Patent Declaration System For Generic Drugs Under The Drug Patent Linkage System

With the gradual acceleration of international development and the booming pharmaceutical industry,the contradiction in supply in China’s pharmaceutical market has become more and more obvious,and the mismatch between the people’s huge demand for pharmaceuticals and the lagging development level of related industries has become more and more prominent.patent linkage system has landed in China.The transplantation of the law should not only remain at the level of ideas,but should also be improved and perfected in practice.China’s research on the patent linkage system for pharmaceutical products basically remains at the superficial introduction of the extraterritorial system.and there is a lack of relevant research on the generic patent declaration system as a sub-system,At present,the generic patent declaration system is only initially applied in China,and the specific design of the system is quite controversial,especially in view of the fact that there are few applications and cases of the relevant drug system in China,which makes it difficult for practical research.This article focuses on the generic patent declaration system.By sorting out the basic concepts and relationships between this system,linking their jurisprudential significance and practical value,and making suggestions for the construction of the system in China on the basis of comparing the content of the current system in China with that of typical overseas countries.The United States and Canada,as the pioneer countries in the application of the patent declaration system for generic drugs,have more comprehensive provisions on the content of the declaration system and the opposition mechanism of the patent registration system.In this.paper,we hope to analyze the foreign system,affirm the reasonable points of the system and remove the deficiencies and improper points,refer to the parts with operability and value for reference,and improve China’s generic patent declaration system on the basis of a comprehensive study of the questionable points of the existing system.Based on this,this article starts from refining the content of the generic drug patent declaration system and improving the drug patent registration system,starting from the two points of patent declaration by generic drug applicants and patent registration by patent owners,and refining the relevant system by refining the Implementation Measures for Early Settlement of Drug Patent Disputes(for Trial Implementation).This paper proposes to further regulate the standard of proof for generic drug patent declarations and clarify the non-compliance monitoring mechanism;on the premise of adhering to formal examination,to empower the drug supervision and administration department to delete and amend improperly registered patent information,to strengthen the interconnection between the drug supervision and administration department and the patent office,and to promote the two-way transfer of functions between the two departments,so as to build a perfect patent registration system objection mechanism in China.By improving the patent declaration system for generic drugs,we will,on the one hand,improve the level of protection for drugs in China’s pharmaceutical industry and,through "strong protection",motivate China’s original drug companies to actively develop innovative drugs,and,on the other hand,encourage generic drug companies to produce and market generic drugs,so as to stimulate China’s drug market,form a mutual circulation of original and generic drugs,and facilitate the "easy access to good drugs".This will stimulate the drug market in China,create a mutual circulation of generic drugs and promote the availability of "good drugs",thus contributing to the drug market in China.