On The Legal Control Of Gene Therapy

Gene Technology, which is a newly thriving one, is gaining growing attention from all over the world. The appearance of Gene Technology brings forward a lot of challenges to the Civil Law, the Administrative Law, the Intellectual Property rules, especially to the Patent Law. The scholastic of law is compelled to consider the essential problems of the intellectual property over again. For instance, to distinguish invention and discovery, the moral and ethic problem of the Patent Law, the patent examination of inventory, the principle of the patent attribution, etc. The great dispute which Gene Technology has raised in the medicine circles calls for the timely and properly intervention of law. The confliction and amalgamation between the technology and law lies on the establishment and the right of the system and suited measure of all groups. The writer combines the characteristic of the Gene Technology Intellectual Property discuss the feasibility of the patent protect for Gene Technology and the law status of Gene Therapy. Investigate the law mechanism of the Gene Technology. As a whole, the writer has pay more attention to the basic theoretic issue of intellectual property, especially the patent system, and put forward a lot of opinions and advices in a create way with particular analysis. In this thesis, thewriter divides it into four parts:Part one dissertates the general situation of Gene technology and Gene Therapy. The writer analyzes the profound changes which Gene Therapy brings to us, and analyzes the development and changes of Gene Therapy, points out its venture and prevention which need the intervention of law.Part three analyzes the control and regulate function of patent system, administrative law, criminal law for Gene Therapy. The key part is the amalgamation and conflict between the Gene Therapy and patent system,. Since the regulations of patent system abroad and home are not very clear, sometimes we don' t now what to do in legislation and practice, the writer discuss the problem particularly.Part three analyzes the legislation and the theoretic argumentation overseas, the writer compare the advantages and disadvantages between the American pattern and the Austrian pattern and brings forward her own opinion .Part four dissertates that the major idea of this thesis is to establish the particular legal system of Gene Therapy in China, the writer advances some advices for the basic principle, the content and the administrant procedure and organization of the particular legal system of Gene Therapy, which may have some benefits to the legislation of Gene Therapy in China.