| Drugs are special products,which are closely related to life and health.To protect life and health needs to improve the accessibility of drugs,and to improve the accessibility of drugs should take into account the original research drugs and generic drugs.On the one hand,we need to encourage the development of new drugs through patent protection.On the other hand,we must pay attention to the development of generic drugs.How to balance the two,different countries have different approaches.In 1984,the United States established the drug patent link system through the Hatch-Waxman Act to establish a link between drug marketing approval and drug patent disputes,and advance patent disputes to the drug marketing approval stage for settlement.The system establishes a good competitive space for original research drugs and generic drugs.On the one hand,it strengthens the protection of original patent drugs and encourages innovation.On the other hand,it encourages generic drugs to challenge patents as soon as possible.Eventually,the balanced development of original research drugs and generic drugs will be achieved.Since 2017,China has issued a series of reform documents that clearly require the exploration of the establishment of a drug patent link system.Compared with the systems of other countries,China has not yet established a drug patent link system in the general sense.It is only a system with patent link elements and cannot play the above-mentioned positive role.If you want to play the role of the system,you must improve the system,promote the development of the pharmaceutical industry by improving the drug patent link system,and achieve a win-win situation for the original research and generic drugs in China.This article is divided into four chapters.First,a basic introduction to the drug patent link system;then,in view of the establishment of the system by the United States,the author focuses on the US drug patent link system and analyzes the relevant practices of the European Union,Japan,India and other countries;Then through the investigation of the foreign system,it is found that there are many problems in China’s existing patent link system;finally,the author makes specific suggestions based on China’s national conditions. |
