On The Perfection Of China’s Drug Patent Linkage System

As a special commodity,medicines are related to the national economy and the people’s livelihood.Therefore,countries in the world prefer to give them special intellectual property protection,especially patent protection.Drug research and development has the characteristics of large investment,high risk and long development cycle,which determines its dependence on patent protection is higher than others.Without effective patent protection,few companies or individuals dare to engage in such high-risk investments.However,excessively high level of patent protection may lead to the weaker of the pharmaceutical market and the higher of the drug prices,which will not conducive to the citizens’ health.The drug patent linkage system is constructed on the basis of taking into account the protection of patent rights and the right to protect citizens’ health,which provides a creative solution to many problems faced by our country.The "Provisions for Drug Registration" and the "Patent law" in China have been revised several times,which have initially established drug patent linkage system,but only stay in the form and lack of operability.In reality,there are still a large number of infringing generic drugs listed.In recent years,China’s pharmaceutical industry is experiencing the optimization and upgrading as well as the baptism of the international wave.China has issued a series of policy regulations on improving the quality of generic drugs,optimizing the structure of China’s pharmaceutical industry,and encouraging medical innovation.In October 2017,General Office of the CPC Central Committee clarified the general direction of establishing a drug patent linkage system which is similar to the USA.It can be seen that China’s determination to establish a substantive drug patent linkage system,but from the current regulations,it still has many shortcomings.Based on the theoretical analysis of the system,this paper intends to make reasonable suggestions for the improvement of China’s drug patent linkage system by drawing on the legislation and practical experience of the United States.This paper is divided into the following four parts:The first part of this paper mainly introduces the drug patent linkage system.Firstly,it introduces the meaning of related terms for later understanding.Secondly,it introduces the back ground of this system to understand the background of its generation.Finally,it introduces the theoretical basis and value pursuit of this system in order to prove its rationality as well as provide theoretical support for the analysis of the following.The second part of this paper mainly introduces the legislative status and reflection of drug patent linkage system in China.First of all,it introduces the relevant provisions of China,and analyze the shortcomings.China’s current regulations on this system are still in the form.Then,the author uses the case to demonstrate the practical problems caused by the current system and analyzes the necessity of perfecting the drug patent linkage system in our country.The third part of the paper mainly introduces the practice of the drug patent linkage system in the United States and its enlightenment to China.The reason for choosing the United States is because it was the first country to implement this system as well as it achieved the best implementation effect.Moreover,as far as China’s recent normative legal documents are concerned,it seems to have the tendency to establish the US-style drug patent linkage system.The author first sorts out the relevant legal provisions of the United States,and then sorts out and evaluates its institutional advantages and defects.Finally,the corresponding enlightenment is drawn,which can be used for reference in the improvement of China’s system.The fourth part of the paper is mainly to put forward specific suggestions for improving the patent linkage system in China.The author comprehensively considers the status quo of China’s pharmaceutical companies,the health needs of citizens,and the practical implications of the United States,from the three aspects to put forward specific suggestions for improving the patent linkage system of China,such as improving laws and regulations,improving the legislative level and simplifying the application process of generic drugs.