I. Protection Practices for Genetic Resources and Traditional Knowledge

The main problem in applying the IP system to protect the TCM industry is the lack of coordination and integration between TCM IP protection and the existing IP system in terms of subject characteristics and creative features. The broader context of this problem is that the coordination challenge between genetic resources and traditional knowledge on the one hand, and IP on the other, has remained unresolved for a long time. The concepts of “Chinese medicine” and “Chinese materia medica” within “Traditional Chinese Medicine” can respectively be included in the discussion categories of traditional knowledge and genetic resources. The IP protection of TCM is, at its root, a matter of protecting genetic resources and traditional knowledge, and exploration of this issue has been ongoing for many years.

(A) Institutional Practice in the International Community

As early as the last century, the international community began to explore the relationship between the acquisition and use of genetic resources and traditional knowledge and the IP system. Why has the international community long explored an IP issue that encompasses “Traditional Chinese Medicine”? First, although China’s TCM and Chinese materia medica are globally renowned, China is not the only country that uses animal and plant materials as medicinal sources and has summarized traditional knowledge for curing diseases. Before modern medicine, other countries also had practices of using animal and plant genetic materials as medicinal sources, thereby summarizing much traditional knowledge manifested in methods of using such materials. Second, relying on the rapidly emerging biotechnology of the 1970s, Western developed countries, guided by the traditional knowledge accumulated in major developing countries including China, have scientifically developed TCM genetic resources and then protected the developed products through modern IP systems such as patents and trademarks, thereby reaping huge benefits. For example, Japan has used TCM traditional knowledge recorded in ancient Chinese texts such as the “Treatise on Cold Damage and Miscellaneous Diseases” to develop hundreds of patents. South Korea has changed China’s Niuhuang Qingxin Pills from “pill form” to oral liquid and then applied for a patent. However, developing countries that have long preserved these genetic resources and accumulated this traditional knowledge, especially certain communities within developing countries, have not received any benefits from this process. This conduct of developed countries is also known as “biopiracy” or “biocolonialism,” which violates global distributive justice and hinders the realization of developing countries’ rights to existence and development. To balance this issue, foreign scholars began researching the integration of genetic resources, traditional knowledge, and the IP system as early as the 1980s and 1990s, and institutional efforts have also been made at the international level.

1. Convention on Biological Diversity

The Convention on Biological Diversity (CBD), initiated by the United Nations Environment Programme in 1992, requires developed countries, after obtaining biological and plant materials from developing countries and creating new products protected by the IP system, to find ways to provide corresponding benefits to the countries and communities that preserved the biological and plant materials and accumulated related traditional knowledge. These benefits should include priority access to the results and benefits of scientific R&D based on genetic resources, and should be conducted through consultation. This rule is internationally called “Genetic Resource Access and Benefit-Sharing Rules.” China is also an important party to the CBD. In May 2021, the 15th Conference of the Parties to the CBD was held in Kunming, Yunnan.

2. Nagoya Protocol

In 2010, relevant parties to the CBD adopted the “Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from Their Utilization to the Convention on Biological Diversity” in Nagoya, Japan. This detailed the system for accessing genetic resources and traditional knowledge related to genetic resources and sharing benefits, further institutionalizing principles such as national sovereignty, prior informed consent, and fair benefit-sharing under mutually agreed terms. Especially regarding non-monetary benefits, it identified methods for sharing technology development benefits, such as “joint ownership of relevant IP rights,” “sharing R&D results,” “coordinating, cooperating, and contributing to R&D programs in the genetic resource-providing country as far as possible,” “participating in product development,” and “enhancing technology transfer capabilities.”

3. Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC)

The CBD, the Nagoya Protocol, and other instruments have formally placed the issue of integrating genetic resources and traditional knowledge—including TCM—with the IP system before decision-makers of various countries. For this reason, the World Intellectual Property Organization also established the “Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC) ,” continuously exploring the integration of genetic resources and traditional knowledge protection with the IP system. The IGC is a forum for member states to discuss IP issues arising from access to genetic resources, benefit-sharing, and the protection of traditional knowledge and traditional cultural expressions. It aims to develop one or more international legal instruments for the effective protection of traditional knowledge, genetic resources, and traditional cultural expressions. Through reaching inter-state agreements, the IGC seeks to accurately define the meaning of traditional knowledge, genetic resources, and traditional cultural expressions; determine who the rights holders are; resolve conflicting claims among communities; determine what rights and exceptions should apply; and explore whether IP-type rights are suitable for protecting traditional forms of innovation and creativity. At the same time, through the IGC process, the status of genetic resources and traditional knowledge in the IP system is elevated, and traditional IP terms such as “protection,” “originality,” “novelty,” and “public domain” are reexamined.

4. Regional Comprehensive Economic Partnership (RCEP)

On November 15, 2020, the trade (commerce) ministers of the 10 ASEAN countries and five dialogue partner countries—China, Japan, South Korea, Australia, and New Zealand—jointly signed the Regional Comprehensive Economic Partnership (RCEP). In Chapter 11 on “Intellectual Property,” Section 7 lists “Genetic Resources, Traditional Knowledge, and Folklore,” essentially treating genetic resources and traditional knowledge as IP issues—a situation not seen in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

5. Practices of Other Countries

Driven by the international environment, Peru, India, Costa Rica, and other countries rich in genetic resources and traditional knowledge enacted relevant domestic laws in the early 21st century, covering areas such as “the scope of protection of traditional knowledge related to genetic resources,” “the objectives of the governance framework for traditional knowledge related to genetic resources,” “ownership of traditional knowledge related to genetic resources,” “prior informed consent system,” “definition of traditional knowledge related to genetic resources in the public domain,” “duration of rights for traditional knowledge related to genetic resources,” “registration of traditional knowledge related to genetic resources,” “forms and proportions of benefits for commercial development,” “procedures for成果 transformation and benefit-sharing methods,” “IP acquisition procedures and benefit-sharing forms,” and “third-party transfer for research or commercial use, exemption from approval.” These provisions are detailed and explicit.

(B) Domestic Institutions

It is precisely based on the conceptual foundation established by international institutional frameworks such as the CBD, the Nagoya Protocol, and the Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC), as well as the exploration of this issue by foreign academia, that this issue attracted widespread attention from Chinese scholars at the end of the 20th century and the beginning of the 21st century. At that time, universities such as the Chinese Academy of Social Sciences, Jinan University, Guizhou University, Guizhou Normal University, and South-Central Minzu University had IP scholars专门 conducting research on genetic resources and traditional knowledge.

In addition to research by the IP academic community, the China National Intellectual Property Administration (CNIPA), led by its Department of Treaty and Law, has for many years held the “Seminar on the Protection of Genetic Resources and Traditional Knowledge, ” coordinating representatives from the Publicity Department, the Ministry of Science and Technology, the Ministry of Ecology and Environment, the Ministry of Agriculture and Rural Affairs, the Ministry of Commerce, the Ministry of Culture and Tourism, the National Administration of Traditional Chinese Medicine, and universities and research institutes to jointly explore how to promote the protection, inheritance, and innovative development of China’s genetic resources, traditional knowledge, and folk literature through multiple measures. This seminar continued to be held even during the COVID-19 pandemic. In December 2022, within this framework, CNIPA and WIPO jointly hosted the “International Symposium on Intellectual Property and Traditional Knowledge and Genetic Resources” online.

China’s “Outline of the National Intellectual Property Strategy (2008)” and “Outline for Building a Strong Intellectual Property Country (2021-2035)” have continuously included genetic resources and traditional knowledge within the scope of IP strategic planning. On the basis of academic research and institutional discussion, in accordance with international documents such as the CBD and the Nagoya Protocol, and based on the “National Security Legislative Plan” and the State Council’s legislative work plan, the Ministry of Ecology and Environment drafted the “Regulations on the Access to and Benefit-Sharing of Biological Genetic Resources (Draft)” (exposure draft) in April 2017 and solicited public comments. However, no further progress has been made to date.

II. Insights for the IP Protection of Traditional Chinese Medicine

Genetic resources and traditional knowledge are characterized by the complexity and collectivity of rights holders and the historical inheritance of their formation process. The definition of TCM in China’s “Traditional Chinese Medicine Law”—a collective term for the medicine of all ethnic groups in China, including Han and minority ethnic groups, reflecting the Chinese nation’s understanding of life, health, and disease, and a medical and pharmaceutical system with a long historical tradition and unique theories and technical methods—reflects the similarity of TCM to genetic resources and traditional knowledge. Therefore, the research motivation and development history of domestic and international IP issues on genetic resources and traditional knowledge have positive implications for the current IP protection of TCM.

(A) The Root of the Dilemma in Protecting TCM Intangible Assets Through the IP System Lies in the Lack of Coordination Between the Two

First, the collective and shared nature of TCM intangible assets is incompatible with the certainty of IP rights holders. The prerequisite for applying the existing IP legal system to protect related objects is the certainty of the rights holder. Only when the scope of the rights holder is clear can the boundaries of rights and obligations be legally defined. The rights holders of genetic resources and traditional knowledge, including TCM, often manifest as subjects such as ethnic groups and indigenous communities, displaying group and regional characteristics tied to the historically inherited production or livelihood of specific regional groups. In particular, the discoverers of TCM medicinal materials and the methods of using TCM formulas are often difficult to ascribe to specific individuals or groups. They are typically the result of continuous exploration, practice, and accumulation by a group of people or several generations within a specific region, reflecting collectivity and shared nature.

Second, the relative openness and historical inheritance of TCM intangible assets are incompatible with the creativity and novelty requirements of IP. Under the current IP system, applying for patent protection requires the invention, utility model, or design to possess creativity, novelty, and practicality. Applying for copyright protection requires the work to be original. Applying for trademark protection requires the mark to be easily distinguishable, not conflict with prior rights, and be registered. Obtaining trade secret protection requires the information to be unknown to the public, have commercial value, and be subject to confidentiality measures.

TCM, in terms of its form of creation, involves历代 medical explorers continuously summarizing and refining the experience of their predecessors, based on long-term selection, domestication, cultivation, and accumulation of the medicinal properties of animals and plants. Related knowledge has developed through generations and is the crystallization of the experience, wisdom, and techniques of the Chinese people in their long struggle against disease. It is based on the use of traditional knowledge in the public domain, with innovations made by standing on the shoulders of predecessors. The relative openness and historical inheritance of TCM intangible assets are incompatible with the creativity and novelty emphasized by the IP system. Most TCM genetic resources and traditional knowledge and materials have been disclosed through literature. For example, China’s “Dictionary of Chinese Materia Medica” includes up to 5,767 types of Chinese medicinal materials, enabling foreign companies or other entities to freely use them and even apply for IP protection after innovation.

(B) The Dilemma of Protecting TCM Through the IP System Cannot Be Changed in the Short Term

The reform of old systems and the formation of new systems require long-term gaming, struggle, and compromise among different interest groups. The formation of different IP rights—patents, copyright, trademarks, geographical indications, trade secrets—and the achievement of international consensus have all gone through long historical processes. Even China’s several major IP systems can only be revised about once every ten years. The introduction of a new type of IP system requires a long period of exploration, trial and error, and coordination. For example, although geographical indications and trade secrets have been widely applied in administrative and judicial practice in China, there is still no unified legislation for either.

The IP system is one of the most international systems. Patents, trademarks, copyright, etc., all have international agreements. The operation of domestic IP systems cannot break through existing international frameworks. Changes to domestic IP systems usually require integration and coordination with the international system. The IP issue of genetic resources and traditional knowledge involves conflicts of interest between developed countries that hold the discourse power over modern IP systems and biotechnology, and developing countries. Therefore, even with the efforts of international organizations and agreements such as the IGC and RCEP, and active promotion by relevant domestic departments, it is not easy to achieve constructive results in the short term in integrating traditional knowledge and genetic resources, including TCM, with the IP system framework.

(C) TCM IP Protection Should Focus on Selectively Applying Existing IP Types

Precisely because of the fundamental difficulties in protecting TCM intangible assets through the IP system, there is currently no single type of IP right that can be directly对标 applied to TCM intangible assets. The most appropriate form of protection should be chosen within the existing IP system framework.

1. Emphasize Patent Applications for New Products and New Methods

Countries with advanced biotechnology, such as the United States, France, the Netherlands, Japan, and Germany, have been developing pharmaceutical and health products from genetic resources and traditional knowledge guidance of developing countries since the last century and protecting them with the IP system. Although TCM faces difficulties in patent grant, relying on modern biotechnology to extract TCM compound preparations from Chinese medicinal materials, discover new uses of TCM materials to form new formulas—the creation of new products—and improvements in methods for extracting, separating, and purifying active TCM ingredients, methods for preparing TCM preparations and their process steps, and processing and炮制 techniques for TCM materials are fully applicable to the patent system. Under the existing IP system unchanged, enterprises and research institutes should focus on new products and new methods, strengthening investment from strategic and institutional perspectives, and achieving patent breakthroughs.

2. Emphasize the Use of the Geographical Indication System

Within the existing IP system framework, the geographical indication system is closest to the protection needs of genetic resources and traditional knowledge. As an internationally recognized IP system, it has already broken through traditional IP requirements such as creativity, novelty, and明确 subject identity. Applying for a geographical indication requires that the product is a well-known, high-quality, or specialty product with distinct regional characteristics; the raw materials have natural regional attributes; the product is processed or produced in a specific region; the product has a relatively long production, processing, or natural history; and the product has stable quality. For TCM that meets the conditions for geographical indication, application for geographical indication protection should be actively pursued.

Currently, the existing systems for protecting origin through geographical indications include: the registration and protection system for “collective trademarks” and “certification marks” led by CNIPA based mainly on the Trademark Law; the “Geographical Indication Protection Products” registration and protection system led by the State Administration for Market Regulation based mainly on the “Provisions on the Protection of Geographical Indication Products”; and the “Agricultural Product Geographical Indication” certification and protection system led by the Ministry of Agriculture and Rural Affairs based mainly on the “Administrative Measures for Agricultural Product Geographical Indications.” These three tracks complicate the identification and management of geographical indications. Based on this, at a press conference held by the State Council Information Office on April 24, 2023, CNIPA Commissioner Shen Changyu introduced that specialized legislation on geographical indications would be accelerated, the two models of specialized geographical indication protection and trademark protection would be coordinated, and a unified geographical indication recognition implementation plan would be formulated to achieve a unified entry and exit for geographical indication recognition.

It should be noted that in practice, the applicant is generally a group, association, or other public interest organization. The applicant should have professional and technical personnel and professional testing equipment, and submit the approval document from the people’s government or industry competent authority governing the area indicated by the geographical indication. Therefore, although the characteristics of geographical indication rights make them naturally suitable for TCM IP protection, the initiative and capacity of enterprises or individuals in promoting geographical indication protection are weaker compared with patents, trademarks, and copyright, requiring active coordination and promotion by government agencies.

3. Emphasize the Use of the Trade Secret System

The Anti-Unfair Competition Law, the Criminal Law, the “Provisions of the Supreme People’s Court on Several Issues Concerning the Application of Law in the Trial of Civil Cases Involving Infringement of Trade Secrets,” and other laws and judicial interpretations form a relatively detailed system of trade secret protection. Applying the trade secret system requires that the relevant information is unknown to the public, has commercial value, and is subject to confidentiality measures. Compared with patents, trade secrets have a broad scope, encompassing information beyond technology, extending to business data such as customer and supplier lists, business plans, market research, and information strategies. Unlike the high examination standards and disclosure requirements of patents, trade secrets have lower protection costs, require no fees, consume no significant time like patent applications, and have no term limit.

Whether it is TCM with complex formulas and production techniques, unclear material structure of products, and products from which it is difficult to deduce the manufacturing process through reverse engineering, or TCM with lower technical content, certain know-how characteristics, and often just special dosing formulas, special processing techniques, or special material skills—all are suitable for trade secret protection. It should also be noted that since the subject of trade secret rights is often the enterprise itself, the protection of related business and technical information needs to be emphasized and promoted at the overall enterprise and organizational level, unlike the patent system which can be quantified to individual creative contributions. Therefore, consensus should be reached at the management level and implemented in accordance with legal provisions.

III. Conclusion

The ultimate goal of exploring IP protection for genetic resources and traditional knowledge beyond the existing IP framework is to create a new type of IP form centered on genetic resources and traditional knowledge. The IP protection of TCM should be integrated with the trends in genetic resources and traditional knowledge protection. The IP system is dynamic. Patents, copyright, trademarks, geographical indications, trade secrets, new plant variety rights, and the different functions within each right—these did not emerge simultaneously but entered the broad framework of the IP system in a sequential order with the development of industry and commerce. Although they each have their own characteristics, they share a common feature: they manifest as intangible information. Therefore, it is possible to incorporate them into the IP system without eroding its foundation.

Compiled from the speech outline at the “Key Unit Discussion Meeting on TCM IP Protection” on July 10, 2023.

References:

[1] Zhao Wei: “Research on the Innovation of Genetic Resource IP System from the Perspective of Justice,” Doctoral Dissertation, University of Science and Technology Beijing, 2022. [2] Xu Jiali, Zhao Wei: “Beyond Intellectual Achievements: Attribute Conflicts and Compatibility Between Biological Genetic Resources and Intellectual Property,” Social Science Journal, 2020, Issue 5. [3] Qi Jiangang: “Analysis of Problems and Countermeasures in China’s TCM IP Protection,” https://mp.weixin.qq.com/s/2PJcxfbGtIpk-ogc7LTBfg, accessed July 9, 2023. [4] Deng Heng, Yang Xue: “Legal Protection of Traditional TCM Knowledge: Model Selection and System Design,” Medicine and Jurisprudence, 2023, Vol. 15, Issue 2. [5] Li Shilin et al.: “Research Report on the Development of TCM IP Protection,” https://mp.weixin.qq.com/s/Mu-HJBUJW5C7r17Nj4xoUg, accessed July 9, 2023. [6] Chen Douran: “Remedial Pathways for Tort Liability for TCM Technology Trade Secrets,” https://mp.weixin.qq.com/s/nIwX4Tnjm6F4bGVe6LmztA, accessed July 16, 2023. [7] “Opinions of the Supreme People’s Court on Strengthening Judicial Protection of TCM IP” (Fa Fa [2022] No. 34).