Quick Facts
- Online rumors such as "Japan applied for a patent for "Typhoid Fever", "South Korea has also successfully applied for traditional Chinese medicine", "Japanese Kampo medicine occupies 90% of the global traditional Chinese medicine market sales share, while the mainland only accounts for 2%" and a series of statements are untrue.
- The claim that Japanese Kampo accounts for 90% of the global traditional Chinese medicine market, is not supported by reliable data. Relevant data show that in 2022 alone, the revenue of two representative Chinese medicine companies in the mainland will be close to 5 times that of the national market in Japan.
Event background
Recently, a news widely circulated on Chinese social platforms that Japan applied for a patent for "Typhoid Fever", and South Korea also successfully applied for traditional Chinese medicine, and cited the recent news that "Shaanxi Ziguang Chenji Pharmaceutical was acquired by Japan" said that Japanese Kampo medicine occupies 90% of the global traditional Chinese medicine market sales share, while the mainland accounts for only 2%.
Screenshot of the recent Internet legend method
Combined with a series of online legends in the "Japan", "Typhoid Theory" and "Patent Application" and other keywords in the Internet legend method, the results showed that a series of statements such as "Japan preemptively registered 210 ancient patents for traditional Chinese medicine" and "Japan obtained 210 ancient patents in "Typhoid Miscellaneous Diseases" and "Golden Essentials" have long been circulated on the Chinese Internet, but the relevant statements have not provided empirical evidence and authoritative sources.
Similar streaming legends are displayed on Google search engine and Chinese social platforms
Mincha
Japan patented "Typhoid Fever"?
In fact, as early as 2019, some scholars took Japanese Kampo Medicine as an example, and through analyzing the administrative management of Kampo medicine and the patent applications related to Kampo Medicine, said that the classic formula of traditional Chinese medicine could not obtain patent authorization in Japan. Not only that, through the analysis of patent jurisprudence, it can be found that the classic prescription of traditional Chinese medicine belongs to the category of "prior art" in the patent law, and has also lost the basis for obtaining patent rights.
Screenshot of part of the article "Analysis of Overseas Patent Registration and Protection Suggestions for Chinese Medicine Classics"
According to the article, the Japanese Ministry of Health, Labour and Welfare promulgated the "Standards for the Recognition of General Kampo Preparations" (hereinafter referred to as the "Standards") in 1975. According to the relevant requirements of Japanese drug registration, any enterprise can independently determine the finished dosage form, formulate the preparation process and quality standards within the scope of the prescription composition, dosage and function specified in the "Standards".
After the "Benchmark" was supplemented in 2012, the number of prescriptions increased from 210 to 294, and most of these prescriptions are from classic Chinese medicine works such as "Typhoid Fever", "Essentials of Jin Kuang", "Hejiang Formula", "Rejuvenation of Ten Thousand Diseases", "Secret Prescriptions of Outer Taiwan" and "Thousand Golden Formulas", which belong to the category of classic formulas of Chinese medicine.
The 294 prescriptions included in the "Benchmark" all contain clear matching, dosage and functional indications, of which the dosage of each drug is mostly a clear range, and the functional indications are mainly expressed in the names of Western medical diseases. It can be seen that the Benchmark has become a typical public document in the sense of patent law, and nearly 300 prescriptions are "prior art".
Screenshot of the "Guidelines for the Recognition of Preparations for General Kampo" issued by the Ministry of Health, Labor and Welfare of Japan
At the same time, according to Article 22 of the Patent Law of the mainland, "prior art" refers to technology that was known to the public at home and abroad before the filing date. During the patent application process, patent examination conducts an investigation of "prior art" to confirm whether the patent application meets the patent protection requirements such as novelty and non-obviousness.
However, the classic formulas of mainland Chinese medicine are all derived from Chinese medicine classics, and have been repeatedly used and widely used by contemporary Chinese medicine works, and their public status is undoubtedly undoubted, and it does not have sufficient novelty. Therefore, under normal examination conditions, it is difficult for Chinese medicine classics to obtain patent protection according to the patent legal system.
In addition, we searched domestic and foreign patent databases using "Typhoid Fever" and its common English and Japanese translations as keywords, and did not find any information related to the patent application directly using "Typhoid Fever" in Japan. This also verifies the fact that TCM texts cannot be directly used to apply for patents.
Combined with the views of scholars and the search results, it is inferred that Japanese companies do not have legal and technical space to apply for core patents for the classic formulas of traditional Chinese medicine, and most of them can only protect their own products through peripheral defensive patents such as addition and subtraction, new therapeutic uses, preparations, and quality control.
South Korea also successfully applied for traditional Chinese medicine?
According to the Korea Broadcasting Corporation (KBS), the "Gangneung Dragon Boat Festival" declared by South Korea was officially designated by UNESCO as a "Masterpiece of the Oral and Intangible Heritage of Humanity" on November 24, 2005. Since then, some mainland media quoted a folklore expert as saying, "After South Korea successfully applied for the Dragon Boat Festival, it planned to change traditional Chinese medicine to Korean medicine to apply for World Heritage Sites", which immediately caused an outcry in public opinion.
Screenshot of a report by the Korea Broadcasting Corporation on November 25, 2005
The International Herald then contacted the South Korean side for verification. Xinhuanet reported on October 24, 2006 that Ko Tae-geun, director of the Korean Policy Group of the Ministry of Health and Welfare, made it clear that in order to cooperate with the commemoration of the 400th anniversary of the publication of the Korean medicine sacred book "Eastern Medicine Treasure Book" to be held in 2013, South Korea is preparing to apply for UNESCO's "Memory of the World" project, and not to apply for Korean medicine as a UNESCO World Heritage Site. The official also explained that this should have been a "misunderstanding."
Five years later, the State Administration of Traditional Chinese Medicine held a press conference to announce that on November 16, 2010, the Intergovernmental Committee for the Safeguarding of the Intangible Cultural Heritage of UNESCO had inscribed the mainland "Traditional Chinese Medicine and Acupuncture" on the Representative List of the Intangible Cultural Heritage of Humanity, and stated that the successful application of the project was a recognition of traditional Chinese medicine culture.
As of July 17, a search for "Public of Korea" was entered in the search bar of the official websites of "World Heritage" and "Intangible Cultural Heritage", and the column "Traditional Chinese Medicine" was not displayed.
Screenshot of World Heritage Korea-related heritage items
According to related information, there are currently 13 World Heritage Sites in Korea, of which 11 are cultural heritage and 2 are natural heritage.
Japanese Kampo Medicine occupies 90% of the global traditional Chinese medicine market sales share, and the mainland accounts for only 2%.
The production and sales of Japanese Kampo medicine are very mature. According to the Japan Medical Association, more than 70% of Japanese doctors prescribe Kampo medicines in their daily clinical practice, and the Japanese national insurance system covers 148 Kampo medicine prescriptions. Taking Tsumura, Japan's largest Kampo pharmaceutical manufacturer, as an example, public information on the company's official website shows that its share of the Kampo preparation market in Japan has always exceeded 80%.
Screenshot of the data related to the share of Japanese domestic market of Tsumura Kampo Pharmaceutical from 2010 to 2020
According to the data, Tsumurun's revenue in 2022 will be about 140 billion yen, or about 7.3 billion yuan. Among them, the revenue in the domestic market is about 125 billion yen (about 6.5 billion yuan), and the Chinese market is about 15.3 billion yen (about 800 million yuan).
Screenshots of relevant data
What is the level of Chinese medicine companies with annual sales of 7.3 billion yuan?
Taking two well-known Chinese medicine brands in mainland China and two listed companies with the largest market value in the field of traditional Chinese medicine, Pian Zixi and Yunnan Baiyao as examples, according to the financial reports disclosed by the two companies, the revenue of Yunnan Baiyao in 2022 will reach 36.488 billion yuan, and the revenue of Pian Zixi in 2022 will be 8.694 billion yuan. However, the lower revenue of both companies also surpassed Japan's Tsumura.
According to the estimated proportion of 80% of the Japanese Kampo medicine market of Tsumura Company, the sales of Japanese Kampo medicine market do not exceed 9 billion yuan, and the revenue of Yunnan Baiyao and Pian Zixi, the two representative Chinese medicine companies listed above in the mainland, is close to 5 times the national market in Japan, this data does not include other Chinese medicine brands and companies, such as Ma Yinglong, Sunflower Pharmaceutical, Renhe Pharmaceutical, Dong'a Jiao, Sanjiu Pharmaceutical, Beijing Tongrentang and so on.
According to the latest data from China's Ministry of Industry and Information Technology and the National Bureau of Statistics, as of 2021, the overall size of the mainland traditional Chinese medicine market has reached 886.4 billion yuan.
To sum up, a series of online legends such as "Japan applied for a patent for "Typhoid Fever", "South Korea has also successfully applied for traditional Chinese medicine", "Japanese Kampo medicine occupies 90% of the global traditional Chinese medicine market sales share, while the mainland only accounts for 2%" and a series of online legends are untrue. Through the analysis of the disclosure of classical Chinese medicine formulas in Japan, the administrative management of Japanese Kampo medicines, and the analysis of patent jurisprudence, "Typhoid Fever" cannot be granted a patent in Japan; South Korea has not declared traditional Chinese medicine, but only submitted a medical book called "Eastern Medicine Baojian" to the "Memory of the World" project.
In addition, the statement that "Japanese Kampo Medicines account for 90% of the global traditional Chinese medicine market" is not supported by relevant data. Data show that in 2022 alone, the revenue of two representative Chinese medicine companies in mainland China will be close to 5 times that of the national market in Japan. At the same time, according to the Japanese Kampo Drug Manufacturers Association, about 80% of the Chinese medicinal materials of Kampo medicine in Japan are imported from China.