药品专利链接制度的正当性及制度价值分析

Analysis About the Legitimacy and Value of Drug Patent Linkage System

药品专利链接制度为药品专利权人提供了在药品上市前解决专利纠纷的途径,是社会纠纷解决机制得以实现的手段之一。该制度符合我国的知识产权政策立场和建设创新型国家的政策目标。药品专利链接制度的价值体现在行为规范价值和主体激励价值。该制度有助于强化药品专利权的保护,激励药品创新;有利于促进仿制药与创新药的充分竞争,实现医药产业的良性发展;有助于解决公民健康需求与药品供给不足的矛盾。该制度所要实现的终极价值目标在于通过强化药品专利权的保护,有效激励新药的研发,促进仿制药的上市,保障药品的可及性。因此,药品专利链接制度是解决我国药品专利保护不力、医药产业创新不足和高质量药品紧缺问题的重要途径,是落实国家医药产业创新发展与深化审评审批制度改革鼓励药品创新政策的重要制度设计。

Drug patent linkage system provides a way for drug patent holder to resolve patent disputes before generic drug listing, and it is one of the means to realize social dispute resolution mechanism. The system is in line with China's intellectual property policy stance and the policy objective of building an innovation-oriented country. The value of drug patent linkage system is reflected in the norms of behavior and the value of incentive. This system is conducive to strengthen the protection of drug patent rights and to encourage drug innovation;favorable , to promote sufficient the full competition between generic drugs and innovative drugs , achieving , to realize the healthy development of the pharmaceutical industry;helpful, and to resolve the conflict contradiction between the needs of public health and insufficient medication supplyhealth needs of citizens and the insufficient supply of drugs. The ultimate goal of the system is to effectively stimulate the research and development of new drugs, promote the listing of generic drugs and guarantee the accessibility of drugs by strengthening the protection of drug patent rights. Therefore, drug patent linkage system is an important way to solve the problems of weak patent protection, inadequate innovation in pharmaceutical industry and shortage of high-quality drugs in China. It is also an important system design to implement the innovation and development of national pharmaceutical industry and to deepen the reform of examination and approval system for to encouragement of drug innovation policy.