Patent analysis and application to assist new drug research and development of Laimei pharmaceutical

Founded in September 1999, Chongqing Laimei Pharmaceutical Co., Ltd is a high-tech pharmaceutical enterprise integrating scientific research, production and sales Recently, it announced that it plans to invest no more than 50 million US dollars (about 310 million yuan) from TVM capital (China) and China biomedical fund phase I Phase I (limited partnership) of China biomedical fund co founded by (general partnership) becomes the limited partner of the fund On November 19, 2014, in the stability Laboratory of Chongqing Laimei pharmaceutical R & D center, the experimenters were extracting the experimental samples Laboratory of impurities, R & D center of Chongqing Laimei Pharmaceutical Co., Ltd., the laboratory staff are developing new drugs All the pictures in this column were taken by Mei Yin, a reporter, along with the national four kinds of new drugs against peptic ulcer independently developed by Chongqing Laimei Pharmaceutical Co., Ltd (hereinafter referred to as "Laimei pharmaceutical"), esomeprazole enteric coated capsule officially went on the market, breaking the monopoly situation of international pharmaceutical giants on the domestic market of the drug Yuan yuan, manager of Intellectual Property Department of Laimei pharmaceutical, said that patent analysis and application have helped make it the first pharmaceutical company in China to successfully develop esomeprazole What role does patent analysis and application play in new drug research and development? "What's the new research trend in the world? What's the status of competitors' patents? How to avoid and bypass others' existing patents? These questions can be found in a large number of patent analysis It can be said that this can not only "know yourself and your enemy", but also "stand on the shoulders of giants", reduce detours and shorten R & D time " Yuan yuan for example, at the beginning of the project, the company analyzed the related patents of esomeprazole for many times, and found that one of the three original research patents held by AstraZeneca was highly related to the R & D path of Laimei pharmaceutical industry In other words, if new drugs are developed according to this path, there is likely to be a risk of infringement Therefore, the company successfully evaded the risk of infringement in R & D and accelerated the R & D progress According to the current medical examination and approval system in China, esomeprazole enteric coated capsules produced by Laimei pharmaceutical industry have a three-year monitoring protection period, that is, they have the right to produce and sell the drug exclusively in China within three years "It's like seizing the market." In Yuan Yuan's view, in the next few years, the drug is expected to become the largest single product sales revenue of the enterprise, with an annual sales volume of 1 billion yuan, and the drug is also expected to become the company's most profitable product Yuan Yuan disclosed that at present, the company has applied for two invention patents for esomeprazole, one of which has been authorized Peptic ulcer is a common digestive disease, and its incidence rate is 28% in some parts of China Esomeprazole is a new generation of proton pump inhibitors (PPI) Compared with other PPIs, esomeprazole has the advantages of shorter course of treatment, more stable effect, more rapid and lasting effect, and has become the first-line drug for the treatment of peptic ulcer "Esomeprazole was first developed by AstraZeneca, an international pharmaceutical giant, and has been listed in major European and American countries since 2001 Only AstraZeneca's imported products have been in the domestic market." Yuan yuan, manager of Intellectual Property Department of Laimei pharmaceutical, introduced that through patent analysis and application, esomeprazole enteric coated capsule independently developed by Laimei pharmaceutical obtained new drug certificate and production approval document in 2013, filling the gap in relevant fields in China "Patent analysis allows us to" stand on the shoulders of giants ", reduce detours and shorten R & D time." Yuan yuan for example, at the beginning of the project, the company analyzed the related patents of esomeprazole for many times, and found that one of the three original research patents held by AstraZeneca was highly related to the R & D path of Laimei pharmaceutical industry In other words, if new drugs are developed according to this path, there is likely to be a risk of infringement Therefore, the company successfully evaded the risk of infringement in R & D and accelerated the R & D progress According to the current pharmaceutical approval system in China, esomeprazole enteric coated capsules produced by Laimei pharmaceutical have a three-year monitoring protection period, that is, within three years, it has the right to exclusively produce and sell the drug in China In the next few years, the annual sales of the drug researched and developed by Laimei pharmaceutical industry is expected to reach 1 billion yuan level, and the drug is expected to become the most profitable product of the company At present, the investment promotion of Esomeprazole in China is progressing smoothly, with a large amount of bidding in 15 years Esomeprazole enteric coated capsules (lemesu) were successively sold in Chongqing (August), Hubei (October) and Shandong (November), with fast volume Anhui, Hunan and other winning provinces are waiting for implementation The bidding price is about 72-76 yuan, only 1-2 yuan lower than the original drug "nexin" China's investment promotion has been successful, covering 60% of the top three hospitals and about 30% of the top two hospitals Esso is the largest drug in digestive department, gradually replacing omeprazole market share in PPI acid suppressive drugs, and it is a medical insurance product, with a good market foundation for the original research drug It is estimated that "laimeishu" won the bid in most provinces in 15 years, and its sales volume is expected to exceed 500 million yuan, with a growth rate of more than 30% in the future.