具有重大意义。但市场中一些原研药企业使用药品专利常青化策略,不正当地延长专利保护期限,阻碍了仿制药企业进入医药市场的时间,使药品价格难以降低,药品的可及性不能得到保障,不利于药品领域的整体创新能力发展。因此,对药品专利的保护与规制显得极其重要。本文首先就药品专利常青化策略产生原因和具体表现形式进行概述,其次就药品试验数据专有权保护制度和2021年实施的《专利法》中规定的药品专利期限补偿制度、药品专利链接制度是否有助于遏制我国药品专利常青化问题展开讨论,总结我国药品专利制度的不足,并借鉴国外关于专利常青化策略的规制方法 ,提出建立严格的专利审查标准,完善药品保护的配套专利制度,细化反垄断审查指南的措施建议,有效降低垃圾专利的申请量,进而促进药品行业有序竞争,为我国药品行业的创新和发展提供制度支持。

Medicines have been closely related to human health since ancient times, and at the same time, as a special commodity, they can bring huge benefits to pharmaceutical companies. Therefore, the healthy development of the pharmaceutical field is of great significance to the development of original research and generic pharmaceutical companies in China. However, some original research drug enterprises in the market use the drug patent evergreen strategy to improperly extend the term of patent protection,which hinders the generic drug companies from entering the pharmaceutical market, making it difficult to reduce drug prices, and cannot guarantee the availability of drugs, as a barriers to the development of innovation capacity. Therefore, the protection and regulation of drug patents are extremely important. This article firstly outlines the reasons and specific manifestations of the evergreen strategy of drug patents. And secondly, whether the protection system for the exclusive rights of drug trial data, and the compensation system for the term of drug patents and the linking system for drug patents stipulated in the Patent Law that has been implemented in 2021, it can help to curb the evergreen related issue of our country’s drug patents will be discussed, and the shortcomings of our country’s drug patent system will be summarized. And drawing lessons from foreign regulatory methods on patent evergreen strategy, and proposing measures to establish strict patent examination standards, improving the supporting patent system for drug protection,and refining anti-monopoly examination guidelines, aim to effectively reduce the number of applications of junk patents, and then promote orderly competition in the industry, so as to provide an institutional support for the innovation and development of our country’s pharmaceutical industry.