Research On Bolar Excepyion Rule Of Drug Patent

As a special commodity,medicine is related to public health.The patent law in our country for the third time when a change is introduced "Bolar exception rule" in 2008,namely the medicine test infringement exceptions,if it is for the purpose of the administrative examination and approval,in the patent protection period of medicine or medical instrument manufacture,use,import patented medicines or patented medical apparatus and instruments,and dedicated to the manufacture,import patented medicine or patented medical devices shall not be regarded as infringement,this for our country "drug testing is not infringement" provides a legal basis.However,this is only a general rule,and there are many problems in how to implement and apply it in practice,which makes the rule cannot be well applied,which makes the Chinese version of the "Bolar exception rule" become a decoration and useless,which has something to do with the incomplete legislation of this rule in China.We should,therefore,on the fifth of the first paragraph of law sixty-nine the provisions of the detailed analysis and research,the problems existing in the law of loopholes to deconstruct,and then puts forward the rationality Suggestions,for which,in practice play its public health maintenance,reduce the medical cost,promote the development of generic drug companies,for which the specific application can be achieved in practice.Firstly,this paper is to introduce Bolar exception Bolar exception rule originated in the United States,in the United States Bolar exception rules applicable scope after many times of court case,which is formed by thecause of Bolar exception rule in the United States to explain more and more broad,this greatly promote the development of pharmaceutical industry in the United States,to satisfy the public demand for drugs,maintain the public health.Based on this,Bolar exception rule was introduced in China in 2008,and its existence has certain legitimacy and rationality.Secondly,combined with foreign legislation on Bolar exception rule and domestic judicial practice,the existing problems of Bolar exception rule in China are put forward.Although Bolar exception rule is established in the patent law of China,it is too general,which makes it unable to play its due role.In our country,Bolar exception rules are too general in terms of applicable object,applicable time,applicable region,applicable behavior purpose,applicable behavior type,etc.,so the application is not clear and needs to be improved.Finally,On the one hand,the article of Bolar exception rule in China is deconstructed,and the existing problems are suggested.For example,the object scope of Bolar exception rule in China can be further extended to pesticides and agricultural tools.The scope of Bolar exception can include sales and promised sales,but the subject of application should be clearly defined.The geographical scope of Bolar exception rule can be extended to foreign countries,even if the test behavior is for the administrative approval of foreign countries,Bolar exception rule can also be applied.On the other hand,from the perspective of possible infringement by generic drug manufacturers or third-party providers,the purpose of Bolar exception rule,namely "the purpose of administrative approval",can be considered from the "objective aspect",not only judged subjectively.The action of a pharmaceutical company applying for the registration of a generic drug during the patent protection period of a patented drug does not constitute infringement,and its action can be included in the Bolar exception rule.The sales behavior provided by the third party must not be "for the purpose of sales",and its remuneration can be regarded as labor remuneration.Meanwhile,the third party providing the behavior should maintain a reasonable duty of care;The information obtained by the generic drugmaker,even if not disclosed,does not constitute infringement.