药品专利链接制度是链接药品的专利纠纷阶段与上市审批阶段的一种制度，目的在于仿制药上市审批之前解决早期专利纠纷，由于药品专利链接制度涉及原研药企与仿制药企两方的利益，对原研药企的保护有利于推动药品领域的专利创新，对仿制药企的保护有利于降低药品价格，实现药品可及性，因此这一制度的推出有利于专利创新与药品可及性之间的矛盾。另一方面，药品专利链接制度是基于中美两方签订的双边协定制定，受美国专利保护霸权的影响，若全球建立起高标准的药品专利保护制度，有利于美国的跨国药企获取更高的利润额，但高标准的专利保护机制却无法适配我国现有的医药市场，势必会使原研药长期霸占市场份额，缺乏竞争，将给维护公共健康带来巨大负担。

因此，我国在建立药品专利链接时并未完全移植美国的专利链接制度，而是在美国的专利链接制度的框架下，根据我国国情进行了创新性的制度设计。我国的药品专利链接大致也可分为四个部分，分别是专利信息公示制度、专利声明制度、等待期制度及首仿药独占期制度，相对于美国的药品专利链接制度，我国通过双确权通道、缩短等待期等措施在一定程度上均衡仿制药企与原研药企的利益，但同时，我国刚刚落地的药品专利链接制度在专利信息登记平台的构建、与上位法的衔接、对大分子生物药的特殊保护、对垄断行为的规制和监管以及程序设计等方面仍然存在不足。

美国是药品专利链接制度的初创者，经过近四十年的实践不断完善，并通过“拟制侵权”制度、专利舞蹈制度、反垄断审查等多种手段不断平衡调整原研药与仿制药间的较量，以期建立良性的竞争市场。加拿大、韩国、澳大利亚等国也纷纷建立了药品链接制度，并在本国制度基础上做出了一些特色化的调整，例如加拿大与韩国的药品专利链接制度中均规定药品上市审核机关对登记的专利具有实质审查权。
我国在进行药品专利链接制度的完善时也可参考美国在制度完善中采取的部分措施以及韩国等其他国家在内化制度时所做的特色改编，通过优化专利信息登记平台，建立“拟制侵权”制度以及完善监管和程序设计等方式使药品专利链接制度运行更为高效流畅，同时能够在早期解决专利纠纷问题。

The drug patent linking system is a system for linking the patent dispute stage and the marketing approval stage of drugs, The purpose is to resolve patent disputes before the approval of generic drugs for listing. The protection of original pharmaceutical companies is conducive to promoting patent innovation in the field of pharmaceuticals, and the protection of generic pharmaceutical companies is conducive to reducing drug prices and achieving drug accessibility. Therefore, the introduction of this system is conducive to achieveing the balance between patent innovation and drug accessibility. On the other hand, the drug patent linking system is formulated based on the bilateral agreement signed by China and the United States. It is influenced by the hegemony of U.S. patent protection. If a high-standard drug patent protection system is established around the world, it will help U.S. multinational pharmaceutical companies to obtain higher profit. However, the high-standard patent protection mechanism cannot adapt to my country's existing pharmaceutical market, which will inevitably lead to the long-term market share of original research drugs, lack of competition, and will bring a huge burden to the maintenance of public health.          

Therefore, my country did not completely transplant the patent linkage system of the United States when establishing the drug patent linkage system, but carried out an innovative system design according to my country's national conditions under the framework of the patent linkage system of the United States. Our drug patent link can be roughly divided into four parts, namely the patent information publicity system, the patent declaration system, the waiting period system and the first generic drug exclusive period system. Measures such as channels and shortening the waiting period have balanced the interests of generic pharmaceutical companies and original pharmaceutical companies to a certain extent. However, at the same time, the construction of the patent information registration platform, the connection with the upper-level law, the connection between the drug patent linking system and the macromolecular. There are still deficiencies in the special protection of biological drugs, the regulation and supervision of monopoly behavior, and program design.

The United States is the founder of the drug patent linkage system. After nearly 40 years of practice, it has been continuously improved, and has continuously adjusted the balance between original research drugs and generic drugs through various means such as the "fake infringement" system, patent dance system, and anti-monopoly review. Contest in order to establish a healthy competitive market. Canada, South Korea, Australia and other countries have also established drug linkage systems, and made some characteristic adjustments on the basis of their own systems. For example, the drug patent linkage systems of Canada and South Korea both stipulate that the drug marketing review authority has the substantive examination power over registered patents. When improving the drug patent link system, We can also refer to some of the measures taken by the United States in the improvement of the system and the characteristic adaptations made by other countries such as South Korea when internalizing the system. The system and the improvement of supervision and program design make the operation of the drug patent linkage system more efficient and smooth, and at the same time, it can resolve patent disputes at an early stage.