Value Examination and Risk Regulation of the Technical Secrets Protection of Traditional Chinese Medicine

Bian Xianyin Wang Jinjin

Abstract： The Intellectual Property （IP） rights system protecting modern medicine is based on western science and technology， with western medicine as the main object of protection， and patent protection as the core means. This patent protection system does not fit the theoretical system of traditional Chinese medicine （TCM）， so when dealing with the protection of TCM IP rights， problems arise if TCM rights holders rely on that patent system. In contrast， the protection of technical secrets， which has been behind the patent system for a long time， can effectively make up for the insufficiency of the traditional IP protection system with patents as the core. Such protection has become the new normal in the protection of TCM property rights. However， the protection of technical secrets also has inherent shortcomings and conflicts with the information disclosure system involving the public interest of the society， so it faces difficulties in realizing the protection of TCM technical secrets. This article reviews the unique value of the protection of technical secrets in the field of TCM IP rights protection， seeking solutions for the dilemma of TCM technical secret protection， and providing ideas for constructing and perfecting TCM technical secret protection from a legal perspective.

Key words： TCM technical secrets; risk regulation; legal protection

CLC：F 270          DC：A               Article ID： 2096-9783（2021）03-0137-12

1 Introduction

Traditional Chinese medicine （TCM） is one way that China extensively participates in international competition in the field of biomedicine. China has the innate advantages of extremely valuable biological resources and the crystallization of extremely broad national wisdom. China's Traditional Chinese Medicine Law defines TCM as "including medicines of Han and ethnic minorities". TCM， as a  collective name for the medicines of all ethnic groups in mainland China， is a medical system that reflects the Chinese nation's understanding of life， health， and disease， and has a long history and tradition including unique theories and techniques. TCM has always been responsible for the great mission of the physical and mental health， survival， and development of the Chinese nation and its people. TCM has also faithfully recorded the rich experience of fighting diseases for thousands of years. More than 100 000 prescriptions of TCM are recorded in the vast sea of TCM. Even today， there are countless single prescriptions， secret prescriptions， and proven prescriptions that are widely used. It can be said that Chinese medicine is the life and health of Chinese people[1].

At the beginning of 2020， a new coronavirus epidemic swept the world. The COVID-19 pandemic belongs to the category of "epidemic" in Chinese medicine. Plagues have always been part of human history and China is no exception. In the historical records of China， the record of plagues were not extensive， but they have left their mark in a long historical process[2]. From the Western Han Dynasty to the late Qing Dynasty， China had at least 321 large-scale plagues. It is precisely because of the intervention of TCM that the Chinese nation has been saved dozens of times from plagues. Therefore， valuable experience in prevention and treatment has been gained from such disasters.

Today， in the process of prevention and control of COVID-19， Chinese medicine has also played an important role. Through the combination of clinical diagnosis and disease differentiation of COVID-19， a series of Chinese medicine treatments with positive therapeutic effects have been found， especially through clinical screening. These include the "three medicines and three prescriptions". The "three medicines" are three Chinese patent medicines： Jinhua Qinggan granules， Lianhua Qingwen granules and capsules， and Xuebijing injections. The "three prescriptions" refer to the Qingfei Paidu Decoction， the dampness decoction， and the Dufang and Xuanfeibaidu prescription. These treatments have effectively shown that patients turn from critical to health time and time again. Adding a powerful traditional medicine weapon to combat the global epidemic prevention and control and once again demonstrating the unique value of TCM in the fight against disease.

The intellectual property （IP） protection system is built around the patent system as its core. Chinese medicine patents are the main types of modern Chinese medicine needing IP protection. Western IP systems， based on the legal concept of patents， are difficult to simply integrate with the characteristics of the theoretical system of TCM. The contradictory elements of TCM and Western patent systems laid a stumbling block for the protection of Chinese medicine property rights. According to statistics， from 2002 to 2008， the actual number of Chinese medicine patent applications approved accounted for 51.58% of the total number of Chinese medicine applications; moreover， only 15.33% of the patent applications were approved[3]. Nearly half of the Chinese medicine patent applications failed to enter the substantive examination stage. Compared with the general patent authorization rate， the TCM rate is very low， mainly concentrated in the methods of TCM preparation.

TCM IP protection by patents has proven difficult， but the State Administration of TCM's survey of 120 key domestic Chinese patent medicine companies shows that 61.8% of 401 kinds of Chinese patent medicines are protected by means of technical secrets[4]. The technical secret protection system can effectively protect the property rights of Chinese medicine and bridge the gap between the subject and object of the property rights of TCM. To protect its core TCM technical information， the rights holders of China's "Pneumonia No. 1 Recipe" widely used in the prevention and treatment of COVID-19 did not apply for patent protection. Doing so would require them to disclose the composition and ratio of Chinese medicine ingredients， so they chose to abandon patent protection and keep their technical secret. Secret protection means to hide from public knowledge the high-value prescription composition and active pharmaceutical ingredients （API） compatibility method. In this context， the protection of TCM technical secrets has gradually become common practice.

2 The Origin of the Problem of TCM IP Protection

In choosing the protection system for TCM IP rights， there are mainly two paths： traditional patents and technological secrets; these two main systems use radically different strategies. In China's Patent Law， most of the drug protection clauses have been borrowed from foreign laws and regulations to protect western medicines. The protection afforded to western medicines by the patent system is difficult to apply to Chinese medicines because they have different theoretical systems. Patent protection has a vacuum in the field of Chinese medicine.

The prominent problem is that the acquisition of patent rights has high standards and strict requirements for novelty， creativity， and practicality， and the scope of protection has difficulty fully covering the technical knowledge system of TCM. To get a patent， the rights holder must bear the burden of patent information disclosure， which brings the potential risks of counterfeiting and infringement. At the same time， much TCM knowledge has entered the public domain， making it difficult to apply for patents， including but not limited to classic Chinese medicine prescriptions. Traditional knowledge of Chinese medicine still plays a role in preventing and curing diseases in modern society， but it is not protected because of the loss of patentability. After the resources of Chinese medicine become known abroad， they are developed as "foreign Chinese medicines" and sold back to China[5]. After these traditional cures are changed by western researchers， the adapted medicines are patented. This practice threatens biological resources and causes huge economic losses for China.

2.1 Difficult to Meet the "Three Characteristics" Requirements of Patents

As the core property rights protection system， patents have a sufficient development history and mature legal framework. In principle， patents require three elements： novelty， creativity， and practicality. In the field of Chinese medicine， the current academic circles generally tend to strictly examine patents following the "novelty， creativity， and practicality" examination standards to ensure the quality of Chinese medicine patents. This puts higher requirements on Chinese medicine patent applications. The granting of rights has brought difficulties.

TCM attaches great importance to the source， production， and proper compatibility of Chinese medicine. TCM relies on the natural properties of Chinese medicinal materials and the unique diagnosis and treatment methods of Chinese medicine to play its role in curing diseases and saving people. In contrast to Western medicine， Western medicine emphasizes the "essence" of life activities in the human body. Also， in "basic" research， Western medicine attaches importance to modern theoretical foundations such as anatomy， biochemistry， pathology， pharmacology， and clinical research[6]. This has led to the fact that the drug patent protection system， which originated from Western medicine protection， is difficult to simply apply to TCMs that are based on a significantly different worldview. The demand for novelty， creativity， and practicality of the products to be patented makes it a difficult process for Chinese medicines.

From the point of view of novelty， many classic prescriptions in the field of Chinese medicine are mostly recorded in classics， which are "publicly published in domestic and foreign publications"; thus， these prescriptions do not meet the novelty criteria. From the point of view of creativity， Chinese medicine is mostly based on previous results being improved by varying the composition of the API and increasing or decreasing the dosage， without departing from the basic prescription of the predecessors. The predecessor is not a recent invention or creation， so it is difficult to prove that the variation has brought significant progress. From the perspective of practicality， it is difficult for TCM medical compatibility methods and diagnosis and treatment technologies to be applied on a large scale and industrially replicated， and proving a uniform efficacy of Chinese medicine is difficult. This happens because Chinese medicine has the characteristics of personalized medicine; even for the same disease， doctors may use different prescriptions for different patients. Moreover， even for the same person， due to seasonal changes or different stages of disease treatment， the prescription will also change accordingly.

2.2 Risks of Imitating Patent Information Disclosure

The acquisition of exclusive rights for patents comes at the cost of disclosure of technical details. China's Patent Law requires applicants to first publicly disclose and then verify and review the authorization preconditions. Patent applications need to meet the conditions for early disclosure， which means The State Intellectual Property Office must disclose the details of the Chinese medicine product application during the examination process， including the specific formula， composition， and production process of the Chinese medicine. Once the rights holders of many ancient TCM recipes and compound preparations disclose their technical secret information， they face the risk of imitations before obtaining the patent. Such imitations may be based on the existing formula composition but contain certain non-core changes. The addition， subtraction， or substitution of some drugs has little change in efficacy. TCM rights holders typically cannot compare the technical characteristics of their product and the infringing product， so it is difficult to determine whether it is infringing， leading to the fundamental loss of technical secrecy and causing serious economic losses.

At the same time， the technical information disclosed in rejected applications has become public and lost its original value. Another issue is the short protection period of patent rights; invention patents generally last for 20 years， while utility patents last only one decade. After the expiration of the protection period， the patent immediately enters the field of public knowledge， the rights holder no longer has exclusive rights， and the technical secrets of the TCM will be completely lost. This is a vital concern for Chinese medicine rights holders， making them hesitant to choose patent protection. Therefore， many Chinese medicine rights holders are not willing to even apply for patent protection.

2.3 TCM Resources Encountered Overseas Biopiracy

In the current paper， biological plagiarism refers to the use of a nation's first-mover advantages by people in other countries. For example， multinational companies， in the wave of economic globalization， carry out long-arm intervention and malicious plagiarism of genetic biological resources in developing countries. The patent system is supposed to prevent plagiarism of biological resources， but it has been abused so that medical developments have become the "original property rights" of the plagiarists of biological resources. With the exclusive advantages provided by the patent system， such plagiarism has continuously misdirected benefits all over the world. A famous case of biopiracy was the dispute between the United States and India over the "Neem Tree" [7]. Neem is a biological medicinal resource widely used in Indian traditional medicine; the plant is known as the "Blessing Tree" by Indians. American companies have extracted medicinal ingredients from India's traditional genetic resources， bypassing the original rights holders of the resources， and applied for patent protection overseas. This disrespect for the ownership of the biological resources by the country of origin has been intensively opposed and resisted by people in developing countries.

The traditional knowledge used in Chinese medicine is difficult to prove novel， and so it cannot be protected by patents. Companies and organizations in some developed countries take advantage of this and give full play to their strong technical advantages to carry out secondary development of well-known Chinese medicine technology or Chinese medicine formulations. On the basis of applications for patents， exclusive development， use， and licensing are carried out， and high profits can be obtained from it.

We provide the following four examples： First， the "Herbal Composition and Its Application in Chemotherapy" patent filed by Yale University in the United States is for a product derived from the Huangqin Decoction in the ancient Chinese medical classics "Treatise on Febrile and Miscellaneous Diseases" [8]. Second， Japanese scientists have used modern scientific methods to analyze classic Chinese medicine products. The 269 prescriptions recorded in Treatise on Febrile Diseases and Synopsis of the Golden Chamber have been systematically studied. More than one hundred of these commonly used prescriptions were made into medicines according to the original prescriptions; related patents were granted， and huge benefits were obtained[9]. Third， a research institute in Korea developed a composition for relieving hangovers as well as preventing and treating osteoporosis based on the "Shuanghe Decoction". The institute applied for and obtained patent authorization in China. Fourth， a proven prescription for the treatment of eczema in China was plagiarized by a British plant technology company[10]. On this basis， a patented new drug was developed， which achieved sales of several billion yuan in the 1990s.

3 The Institutional Rationality of TCM Technical Secrets Protection

The technology secret protection system has long been ignored by people under the dazzling aura of the patent system. However， in the field of IP protection of Chinese medicine， the technology secret protection system has unique advantages. It adopts a system design contrary to patents. The acquisition， coverage， and time and space restrictions of property rights are more in line with the development of the Chinese medicine industry and the protection demands of the rights holders. Whether it is the spread of secret recipes related to TCM since ancient times， or the innovation of TCM preparations based on classic recipes in modern society， the protection of technological secrets has become the preferred method of IP protection. According to data from the national administrative department of TCM， 60% of key Chinese patent medicine pharmaceutical companies currently protect technical information in the form of technical secrets， and effectively make up for the lack of patent protection by virtue of this system's advantages.

3.1 Theoretical Examination of TCM Technical Secrets

3.1.1 Definition of TCM Technical Secrets

Technical secrets are a type of business secrets， also called "know-how". Technical secrets of TCM comprise technical information that is secret， valuable， and confidential. The origin of ancient commercial secrets originated from the Roman law， and the modern commercial secret system originated from the law of the Venice city-state[11]. At present， due to the differences in legal culture and legal systems between countries and relevant international organizations， there is no unified understanding of the concepts and rights of trade secrets and technical secrets on a global scale. The United States adopted the First Restatement of the Tort Act to define the overall definition of trade secrets， and then adopted the Uniform Trade Secrets Act to define technical secrets in the form of enumeration. Germany's Anti-Unfair Competition Act did not provide a comprehensive definition of trade secrets. A special definition of "trade secrets"， according to the German Federal Court and its doctrine， refers to all information related to business that has the properties of confidentiality and legitimate economic interest. The International Chamber of Commerce believes that proprietary technology refers to the realization of economic purposes， and the technology and the secret technical knowledge necessary for its actual achievement. Article 39 of the TRIPS Agreement summarizes trade secrets as "protection of undisclosed information". China has fully referenced the definition of technical secrets by major countries in the world， and the newly revised Article 9 of China's Anti-Unfair Competition Law stipulates that "trade secrets refer to technical information and business information that are not known to the public， have commercial value， and have been subject to corresponding confidentiality measures taken by the rights holder". This stipulation requires the information to meet the requirements of confidentiality and value.

3.1.2 Legal Attributes of Technical Secrets of TCM

Regarding the legal attributes of technical secrets and TCM technical secrets， many theoretical controversies have arisen in theoretical circles in the early years， mainly summarized as the theory of property rights， IP rights， and the theory of personal rights. In recent years， cognition has gradually moved from mutual academic and conceptual disputes. The unified understanding is that technological secrets （rights） are special IP rights， and they are also connected with the concept of property rights in a broad sense. The core of the theory of property rights is to treat technical secrets as an intangible property with value and use value， capable of being possessed， used， profited from， and disposed of. The theory is mainly used to protect technical secrets through property law and IP law， preventing infringement on technical secrets. The remedy for civil protection can use both the liability for breach of contract and the liability for tort， which can provide relief to the technical secret rights holders to the greatest extent. Because of this， in the 1990s， the TRIPS Agreement officially included "undisclosed information" into the category of IP rights for protection， and the protection of technological secrets was regarded as property （specifically regarded as special IP rights）; this idea began to be recognized throughout the world[12].

The original technical secrets of TCM were all attached to the practitioners themselves and were inseparable from the practitioners. With the process of technical objectification， more and more TCM technical secrets became free of personal dependence and became independent transactions in the market. The "property" of Chinese medicine[13]， especially the prescriptions， compatibility methods， and preparation techniques of Chinese medicine， directly reflect the IP attributes of Chinese medicine technical secrets.

3.1.3 Elements of TCM Technical Secrets

According to Article 9， paragraph 3 of China's Anti-Unfair Competition Law， China's law adopts the "three essentials" theory for the constituent elements of commercial secrets， namely， secrecy， value， and confidentiality. Similarly， these three characteristics are also the fundamental features and constituent elements of the main types of technical secrets in trade secrets.

The secrecy of TCM technical secrets is the core component and the most significant feature that distinguishes it from other IP systems. Secrecy requires that the holders of TCM technical secrets keep the technical information in a state of confidentiality， unknown to others. This secrecy is "relative" rather than "absolute"; it contrasts to publicly known information. That is， this kind of information cannot be obtained from public channels， so it is considered to be secret. In the field of TCM， there are many TCM diagnosis and treatment techniques and preparation methods recorded in the form of secret prescriptions. Many of these are passed down in a secret manner. They reflect the self-protection consciousness of medical practitioners regarding their technical secrets.

The value of TCM technology secrets refers to the actual or potential economic benefits or competitive advantages that can be brought to the rights holders through TCM technical secrets. Value is the fundamental reason for the protection of TCM technical secrets， including actual value and potential value. It is also the basis and prerequisite for measuring and evaluating TCM technical secrets.

The confidentiality of TCM technical secrets refers to a requirement that reasonable protection measures be adopted by the rights holder of the TCM technical secrets to prevent information leakage. In other words， the rights holder must be making an effort to keep the information secret. The confidentiality measures should suit the commercial value and other specific circumstances. It is an objective means to measure the inherent desire to reasonably protect technical secrets. Many TCM technical secrets are kept secret by the master-disciple inheritance method that relies on the memory of the parties and clinical practice to master， so that learners can encounter the TCM theory and practical technical operations as soon as possible. This kind of interaction between masters and apprentices is personal and meets the requirement for confidential communication of the secret. The feature of contextualization， the transfer of knowledge and technology， is achieved through close contact and mutual exchanges between individuals[14].

3.1.4 Scope of Protection of TCM Technical Secrets

China's courts and relevant administrative authorities have been working hard to explore clear definitions of trade secret protection objects. In 1995， the State Administration for Industry and Commerce "Regulations on the Prohibition of Violations of Trade Secrets" and the Supreme People's Court "Regarding Trial Techniques： Interpretation of Several Issues Concerning the Application of Law in Contract Dispute Cases"， and the 2007 Supreme People's Court "Interpretation of Several Issues Concerning the Application of Law in the Trial of Civil Cases of Unfair Competition" delineate the scope of protection of technical secrets. These documents address design， procedures， product formulations， production technology， production methods， and technical solutions. The definition covers products， processes， materials， and improvements made using scientific and technological knowledge， information， and experience.

In TCM， the scope of technical secret information refers to the technical knowledge that people obtain from practical experience or skills in the production and manufacturing of the medicine， including but not limited to TCM formulas， production processes， processing techniques， diagnosis， and treatment technology. Some TCM formulas or prescriptions have been published， appearing in the form of text or books. However， using most TCM formulas or prescriptions requires unpublished information such as the composition of the relevant medicines， their preparation methods， and the proportions of various medicinal ingredients; these parts of the technology are still held firmly in the hands of its rights holders. This is where the secrecy of TCM technical secret information lies， and this is also related to the protection scope of TCM technical secrets.

3.2 Value Review of TCM Technical Secrets

The inheritance of IP rights of TCM through the technical secret protection system has been a rational choice for Chinese medicine rights holders since ancient times. TCM has a long history of development and a complex system. Many methods related to disease treatment are passed on from generation to generation through oral teaching and teacher-apprentice teaching. The training is coupled with the influence of traditional inheritance concepts， passed on by famous TCM doctors. The secrets of the proven treatments are not proven through long-term clinical trials， and their excellent curative effects may not be disclosed; they are only passed on through the family， paying attention to the protection of exclusive skills or formulas[15]. It can be seen that the value and advantages of the protection system of TCM technical secrets compared with the protection of the patent system are very significant.

3.2.1 Efficient and Safe in Obtaining Rights

At present， TCM resource rights holders typically prefer the protection of technical secrets， benefiting from the superiority of the technical secret protection system， rather than any patent protection system. The acquisition of the right to secrets of Chinese medicine technology does not require any departmental approval or registration， which circumvents the time limit of the review cycle. Its advantages in obtaining rights are very attractive to Chinese medicine companies， especially small and medium-sized companies.

On the one hand， the theory behind TCM technology is difficult to understand， and when the method of inheritance is special， the "novelty， inventiveness， and practicality" conditions required by patent protection do not apply to technical secrets. Thus， the technical secrets of TCM do not require disclosing the content of the rights. The novelty and creativity of TCM， which is difficult to prove with Western medicine theory， can still be protected as technical secrets. On the other hand， some technical information about TCM has outstanding， advanced， and novel characteristics. For a considerable period of time after the discovery of such information， others cannot conduct independent research and development on the secret because they lack a starting point. In this case， a patent application， requiring enough information to give competitors a starting point， has the potential for huge economic risks caused by technology leakage. Therefore， the protection of technical secrets is more appropriate.

3.2.2 Break the Limit on the Protection Time

China's Patent Law clearly stipulates the approval time and duration of patent rights for three types of IP. The length of the term is positively related to the degree of innovation of the patent object. In contrast， there is no certain limit on the protection period of TCM technical secrets; as long as they remain confidential， they are in the protection period. In theory， the TCM rights holder can exclusively possess the technical information indefinitely， as long as reasonable confidentiality measures are taken to keep the valuable technical information unknown by the public. TCM is China's traditional medicine， and some TCM techniques have been passed down for millennia. Considering TCM's long history compared with the 20-year patent protection period of public technical information， the long-term protection of the technology secret system seems preferable. The first-class protected varieties of TCMs such as "Yunnan Baiyao" and "Pien Tze Huang" have been protected by means of technical secrets， and these could even be considered state secrets that continue to this day.

3.2.3 Comprehensive Coverage in the Scope of Protection

Compared with the protection of patents and drug varieties， the protection system of TCM technical secrets covers a wider scope. As long as the objects of protection are confidential and valuable， and protection measures are taken for the parties， the technology secrets system can be applied and be recognized by the law. In particular， the technical secrets of TCM often affect the rights holder's strategic choice of the IP protection system. Considering the novelty and creativity， the composition of a TCM formula is very complicated， and it is difficult to crack or develop Chinese medicine preparations through reverse engineering and independent invention. The processing technology has special requirements， and the formulas and techniques with core economic value in the preparation process of TCM products， or the diagnosis and treatment methods of TCM， are all suitable for the protection of technical secrets.

4 The Paradox of Implementing the Protection of TCM Technical Secrets

The protection of TCM technical secrets has become an important system choice for the protection of TCM IP rights. However， examining the means of protection of technical secrets itself， there are paradoxes and difficulties in application and implementation： TCM IP rights do not require disclosure of technical information when technical secret protection is chosen. However， the regulators and consumers of TCM have the right to require the rights holders to make necessary disclosures. The protection of technical secrets gives IP rights based on secrecy， value， and confidentiality， but for the good of society， it cannot exclude all independent inventions and verification by third parties[16].

4.1 Unpredictable Risks of Leakage

In protecting technical secrets of TCM， there are mainly two aspects of technical secret leakage risks. First， the rights holders of TCM technical secrets themselves have not universally realized the importance of technical secrets due to poor confidentiality measures and weak awareness of confidentiality. Those seeking protection must adopt a reasonable degree of confidentiality measures， and in some cases， the economic benefits of technical secrets have been wiped out because of the negligence of the rights holder. Moreover， illegal acquisition， use， and disclosure of protected technical secrets frequently result in deliberate infringement of the technical secrets of the rights holder. Even authorized users of the secret may exceed the agreed scope of authorized use， violating the contract's principle of good faith and the obligation of trust to protect technical secrets. In particular， in the absence of a confidentiality agreement and other constraints， in-service employees may even take risks in the face of powerful or rich interests and disclose the core information of the company to the outside world. At the same time， China's drug regulatory authorities have access to TCM technical information in the process of reviewing TCM drugs， but China's Anti-unfair Competition Law only requires governments at all levels to take measures to stop unfair competition and create a good environment for fair competition. The environment and conditions do not stipulate the government's confidentiality obligations.

4.2 Hard to Fight Reverse Engineering and Independent Invention

"Reverse engineering" is clearly defined in the Chinese Supreme People's Court's "Interpretation of Several Issues Concerning the Application of Law in the Trial of Unfair Competition Civil Cases". The term refers to the disassembly， surveying， mapping， and analysis of products obtained from public channels through technical means. Such analysis obtains technical information about the product. Reverse engineering and independent invention can promote the advancement of medical technology， and this is recognized and encouraged by law. However， these acts themselves will break the confidentiality of technical secrets and cause the termination of the right to technical secrets. The protection of technical secrets is soft and nonexclusive. Under the premise of obtaining it lawfully， multiple subjects may simultaneously master the same technical secret. Some effective but simple TCM products are relatively easy to reverse engineer and then imitate， thereby obtaining the core technical components， which leads to the loss of the value of the property rights of the rights holder.

4.3 Conflicts with the Public Interest Defense Rules

The Public Interest Defense Rules is to proceed from the protection of national interests， social order， and the legitimate rights and interests of the general public. In the interest of the public， the law can require the owners of technical secrets directly related to the above-mentioned interests to actively accept legal supervision and undertake necessary disclosure obligations， so as to prevent violations. Misuse of technical secret rights causes harm to the public good. Thus， a conflict exists between open and undisclosed information in the legal relationship of rights and obligations between the rights holders of TCM technical secrets， regulatory authorities， and consumers. This situation is covered by the conflict model of public interest defense rules[17].

Conflicts with the public's right to know： It is reasonable for the technical secrets of TCM to be protected， but it is also an established fact that consumers' right to know is severely damaged. TCM companies may refuse to disclose drug information， and this ignorance may cause harm to consumers. Lawsuits are triggered because of infringement of consumers' informed consent. The conflict between the rights holders of TCM technical secrets and the public's right to know is prominently manifested in the contradiction between TCM producers' protection of technical secrets and consumers' major concerns about the diagnosis and treatment of TCM products related to personal life and health. For example， Yunnan Baiyao has been taken to court twice because the Chinese version of the product description does not indicate the ingredients and content of the ingredients， while the US version of Yunnan Baiyao listed each of the main ingredients[18]. Both lawsuits were rejected on the grounds that the Yunnan Baiyao formula was a national top-secret Chinese medicine.

Conflicts with the disclosure requirements of the drug regulatory authorities： Due to the authorization management behavior of the relevant laws and administrative regulations on the supervision of TCM， the Regulations on the Implementation of the Drug Administration Law gives the regulatory authorities the ability to require the Chinese medicine companies to disclose drug information based on the need to maintain social welfare. Provisions also exist for the disclosure of technical information. In addition， the Regulations on the Disclosure of Government Information also require the administrative supervisory authority to have a significant impact on the public interest， which can require limited disclosure of TCM technical secrets to specific groups.

5 Risk Regulation of TCM Technical Secret Protection

5.1 Combination of Technical Secret Protection and Patent Protection

A patent is the most effective means to protect inventions and creations because it has the strongest exclusivity and is a rigid system. Compared with the patent system， the technical secret system has the characteristics of recessive and weak rigidity， but it is suitable for protecting TCM technologies that are not easily cracked. The two protection modes each have advantages and disadvantages， and they can be combined to protect the IP rights of Chinese medicine.

Case 1： The protection of technical secrets is dominant， and the protection of patents is supplementary. In this case， the IP rights contained in Chinese medicine can be divided according to commercial value and importance， and the advantages of the patent system and the technical secrets system can be protected by supporting them. This allows rights holders to combine key offense and defense ideas. When certain technical information of TCM has an obvious dominant position and a high degree of novelty and creativity， we recommend that the rights holder adopt technical secret protection methods， strictly avoid the disclosure of core secrets， and take advantage of the superior position brought by technological advantages. The remaining non-core technical information can be protected by open patents， so that the exclusive possession of patents can be used to exclude others' reverse engineering and independent inventions from harming the value of TCM technical secrets.

Case 2： Patent protection is dominant， and technical secret protection is supplementary. The modernization of many TCM products is particularly inadequate. Most of them rely on a certain recipe or secret recipe to make simple improvements， so it is difficult to achieve a detailed grasp of the efficacy of such medicine at the micro level. Although such TCM products have unique and good effects in treating certain types of diseases， their "simplistic" preparation techniques are very easy to reverse-engineer and technically plagiarize. In this case， the products should be presented as meeting the requirements of patent novelty， creativity， and practicality. Most of the technical information required in the patent application actively applies to the patent protection， thereby excluding others from reverse-engineering the TCM product. At the same time， in order to avoid the loss of technical secrecy due to the disclosure of information required by the patent application， the technical secret system can be used to protect the most critical components and techniques.

Combing the techniques， as shown above， can achieve full control of the IP rights of the Chinese medicine. Consider， for example， the IPR protection strategy of "Pneumonia No. 1 Formula" used in the prevention and control of COVID-19. The treatment， though widely used， has never been fully disclosed in terms of the formulation of the API and its dosage. Secrecy is used to protect its core formulation， thereby avoiding information disclosure， loss of confidentiality， and counterfeiting. At the same time， the rights holder has applied for patents to cover the corresponding dosage form， preparation method， and pharmaceutical use of the composition， as well as the effective ingredient and its extraction method， new preparation method， and mixing method. This patent protection encourages in-depth research to be conducted on new dosage ratios and uses related to COVID-19[19].

5.2 Coordination of Technical Secret Protection and Information Disclosure

When comparing the protection of technical secrets of TCM IP rights with the consumers' right to know， the two are equal powers. The resolution of conflicts lies in following the country's TCM-related laws and administrative procedures. The disclosure principle of the regulations stipulates that the most important consideration is whether the disclosure of relevant TCM technical information involves the protection of the consumers' right to life and health.

If the medicinal ingredients of a certain compound or preparation contain toxic pharmacology， which is substantially or potentially harmful to human health， the rights holder should specify those ingredients' use， incompatibility， method of use， and adverse reactions that are likely to occur. The relevant information should be truthfully disclosed. In contrast， when the protected core technical secret information of TCM required by consumers has no important connection with the protection of social welfare and the maintenance of consumers' lives and health， the relevant rights holders should be allowed to keep their technical secrets. They may refuse to disclose relevant information. Therefore， the law must take into account the interests of both parties and seek a balance between the right to have secret technology and the consumers' right to know. A limited derogation of the right to know is the key to solving the problem.

Based on the above-mentioned principle of related interests and balance of interests， the conflict between the confidentiality of TCM technical secrets and the public welfare requirements of technical information disclosure can be coordinated. A nonpublic disclosure system can be established in accordance with the law to disclose the secrets to only specific groups within a priority range. This compromise can protect the rights holders of TCM technical secrets， allowing them to realize their economic interests in social production. It is not necessary for the industry or the public to know the secret if it is known by a specific person who verifies public safety. The information is still confidential and still retains the nature of a technical secret. Possession rights can be maintained while also meeting the administrative function needs of the statutory Chinese medicine regulatory department and protecting the right to know of the Chinese medicine consumer group. However， limited disclosure may reduce the effectiveness of the disclosure of information. At the same time， the administrative department must strictly abide by the obligation of good faith and trust after obtaining technical information， and it must keep the technical secrets of TCM enterprises confidential.

5.3 Combination of Technical Secret Protection and Traditional Knowledge Benefit-sharing

Intellectual Property Achievements of TCM： compounds of TCMs， proprietary Chinese medicines， and other products with relatively strong patentability can be protected by the patent system. For secret recipes， special processing methods， and disease diagnosis and treatment know-how in the field of TCM， the rights holders prefer technological secrets for protection. TCM prescriptions have been recorded in TCM medical classics for thousands of years， and some have become TCM knowledge in the public domain of Chinese society. Facing the reality and potential value of domestic knowledge of TCM， there is no corresponding law to provide special protection for such TCM medicinal knowledge. This places some TCM knowledge in the category of "public resources"， subjecting it to legal infringement[20].

Organizations in some developed countries derive huge benefits from the current international IP system. They make use of the IP system's weaknesses related to the protection of traditional medicine knowledge to develop and utilize traditional resources originating in other countries. IP rights granted in these circumstances force developing countries with relatively backward technology and economy shoulder the obligation to protect the IP rights of developed countries. At the same time， the traditional resources handed down by the developing country's ancestors are used by developed countries for free; this is international biopiracy.

China's Traditional Chinese Medicine Law stipulates that rights holders of TCM knowledge have the right to share in the benefits regarding the development and utilization of that knowledge. To establish and improve the benefit-sharing mechanism of TCM knowledge， it is necessary to follow the principle of benefit-sharing in the Convention on the Conservation of Biological Diversity and the Nagoya Agreement[21]. These agreements cover traditional knowledge related to genetic and biological resources， requiring the user to respect countries or communities that possess traditional knowledge. The agreements make it necessary to obtain prior informed consent， to jointly negotiate cooperation conditions， and to share benefits.

To make these international measures effective， a database of TCM knowledge should be established， and the government should set up a special management agency to be responsible for the collection， protection， operation， profit distribution， supervision， and inspection of traditional medicine knowledge. On the one hand， open registration of disclosed traditional medical knowledge is encouraged to encourage the public to improve and innovate on traditional knowledge. On the other hand， the implementation of closed registration of technical secrets requires secret negotiations with the technical secret rights holders to obtain such knowledge. Coordination of technological secrets and benefit sharing can effectively curb the "biological piracy" originating in developed countries[22].

6 Conclusion

Modern society generally advocates the use of IP rights to protect the property rights of Chinese medicine. Although Chinese medicine has always been a traditional field of advantage in China， the protection of TCM IP rights is a weak point of IP research in China. Intellectual property rights protection based on patents can be used to protect Chinese medicine， but difficulty has been encountered. The traditional technical secret protection system has filled the effectiveness gap of patent protection.

At present， some scholars in China are proposing special legislation on the protection system of technical secrets， covering them like trade secrets. The reason is that the laws， departmental regulations， and local regulations related to the legal protection of technical secrets are relatively scattered and need to be integrated to arrive at a unified， effective system of regulations. Technical secret protection law or regulations are conducive to unification to aid law enforcement， judicial processes， and law-abiding protection of secrets; such a system would also be a reference for the legislation of the developed countries and regions to protect the technical secrets of other parts of the world.

The authors of this paper believe that China is at the stage when the conditions for separate legislative protection of technical secrets are still immature， but TCM firms can choose from the current legal framework more pragmatically. At present， the protection of IP rights of TCM developers by using secrets is not intended to counter the core position of the patent system; it is not necessary to over strengthen the application proportion of technical secret protection. The only way to coordinate the full cooperation of technical secret protection and IP protection in practical application is to give full play to it. Technical secret protection has great advantages in the field of TCM to resolve the potential risks of technical secret protection by patents and make up for the inherent shortcomings of the international patent system. Protection by secrecy， sometimes in combination with patent protection， promises to maintain the heritage of the cultural treasure of TCM IP.

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中醫药技术秘密保护的价值审视和风险规制

卞先银，王金金*

（中国科学技术大学 知识产权研究院，合肥 230009）

摘    要：现代医药的知识产权保护是建立在以西方科技为发展基点、西医药为主要保护对象、专利保护为核心手段基础之上的产权保护制度。在应对中医药的知识产权保护时，一味遵循西药的专利保护制度无法适应中医药理论体系，依靠专利制度进行中医药知识产权保护往往捉襟见肘。相比之下，长期处于专利制度云翳背后的技术秘密保护手段，能够有效弥补传统以专利为核心的知识产权保护制度不足，成为了中医药产权保护的新常态。同时，技术秘密保护也存在着固有的缺陷，并与涉及社会公共利益的信息公开制度存在冲突。本文致力于主动审视技术秘密保护手段在中医药产权保护领域的独特价值，积极找寻破解中医药技术秘密保护困境的方法，从法律视角提供构建和完善中医药技术秘密保护的思路。

关键词：中医药;技术秘密;风险规制;法律保护