Research On Pharmaceutical Patent Linkage System

China is going to establish the pharmaceutical patent linkage system.Although the system has promoted development of pharmaceutical industry in the United States,there are still various problems.Due to different national conditions,it is necessary to dig deeper.The patent linkage and related systems in US and China are compared,and the problems in both countries are analyzed in this paper.After that,the improvement directions of China's pharmaceutical patent linkage system are discussed and reasonable suggestions are provided.Drugs must be approved by the government to ensure their safety and effectiveness,and the pharmaceutical industry relies heavily on patent protection.The patent linkage connects the administrative approval of generic drugs with the patent protection of brand drugs,so as to achieve the goal of their coordinated development.The US patent linkage system mainly includes orange book,abbreviated new drug application,patent declaration and patent challenge.The related systems include supplementary experimental data,post-licensing procedures,Bolar exception,etc.Correspondingly,China's pharmaceutical patent linkage system and the related systems are discussed.The pharmaceutical patent linkage system in the United States has been constantly adjusted and revised,but problems keep coming,including patent accumulation,reverse payments,etc.While the biggest problem in China is how to make the system work as expected.Based on China's national conditions,priority should be given to citizens' health rights,and then to Chinese medical innovation and generic development.Therefore,whatever beneficial for the above goals should be strengthened,and the opposite should be restrained.The laws,regulations and procedures should be revised or adjusted accordingly.