Research On The Chinese Drug Patent Link System

The development and protection of drugs are also very important.There is a huge market demand for generic drugs among the public in China.However,the r&d and innovation capacity of China’s pharmaceutical industry is still in the third echelon in the world,leading to the outstanding contradiction between doctors and patients.The patent system is the core of the pharmaceutical industry operation mechanism,and system of drug patent link will be listed drug approval system and a patent infringement lawsuit links up,is a kind of new mode of pharmaceutical patent protection,to the advantage of pharmaceutical intellectual property are continuous improvement in the dynamic game,both security innovation drugs and generic drugs enterprises the interests of both sides at the same time,also meet the demand of the social public life and health.Based on the current situation of China’s national drug industry,there are some relevant provisions of the drug patent link system in China,but there are still many deficiencies.The first part of this paper mainly introduces the basic content and value theory of drug patent link system.First,it briefly explains the basic connotation and core procedure of the system.Then,it reflects from the historical background that the system is the product of historical choice.Then,by analyzing the advantages and disadvantages of the system,the author points out that the value goal of the system is to maintain the balance of interests between the original drug manufacturer and the generic drug manufacturer,the drug patent and the public interest.The second part mainly analyzes the current situation of legislation and practice in China.China’s drug patent link system is still in the process of exploration,there are such problems as the lack of coordination mechanism of legal policies and operation,the lack of integrity and authority of the information registration of listed drug catalogue,the abuse of patentee andthe lack of supporting system.Thus,it is difficult to achieve the goal of balancing the interests and values of the system itself.The third part is the analysis and reference of the drug patent link system outside the region.After years of implementation and adjustment of the drug patent link system in countries outside the region,the system design is relatively sound,which has indeed played a role of balancing interests in practice.However,there are inevitably various problems,such as the frequent phenomenon of "reverse payment and settlement agreement",whose solutions can also be referred to.The fourth part is based on the reference of foreign drug patent link system and the existing legal situation in China,and puts forward some concrete Suggestions on how to improve China’s drug patent link system.For example,we should improve the system of disclosure of drug patent information,establish a mechanism to simulate infringement,improve the patent challenge mechanism and the exclusive period of the first imitation drug market,establish a monopoly investigation system for the original research drug,and improve the mechanism for coordinating the operation of the system.