Research On The Relationship Of The Pharmaceutical Registration Administration And The Pharmaceutical Patent Protection

Pharmaceutical inventions large investment, high risk, long cycle, the market is wide in the field of the invention is highly dependent on patent protection, the field of medicine is one of the protection of intellectual property rights, especially patent protection dependence on the highest technical areas. Pharmaceutical patent protection and drug supervision and management departments of administrative examination and approval procedures are closely related to drugs are a special class of goods required by the drug supervision and management departments to determine their safety, effectiveness, approval of production listed. If the drug involved in drug supervision and administration department for approval to another person’s patent, the examination and approval procedures will inevitably affect the pharmaceutical patent protection status. What to deal with the relationship between the enthusiasm of the new drug R&D units and the enthusiasm of the generic drug makers to protect the legitimate interests of pharmaceutical patent protection has a very strong role in the pharmaceutical patent protection and regulatory approval.In this paper, historical analysis, comparative studies, empirical analysis and other methods, is divided into the following five parts:The first part is to start from the basic concept of the management of drug registration and patent protection, combing the history of the change review and drug patent protection for the drug registration management system. The second part of the first through the analysis of the relationship between the management of drug registration and patent protection of a link between the two, the difference and cross-impact and coordination to deal with the relationship between philosophy is the principle of the balance of interests. The third part is an overview of the provisions of the patent related issues of the Administration of Drug Registration Act, and the existing system and the lack of actual operation. The Forth Part discusses in detail the system of U.S. drug patents link system and extend the patent term, A comparative study of the system, the United States, China has a need to draw on the useful experience of foreign countries, to build properly handle the relationship between drug registration and patent protection system. The fifth part is how to coordinate the pharmaceutical patent protection and drug registration approval the relationship between some reasonable proposals, including the perfect drug registration management system, and of whether the establishment of drug patent extension system thinking.