The Construction Of The Declaration System Of Generic Drug In China

With the release of the movie "I’m Not the God of Medicine",the relationship between the availability of medicines and patent protection has sparked public debate.Especially in the context of the raging new crown epidemic this year,public medical services have attracted much attention from the society.Since my country’s entry into the WTO,China has continuously strengthened its patent protection for medicines.In2017,the official announcement of the Catalogue of Listed Drugs in China and the fourth revision of the Patent Law gradually outlined my country’s patent dispute resolution system.In 2020,China and the U.S.signed the "China-U.S.Trade Agreement" in Washington,U.S.,in which section 3 mainly reached drug-related intellectual property rights clauses.China promised to establish an early settlement mechanism for drug patent disputes nationwide.So far,my country’s implementation of the patent linkage system has entered a substantive stage.As the beginning of the early settlement mechanism,the patent declaration system must be the primary object of construction.Starting from the theoretical basis of the patent declaration system,the author elaborates on the rationality and necessity of building a patent declaration system.On the premise of comparing and analyzing the implementation experience and system content of foreign countries,the author establishes a patent declaration system with Chinese characteristics,which is the cause of drug patent disputes.Consolidate the foundation for early settlement.Chapter One is an overview of the patent declaration system.First,the concept of early settlement of drug patent disputes is introduced,and the relationship between patent declaration and patent link is defined,and the rationality and necessity of introducing the patent declaration system are discussed.The "early settlement of drug patent disputes" mentioned in the Sino-US economic and trade agreement,the core of this mechanism is the patent linkage system,both of which are aimed at realizing the prior and effective settlement of drug patent disputes.Secondly,it introduces the rationality of the drug patent declaration system,and discusses it through two basic principles.That is,in the whole system,the principle of fine balance of interests is perfectly presented.In addition,the principle of economic benefit is also followed.Finally,it introduces the necessity of introducing the patent declaration system,starting from several aspects of my country’s generic drug application and protection status and existing problems.The second chapter mainly introduces the comparative analysis of the foreign patent declaration system.By comparing and summarizing the provisions of the patent declaration system of different countries,the rules of the patent declaration system are elaborated in detail.This chapter divides the patent declaration system into three items: the proposal of patent declaration,the examination of patent declaration,and the result of patent declaration.It analyzes and compares the legislative situation of various countries from the various processes of patent declaration,and tries to explore the unique path of our country.The early settlement system of patent disputes in my country is just in its infancy,and the systematic patent declaration system has not yet taken shape.Only by taking its essence and removing its dross can it benefit the rapid development of my country’s pharmaceutical industry.The third chapter mainly elaborates the suggestion of constructing our country’s characteristic patent declaration system.On the basis of the use of comparative analysis,comprehensive consideration of the principle of balance of interests and the principle of benefit,from legislation to system content,comprehensively construct my country’s patent declaration system.It mainly includes clearly declaring the subject and object,subdividing the types of patent declarations,and establishing a supervision mechanism.This article analyzes the current situation of my country’s pharmaceutical industry,and refers to the purpose of the Sino-US economic and trade agreement,and puts the construction of the patent declaration system in the first place.On the one hand,it has strengthened the protection level of drug patents in my country,affirmed the achievements of drug innovation,and encouraged enterprises to strengthen the level of innovation;on the other hand,it is also conducive to speeding up the approval of generic drugs,alleviating the contradiction between patent rights and drug availability,and ultimately making the public Can afford medicine and use good medicine.