The Understanding, Application And Complement Of Item5of Article69in The Patent Law Of China

The third time amendment of the patent law on2008，added a new article about theexemption of the patent infringement. It also is commonly called the Bolar exception,and finally was listed as item5of article69in the patent law of China, namely "to get theinformation for the government approval requirement, any person manufacture, use,import patent drugs or the patent medical devices, and special for whom manufacture,import patent drugs or patent medical devices, shall not be deemed as infringement".This is an article special used in drugs and medical device industry, aims to promote thegeneric-drug marketing in time, and to alleviate the pressure of the public health problem.Since always, China’s high cost medicare was blamed, high medical billsprocrastinated many Chinese people illness. Since the Bolar exception got a big success inthe drug price problem solvation, introducing this article into China’s patent law seemshave given us a little hope on how to reduce the price of the drugs. Plus many importantdrugs’ patent period arrival, the article’s coming was highly praised. But regretfully, afterthis article was introduced two years later, we still have not seen any suits about thisarticle, and also we did not see any change in the drug and medical device industryinitiated by this article. So the purpose of this thesis is that, to find out the reason of thearticle’s unable in the drug industry change and the drug price reduce.One of the paper’s starting point is that, the development of generic drugs by theinfluence of various factors, and only an exemption article’s effect seems very small.Therefore, this paper analyzes the present situation of generic drugs industry, and try toexplore various factors of the influence of the development of generics, so that to judgewhat a role the item5of article69can play.The other starting point of this paper is that, law itself does not have definiteapplicable condition is one of the reasons of the law difficult to apply. Therefore，thispaper have analysed the item5of article69in detail, involving specific connotations,suitable subjects, suitable subjects and so on, to uncover the drawbacks in it. Comparingwith the same regime of foreign countries to get the revelation of remedying the law. The author’s conclusion is that：although the aim of the item5of article69is topromote generics to come into the market in order to low the price of drugs. But in China,the price problem will never be resolved only by listing the generics, what is moreimportant is the medical system. If it is not reformed with great leaps, any technical clauseis fruitless.