On The Development And Application Of Bolar Exception

In2008， our country completed the third revision of the Patent Law, one of theimportant new points is: In article sixty-nine of the “None of the following shall bedeemed an infringement of the patent right” to add the item (5)“For the purpose ofproviding the information needed for the administrative approval, manufacture, use,import of a drug or a medical apparatus, and exclusively for such manufacture anyimport of a patented drug or a patented medical apparatus. This provision is theinternational “Bolar exception”. The establishment of the “Bolar exception” of thelegislation in our country, on our country’s pharmaceutical industry, especiallygenerics companies is of great significance. It not only solves the patent infringementlaw suitable problem of the generic drugs manufacture,examination and approval,further improves our patent law in accordance with international standards, but alsoprovides a legal basis for the to encourage generic industry’s development at the endof the pharmaceutical patent protection, reduces the price of drugs, safeguards theinterests of public health.In this context, this article will be based on fully carding,summing up the “Bolar exception” origin, development and application, combinedwith our institutional system and judicial practice in our country, make somesuggestions or our perfect and mature use of the system of “Bolar exception”.Except for the preface and epilogue, this article is divided into three chapters.The first chapter introduces the development of “Bolar exception”. This part firstlyintroduces the meaning, the origin, the development of “Bolar exception”, especiallyin its origin, perfect, development, application of the United States, which is its origin.Followed by the introduction of the relevant judicial cases to deduce the process of“Bolar exception” established in our country, and explains its important significance.It also introduces the legislation about the “Bolar exception” in other countries andthe the reasons that apply to the field of medicine. This is the premise foundationanalysis the legal rationality of “Bolar exception” in the second chapter. The first partof the second chapter from the perspective of patent protection and restriction andbalancing of interests clarifies the necessity and timeliness of “Bolar exception”. Thesecond part analyzes the international treaties, and the use of the rules of the WTO in solving the pharmaceutical patent imitation cases in advance, through a WTO’stypical case——“Canada–Patent Protection Of Pharmaceutical Products”， explainsthe feasibility of “Bolar exception” from the view of pharmaceutical patents andpublic health. The third chapter discusses the “Bolar exception” in the application andimpact on the pharmaceutical industry in our country. The chapter,by introducing“extension of pharmaceutical patent term” and “patent linkage of medicalexamination and approval”, which is mature matched with the “Bolar exception” inthe U.S.A., and by contrasting with problems arising from administrative examinationand judicial operation in our country, gives some constructive suggestions. Finally,this article analyzes the impact of the domestic pharmaceutical industry after ourcountry introduced “Bolar exception”, and provides a reference for the generic drugcompanies and original research enterprises how to pay attention to the use of theprovisions to protect their own interests.