Research On Legal System Of Drug Patent Link

In recent years,the pharmaceutical industry has attracted more and more attention.At present,most pharmaceutical manufacturers use patents to compete in the market,the price of original research drugs remains high,generic drugs have penetrated into people's daily life,has become an indispensable part,drug patent link system came into being.In the process of the fourth revision of the Patent Law,the introduction of the drug patent link system has caused controversy: on the one hand,the level of drug patent protection in China needs to be improved;on the other hand,too high protection standards may not adapt to the national conditions of our country.Since 2017,a number of documents,such as the Regulations on the Administration of Drug Registration(revised version),have carried out the system Preliminary design.In January 2020,China and the United States signed the latest Economic and Trade Agreement between the Government of the People's Republic of China and the Government of the United States of America,which once again made clear the requirement that China establish a drug patent link system.The third section of the first chapter deals with drug-related intellectual property rights,mainly drug patents.For example,the effective mechanism for the early resolution of patent disputes is also put forward.It can be seen that there is a clear direction for the construction of this system in our country,and some elements of the drug patent link system are already available in the existing regulations in our country,however,the existing conditions and regulations are not yet mature and complete,and need to be further clarified and refined.This essayr discusses the legal system of drug patent link in four aspects.The part one is the fundamental theory of drug patent link.The drug patent link refers to the link between the approval of the drug registration application and the examination procedure of the corresponding new drug patent and the function of the pharmaceutical department and the patent department,which has the operation mechanism of the three stages of the original research drug listing,the generic drug listing and the pharmaceutical patent challenge.The theory of interest balance and the perspective of legal economics provide the theoretical basis for drug patent link.The second part is the legal system and evaluation of extraterritorial drug patent link.Looking at the international agreements such as TRIPS agreement,CPTPP and FTA,as well as the legal system of drug patent link in three countries in the United States,Canada and South Korea,it has the following characteristics: the registration of drug patent information is relatively strict,the patent challenge system is relatively complete,the proposed infringement system is relatively perfect,and the functions of the relevant departments are clearly divided.The third part is the current situation and problems of the legal system of drug patent link in China.China has initially formed a legal system of patent links,but there are four problems: the list of listed drugs in china needs to be improved,the patent challenge system needs to be refined,the patentee's litigation lack of legal basis and the functional links of relevant departments need to be strengthened.The fourth part consummates our country medicine patent link legal system proposal.Combining with our country's national conditions and drawing on foreign mature experience,the legal system of pharmaceutical patent link in our country should perfect the system of "China List of Listed Drugs ",clarify the patent challenge system,establish the mechanism of fictitious infringement and strengthen the communication mechanism between departments.