药品专利链接制度建构的中国方案：理论、原则与路径

药品专利链接制度作为专利纠纷的早期解决机制，解决了药品上市行政许可与专利权保护的衔接机制问题,该制度的创设遵循我国私有财产不受侵犯的宪法原则。制度构建应以法益衡平理念为基本指导原则，结合我国药品监管体系、医药产业政策和专利行政、司法保护运行机制设计相关内容，该制度构建涉及行政权、财产权、健康权之间的冲突与协调问题。我国具体制度设计应遵循生命健康权优先保护、合理保护、效率与公平兼顾协调3个原则，重点调和不同利益主体之间的紧张关系。除科学设置药品上市目录集、专利声明、暂缓审批期、首仿药市场独占期外，还应注重药品专利链接制度与药品试验例外、专利诉讼、专利行政处理、强制许可等制度的协调与衔接。

China's Plan for the Construction of Drug Patent Linkage System: Theory,Principles and Approach

It is an urgent problem to stimulate drug innovation and research and development to improve the quality of generic drugs in the development of China's pharmaceutical industry. Based on the particularity of drugs, the listing needs to be approved by the national drug regulatory department. During this period, drug patents are in the dilemma of unfavorable protection and unresolved disputes.Therefore, policy makers and legislators need to design a system to solve this problem. From the two dimensions of the actual needs of the innovation and development of domestic pharmaceutical industry and the needs of the development of international trade, it is proved necessary to build a pharmaceutical patent linkage system in contemporary China.China's patent law amended and passed in October 2020 has added relevant provisions on the early settlement mechanism of drug patent disputes, that is, the "drug patent linkage system" in academic circles.The so-called drug patent linkage system refers to a series of institutional arrangements that link the protection of drug patents with the registration and approval of drugs, and timely solve the patent disputes involved in the drugs to be applied for listing during the drug approval period.Drug patent linkage system is an institutional form that balances the conflict between the interests of drug manufacturers and public health. It contains rich theoretical basis, which is particularly important to discuss in depth.The drug patent linkage system involves the balance of interests between the drug patentee and the generic drug applicant. For the legal issues involving patents, the patent law should make principled provisions to provide the necessary legal basis. The relevant specific contents can be refined by the relevant competent departments and judicial organs in accordance with the law, and issue the corresponding departmental rules and judicial interpretations.The basic orientation of the function of drug patent linkage system is an effective mechanism for the early settlement of drug patent disputes, providing drug patentees with relief ways for patent validity or infringement disputes before drug listing, and solving the connection mechanism between drug listing administrative license and drug patent protection.As an early settlement mechanism of patent disputes, the drug patent linkage system solves the problem of linking up the administrative licensing and patent protection. As far as the drug patent linkage system itself is concerned, it is a double-edged sword. Under the positive effect of promoting new drug research and development and resolving patent disputes in advance, it also has a negative effect of hindering generic drug competition and threatening drug accessibility.In view of this, constructing the drug patent linkage system, our country should take a relatively cautious position in the design of its relevant rules.This study points out the guiding concepts and basic principles that should be implemented when building the drug patent linkage system in China. On this basis, combined with China's national conditions, refine the specific rules of the drug patent linkage system.China should build a right guarantee system with the right to life and the right to health as the core.In the basic rights system constructed by the constitution, the right to life and the right to health occupy the core and basic position, and all other rights are based on the right to life and the right to health.When individual life and health are threatened, Individual life and health should be given priority.This system is consistent with the constitutional principle of inviolability of private property in China. It should be based on the principle of equity of legal interests, combined with the drug regulatory system, pharmaceutical industry policy and patent administration, judicial protection operation mechanism to design the relevant specific content constructing the system in our country. The construction of the system involves the conflict and coordination between administrative power, property right and health right.It should follow three specific principles: priority protection of the right to life and health, reasonable protection, and coordination of efficiency and fairness, which should help to reconcile the tension between different stakeholders. In addition to scientifically setting up drug listing catalogue set, patent declaration, deferred approval period and exclusive period of the first generic drug market, it should also pay attention to the coordination and connection between patent linkage system and drug trial exception, patent litigation, patent administrative treatment, compulsory license and other systems.The drug patent linkage system should be connected with China's unique patent administrative processing system, so as to quickly determine the legal status of patent rights and provide stable expectations for the parties and the public.The drug patent linkage system is still in its infancy in China. How to scientifically construct the system and make it play its due role still needs systematic and in-depth research and empirical test.We believe that the drug patent linkage system constructed by China can contribute Chinese wisdom and scheme to the formulation of international rules on intellectual property rights.#br#