Research On Pharmaceutical Patent Linkage System

As a special commodity,medicine has been an essential part of fulfilling the right of life and health.The accessibility to drugs is closely related to public health and has an important social role.However,due to the high difficulty,high risk and high investment in drug research,the pharmaceutical industry is highly dependent on intellectual property protection,especially patent protection.While the pharmaceutical patent stimulates innovation of medical technology,it also squeezes the living space of generic drugs.The lack of competition in the pharmaceutical market drives the price of drugs up due to the patent monopoly,and the price is an important factor affecting the accessibility of drugs.This has created a contradiction between the patent system and public health in the pharmaceutical industry.As a developing country,China also faces problems of drug accessibility and public health crisis.As early as the 2007 edition of "Drug Registration Regulation" and the third amendment of "Patent Law",China has introduced the American pharmaceutical patent linkage system to solve the above problems,but has been no complete supplementary provisions for a long time.In 2017,the Chinese government explicitly proposed to establish pharmaceutical patent linkage system,facing the inconvenience of generic drug approval and patent dispute resolution brought by existing provisions.Embarking from Chinese national basic conditions and the reality of pharmaceutical industry,this paper comparatively analyses the current situation of industry and legislation in the United States and other countries,and puts forward suggestions of perfecting pharmaceutical patent linkage system in China.This paper is divided into four parts:Part Ⅰ is the definition of pharmaceutical patent linkage system.First,the relevant concepts of drug patents in pharmaceutical industry are enumerated in order to facilitate the later discussion.Then considering background of the system,this part divides the main content into two parts of drug supervision and patent provision.On the one hand,it avoids the simple list of relevant regulations;on the other,it is easy to understand the contents at a macro-level.Part Ⅱ is the theoretical framework of pharmaceutical patent linkage system.Atfirst,this part clarifies the balance of interest and legal economics as the basis of theoretical analysis of system,and then clarifies interested parties of the conflict in the system,which are original drug companies and generic drug companies,as well as drug patents and public health.And then,this paper draws the purpose of this part,that is,the value goal we should scrupulously abide by when constructing the system.Part Ⅲ is the development of pharmaceutical patent linkage system in China and abroad.On the basis of Part Ⅱ,the paper elaborates the system’s upper theory,this part will focus on sorting and classifying legislative status of foreign countries,and concludes them as three modes of patent linkage in pharmaceutical industry.At last,this part will elaborate current legislation and its shortcomings,from the domestic provisions of patent and drug supervision.At the same time,combining with a brief summary of domestic new legislation in 2017,this will prepare the fourth part.Part Ⅳ is the perfection of Chinese pharmaceutical patent linkage system.This part puts forward two standpoints of perfecting the system.First,Industry Selection,we need to follow the model of Canada and Korea,that is,"emphasize the balance between imitation and innovation".Second,Valua Selection,should be guided by public health.These conclusions are the result of Part Ⅱ and Part Ⅲ.Finally,according to the content of Part Ⅰ,that the system is divided into drug supervision and patent provision,this part puts forward pharmaceutical administrative and patent legislative proposals,to perfect pharmaceutical patent linkage system in China.