Yuanpeng SUN, Yusi LIU, Zheng CHENG, Zhe WU, Yanling SUN

College of Basic Medicine, Hubei University of Science and Technology, Xianning 437100, China

Abstract The discovery of highly effective medicine "Qingfei Paidu Decoction" for COVID-19 is a new era gift of traditional Chinese medicine to the world. The traditional Chinese medicine Scutellaria baicalensis Georgi, as a medicinal plant in the family of Labiatae, is the dominant variety of genuine medicinal material in North China. It is the leading traditional Chinese medicine in the advantageous area of agricultural products with Chinese characteristics in Shangdang of Changzhi City, and it is one of the 21 herbal medicines in the new national prescription "Qingfei Paidu Decoction" for the rapid and effective treatment of COVID-19. This paper introduces S. baicalensis Georgi and its traditional Chinese medicine GAP base, ecologically suitable planting county and medicinal value in poor areas, and studies the intellectual property resources related to S. baicalensis Georgi, such as traditional knowledge, biological genetic resources, patents, new plant varieties, geographical indications, and trademarks. This paper mainly discusses the inheritance essence, innovation and high-quality development strategy of S. baicalensis Georgi under the rural revitalization strategy and traditional Chinese medicine development strategy from the aspects of intellectual property rights, important agricultural cultural heritage, advantageous areas of characteristic agricultural products and so on.

Key words Scutellaria baicalensis Georgi, Qingfei Paidu Decoction, COVID-19, Chinese herbal medicine, High-quality development, Rural revitalization strategy, Development strategy of traditional Chinese medicine

1 Introduction

Traditional Chinese medicine is the treasure of ancient Chinese science, the key to open the treasure house of Chinese civilization, and the unique health resources of China. It has characteristic advantages in serving economic and social development, and makes an important contribution to human health[1]. Traditional Chinese medicine not only plays a leading role in the treatment of before it arises, but also has a synergistic role in the treatment of major diseases, and plays a core role in recovery.

The discovery of highly effective medicine "Qingfei Paidu Decoction" for COVID-19 is a new era gift of traditional Chinese medicine to the world[2-3]. After the outbreak of COVID-19, the National Administration of Traditional Chinese Medicine of China quickly launched the clinical screening study of effective prescriptions for the prevention and treatment of COVID-19 with traditional Chinese medicine. Based on the clinical observation and data analysis of the clinical efficacy of traditional Chinese medicine prescription "Qingfei Paidu Decoction" in treating COVID-19 in Shanxi, Hebei, Heilongjiang and Shaanxi provinces, the National Health Commission and the National Administration of Traditional Chinese Medicine of China jointly issuedNoticeonRecommendingtheUseof"QingfeiPaiduDecoction"intheTreatmentofNovelCoronavirus-infectedPneumoniawiththeCombinationofTraditionalChineseandWesternMedicineon February 6, 2020, recommending the use of "Qingfei Paidu Decoction" to the whole country.

IntheDiagnosisandTreatmentProgramforNovelCoronavirusPneumonia(TrialVersion7), "Qingfei Paidu Decoction" is the core of traditional Chinese medicine treatment. Qingfei Paidu Decoction plays a unique role in the anti-epidemic battlefield, and the total effective rate has been proved to be more than 90%. The highly effective traditional Chinese medicine mainly comes from the combination of traditional Chinese medicine classic prescriptions in Zhang Zhongjing’sTreatiseonFebrileandMiscellaneousDiseases, which is composed of Maxing Shigan Decoction, Shegan Mahuang Decoction, MinorBupleurumDecoction, Wuling Powder, Juzhijiang Decoction, combined with yam andAgastacherugosus[2-3]. Among them, Xiao chaihu Decoction and Wuling Powder are included in the top ten famous prescriptions of traditional Chinese medicine.

Recent studies on the prevention and treatment of COVID-19 have been highly valued, especially the clinical efficacy observation and theoretical analysis of "Qingfei Paidu Decoction"[3-6]. However, the research on 21 herbs such asScutellariabaicalensisGeorgi in Qingfei Paidu Decoction has not attracted due attention.TheOpinionsoftheCPCCentralCommitteeandtheStateCouncilonPromotingtheInheritanceandInnovativeDevelopmentofTraditionalChineseMedicine, issued on October 20, 2019, put forward 20 suggestions on six aspects of the inheritance and innovative development of traditional Chinese medicine. On October 25, 2019, the first national conference on traditional Chinese medicine held in the name of the State Council sounded the horn of inheritance and innovative development of traditional Chinese medicine.

The protection and application of intellectual property rights is an effective measure to promote the inheritance, innovation, high quality and modern development of traditional Chinese medicine[7-11]. In November 2019, the General Office of the CPC Central Committee and the General Office of the State Council issued theOpinionsonStrengtheningtheProtectionofIntellectualPropertyRights, requiring: "improve the protection system for new areas of new business type, study and formulate measures for the protection of traditional culture, traditional knowledge and other fields, and strengthen the protection of intellectual property rights of traditional Chinese medicine".

In view of this, this paper discusses the inheritance essence, innovation and high-quality development strategy ofS.baicalensisGeorgi under the rural revitalization strategy and traditional Chinese medicine development strategy.

2 S. baicalensis Georgi and its medicinal value

S.baicalensisGeorgi, is a perennial renascent herb of the genusScutellariaof Labiatae[12], which belongs to one of forty bulk medicinal materials[13].S.baicalensisGeorgi mostly grows on the sunny slopes and hilltop grasslands, and they are heliophilous, cold-tolerant and drought-tolerant. It also grows well in arid and dry soil, mainly distributed in Northeast, North and Northwest China, especially in Shanxi, Shaanxi, Ningxia, Hebei, Inner Mongolia, Gansu, Shandong and other provinces. In addition, it is also distributed in Russia’s eastern Siberia, Mongolia, Korea and Japan. The artificial cultivation areas ofS.baicalensisGeorgi in China are mainly four major producing areas: Shanxi, Shandong, Gansu and Shaanxi.

The traditional Chinese medicineS.baicalensisGeorgi is the dominant variety of authentic medicinal materials in the producing area of genuine medicinal materials in North China. It is one of the famous "ten Dang medicines". The relevant national special areas are the dominant areas of Shangdang traditional Chinese medicine agricultural products with Chinese characteristics in Changzhi City, Shanxi Province.

According to theRegionalLayoutPlanofCharacteristicAgriculturalProductsoftheformerMinistryofAgriculture(2013-2020), the dominant counties ofS.baicalensisGeorgi are: Anguo City, Xingtai County and Longhua County of Hebei Province; Yiyuan County, Linqu County, Juxian County, Yishui County and Pingyi County of Shandong Province.

The former State Food and Drug Administration carried out GAP (Good Agricultural Practices) certification for 196 traditional Chinese medicine bases, including 3S.baicalensisGeorgi GAP bases (Table 1).

Table 1 GAP base of Scutellaria baicalensis Georgi

According to the national survey of traditional Chinese medicine resources and germplasm sharing data, the Traditional Chinese Medicine Resource Center of the Chinese Academy of Traditional Chinese Medicine put forward theRecommendedCatalogueofEcologicallySuitableMedicinalMaterialsforPlantinginPoverty-StrickenAreas[14]. Referring to this recommended catalogue, this paper summarizes that the poverty-stricken areas ecologically suitable for plantingS.baicalensisGeorgi involve 14 provinces, including Heilongjiang, Inner Mongolia, Shanxi, Shaanxi, Ningxia, Liaoning, Hebei, Henan, Gansu, Qinghai, Hubei, Hunan, Guizhou and Sichuan, 135 counties in total (Table 2).

Table 2 Counties ecologically suitable for planting of Scutellaria baicalensis Georgi in poverty-stricken areas

According to the different processing methods, the Chinese herbal medicine is divided into Huangqin Pian and Jiu Huangqin, and it is one of the ten famous prescriptions of traditional Chinese medicine, such as MinorBupleurumDecoction. It is one of the 21 herbal medicines in a new national prescription of Qingfei Paidu Decoction for the rapid and effective treatment of COVID-19[2-3].

Traditional Chinese medicineS.baicalensisGeorgi has bitter taste and cold nature and can act on lung, gallbladder, spleen, large intestine, small intestine; it has the functions of clearing heat and drying damp, purging fire and detoxification, stopping bleeding and preventing miscarriage. It is mainly used to treat chest tightness and vomiting, distention and fullness, diarrhea and dysentery, jaundice, cough due to the lung-heat, high fever, exasperation and thirst, blood ejection and spontaneous external bleeding, carbuncle, sore, threatened abortion and other diseases.

Modern chemical studies show that flavonoids and diterpenes are the main active components ofScutellariaLinn. The plant has a wide range of pharmacological effects, such as anti-tumor, anti-angiogenesis, liver protection, antioxidation, anti-convulsion, antibacterial and antiviral activity.

3 Intellectual property resources of S. baicalensis Georgi

Strengthening the protection of intellectual property rights is the greatest incentive to improve the competitiveness of traditional Chinese medicine and agricultural economy. Traditional know-ledge and agricultural biological genetic resources mainly include intellectual property rights of cultural heritage, which have the function of inheriting agricultural cultural heritage[15]; invention patents, utility model patents, new plant varieties,etc., mainly creative intellectual property rights, which have the function of encouraging agricultural scientific and technological innovation[9]; geographical indications, trademarks, design patents,etc., mainly identity intellectual property rights, with the function of cultivating the brand of agricultural products[16].

3.1 Traditional knowledgeTraditional knowledge is generally considered to be related to a particular nation and region and based on traditional literary, artistic or scientific works, performance, invention, scientific discovery, design; markings, names and symbols,etc[8].

The traditional knowledge ofS.baicalensisGeorgi mainly contains traditional agricultural knowledge and traditional medical knowledge, including the human factors of geographical indications and authentic medicinal materials ofS.baicalensisGeorgi, traditional cultivation, traditional processing and traditional formula ofS.baicalensisGeorgi, land use system and agricultural landscape for traditional cultivation ofS.baicalensisGeorgi, and legends of Li Shizhen andS.baicalensisGeorgi.

However, due attention has not been paid to the protection and utilization of traditional knowledge and cultural heritage related toS.baicalensisGeorgi. The traditional Chinese medicine database which can be used to retrieveS.baicalensisGeorgi has not been established. There are not many national invention patents and national utility model patents based on the traditional knowledge ofS.baicalensisGeorgi. In one of the ten famous prescriptions of traditional Chinese medicine—XiaochaihuDecoctionand the new national prescription of traditional Chinese medicine—QingfeiPaiduDecoction, the cellular and molecular biological mechanisms of the effective components ofS.baicalensisGeorgi are still not very clear.

TheCompendiumofMateriaMedica(Jinling Edition in 1593) and theInnerCanonofHuangdi(printed and published by Hushi Gulin Shutang in 1339) were selected into the Memory of the World Register in 2011. The inheritance, innovation and development ofS.baicalensisGeorgi traditional knowledge in these two kinds of world memory cultural heritage are tasks to be completed in the new era.

In China, there are 29 items of world intangible cultural heritage, such as acupuncture and Tibetan medicated bath, and 23 items of traditional medicine, 239 items of traditional skills and other national intangible cultural heritage. However, the traditional medicine and traditional skills mainly related toS.baicalensisGeorgi (especially the related traditional specialty production skills) have not yet been included in theWorldIntangibleCulturalHeritageListand theNationalIntangibleCulturalHeritageList.

In China, there are 118 kinds of important agricultural cultural heritage in China, such as Chongqing ShizhuCoptisproduction system[15], and 17 kinds of important global agricultural cultural heritage, such as ancient mulberry trees along the old route of the Yellow River in Xiajin, Shandong Province. But so far, there is no Chinese important agricultural cultural heritage or global important agricultural cultural heritage in the unique traditional agricultural production system mainly related toS.baicalensisGeorgi.

3.2 Biological genetic resourcesThere are more than 300Scutellariaspecies in the world, and more than 100 species in China, which are produced in both the north and the south. This plant is often used in medicine, andS.baicalensisGeorgi is one of the famous traditional Chinese medicines. The main varieties ofS.baicalensisGeorgi are YunnanScutellaria,ScutellariaviscidulaBunge, JinyunScutellaria, GansuScutellaria, ReheScutellariaand so on.S.baicalensisGeorgi has a long history in China, and new varieties such as "WanhuaScutellaria" have been cultivated.

3.3 PatentSo far, there are 42 866 authorized national patents involvingS.baicalensisGeorgi, of which 42 495 are invention patents, accounting for 99.13%; 362 utility model patents, accounting for 0.84%; 9 design patents, accounting for 0.02%. Among them, utility model patents and design patents (patterns used for the design of packaging materials,etc.) are quite few. These national patents are mainly granted in the last six years (Fig.1). As of March 31, 462 national patents was granted this year.

Fig.1 Dynamics in the number of national patents granted to Scutellaria baicalensis Georgi (1985-2019)

Among the main producing provinces ofS.baicalensisGeorgi, Shandong, Henan, Sichuan, Hunan and Hubei have obtained many patents related toS.baicalensisGeorgi (Table 3). The origin of geographical indicationS.baicalensisGeorgi (Table 5-6) involves 3 provinces and 4 counties (Table 4), and the national patents involvingS.baicalensisGeorgi are quite few (Table 4). The scientific and technological innovation ability and patent protection of these original counties need to be improved.

3.4 New plant varietiesA new plant variety refers to a new plant variety that has been artificially cultivated or developed from the discovered wild plants, with novelty, specificity, consistency, stability and proper naming. There are two systems for the protection of new plant variety rights in China: agricultural plant variety system and forestry plant variety system.

Table 3 Number of national patents related to Scutellaria baicalensis Georgi in the main producing provinces

Table 4 Number of national patents related to Scutellaria baicalensis Georgi in the county of origin of S. baicalensis Georgi

Table 5 Geographic indication trademark of Scutellaria baicalensis Georgi

The new plant variety right ofS.baicalensisGeorgi should belong to the agricultural plant variety system. However, since 1999, the Ministry of Agriculture and Rural Affairs and the former Ministry of Agriculture have published theEleventhAgriculturalPlantVarietyProtectionListofthePeople’sRepublicofChina, which contains neitherScutellariaLinn., norS.baicalensisGeorgi. In view of the fact that China has not officially begun to grant the new variety right of agricultural plant toS.baicalensisGeorgi, the new variety right of this medicinal plant can only be protected by invention patent.

3.5 Geographic indicationsThere are three systems in the protection system of geographical indications in China: (i) the protection of geographical indication products of the State Intellectual Property Office; (ii) the registration of geographical indication trademarks (certification trademarks or collective trademarks) of the State Trademark Office; (iii) the registration of geographical indications of agricultural products of the Ministry of Agriculture and Rural Affairs.

Table 6 Agricultural product geographical indications of Scutellaria baicalensis Georgi

There is no geographical indication product protection forS.baicalensisGeorgi under the original national quality inspection system and the State Intellectual Property Office, and there is no geographical indication product. There are two kinds of this traditional Chinese medicine (JuxianScutellariaand LuzhouScutellaria) (Table 5), and three kinds of geographical indications of agricultural products (YaozhouScutellaria, JuxianScutellaria, JiangxianScutellaria). The protection scope of geographical indications covers Shandong, Shanxi and Shaanxi provinces, with a total of 4 counties of origin (Table 4). However, the above geographical indicationS.baicalensisGeorgi has no national standards for its geographical indication products, and this traditional Chinese medicine is still lacking in national standards and world standards.

3.6 TrademarkIn the Regulations for the Implementation of theTrademarkLawofthePeople’sRepublicofChinain 1995, collective trademarks and certification trademarks were included in the scope of legal protection for the first time.S.baicalensisGeorgi has no collective trademark, and it has only two certification trademarks (Table 5). The certification trademarks ofS.baicalensisGeorgi are geographical indication trademarks (Table 5). There is no provincial famous trademark or Chinese well-known trademark ofS.baicalensisGeorgi. The related products ofS.baicalensisGeorgi have provincial famous trademark and Chinese well-known trademark, for example, the "Heibao" trademark of bear bileScutellariaeye drops is a famous trademark of Heilongjiang Province, and the "Wang Laomei" trademark ofS.baicalensisGeorgi extract is a famous trademark of Gansu Province, andScutellariatoothpaste was once a famous trademark in Zhejiang Province. The "Baiyun" trademark of compoundScutellariatablets is a well-known trademark in China.

4 Inheritance and innovative development strategy of S. baicalensis Georgi

4.1 Establishing a searchable database of traditional Chinese medicineIt is necessary to collect and sort out the traditional Chinese medicine knowledge ofS.baicalensisGeorgi from classic prescriptions of traditional Chinese medicine, national prescriptions, ancient classical prescriptions, old traditional Chinese medicine, folk prescriptions, Memory of the World—CompendiumofMateriaMedica,InnerCanonofHuangdi,etc., especially traditional processing techniques, traditional prescriptions, traditional pharmacology and so on. It is necessary to strive for the national intangible cultural heritage project of traditional medicine and traditional skills, establish a database of traditional Chinese medicine that can retrieveS.baicalensisGeorgi to provide the traditional Chinese medicine big data, and protect the intellectual property rights of traditional knowledge ofS.baicalensisGeorgi.

4.2 Carrying on the farming cultural heritage ofS.baicalensisGeorgiIt is necessary to collect and sort out the traditional agricultural knowledge ofS.baicalensisGeorgi, especially the human factors ofS.baicalensisGeorgi geographical indications and authentic medicinal materials, traditional planting knowledge, related legends and folklore, as well as the land use system and agricultural landscape for traditional cultivation. It is necessary to strive for national intangible cultural heritage projects of folk literature and folklore, to strive for pilot projects of important agricultural cultural heritage in China and the world, and to carry on and carry forward the agricultural cultural heritage ofS.baicalensisGeorgi.

4.3 Protecting biological genetic resourcesIt is necessary to thoroughly investigate the wild resources and planting variety resources ofS.baicalensisGeorgi, and make full use of world natural heritage, world geopark, national nature reserve, national botanical garden, national forest park, national scenic spot, and national geopark. In the 18 main producing provinces ofS.baicalensisGeorgi, especially the hometown ofS.baicalensisGeorgi in China, the geographical indicationS.baicalensisGeorgi county of origin and the dominant county ofS.baicalensisGeorgi, it is necessary to protect the biological genetic resources ofS.baicalensisGeorgi and protect the diversity.

4.4 Purifying and rejuvenating characteristic varieties ofS.baicalensisGeorgiIt is necessary to carry out in-depth basic research on the protection of wild resources, breeding of fine varieties, and ecological cultivation ofS.baicalensisGeorgi, make full use of the germplasm resources ofS.baicalensisGeorgi, promote the purification and rejuvenation of characteristic varieties ofS.baicalensisGeorgi, speed up the selection and breeding of a number of new varieties with strong authenticity, obvious efficacy and stable quality, build seed and seedling breeding base of genuine medicinal materials with high standard, large scale and high quality, and improve the ability of supplying seeds and seedlings of genuine medicinal materials ofS.baicalensisGeorgi. It is necessary to make use of national invention patents to protect creativity and innovation in variety selection, and strive to make the Ministry of Agriculture and Rural Affairs to includeS.baicalensisGeorgi in theListofAgriculturalPlantVarietiesProtectionofthePeople’sRepublicofChinaat an early date.

4.5 Enhancing the contribution of scientific and technological innovationIt is necessary to collect and sort out the traditional knowledge related toS.baicalensisGeorgi, vigorously carry out scientific innovation based on traditional knowledge, innovate and popularize new agricultural technologies, develop intelligent agriculture, innovate processing techniques, and develop new products ofS.baicalensisGeorgi proprietary Chinese medicine. It is necessary to adhere to the dual drive of scientific and technological innovation and institutional innovation in order to create a goodS.baicalensisGeorgi innovation policy environment and local innovation and entrepreneurship environment. It is necessary to promote collaborative innovation in various forms onS.baicalensisGeorgi industry-study-research, as well as interdisciplinary fusion and innovation, especially to strengthen the market-oriented factors of technological innovation and enhance the dominant position of enterprise innovation.

4.6 Promoting standardized and ecological planting ofS.baicalensisGeorgi in suitable areasIt is necessary to investigate the climate, soil, water quality, germplasm and other natural factors of geographical indicationS.baicalensisGeorgi and authentic medicinal materials, and study the suitability and authentic nature of traditional Chinese medicineS.baicalensisGeorgi, so as to prevent blind expansion of species in unsuitable areas. It is necessary to adhere to the principles of suitability and authenticity, adopt ecological planting technology, mechanized production technology, and information management technology, build a standardized production system ofS.baicalensisGeorgi, improve the standard system of production technology, initial processing of producing areas, and quality and safety, and promote standardized and ecological planting in suitable areas ofS.baicalensisGeorgi.

4.7 Building production base of authentic medicinal materialsIt is necessary to investigate in detail the geographical indications, authentic medicinal materials and dominant counties ofS.baicalensisGeorgi, and adhere to the authentic characteristics and optimal layout ofS.baicalensisGeorgi in accordance with the authenticity and suitability ofS.baicalensisGeorgi and the results of the third and fourth national survey of traditional Chinese medicine resources. In these key counties, in accordance with the requirements of theNationalGenuineMedicinalMaterialProductionBaseConstructionPlan(2018-2025) and theNationalQualityStrategicPlanforPromotingAgriculture(2018-2022), it is necessary to comprehensively improve the construction ofS.baicalensisGeorgi authentic medicinal material production base from the aspects of improving the level of production science and technology, standardized production level, industrialization level, and quality and safety level.

4.8 Creating the dominant area of characteristic agricultural products ofS.baicalensisGeorgiIn accordance with the requirements of theNationalPlanfortheConstructionofDominantAreasforCharacteristicAgriculturalProducts(2017-2020)[23], the dominant areas of national and provincial characteristic agricultural products ofS.baicalensisGeorgi should be established in the four major producing areas of Shanxi, Shandong, Gansu and Shaanxi. There is a need to focus on the construction of Changzhi Shangdang traditional Chinese medicine agricultural products dominant area. From the aspects of standardized production base, processing base, warehousing and logistics base, science and technology support system, brand construction and marketing system, quality control system, construction and operation mechanism, it is necessary to build dominant areas and counties of characteristic agricultural products ofS.baicalensisGeorgi, and buildS.baicalensisGeorgi industrial cluster.

4.9 Building regional common brandIt is necessary to deeply study the natural and human factors of geographical indicationS.baicalensisGeorgi, and explore the demonstrative significance and value of its producing region.S.baicalensisGeorgi regional common brand should be selected on the basis of geographical indication products, geographical indications of agricultural products, collective trademark and certification trademark (including geographical indication trademark), Chinese well-known trademark and so on. On the basis of regional comparative advantage, it is necessary to launch high-qualityS.baicalensisGeorgi products, effectively improve the level of brand management, establish a brand catalogue system, and optimize brand identification, establish a regional common brand authorization mechanism and brand crisis early warning, risk aversion and emergency response mechanism. It is necessary to buildS.baicalensisGeorgi regional common brands in an all-round way and strive to be among China’s top 100 regional common brands of agricultural products and China’s top 100 regional brands (geographical indication products).

4.10 Protecting and applying agricultural intellectual property rights ofS.baicalensisGeorgiAccording to theOpinionsonStrengtheningtheProtectionofIntellectualPropertyRightsissued by the General Office of the CPC Central Committee and the General Office of the State Council, it is necessary to improve and strengthen the creation, protection, application and management ofS.baicalensisGeorgi agricultural intellectual property rights, give full play to the functions of traditional knowledge and agricultural biological genetic resources in carrying forward agricultural cultural heritage, and stimulating agricultural scientific and technological innovation and driving functions such as invention patents, utility model patents, and new plant varieties, as well as the functions of cultivating the brand of agricultural products in geographical indications, trademarks and design patents to promote the development of knowledge agriculture and rural knowledge economy.