Studies on Patents and the Associated Anti-cancer Drug Development in China
- Pp. 121-204 (84)Jinhua Shen, Guohua Zhu, Lichun Sun, Gengping Zhang, Leyang Qin, Feng Yang, Ruru Gao and Xinhong Fan
This chapter consists of five sections. The first part analyzes the macro policies of Chinese anti-cancer drugs, sorts the existing policies and regulations in China and clarifies the main departments of Chinese domestic drug regulation. </p><p> The second part is the analysis of Chinese domestic anti-cancer drug patents. Based on the domestic Chinese invention patents as the data source, this section analyzes Chinese domestic anti-cancer drug patents, major competitive countries and regions, developmental characteristics of patented technology, and the main applicants. It can be found that Chinese local patent applications have increased yearly since China began to protect drug patents in 1992. Up to the retrieval date, there is a total of 57,280 pieces of invention patents in China. Patent applications of China, the United States, Japan, Germany and Britain occupy the top 5 positions. Among them China has the most patent applications. However, high-level patents are few The patent applications of the United States rank second, but the patent quality is considerably ahead, with rapid development in the Chinese patent markets. In addition to the focus and hotspots of patent applications of China, the United States, Japan, Germany and Britain also are analyzed in this part. Bode Gene Dev. Co., Ltd. Shanghai, Roche Holding Ltd., Merck & Co., Ltd., Pfizer Inc., Novartis AG are the top 5 patentees in terms of patent applications, with differences in development in the Chinese market, technical focus and hotspots. </p><p> The third part is the analysis of patent applications in foreign countries by Chinese applicants. Up to the retrieval date, Chinese applicants have a total of 4,036 invention patents in foreign countries. Since China's accession to the WTO, the amount of patent applications through the WIPO and EPO has increased rapidly. The United States is the most popular country for Chinese inventors. From the view of technical fields, patent applications in the field of A61K 31/00 (pharmaceutical preparations containing organic components) are the highest, up to 645 pieces. The top 10 of the International Patent Classification (IPC) accounts for 45% of the total applications. From the view of applicants, Roche Holding Ltd. is the most powerful company, occupying the leading position through their technical strength and number of patents. The patent applications of Medipharma SA are far ahead, but are relatively weak in strength. There is a large gap between these two companies and the other companies both in strength and the number of patents. </p><p> The fourth part is a case study. According to the statistics of GLOBOCAN, new liver cancer cases in China accounted for about 50% of cases (up to 782,000) in 2012. Based on the analysis of Chinese local anti-cancer drugs, the attention of Chinese inventors concerning liver cancer has increased in recent years. From the perspective of Chinese domestic patents, China's patent applications account for 74.6% of total applications, however important patents and core patents account for only 2%. The number of top 10 IPC patent applications is 2,430, accounting for 43% of the total. From the perspective of applicants, the applications of Fudan University and the Chinese Academy of Sciences are the highest, at 80 pieces each. The technical strength of the Chinese Academy of Sciences is the highest, while GlaxoSmithKline plc. is relatively weak. From the perspective of Chinese applicants in foreign countries, Chinese inventors contributed 738 pieces of patents for liver cancer drugs from 1985 to 2015. The United States, Japan, South Korea, Canada and Australia are the main countries where Chinese inventors apply for patents. The five countries account for 67.8% of the total patent applications. The patent applications of the top 10 IPCs is up to 371, accounting for 50.3% of the total. Among them, A61K 31/00 (pharmaceutical preparations containing effective organic components) is the key IPC. Hangzhou Bensheng Pharmaceutical Co., Ltd. has applied for 34 pieces of patents, located at the right end of the horizontal axis, indicating the patentee’s powerful technology.