Research On The Drug Patent Linkage Syste

Medicine is a kind of special goods,related to people’s life and health and life safety.Since the reform and opening up,China’s pharmaceutical industry has developed rapidly,but it is still relatively low compared with the advanced medical technology and innovation ability of the West.The quantity of domestic generic drugs is large but the quality is not high,and the scale of the generic drug industry is large but the innovation ability is weak,which does not match the people’s demand for high-quality drugs with superior efficacy.The drug patent link system links the ownership status of the original drug with the listing and approval procedure of generic drugs,and solves the possible patent disputes before the listing and approval of generic drugs.It not only protects the rights of the original drug enterprises,but also avoids the loss of the generic drug enterprises,and protects the interests of both the generic drug enterprises and the original drug enterprises.Drug patent linkage system is a stable mechanism and reasonable choice to realize the healthy development of drug industry and people’s healthy life.In the Patent Law and the Implementation Measures of the Early Settlement Mechanism for Drug Patent Disputes(Trial)promulgated by China in 2021,the new system of drug patent linkage has been brought to the national level.This paper analyzes the operating mechanism and value trend of drug patent link system,draws on the foreign system legislation and practice experience,and puts forward corresponding countermeasures for the problems existing in the practical operation of patent link system according to the existing legal provisions.Starting from the origin and development process of Chinese medicine patent link system,this paper expounds the concept,operation mechanism and function of drug patent link system,and reflects the necessity and effectiveness of the implementation of drug patent link system from the era environment at that time.Secondly,through the study of foreign drug patent link system,the defects and improvement ways of the system are summarized,so as to provide reference for the construction of domestic patent link system.In addition,the paper also analyzes the construction status of the drug patent link in our legal system and the problems existing in the implementation.In general,on the whole,China’s drug patent linking system is basically the same as that of the United States,but considering the special situation of China,it is very different from the United States in the value orientation of the law and the setting of procedures,thus producing the drug patent linking system with Chinese characteristics.This paper also points out the defects in the current patent linking system,such as the lack of regulation of reverse payment agreement,patent information registration and other practical problems.At the end of the paper,in view of the current problems in the process of constructing the patent link system of our country,this paper gives some improvement methods,including: In order to ensure the authenticity and integrity of patent registration information,we should strictly limit the time of the supplementary registration of patent registration information platform,establish the procedures for the third party to raise objections and punish the behaviors that violate the legal provisions.The filing and examination of reverse payment agreement should be strengthened to reduce the damage caused by unfair competition.It is suggested that administrative organs should deepen functional links in dealing with drug patent application,listing and patent dispute resolution mechanism.