On The Perfection Of The Regulation System Of Patent Drugs And Generic Drugs In China

Nowadays，it has become a common idea, but the incentive system of thegeneric drug has not received due attention as it deserves. The rules and regulationsare specific in the pharmaceutical drug area for its intrinsic characteristics, it takesquite a long time period from the time of successful development of a particular drugto the time of marketing, what’s more, the BOLAR exception is established almost inevery country, these are the aspects that threaten the benefits of multinationalpharmaceutical companies, but the system in their country are more than these, theyalways have other regulations go in favor for the drug companies, in addition, thefavorable regulations are simultaneously limited by some kind of generic drugregulations. The mainstream view, in fact, are driven by their own interest, may putpressure on strengthening the protection. Upon reviewing the relevant rules andregulation in U.S., we will understand that it is not only the patent system, but also thegeneric system that makes U.S. pharmaceutical industry successful, the system alsoincludes other design, such as the extension protection, the exclusive data protection,the examination and approval system, the flexible application of U.S. courts.As the biggest developing country in the world, the drug protection will directlyaffect the national interest, we should not go with the flow, and should not beenmislead by the so-called main view, we should do our own research, start from thehistory of American system, do systematic analysis of the relevant design, trackingthe effective application in the judicial practice. Upon these, we can summarize thechallenge and risk in front of our generic companies, and make some suggestion onour system. It is certain that only with considering the situation of our country can wemake a better system to deal with the appropriate protection of the patent drug and thegeneric drug.This paper has five parts, the introduction part will go through both thechallenges and the chances of our pharmaceutical companies, Part I will make a briefintroduction of the drug patent and the generic drug system, it includes the definitionand the history of the generic drug, the different extension protection after patent term in different nations, the introduction of the generic drug application system.Part II will analysis the balancing protection of the brand drug and the generic drug,the related judicial practice and the strategy of local companies. We will focus on thejudicial practice in this paper. The content will also include the application andadministration system of the generic drug in U.S. Part III will discuss the protection ofpatent drug in our country and the application of the generic drug producing, themarket access and etc. Part V will propose some suggestion for improvement of thegeneric drug application and administration.