专利链接制度的实施对仿制药产业的影响分析

Analysis of the influence of the implementation of patent linkage system on the generic drug industry

专利是保护药品创新最重要的方式,药品专利制度深刻影响着药品产业的发展。目前,在我国现行的药品管理制度以及专利法规中,已经正式引入了药品专利链接制度的规定,本文以我国首个药品专利链接诉讼案件为例,探求解析目前药品专利链接制度在我国的试行效果及对仿制药行业的影响,从而对仿制药企业在专利声明类型的抉择和资料的真实性方面给予建议,原研药企业则需要把握维权时机并在专利纠纷解决路径上谨慎选择,并基于我国国情的民行二元分立体制对专利纠纷早期解决途径的束缚和专利声明类型中尚需解决的问题,提出需要适时回顾分析专利链接制度的实施情况,提高行政裁决的法定地位,使其具有一定的确权属性,以及需要适当进一步细化专利声明类型,对不同情况的侵犯专利情形应加以规范等。

Patents have long been considered as the most important way to protect pharmaceutical innovations,and the drug patent system has exerted a profound impact on the development of the pharmaceutical industry.In the context that domestic effective drug regulations and patent laws and regulations have covered the provisions on drug patent linkage system,this paper,by taking the first case of domestic drug patent linkage litigation as an instance,analyzes the trial effect of the newly launched drug patent linkage system in China,explores its impact on the generic drug industry,and tries to give suggestions to generic drug enterprises on the choice of patent application types and the authenticity of application materials.The research⁃based pharmaceutical enterprises need to seize the opportunity to safeguard their rights and protect themselves against patent infringement by choosing an appropriate method to resolve patent disputes.Moreover,given the constraints of China's binary separation of procedures of patent infringement and patent invalidation on the early solution of pharmaceutical patent disputes and the problems awaiting to be solved in different types of patent applications,this paper also puts forward related suggestions on patent protection,including the necessity of timely review and analysis of the implementation of the patent linkage system,enhancement of the legal status of administrative adjudication to enable some authorities of administrative confirmation,and the necessity for clearer definition of types of patent applications and further standardization of patent infringement cases under different circumstances.