On The Perfection Of China’s Pharmaceutical Patent Linkage System

At present,China is moving from a pharmaceutical country to a pharmaceutical power,encouraging drug innovation and creation,promoting the production of generic drugs,and ensuring the public’s access to drugs has become an important topic.The newly revised Patent Law establishes a Linkage System of Pharmaceutical Patent,that is,an early resolution mechanism for pharmaceutical patent disputes,which fully reflects the value orientation of this system: to ensure the balance of interests of original pharmaceutical enterprises,generic drug enterprises and the public,improve efficiency and avoid waste of resources.Based on this,the theory of interest balance is used to analyze the improvement of China’s link system,and at the same time,game theory is used to study the rational decisions that may be made in various contradictions and cooperation between multiple subjects involving the link system,so that the improvement of China’s system will eventually produce the effect in line with the institutional goals.At present,China’s Linkage System of Pharmaceutical Patent has moved from a low level of weak protection to a high level of strong protection,which is mainly composed of six sub-systems: drug patent registration and publicity system,patent declaration system,opposition period system,waiting period system,drug review and approval classification processing system and first generic drug exclusive protection system.However,there are still some shortcomings in China’s linking system,including the imperfect pharmaceutical patent registration and publicity system,the current regulation of patent registration content in China is not clear enough,there is a lack of review and error correction mechanism for publicized pharmaceutical patent information,and the provisions on the change of pharmaceutical patent information are not clear;The provisions of the patent declaration system need to be improved;The length of the waiting period and the method of initiation are still debatable,the legal regulation of the exclusive period system for the first generic drug is not perfect,and there is a lack of prevention and supervision system for the abuse of the link system.At the same time,the comparative method of the drug patent linkage system is investigated,and the legislative practice,actual operation status and implementation effect of the United States,Canada,South Korea and other countries that have established the pharmaceutical patent linkage system are compared and analyzed.Summarize and analyze the advantages and disadvantages of different legislative models,absorb and reasonably learn from the useful attempts,explorations and experiences of these countries in drug patent protection and drug regulatory system reform,and provide extraterritorial legislation and practical experience for improving China’s pharmaceutical patent linkage system in combination with the actual development of China’s pharmaceutical industry,pharmaceutical innovation policies and institutional environment.In the process of promoting the improvement of the Linkage System of Pharmaceutical Patent,it is suggested that the first thing is to improve the drug patent registration and publicity system,including improving the management of the "China Catalogue of Listed Drugs",establishing a patent information registration review and error correction mechanism,and refining the provisions on the change of drug patent information;Second,further refine the relevant provisions of the patent declaration system,including refining the notification obligation of generic drug applicants,clarifying the scope of "relevant patents",clarifying the legal responsibilities of generic drug enterprises in the patent declaration system,and optimizing the setting of patent claim types;Third,reasonably set the waiting period,including optimizing the length of the waiting period,strictly setting the waiting period activation conditions,and improving the legal regulation of the malicious start waiting period;Fourth,improve the exclusive protection system for first generic drugs,including clarifying the circumstances of joint patent challenges and clarifying the reasons for the elimination of the market exclusivity period;Fifth,strengthen the regulation of the abuse of the drug patent linkage system,including the establishment of a regulatory mechanism for the operation of the system and the strengthening of the review and supervision of reverse settlement agreements.