以下文章来源于中草药杂志社 ，作者束雅春，江志伟

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Intellectual property protection of traditional Chinese medicine is an important means of innovation and development, patent is an important carrier of intellectual property protection of traditional Chinese medicine, and patent information is an important open scientific and technological document resource, which can help researchers formulate substantive protection and development strategies and promote the development of Chinese traditional medicine industry [1]. Traditional Chinese medicine health food is a kind of food, with the commonality of general food, its raw materials are mainly from the same origin of medicine and food traditional Chinese medicine and its composition, through advanced production technology, it contains a wealth of effective ingredients to play the role of the maximum, so as to regulate the human function, suitable for specific functional needs of the corresponding population to eat special food. The theory of the homology of medicine and food has a long history in China. There are some related contents in the books such as Huangdi Neijing and Qianjin Prescription. "Vegetarian question · Wuchang Politics" cloud: "Big poison treatment, ten to its six; Often poison treatment, ten to its seven; Small poison treatment, ten to its eight; Non-toxic treatment, ten to nine. Grain meat, fruits and vegetables, eat up." Among them, non-toxic drugs can be regarded as the earliest recorded to erase the boundary between medicine and food, and it can be understood as a product with the same origin of medicine and food. Compared with toxic drugs, they can also achieve curative effects and are more suitable for long-term use [2], which is also the historical source of traditional Chinese medicine health food. With the improvement of people's living standards, people pay more and more attention to physical health, and the concept of "cure disease" has gradually become a trend. According to statistics, most people in sub-health conditions such as "poor skin condition", "insufficient qi and blood", "hair loss", "anxiety and depression", "insomnia" and other people are willing to take medicinal diet, but "do not know the formula", "do not want to make" and "do not know how to purchase medicinal materials" [3]. Therefore, the market demand of Chinese medicine health products is increasing, and it has become an important part of the national health cause, and then the research and development of Chinese medicine health products has gradually greater research significance.

In recent years, the research on traditional Chinese medicine health products has been applied for patent and listed. Yang Shengxiang et al. [4] invented a Chinese medicine composition, health food and preparation method for relieving dysmenorrhea based on Brazilian ginseng, and applied for a patent; Huang Meiqun [5] invented a healthy food containing deer antler, polygalea, ginseng and other traditional Chinese medicine ingredients, and applied for a patent. At present, among the Chinese traditional medicine health products registered in China, the Chinese wolfberry as the raw material is the most, with 1 697, followed by American ginseng, Astragalus, ginseng and Tuckaia [6]. However, there are not many statistics and researches on patent application of TCM health products in China, and the market prospect of TCM health products has not been comprehensively analyzed. Therefore, from the perspective of global patents, this paper carries out technical theme analysis for TCM health food, focusing on the country (region), time and distribution of main applicants of TCM health food related patent applications since 2016, and carries out branch and cluster analysis of technologies, in order to provide reference for relevant enterprises and research institutes.

• 1. Data and methods

Patent data sources and graphs are from the Orbit patent information retrieval and analysis database of Questel, a French company. Topics include Chinese medicine and food. Search strategy: Chinese medicine and its extended elements, food and its combination of extended elements were searched in the full text field, and further defined by the international patent classification (IPC) number of the related subject; Search method: Subject word +IPC number, (traditional Chinese medicine or TCM or herbal medicine or herb*) AND (Food or Drink* or beverage* or Edible or Oral) AND (A23L or A61K or A61P). The search period was from January 2016 to May 2023, and the data volume reached 52,705 pieces. Subject-related data is selected and retained through manual reading, and the subject-related data is imported into Orbit database, and its analysis module platform is used for statistical analysis and chart drawing.

France Questel company is a global leading intellectual property database service provider, the core product Orbit intellectual property database is one of the world's earliest patent databases, Orbit system contains the world's most comprehensive and latest patent and design patent information. With the help of Questel's Orbit patent information retrieval and analysis database, this study carried out technical topic analysis on the relevant technologies of traditional Chinese medicine health food since 2016, combined the time, region, legal status, applicant and technical classification elements in various ways, and analyzed the status, trend and technical composition [7-8]. Comprehensive analysis to understand the technical picture of the field.

In this study, the overall development trend of TCM health food technology was analyzed to determine the current development state of related technology. Since 2016, the number of patent applications related to traditional Chinese medicine health food has generally shown a decreasing trend (Figure 1), which is consistent with the background of drug regulatory departments in China, the United States, Europe, Japan and other countries (regions) to strengthen the control of traditional Chinese medicine since 2016, which raises the threshold of technology research and development and puts higher requirements on the innovation ability of applicants. However, the annual number of patent applications for this technology still reaches more than 3,000, and the subject technology is still in a state of rapid development.

This study comprehensively analyzed the legal protection status of TCM health food related patent technologies to consider the degree of technological innovation. Among the patent applications of TCM health food, 21.5% were in patent applications, 11.0% were authorized patents, and the number of patent applications of two legal states accounted for less than 35%. 35.0% of the patents given up exceeded the number of patents granted and applied for; The number of revoked patents accounted for 32.5% (Figure 2), which is roughly the same as the number of patents granted and filed. Based on the above data analysis, although Chinese medicine health food technology has developed rapidly, it has not yet formed a large-scale technology cluster with intellectual property protection, which is also consistent with the overall authorization rate of domestic patent applications for food composition related technologies is not high. At the same time, the rapid development of technology accelerates the upgrading of technology, and patentees can protect intellectual property rights more reasonably according to the development trend of technology, abandon old technology in time, and stimulate innovation vitality. In addition, there are also some less innovative technologies that have not been granted patents.

On the basis of establishing that Chinese medicine health food technology is in a state of rapid development, the specific technology distribution is further comprehensively analyzed from the factors of country (region), time, applicant and legal status, and the technical analysis is carried out from the technical level to explore the hot spots, blank points and important applicants of technology distribution.

2.2.1 Distribution of Countries (regions) Firstly, from the perspective of technical distribution, the countries (regions) applying for TCM health food patents are mainly China, followed by South Korea, the United States, India, Europe and Japan (Figure 3). Most of the raw materials come from natural plants and animals, some of which are from CN-China; WO- World Intellectual Property Organization; KR- South Korea; US- United States; IN- India; EP- European Patent Office; JP- Japan; CA- Canada; AU- Australia; Br-brazil (same as Figure 5).

China has the tradition of diet therapy and tonic. Therefore, health food has a long history of development and good acceptance in China, and it is also the largest market of traditional Chinese medicine health food in the world. Since 2016, 49 774 patent applications for traditional Chinese medicine health food technology have been filed in China. In addition, there is a certain degree of technical activity in other parts of Asia, Europe and the Americas, among which South Korea applied for 1 399, the United States applied for 1 218, India applied for 861, Europe applied for 856, and Japan applied for 732. Among them, Japan and South Korea have always had the tradition of eating medicinal materials. It also brought the technology of traditional Chinese medicine and healthy food to Europe and the United States. Therefore, the development of technology in this field should also focus on the technological dynamics of the above countries/regions.

2.2.2 Country (region) -Time distribution From the perspective of technology distribution time, in China, South Korea, the United States, India, Japan and Europe, where technology is relatively active, China's development of TCM health food technology is the most stable, and the annual number of patent applications since 2016 has been more than 3,000 (FIG. 4). The number of patent applications in South Korea, the United States, Japan and Europe fell slightly in 2021, and the number of patent applications in India reached a small peak in 2020, and the annual number of applications has remained at 100-200 since 2018, which indicates that the technological development advantages in this field have been mainly concentrated in China. The technological development of South Korea, the United States, Japan and Europe is in a certain state of contraction for the time being, while the technological development of India has maintained a slow development. However, due to the comparative advantage of South Korea's early technology, its technology is still at a high level.

2.2.3 Applicants-Country (region) -Legal status distribution From the perspective of innovation subjects, the top 30 applicants are all Chinese applicants (FIG. 5 and 6), indicating that China has been in an absolute dominant position in this field of technology since 2016, and the applicant subjects are enterprises and scientific research institutions. As can be seen from the legal status of the applicant's patent application, the top 5 authorized patents are Jiangsu Kangyuan Pharmaceutical Co., LTD. (42), Heilongjiang University of Chinese Medicine (36), Henan University of Chinese Medicine (27), Nanjing University of Chinese Medicine (24), Shuguang Hospital affiliated to Shanghai University of Chinese Medicine (24), and the number of valid patents currently formed is small. Most patent applications are in the application and invalid state, and the number of invalid is more than the number of applications, indicating that although each applicant is highly active in the field of technology, but has not effectively formed a key technology with independent intellectual property rights, but because there are some patents in the application, there is still some room for authorization.

2.2.4 Applicant - Time distribution For the innovation subjects with a relatively large number of applications above, further analysis of their technological activity status to determine the applicants to focus on. Specifically, Guangxi University, Jiangsu Kangyuan Pharmaceutical Co., LTD., Lunan Pharmaceutical Group Co., LTD., Heilongjiang University of Chinese Medicine, Henan University of Chinese Medicine, Nanjing University of Chinese Medicine, Jiangxi University of Chinese Medicine, Shuguang Hospital Affiliated to Shanghai University of Chinese Medicine, China Pharmaceutical University, Chengdu University of Chinese Medicine Affiliated Hospital, Beijing University of Chinese Medicine, Guangdong Yifang Pharmaceutical Co., LTD., Jilin University Nanjing University has continuously applied for patents since 2016 (Figure 7), and is a traditional active applicant in the field of this technology, with relatively mature technology and a high degree of innovation. Among them, Jiangsu Kangyuan Pharmaceutical Co., LTD., Heilongjiang University of Chinese Medicine, Henan University of Chinese Medicine, Nanjing University of Chinese Medicine and Shuguang Hospital affiliated to Shanghai University of Chinese Medicine have authorized 42, 36, 27, 24 and 24 patents respectively.

Through the above overall and local trend analysis, the global patent applications of TCM health products have been in a stable state since 2016, of which the unsolved patents accounted for 21.5% (Figure 1, 2), and there is still a large space for authorization, indicating that TCM health food is in a rapid and stable development period of patent life cycle. From the perspective of the activity of the top 30 applicants in the number of patent applications, in addition to the new active applicants, the traditional active applicants have continuously applied for patents related to this technology (Figure 7), continued research and development and innovation of this technology, and their own technology has formed a certain scale of intellectual property protection, indicating that Chinese medicine health food is also in the stage of rapid and stable development of technology life cycle.

According to the characteristics of technology distribution, this study made statistics on the technical categories of Chinese medicine health food technology related patents, summarized the technical hot spots and blank points, and also carried out a detailed analysis of the technical distribution of the main innovation subjects in this field.

2.4.1 Technical Hotspots and blank Spots2

From the technical fields of distribution, the technical fields of TCM health food patent applications are mainly distributed in pharmaceutical, food chemistry, organic fine chemistry and other special equipment, and the number of applications is 36 217, 20 673, 4 688 and 1 457, respectively (FIG. 8). As the cross-field of medicine and food, TCM health food is still the hot technology field of pharmaceutical and food chemistry, but the fields of medicine and food are comprehensive technology fields, so there is a phenomenon of cross-technology fields, which indicates that the technology is tending to the development trend of multi-technology fields on the premise of maintaining the advantages of traditional technology fields. The diversity of product form and function is also in line with the market demand; At the same time, this also shows the consumer's demand for product diversification and functionalization, so it is necessary for technology research and development entities to carry out technological innovation in multi-technology fields to meet market demand and tap market potential. 

• From the specific clusters corresponding to relevant technical fields, the technical clusters of TCM health food patent applications are mainly distributed in A23L-033, A61P-029 and A61P-001, and the corresponding technical clusters are respectively changing the nutritional properties of food, nutritional products and their preparation or treatment. Non-central analgesics, antipyretics or anti-inflammatory agents and drugs for the treatment of diseases of the digestive tract or digestive system, the number of patent applications corresponding to the above technical clusters accounted for about 25% of the total patent applications (Figure 9). Among them, changing the nutritional properties of food, nutritional products, and the preparation or treatment of traditional Chinese medicine health food are hot clusters, and a single cluster accounts for about 12.5% of the total applications. Nutritional products are the main functions realized by traditional Chinese medicine health food, occupying a leading position in technical efficacy, and are also the technical clusters with the largest market demand.

The less distributed technical clusters of TCM health food patent applications are A23L-019, A23L-002 and A23L-007, corresponding to the preparation of fruits or vegetables, their preparation or treatment, non-alcoholic beverages and their dry compositions or concentrates, products containing cereals, malt products and their preparation or treatment. The blank areas of technical cluster distribution are A23B, A23C, A23D, A23F, A23G and A23J, and the corresponding technical clusters are stored, ripe or canned products, dairy products, milk or cheese substitutes and their preparation, edible oil or fat, coffee, tea and their substitutes manufacturing, preparation or brewing, respectively. Preparation of cocoa, cocoa products and their substitutes, sweets, chewing gum, ice cream and edible protein compositions, edible protein processing, edible phospholipid compositions. Combined with the product form and use of health food and the above characteristics of cluster distribution, the technical cluster distribution of traditional Chinese medicine health food patent application is less and blank areas are suitable for development of health food.

2.4.2 Technology activity On the basis of the overall understanding of technology distribution, the technology distribution is further analyzed from the main applicants in the field. The top 30 Chinese medicine health food patent applicants mainly applied for patents in pharmaceutical and food chemistry (Figure 10). In addition, other active technology areas are organic fine chemistry, other special equipment, medical technology, basic materials chemistry, chemical engineering, macromolecular chemistry/polymers, testing and biotechnology, and the distribution of technology areas has a rich diversity, covering technology research and development and the entire industry chain. This shows that traditional Chinese medicine health food has now formed a multi-function and multi-category product system. In order to achieve the diversity of products, various technical fields have been derived. It is the increasingly rich consumer demand and unlimited market potential space that promote the comprehensive development of this technology. The main body of technological innovation is also becoming more and more skilled in the use of intellectual property rights to protect related technologies and establish technical barriers in order to fully implement the transformation of patented technologies within the technological life cycle and legal life cycle.

This study made a statistical analysis of patent applications for traditional Chinese medicine health food from the perspective of technical distribution, and found that patent applications in China were the most active in terms of region, time and applicants, and also affected the world to varying degrees, indicating that the health concept of traditional Chinese medicine and food is gradually spreading to the world and gradually widely accepted by other countries in the world. It has great market potential and good development prospect. In addition, this study made a comprehensive analysis of the patent applications of TCM health products from the perspective of the applicant's legal status and technical composition, and found that each applicant was highly active in the technical field, and the technical composition included pharmaceutical, food chemistry, organic fine chemistry, other special equipment, medical technology, basic material chemistry, macromolecular chemistry and other key active technologies. Clustering specific hot spots is to change the nutritional properties of food, nutritional products and their preparation or treatment technology, so it can strengthen the interactive integration of key technologies and hot technologies. At the same time, a series of technical gaps also appeared in the patent analysis, such as cooking oil or fat containing Chinese medicine and edible protein composition, edible protein, edible phospholipid composition preparation, deep processing, storage and other technologies, and has not yet effectively formed a key technology with independent intellectual property rights, which is also a breakthrough in the technology integration innovation of traditional Chinese medicine health products and product development ideas.

As far as the existing reports are concerned, there are few international patent analysis reports on TCM health food, lack of literature reports on technology and product gaps, lack of literature summary in terms of technical composition, and lack of big data analysis and guidance in the development direction of the transformation of results, so that it may be in a "blind" state of development while developing continuously. The precise hot spot or gap filling of technology and products may be slow. The innovation point of this study is to conduct multi-dimensional analysis of the relevant patents of TCM health food technology through Orbit platform, including region, time, applicant and technology category, and determine the development trend, hot spots and blank fields of related product technology, which provides a basis for the research and development of related technology and patent layout. It also provides more specific guidance for the combination of traditional Chinese medicine and healthy food industry. Although the number of patent applications for traditional Chinese medicine health food related technologies is huge, effective patent protection has not yet been formed, and there is a long way to go in seeking a win-win road of technological innovation and patent protection. Studies have shown that there is still a big gap in the conversion rate of patents between Chinese and American universities, and low-quality patents are widespread and patent achievements are lost [12]. Therefore, innovation subjects need to have a deeper understanding of the technical status quo, targeted integration of the hot areas of traditional Chinese medicine health food and core technologies, and fill the technical gaps according to market demand, enhance the height of innovation and patent protection awareness, and give full play to China's comprehensive advantages in this field.