Research On Pharmaceutical Patent Linkage System

In recent years,the state has issued a number of regulatory documents expressing a firm stand for establishing China’s pharmaceutical patent linkage system,and this system is ready to emerge.However,the system is complicated,and there are some contradictions with China’s national conditions.Therefore,it is necessary to conduct in-depth research on the establishment of a pharmaceutical patent linkage system in China.This article comparatively studies the drug patent systems of several countries and analyzes the advantages and disadvantages of the countries’ systems to provide practical suggestions for the establishment and improvement of China’s drug patent linkage systems.The first chapter of this article briefly introduces the related concepts,main content and operation mechanism of the pharmaceutical patent linkage system.The core of the pharmaceutical patent linkage system is to balance the interests of branded drugs and generic drugs.This chapter describes the advantages of this system compared with the traditional mode of drugs registration.Pharmaceutical patent linkage system can advance the possible dispute of drug patent right to the stage of generic drug approval,which can not only protect the patent of branded drug from infringement,but also reduce the risk of infringement after generic drug listing.The United States is the birthplace of pharmaceutical patent linkage sy stem.At the same time,its system is the most comprehensive and complete one.The US’s system has important reference significance for China’s legislation.The second chapter of this article introduces in detail and comprehensively the background and specific content of the US’s pharmaceutical patent linkage system,and evaluates the US’s system.In addition,in order to understand the development of pharmaceutical patent linkage systems in other countries and the drug patent systems in other countries,Chapter two of this article briefly introduces the relevant drug patent systems in Canada,India,the European Union,and South Korea.Both Canada and South Korea have established pharmaceutical patent linkage systems,which are similar to China’s national conditions.Therefore,the Canadian and South Korean systems have important research value for China.Although neither India nor the European Union has established a drug patent linkage system,India ’s generic pharmaceutical industry is at the forefront of the world,and the European Union’s drug innovation is comparable to the United States.Therefore,India’s and the European Union ’s pharmaceutical patent systems are both relatively successful and worthy of our study.The third chapter of this paper starts with the current situation of China’s pharmaceutical industry and the patent system,and focuses on the study of China’s current laws and regulatory documents on pharmaceutical patent linkage systems.At present,the development level of China’s pharmaceutical industry is lagging behind,and the legislation on pharmaceutical patent linkage is not perfect There are still many problems in practice.Given China’s national conditions and experience of several foreign countries,the author puts forward some suggestions,including a system of infringement,a patent declaration system,and a containment period system in chapter four.pharmaceutical patent linkage system is successful in the United States.The author wrote this article hoping to establish and improve China’s pharmaceutical patent linkage system,which can balance the interests of branded pharmaceutical companies and the interests of generic pharmaceutical companies,and ultimately achieving the purpose of protecting pharmaceutical innovation and promoting the development of generic pharmaceuticals.