Impact Study Of The Drug Patent Policy On The Biopharmaceutical Industry

The Drug patent was the core competence of the biopharmaceutical industry and the Drug patent policy directly influence the development of biopharmaceutical industry. The purpose of this paper was to explore the influence of Drug patent policy to biopharmaceutical industry.This paper used the methods of literature review, analyses induction, model analysis and case investigation study. The contents of this paper included drug patent policy of the developed countries such as USA and Japan, and developing countries like India, the influence of drug patent policy to biopharmaceutical industry in these countries, the hot-spot problems of compulsory licensing and generic drugs and their influence to domestic and overseas biopharmaceutical industries, introduction of drug patent policy of China, analysis of the typical cases of recent patent disputes in China, and the advice about drug patent strategy.This paper has four parts. The first part is focused on drug patent policy in USA, Japan and India. This part introduced the influence of the reform of USA patent law pharmaceutical industries. The most important drug patent cases were analyzed. The part also analyzed the drug patent policy reform of Japan in which the patent strategy is very successful. According to the four stages of development in pharmaceutical industry, this part examine the Japanese drug patent policy reform and influences to industry. At the last of this part the Indian drug patent policy and the influences of patent laws were introduced, and the strategies of some Indian medicine company was presented too.The second part was about the analysis of two hot spots of drug patent:compulsory licensing and generic medicines. At first, the legal basis of drug patent compulsory licensing was analyzed. Then the process of patent licensing system development was introduced. This part also studied the situation of drug patent compulsory licensing, illustrated the fact that the drug patent compulsory licensing is still an effective method in developing countries to obtain low-cost drugs. At the end of the part of drug patent compulsory licensing, drug patent compulsory licensing in china was introduced and the influence of drug patent compulsory licensing to biopharmaceutical industry was analyzed.The third part analyzed biological pharmacy patent policy and tactics from cases about patent dispute. Firstly the patent law of China and protect object of biological pharmacy patent were introduced. Then the third amendment of the patent law and patent system about the medical registration regulations was analyzed. In the end the paper analyzed several typical cases of our drug patent disputes and revelation.The fourth part focused on patent strategies of China's biopharmaceutical industry. The paper introduced the current situation of Chinese pharmaceutical company's patent strategy, analyzed the foreign experiences and finally gave recommendations on strategies of drug patent policy to improve the protection of patent.