Comparative Study On Drug Patent Linkage System

Drugs are a special type of product,which is difficult to develop and has a high risk factor.For the pharmaceutical companies,the patent system is an important guarantee for realizing investment returns,continuing research development,and continuing to provide new drugs.However,the development and listing of generic drugs has become an important way to achieve public health.The patent link of the drug is the link between the approval of the generic drugs and the patent period of the patent drugs.That is,the application for generic drug registration should consider the patent status of the previously listed drugs,so that the patent infringement that may be caused after the listing of the generic drug is advanced to the registration stage to promote After the expiration of the validity period of the patent,the generic drug will be listed quickly,thus achieving the purpose of protecting the intellectual property rights of the patented drug and speeding up the listing of generic drugs.The expiration of the validity period of the patented patent patent and the seamless linking of generic drugs.Therefore,the supporting measures for the drug patent linkage system need to be improved.In China,"Pharmaceutical Registration Management Law","Patent Law" and other documents have introduced the provisions on drug patent links,indicating that China has gradually established a drug patent link system,but it still belongs to the formal level of links,and needs further improvement and implementation.This paper starts with the related concepts of the drug patent link system,and locates the drug patent link system.Secondly,it compares with the perfect drug patent link system in the United States and Canada,and points out from the entity system and operation procedures of the drug patent link.The problems existing in the relevant provisions of the drug patent linking system in China and the necessary analysis of the problems;finally,from the perspective of balance of interests,it is pointed out that the drug patent linking system in China should be applied from the drug information disclosure platform,the patent declaration system,the Bolar exception clause and the relevant functional departments.The communication and collaboration between the two sides is improved.