Study On Perfecting The System Of Drug Patent Link System In China

The drug patent link system was first established in the United States.Essentially,it is a system to resolve patent disputes in advance between generic drugs and original drugs.This system involves both sides for generic drugs listed the applicant with the original holder of the drug,when filing a drug approval listed the generics market,need to make a statement of the corresponding original drugs don’t infringement,when the statements have the possibility of infringement,the holder of the original drugs can file a lawsuit,the lawsuit in generic drugs listed before,so the system is also known as drug approval listed of the dispute settlement mechanism in advance.The system protects the interests of the owners of the original research drugs and encourages generic drug manufacturers to actively develop and declare generic drugs.At the beginning of 2020,China and the United States signed the first phase of the economic and trade agreement,which stated that China should establish a drug patent link system,and ensure that the original patent owner has the right to file a lawsuit against the generic drug before it is marketed,including the right to judicial and administrative relief.On October 17,2020,this system was stipulated in Article 76 of the Fourth Amendment to the Patent Law of China,which is to implement the treaty obligations that China and the United States committed themselves to in the first-stage agreement.After that,the relevant departments successively issued the draft of supporting departmental regulations for public opinion,which will be implemented in coordination with Article 76 of the Fourth Amendment of the Patent Law on June 1,2021.In addition,at the beginning of 2020,the global outbreak of COVID-19 made drug patent research become a hot topic again,and how governments respond to the social public’s access to drugs became the hottest topic of discussion.The introduction of drug patent link system in China has its corresponding background,such as China’s intellectual property rights protection policy,drug patent legislation status,drug market situation and the first stage of Sino-US economic and trade agreement,which provide the background support for the introduction of drug patent link system in China.China introduced the drug patent information disclosure system,patent declaration system,suppression period system,first generic drug market exclusive period system and exceptions to the drug patent link system in the draft of the fourth amendment of the Patent Law and related regulations for consultation.Due to the system originated in the United States,South Korea and localization is introduced into the system as a relatively perfect state,the author analyzed the above system and the corresponding system of the United States and South Korea,to find a reasonable place and the problem in our country,to perfect our system of drug patent link system provides feasibility Suggestions,in order to promote the smooth implementation of the system in our country.The drug patent link system as a whole acts as a balancer to strike an optimal balance between original patent rights holders,generic drug manufacturers and the general public in terms of access to drugs.