Review On The Coordination Of The Pharmaceutical Registration Administration And The Pharmaceutical Patent Protection

Patent protection of pharmaceutical invention, with its involving of huge economic and social interests, has been being an extensive concern. However, because of its attributes both of the invention and the pharmaceutical product, the pharmaceutical invention is not only protected by the patent law but also regulated by the regulations of drug administration. The purpose of the thesis is that: based on the current situation of the development of pharmaceutical industry and the legislations of drug administration in China and comparison with the related systems of the U.S. and the E.U., trying to offer suggestions to the related legislation in China.By analytic method, the systems in administration of pharmaceutical and the patent protection in the U.S. and the E.U. etc., which are considered relative perfect, are first analyzed in this thesis and then followed by the situations in China, such as pharmaceutical patent linkage, extension of patent term and"regulatory review exemption".The basic point of the thesis is that: to judge whether a system is perfect does not lie on whether or not it keeps a high standard, but lies on whether or not it is propitious to the development of the state economic. With that point, the following conclusions are drawn in the thesis: the regulations related the pharmaceutical patent protection in the system of administration of pharmaceutical registration should be amended further; and in the precondition of measuring up to TRIPS standard and considering the situation of pharmaceutical industry, the regulations with tendency of enhancing the exclusivity of pharmaceutical patent should be enacted prudently. Finally, the suggestions of the thesis are: the system of pharmaceutical patent linkage should be established and perfected; the regulations on"the regulatory review exemption"should be enacted in the patent system, except the patent term extension.