Research On Chinese Drug Patent Linkage System

Under the background of the construction of an intellectual property power and the strategy of "Healthy China 2030",the drug patent link system,as an important link between drug development and patent protection,is not only related to the effective settlement of drug patent disputes in advance,but also affects the innovation and sustainable development of the domestic pharmaceutical industry.However,in view of the short formation time of Chinese drug patent link system,the current regulations are still insufficient,so it is difficult to meet the development needs of Chinese medicine industry.Therefore,this paper studies the legal basis,system mode and structure of drug patent link by the methods of theory,empirical analysis and comparative analysis,so as to put forward some concrete proposals for the perfection of drug patent link system.In addition to the introduction and conclusion,the full text is divided into four parts:The first part explains the theoretical basis of drug patent linkage system.In essence,the drug patent link system connects the marketing application and administrative approval behavior of generic drugs with innovative drug related patents,so as to solve patent disputes between drugs in advance.At the same time,after considering the different legal attributes of drug marketing approval and drug patent protection,it is clear that the function of drug patent link system is to drive the continuous innovation of drugs,realize the balance of diversified interests and maintain the order of drug market.The second part analyzes the effect and predicament of our drug patent link system.With the establishment of Article 76 of the new Patent Law and the issuance of relevant documents,our drug patent link system has made some preliminary results.However,it is found that the system is faced with many difficulties in the process of operation,including poor connection between the system model and the current regulations,imperfect patent information registration system,unclear patent declaration rules,ominous legal liability of the link subject,unreasonable setting of applicable provisions on the term of rights and the limitation of "action for confirmation".The third part demonstrates the model and structure of China’s drug patent linkage system.The system model of drug patent linkage in the United States and South Korea is the most consistent with the development model of domestic pharmaceutical industry,which can provide referential experience for the improvement of our system.At the same time,considering the current situation and policy demands of Chinese pharmaceutical industry,it is clear that our country should adhere to the drug patent link system model of "imitation and creator-parallel",and discuss the system structure,so that the specific content arrangement of the system structure can fully reflect the development idea of the system pattern.The fourth part puts forward the concrete plan of perfecting China’s drug patent linkage system.Firstly,the patent information registration system should be improved by adding and improving the application mechanism,review mechanism,objection mechanism and notification obligation of patent information change.Secondly,it refines the specific rules of patent declaration,standardizes the types of patent declaration and restricts the notification time limit of patent declaration.Thirdly,clarify the legal liability of the marketing authorization holder and the generic drug applicant;Secondly,reasonably set the applicable provisions for the waiting period and the market exclusivity period of the first imitation drug;Finally,the patent infringement clause is set up in the early settlement mechanism of drug patent disputes.