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On Bolar Exception

Author: ChenZhe
Tutor: ZhangGeng
School: Southwest University of Political Science
Course: Civil and Commercial Law
Keywords: phannaceutical patent experimental exception balance of interests Bolar exception
CLC: D923.42
Type: Master's thesis
Year: 2009
Downloads: 118
Quote: 2
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Abstract

The patent system entrusts with the patent holder the exclusive right,encourages the people by this to research and develop the innovation,achieves the goal of promotioning industry science and technology.Therefore,the patent holder enjoys removes other people to use its technical without its agreement the right.Without the patent holder agreement,any person uses its patent technical will infring upon his property-rights.However,considerating of public interests,many countries allows use of the specific matter which not to constitute the right infringement.For instance,in the 63rd article of Patent law of the People’s Republic of China Stipulates:None of the following shall be deemed an infringement of the patent right: Where any person uses the patent concerned solely for the purposes of scientific research and experimentation.This is experimental use exception.The experimental use exception causes dispute in the competition subject between the patent pharmaceutical factory and the general pharmaceutical manufacturer.In orde to enter the market as soon as possible,general pharmaceutical manufacturer may implement the original factory patent to conduct research and the experiment the necessity before patent period expires to satisfy the market management law.Chinese patent law not stipulat Bolar exception explicitly,the newest revision patent law 69th article stipulates:In order to supply the information which the administrative examination needs,units and individual makes the drugs or medical instruments shall not be deemed to infringement.The experimental use exception have the legal basis in our country.But the general stipulation had not limited the need information of administrative,had not explained whether allows take to utilize seeking to make profit as the goal,also had not defined which behavior are need for the gain.In orde to promote the level of science and technology,the non-patent holder should given the opportunity of research and the behavior shall not be deemed to infringement.Certainly,the rights and interests of the patent holder must take into consideration simultaneously,cannot expand being using of the drugs experimental exception. Found balance between drugs patent holder and between the public interests,so that,we can achieve the goal of promoting the technical level but also stimulate invention and creation. This article attempts to get some proposals that benefit the domestic legislation by reference overseas legislation about the drugs experiment exception. The article is consisted of five parts,the contents are:In part1,it introduces the drugs definition and administrative examination systems of our country as well as overseas.The knowledge is the background which needs to study the drugs experimental exception.This part further analyzes the relation of patent and the drugs.The patent system can promote the drugs development,but also sets the barrier for patent medicine into marketbut more fast.The second part introduces the American origin,the development and the mature utilization of experimental exception.In addition,introducing other countries about the experimental exception in legal regulation.This provided the refer for chineser legislation about the experimental exception.The third part illustrative the case of WTO—Canada Drugs Patent Protection.It analysis the international rules and procedure of WTO.The fourth part pointed out the current conflic between the legislation and the practicet in our country.The Judicial department faces a dilemma in this kind of cases.The contentof part5 is a summary oflegislation and the advice of the solution that the conflict between pharmaceutical patent and publicb benefits.It extents both from the comparative analysisinternational treaties and national practices of some countries that advantages in the Legislation of China.

On Bolar Exception

Abstract

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