Author | He Yueting
Chongqing No. 3 Intermediate People's Court
In September 2021, the Central Committee of the Communist Party of China and the State Council issued the Outline for the Construction of an Intellectual Property Power (2021-2035), which requires the protection of intellectual property rights of traditional Chinese medicine to be strengthened. On December 22, 2022, the Supreme People's Court issued the Opinions on Strengthening the Judicial Protection of Intellectual Property Rights in Traditional Chinese Medicine, which put forward the requirements for comprehensively improving the level of judicial protection of intellectual property rights in traditional Chinese medicine and improving the comprehensive protection system of intellectual property rights in traditional Chinese medicine. This edition features articles on the legal systems for the protection of intellectual property rights in Laos, Thailand, South Korea, Japan and other countries.
Laos: Strengthening the investigation of traditional medicine
At present, most villages in Laos are using traditional medicine methods to treat diseases, and Laos has established special institutions to protect traditional medicine knowledge, forming a sound medical work system.
In 1976, the Traditional Medicine Research Center was established in Laos. The center's role is to record prescriptions issued by folk physicians, conduct surveys of medicinal plants throughout the country, and facilitate the transformation of traditional decentralized pharmaceuticals into large-scale production by state-owned pharmaceutical companies. At present, these work objectives have been completed. All aspects of traditional medicine are collected and recorded, including physicians, medicines, and the distribution of plants and animals that can be used for medicine.
Most provinces in Laos have a traditional medicine station, and the staff of these stations are proficient in both traditional and Western medicine, and they are trained in Western medicine before joining the medical station. Through the study of Western medicine and the mastery of traditional medicine knowledge, they can innovate traditional medicine knowledge and at the same time widely disseminate traditional medicine knowledge.
The Traditional Medicine Research Center also strengthens the international promotion of traditional medicine knowledge through project research and development with foreign medical research institutions, so that Lao traditional medicine can go to the world as a national traditional knowledge.
Thailand: Classification protects traditional medicine prescriptions
Thailand has a well-established system for the protection of traditional medicine knowledge, with the establishment of a committee for the protection and promotion of traditional medicine knowledge, the establishment of a traditional medical school and the Thai Traditional Medicine Knowledge Development Fund, and the development of a plan for the protection of herbal medicines.
In 1999, the Law on the Protection and Promotion of Traditional Thai Medicine Knowledge was enacted and promulgated, which was the world's first special law for the protection of traditional medicine knowledge, which required the strengthening of the protection of traditional herbal medicines and medicinal plants. Thailand's Ministry of Health is responsible for the unified management of medicinal plants in the country, and no one is allowed to use them without government approval.
The Law on the Protection and Promotion of Traditional Thai Medicine Knowledge divides traditional medicine prescriptions into three categories: state-owned prescriptions, private prescriptions, and general prescriptions. A state-owned prescription refers to a prescription issued by the Ministry of Public Health, which enjoys exclusive rights, and the commercial production or research and development of state-owned prescriptions requires government permission, and criminal penalties are imposed for serious infringements. Private prescription refers to privately owned prescriptions, and the exclusive right of private prescription can last up to 50 years after the death of the inventor (consistent with copyright protection), allowing individual holders of private prescriptions to apply for registration, and not allowing the registration of collectively known traditional medicine knowledge. General prescriptions refer to prescriptions that have entered the public domain, are accessible to the general public, and are widely used. This prescription classification management system lays the foundation for the protection of traditional prescriptions, which can effectively prevent the improper appropriation of traditional prescriptions by other countries, and promotes the excavation and development of Thai folk medicine.
South Korea: Strictly control imports and develop the medicinal materials industry
South Korea has passed legislation to establish the equal status of Korean medicine and Western medicine, creating conditions for the development of traditional medicine.
In 2003, the Korean Medicine Incubation Act was enacted, which called for the development of oriental medicine to improve the health of the people. The Act encourages independent research and development of technologies in the medical industry to enhance international competitiveness. At the same time, the Korean Pharmacopoeia was formulated in accordance with the Strategic Resolution on Traditional Medicine 2002-2006 adopted by the General Assembly of the World Health Organization in 2003.
There are many traditional medicine products that have been granted patents in Korea. At present, most of the patents applied for in traditional medicine are compound preparation drugs and preparation methods of preparation drugs. The term of protection of ordinary invention patents is 20 years, while the term of protection of invention patents in medicine can be extended under certain conditions, the term of protection of utility model patents is 10 years, and the term of protection of design patents is 15 years.
As early as 1993, South Korea formulated the "Operation Policy for the Supply and Demand Regulation of Imported Chinese Medicinal Materials" to regulate the domestic market demand and protect the domestic traditional Chinese medicine industry. South Korea's Regulations on the Administration of Imported Pharmaceuticals require all imports of medicinal materials to be submitted to the Korea Food and Drug Safety Agency for quality inspection and filing with the Korea Pharmaceutical Import & Export Association (a private organization authorized by the government). South Korea should strictly inspect imported medicinal materials, ensure the quality of drugs through standardized management of traditional medicine products, require information such as drug names and quality origins to be marked on the packaging (mainly for the import of 36 foreign traditional medicines), and strictly control the quality of drugs.
Japan: Patent protection for methods used to prepare pharmaceutical products
Since the 70s of the 20th century, Japan has granted protection to the preparation methods and product inventions of medicines.
In 1976, Japan decided to grant patent protection for pharmaceuticals. At present, the main items of patent protection for pharmaceuticals in Japan include the protection of chemical substances, the protection of medicinal drugs of chemical substances, the protection of preparation methods used in chemical substances, the protection of the design of drugs, the protection of pharmaceutical machinery, the protection of medicinal plants and their extracts, the protection of biological products, and the protection of prescriptions of medicinal plant extracts (limited to the 210 Kampo medicines in ancient China).
One of the more distinctive features of Japan's intellectual property protection system for botanicals is the Kampo medicine protection system. Japanese Kampo Medicine and Japanese Kampo Medicine originated from ancient Chinese medicine, and the Japanese people have a tradition of taking Chinese medicine. At present, there are more than 20,000 kinds of Kampo preparations in Japan, and 233 kinds of formulas are included in the medical insurance drug price list. Japan attaches great importance to the research of Kampo preparations, most of which have clear ingredient standards, pharmacological studies and clinical efficacy data, and incorporate modern new technologies into the production process, and their products are eye-catching in terms of quality and appearance.
The term of protection for invention patents in Japan is 20 years, and invention patents in medicine can be extended under certain conditions. For utility model patents, the term of protection under Japanese law is 10 years, and there is no substantive examination procedure. The term of protection of a design patent is 20 years. Japan also has provisions on patent conversion, invention patents can be converted into utility model patents under certain conditions, and utility model patents can be converted into invention patents under certain conditions.
India: Preventing the misuse of traditional medicine knowledge
In order to prevent the misappropriation and misuse of traditional medicine knowledge, India has adopted a series of effective protection measures.
India collects and archives traditional knowledge of plants for medicinal and other uses that are already known to the public, and has established dozens of registries in various places to carry out "biological registries". In order to ensure that the intellectual property rights of herbal medicines that have entered the public domain are not infringed, a database of the Traditional Knowledge Digital Library has also been established, which contains 54 official works on traditional herbal medicine, 150,000 traditional medicines and more than 1,500 5,000-year-old yoga practices.
India's traditional medicines and yoga practices are very representative. In 2000, the Council of Scientific and Industrial Research of India found that 80 per cent of the 4,896 plant unilateral drug patents granted by the United States Patent Office were derived from knowledge of seven medicinal plants in India. Three years later, that number had grown to 15,000 in the US, UK and other patent offices, and in 2005 to 35,000. In this regard, India has strict requirements for new inventions in the newly amended Patent Act, as long as they have been published or used anywhere, they do not meet the novelty of the patent application, and the authority of the patent system is maintained.
In order to protect biological resources and traditional knowledge, India has also set up a special regulatory department to manage the collection, use and distribution of benefits of India's traditional resources in a unified manner to protect the rights and interests of the country.
Peru: Establishment of mechanisms for sharing traditional knowledge of indigenous peoples
Due to geographical, economic, cultural and historical reasons, Peru has not yet been able to popularize modern medicine, and about 30% of Peruvians rely on traditional medicine for treatment.
In Peru, there are about 5,000 species of plants with medicinal functions. The most prestigious Peruvian herbal medicine in the overseas market is called maca, which is a plant that grows on the plateau of the Peruvian Andes, and Peru uses maca as the main raw material to produce powders, capsules and various health care products sold in large quantities in the United States, Japan, Europe and other markets, bringing huge foreign exchange earnings. The Ministry of Agriculture announced that it would prohibit any unit or individual from exporting maca seeds, samples, roots, leaves, flower buds, and natural or only rough-processed raw products to foreign countries.
In 2002, Peru enacted the Law on the Protection of Indigenous Peoples' Collective Intellectual Property. The term "collective knowledge" refers to the accumulated and intergenerational knowledge of indigenous peoples and communities in relation to the nature, uses and characteristics of biological diversity. Collective knowledge is characterized by two things: first, it comes from indigenous peoples and communities, and belongs to indigenous groups rather than individuals; The second is that the knowledge is passed down from generation to generation and cannot be taken away or abandoned. In addition, it is subject to legal registration with the government.
According to the Law on the Protection of Indigenous Peoples' Collective Intellectual Property Rights, anyone who wishes to acquire collective knowledge for scientific research, commercial and other purposes must obtain the informed consent of the representative body of the indigenous peoples of collective knowledge. A license agreement is signed between the two parties with the consent of the representative office.
Source: People's Court Daily
编辑：Sharon