Center for Advanced Study & Research on Intellectual Property

 

CASRIP Newsletter - Autumn 2007, Volume 14, Issue 4

Recommendations on How to Protect Traditional Chinese Medicine Knowledge

By Fei Jiao

I. Introduction

In China, traditional herbal preparations account for 30%-50% of the total medicinal consumption. The global market for herbal medicines currently stands at over US $ 60 billion annually and is still growing steadily.[1] A statistic showed that China accounted for only 5% of annual sales of Chinese traditional medicine[2] in the world market. The export volume of Chinese patent medicines (herbal ones only) decreased 16.3% in 1999[3] . The local market was severely impacted by various so called “western Chinese traditional medicine” (including both herbs and drugs) and “botanic drugs”. In fact, Chinese traditional medicine has a great opportunity in the world market for westerners are more open to it. The increasing desire to return back to nature tremendously benefits the development of Chinese traditional medicine. People have been changing their understanding of Chinese traditional medicine. What’s more, the modern science technology laid a base for deciphering the mechanism of Chinese traditional medicine. The new favorite in the world market is Chinese traditional medicines.[4]

To maximize the potential of traditional medicine as a source of health care, the World Health Organization (“WHO”) enacted the “WHO Traditional Medicine Strategy 2002-2005” to help save lives and improve health by closing the huge gap between the potential that essential drugs have to offer and the reality of their inaccessibility for millions of people.[5] It is the first time for the WHO to constitute the strategy and framework for action worldwide. At the same time, due to the huge cost of health care, European countries, the U.S., Japan and other developed countries began to enact or modify their laws to regulate the traditional medicine which includes herbal medicine, botanical drug and natural health products. The purpose of the laws is to insure the safety, efficiency and quality and to manage the procedure and requirements of medicine registration. The laws include the Herbal Medicine Directive 2004/24/EC by Europe in March of 2004, the Guidance or Industry: Botanical Drug Products by U.S. FDA Center for Drug Evaluation and Research in June of 2004, the natural Health Products Regulations by Canada and Pharmaceutical Affairs Law by Japan.

While Chinese medicine is widely used around the world, 70% of the international herbal medicine market has been occupied by foreign companies. Thus, it is an urgent job to protect intellectual property rights of traditional Chinese medicine. First, China should impose the patent system to protect the patentable traditional Chinese medicine knowledge (TCMK)[6] in China and also take advantage of the ability to patent in other countries too. Secondly, using the copyright system to protect the written expressions of TCMK and database should be established to protect TCMK. Third, China should protect TCMK under the global concern of biodiversity. At the same time, China should establish its own sui generis regime. Trademark and trade secret can also efficiently protect parts of TCMK. And finally China also should examine steps taken by other developing countries, such as the neem tree case.

II. Background

A. Definition

Traditional Chinese medicine includes a range of traditional medical practices used in China that developed over several thousand years, such as herbal medicine, acupuncture, and massage. Traditional Chinese medicine is a form of oriental medicine, which includes other traditional East Asian medical systems such as traditional Japanese and Korean medicine. Traditional Chinese medical theory is based on a number of philosophical frameworks. Diagnosis and treatment are conducted with reference to these concepts.[7] Traditional Chinese medicinal knowledge (TCMK) includes diverse traditional theories, methods, beliefs, and practices about illness prevention, diagnosis, or treatment.

Article 2 of the 1992 Convention on Biological Diversity[8] defines the term, “biological diversity”, often shortened to “biodiversity”, as “variability among living organisms from all sources including, inter alia, terrestrial, marine and other aquatic ecosystems and the ecological complexes of which they are part; this includes diversity within species, between species and of ecosystems.” It also defines the term, “genetic resources” as meaning “genetic material of actual or potential value.” Biopiracy is committed when a foreign entity appropriates a biomedical knowledge developed by an indigenous population without just compensation.[9]

B. Importance of Protection

In China more than 12,000 kinds of animals, plants and minerals are used in making traditional Chinese medicine, which has been proven effective for many functional diseases and diseases in the immune system, among others[10] . Acupuncture and qigong are also world famous. Traditional Chinese medicine also witnesses a growing international market as the European Union is making laws on it and the United States has approved clinic research into compounds with herbal medicine ingredients.

Foreign companies on the other hand have benefited greatly from the free use of China’s formulas of traditional Chinese medicine. It is estimated that foreign companies have occupied over 70 percent of international proprietary herbal medicine market. Some even sell their products to China. Traditional Chinese medicine accounts one fifth of China's medicine market, with the output value of patent medicine reaching 38.5 billion yuan (4.67 billion U.S. dollars) a year.[11]

In addition to “generating valuable goods and services”, traditional Chinese medicine can also bring China into the global market to compete with other countries. Compared with “its belated development in key technological areas such as medicinal chemistry, bioengineering, and telecommunication”, China possesses the most advanced TCMK and the huge natural resource.[12] The advantage of possessing the TCMK may also bring China into the field of pharmaceuticals easily. Apart from its economic importance, TCMK reflect national history and cultural heritage of China. Therefore foreign countries and companies’ use without admission and payment is an “abuse or misuse of cultural relics and a violation of national identity”.[13] The State Administration of Traditional Chinese Medicine under the Ministry of Public Health is now the central administrative body that oversees the development of TCMK and issues regulations governing the practice of TCMK.

III. Recent Domestic Legislation and the International Instruments and Organization

In China, no special laws are specifically prepared for traditional Chinese medicinal knowledge protection. And the governing laws likely to cover it, in terms of protection of intellectual activities, fall into the domain of intellectual property protection: that is, copyrights in Copyright Law of the PRC, trademarks in Trademark Law of the PRC, and patents in Patent Law of the PRC, as well as Regulations for the Implementation of those three. The Copyright Law stipulates that the personal and property rights of authors, other citizens, legal entities and other organizations who create the works are protected. (See Table 1: List of China’s Current Laws, Administrative Regulations and Department Rules Regarding Intellectual Property Rights[14] ).

Table 1: List of China’s Current Laws, Administrative Regulations and Department Rules Regarding Intellectual Property Rights

No special legal instruments on traditional Chinese medicinal knowledge are adopted internationally yet. But a couple existing international bodies still can be made full use of.

The first is the TRIPS Agreement. It requires minimum levels of protection for various types of intellectual property rights, including protection of copyrights and related rights, trademarks, geographical indications, industrial designs, patents, and undisclosed protection. The second is the World Intellectual Property Organization (WIPO). It compiles databases to assist national legislative efforts to protect traditional knowledge on a broad sense. It has already engaged in a very substantive program in the Intergovernmental Committee on genetic resources, traditional knowledge and folklore, which has yielded concrete results, including a decision to prepare a document on the elements of a sui generis system for the protection for traditional knowledge.[15]

IV. Strategies of Protecting Traditional Chinese medical knowledge

A. Patent Strategies of Protecting Traditional Chinese Medical Knowledge

Patent is an important part of intellectual property laws. For TCMK, composition of matter for patent is almost procedure or technology, so patent plays an important role of the TCMK protection.

1. Protection of Herb, Animal and Mines Used in TCM

a. Patent issue of Plant

Whether in the TRIPS Agreement or Chinese Patent Law, the elements of patentability are utility, novelty and non-obviousness and the patentable subject matter is invention. So it seems the common plant is not patentable. While new varieties of herbal plants are already under the protection of Plant Variety Protection (UPOV)[16] , most commonly seen traditional medicines are confronted with the challenge of eligibility for protection.

In China, no patent right may be granted for methods for the diagnosis or for the treatment of diseases and animal and plant varieties[17] . So the herbal plant is not patentable. For example, liquorice is used as an herb for treating cough, but it is not patentable. It is easily understandable that the plant is not invention so it is not novel. In order to “protect the rights in new varieties of plants, to encourage the breeding and use of new varieties of plants, and to promote the development of agriculture and forestry,”[18] on March 20, 1997, the State Council of the People’s Republic of China promulgated the Regulations of the People’s Republic of China on the Protection of New Varieties of Plants (Regulations).

However, a patent can be registered even if it is developed from traditional medicines or medicinal plants.[19] For example, an Indian developer Tropical Botanic Garden and Research Institute exploited a new medicine named “Jeevani” from a traditional medicinal plant “arogyapaacha”[20] . This type of plant stems from practices of a traditional indigenous group Kani. But later Indian biological researchers got the plant information, then extracted 12 compound elements from the plant, and developed the popular plant into a new patented medicine “Jeevani” which substantially strengthens the immunity system and resists anoxia. China should learn from other countries to extract the useful plant components to make medicine in order for its patentability. For example, liquorice which is mentioned before is not patentable, however, the useful component extracted from liquorice, which can cure cough, is patentable.

Here, another issue arises that the breeder’s right. The entity which or the person who has accomplished the breeding has an exclusive right in their protected variety[21] for 20 years, in cases of vines, forest trees, fruit trees and ornamental plants, or 15 years, in cases of other plants.[22] The right extends to the “[production or sale] for commercial purposes the propagating material of the protected variety,”[23] and the commercial use of which “in a repeated manner in production of the propagating material of another variety,”[24] and the right to assign in accordance with the law.[25]

For non-commercial use, however, the Regulations permit a third party to exploit the protected variety without authorization from, or payment of royalty to, the rights holder for breeding and other scientific research activities.[26] In order to protect the underdeveloped agricultural and forestry industries,[27] the Regulations also permit the unauthorized use without compensation by farmers for propagating purposes, “on their own holdings, of the propagating material of the protected variety harvested on their own holdings.”[28]

In addition, the Regulations also permit the examining and approving authorities to grant a compulsory license to exploit new plant varieties in the national or the public interest, provided that the grantee of the compulsory license shall pay the rights holder a reasonable exploitation fee. [29]

b. Issues of Biodiversity and Biopiracy

Traditional knowledge of plant genetic resources is under threat. Currently in China 169 kinds of medicinal plant are listed as endangered species and they are controlled and limited in trade and use. Chinese herbal resource is facing the danger of biodiversity because of extinction of specises. 60% to 70% of about 3000 kinds of endangered plants are herbal plants or medical plants[30] . However ongoing viability of the wild herbal plants is at risk because of the sharp increasing demand of the herbal medicine. Plants are vanishing so quickly that the Earth is losing one major drug to extinction every two years. Geoherbalisim, which relates to herbal plants that have special medical efficiency if grown in certain places, should especially be protected.

Geoherbalism can be protected by Geographical Indications (GIs) which identify the specific geographical origin of a product, and the associated qualities, reputation or other characteristics. They usually consist of the name of the place of origin. For example, food products sometimes have qualities that derive from their place of production and local environmental factors. The geographical indication prevents unauthorized parties from using a protected GI for products not from that region or from misleading the public as to the true origin of the product.[31] GIs can make farmers realize the importance of protecting and planting the geoherbalism so that they can help prevent extinction.

Biopiracy threatens certain nation’s biodiversity. Neem is a tree originally from India and other parts of South and Southeast Asia. It is now planted across the tropics because of its properties as a natural medicine, pesticide and fertilizer. Neem extracts can be used against hundreds of pests and fungal diseases that attack food crops; the oil extracted from its seeds is used to treat colds and flu; and mixed in soap, it is believed to offer low cost relief from malaria, skin diseases and even meningitis.[32] Although it seems the world is more biodiverse now, biopiracy makes the original country lose the value of biodiversity. Neem currently is planted across the tropics other than only India and other parts of South and Southeast Asia, so companies needing neem can buy neem not only from India but also other tropic countries. Therefore, India loses more occupied market in the world.

China should learn from India’s experience with the Neem tree. Therefore, the laws or regulations on protecting the genetic resources or biodiversity should be enacted as soon as possible. China is a member of the Convention of Biological Diversity (CBD), a global, comprehensive agreement addressing all aspects of biological diversity: genetic resources, species, and ecosystems, so the laws or regulations can be based on CBD principles and used for reference of the successful experience of foreign countries. India has taken actions to effectively protect its biodiversity. It is regulated that everyone, who wants to apply for patent protection of the research productions based on the generic resource or related traditional knowledge of Indian, must be authorized by the National Biodiversity Authority.

2. Apply Patent

Before talking about the patent application, one concept must be clear. TCMK is not necessarily ancient knowledge, instead in most cases, contemporary information. The term “traditional” used in describing this knowledge does not imply that this knowledge is old or untechnical in nature, but “tradition-based.” It is “traditional” because “it is created in a manner that reflects the traditions of the communities, therefore not relating to the nature of the knowledge itself, but to the way in which that knowledge is created, preserved and disseminated”.[33] So the term “tradition” shall not be deemed as an excuse against the “novelty” requirement for patent application. Much traditional knowledge is truly old and that is controversial for new exclusive right; new things created from traditional knowledge are eligible for regular patent protection as anything else.

Patent protection includes inventions, utility models and industrial designs. The TRIPs stipulate that “patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application.”[34] Likewise, Chinese Patent Law prescribes that “any invention or utility model for which a patent right may be granted must possess the characteristics of novelty, inventiveness and usefulness”. Considering that “methods for the diagnosis or for the treatment of diseases” shall be explicitly prohibited from the granting, TCMK-based methods of diagnosis or treatment of diseases are excluded from this part, such as traditional methods of examining body: inspection of vitality, observation of the tongue coating, inquiry about chill and fever, etc.

To be patented, TCMK should satisfy three requirements, including novelty, non-obviousness and usefulness. TCMK should be used as a basis for further substantive innovations. Inventors could add new major values to traditional medicines, or employ traditional medicines for new uses, to make it novel and non-obvious. Such as, liquid Chinese medicines can be changed into solid granules, or mix different herbal materials or animal parts into a creative combination.[35]

Two successful examples can be referred. First, Istis-Root Granules is originated from traditional Istis-Root decoction. Second is the Maca and Velvet Deer Antler[36] cases, the USPTO had correctly refused separate patent protection for Maca (a fertility boosting plant), and for a modern producer using the similar Velvet Deer Antler, since prior art had been shown. However, the applicants succeeded in obtaining a patent on the combination of the two materials, since absent prior art relating to the combination, the recipe became eligible.[37]

China has laws and regulations that protect the inventions relating to the medication. 3 kinds of medication can be patented: 1) medical compound, biological product and medicine combination used as active components of drugs; 2) the methods of producing medicine; and 3) use of medicine.

Therefore, in conclusion, there are 3 key aspects worth researching. First is the research on the only one medicine which means extracting and purifying the useful component to improve the efficiency. Second is the research on compound. The efficiency of compound can exceed the one of the sole medicine. The key is to reduce the bad side effect of the medicine. The third aspect is the form of the medicine, solid, liquid or granule. The different forms also have the different effect.

3. Infringement of Patented TCM

In January 2007, Beijing High People's Court decided that the Nourishing Blood& Cleaning Brain Granule Patent Infringement Case went in Tianjin Tasly Group’s favor[38] . The court ordered the defendant company, Guangdong Dongguan Group, should stop selling the infringing products and make compensation to Tasly Group, even though this amounted to only 1 RMB. This case is the first successful patent infringement case of TCM, which also indicates a new movement in solving the IPR infringement cases of TCM. Nourishing Blood & Cleaning Brain Granule was developed by Tianjin Tasly Group. It helps relieve headache caused by hypertension and treats headache and calms the liver, to dredge meridians by promoting blood circulation. It was patented in 1999 (Patent No.: ZL93100050.5) and also was involved in Degree Two of National Medicine Variety Protection. (The protection term from Jan. 24, 2005 to Jan. 24, 2012)

In March of 2005, Tianjin Tasly Group found Dongguan Group produced the same granule and provided the mendacious testing report. The experts in Beijing University of Chinese Medicine made a research to compare the recipes of the two companies. The research result states the Tasly’s patented technology of abirritation from pression is better than the public technology. The judgment of court accepted the experts’ testimony that the component and dosage are the two essentials in the Chinese recipe and the dosage change of angelica and chuanxiong rhizome resulted in the new recipe. The judgment pointed out the different doses of angelica and chuanxiong rhizome cause the function change or efficiency change. The person skilled in the technology of this particular field can not get the technology without the testing. Therefore, the defendant infringed Tasly’s patent.

Even though the compensation is only 1 RMB (0.16 U.S. dollar), the significance of the case is to promote the patent protection of TCMK.

This case should be the beginning of protecting the patented TCM. In the documents of applying the patent, the possible innovation can be recorded. In this case, the potential infringement can be avoided. Also, the information public in the patent application should be as detailed as possible. This can prevent infringement as well.

B. Copyright Strategies of Protecting Traditional Chinese Medical Knowledge

When it comes to copyright, TCMK has not entitled enough protection under copyright or neighboring right, since copyright does not give its owner the rights to prevent others from using the idea or the knowledge contained in the copyrighted work; it only restricts the use of the work/expression itself. Therefore, copyrights are applicable to certain sectors of TCMK protection, such as the cultural heritage and public information. However the database and sui generis system can be established to protect TCMK.

1. Whether Folk Secret Therapies and Prescriptions Are Copyrightable

Most of folk secret therapies and prescriptions transmit from generation to generation. Some owners contribute these folk secret therapies to the public in order to take full advantage of them. However these therapies and prescriptions are not protected by the copyright laws.

In September 2006, the first case on the copyright of the therapies and prescriptions finished its legal procedure[39] . Plaintiff was the inheritor of one folk secret prescription “Fang Ku Jun San” which is for treating the fracture. In April 1959 plaintiff presented the prescription to the government. Then the prescription was published in the book of “Collections of Chinese folk secret recipes”. Appellee who is a doctor wrote a book on his methods of therapy in which the plaintiff’s prescriptions are contained. So plaintiff sued appellee of infringement of the copyright. The judge of final decision dismissed the suit because the prescription is not an expressive work and hence not copyrightable.

The judge hold the term “works” used in the law shall mean original intellectual expressions in the literary, artistic and scientific domain, insofar as they are capable of being reproduced in a certain tangible form.[40] In this case, the key is to distinguish the technology (prescription) and the expression of the technology (expression of prescription). The first is in the scope of patent and trade secret and the latter belongs to the scope of copyright. The judge held the prescription records the information of technology so it is not original. Prescription is the mention of the herbal names, the efficiency, the facture, the direction and so on, so prescription is only arrangement and combination of the known herbal medicine. This arrangement and combination is only information of technology, but not the original expression. So the suit was dismissed.

This judgment is arguable whether the prescription is uncopyrightable. The subject matter of copyright in China is the same as the one in U.S.. This Chinese case can be explained with the reference of cases in U.S.. Copyright protection subsists, in accordance with this title, in original works of authorship. And in no case does copyright protection for an original works of authorship extend to any idea, procedure, process, system, method of operation, concept, principle, or discovery regardless of the form in which it is described, explained, illustrated, or embodied in such work.[41] A treatise on the composition and use of medicines, old or new; on the construction and use of ploughs, or watches, or churns; or on the mixture and application of colors for painting or dyeing; or on the mode of drawing lines to produce the effect of perspective, would be the subject of copyright; but no one would contend that the copyright of the treatise would give the exclusive right to the art or manufacture described therein.[42] In this Chinese case, appellee referred to the folk secret therapy in his book just as one method of treatment which is the idea of plaintiff.

Certain mixtures are found to be of great value in the healing art. If the discoverer writes and publishes a book on the subject (as regular physicians generally do), he gains no exclusive right to the manufacture and sale of the medicine; he gives that to the public. If he desires to acquire such exclusive right, he must obtain a patent for the mixture as a new art, manufacture, or composition of matter. He may copyright his book, if he pleases; but that only secures to him the exclusive right of printing and publishing his book.[43] So this may illustrate the difference between the technology and the expression of technology (actually patent and copyright).

Traditional Chinese folk secret therapies and prescriptions are analogous to the food recipes.[44] In the case of Publications Int’l. v. Meredith Corp.[45] , the recipes’ directions for preparing the assorted dishes fall squarely within the class of subject matter specially exclude from copyright protection by Section 102(b). They are excluded from copyright protections as either a “procedure, process, or system”. Protection for ideas or processes is the purview of patent.

Therefore, the Chinese case on folk secret prescriptions are the same as U.S.. For TCMK-based new medicines or medical practices that are eligible for patent application, inventors or relevant researches shall be well aware of the possible consequences when they decide to publicly release articles disclosing the process, therapies or doses of the invention in details, either at international conferences or in the manner of publishing research papers. Otherwise they would sacrifice the tremendous patented profits for a small sum of copyright rewards, and even surrender the patent to foreign counterparts after they make some minor modification.[46]

The owners of folk secret therapies and prescriptions should apply the patent. Copyright can not protect them effectively. Because their therapies and prescriptions are usually kept in their family, they are not in public domain, which means they are novel to public unlike other therapies written in old medicinal books. However, if patent is registered, the prescriptions must be disclosed. In this case, after the term exceeds, the patent right will be lost and others can use them for free. Therefore, most herbalist doctors give patients the already prepared medicine instead of giving the prescriptions. In this way, others can not obtain the components of the prescriptions by decocting the medicine themselves.

Therefore, it is difficult to find an apt form of protecting the folk secret therapies and prescriptions. It seems there are shortcomings of both copyright and patent. Maybe the holders of folk secret therapies and prescriptions should continue to keep these as secrets. They can protect these therapies and prescriptions by trade secret.

2. How to Protect the Ancient Books on TCMK which has Exceeded the Term of Protection.

For some of TCMK ineligible for any intellectual property rights protection, such as traditional medicines or practices in the public domain, that is, codified or universally known, such as therapies documented in ancient Chinese medicinal literary, it is necessary to widely publicize such information so that no other person or entity would illegally patent it.

Ben Cao Gang Mu (Compendium of Materia Medica) by Li Shizhen, is a world famous book for its most complete and comprehensive list of herbs. In China, there are many such ancient books which has exceeded the term of copyright protection. They are precious deposits for Chinese people. Therefore how to protect these old books is an important issue. There are two answers. First is establishing database which will be discussed later in the paper. The second is to arrange and compile the ancient TCMK books.

Article 12 of Copyright Law of the People’s Republic of China provides that “where a work is created by adaptation, translation, annotation or arrangement of a preexisting work, the copyright in the work thus created shall be enjoyed by the adapter, translator, annotator or arranger, Provided that the exercise of such copyright shall not prejudice the copyright in the original work.” and Article 14 provides that “a work created by compilation of several works, parts of works, data that do not constitute a work or other materials and having originality in the selection or arrangement of its contents is a work of compilation. The copyright in a work of compilation shall be enjoyed by the compiler, provided that the exercise of such copyright shall not prejudice the copyright in the preexisting works.” provide the legal protection to the arrangement and compilation of the ancient TCMK collections. Also, in the world, the Berne Convention and the TRIPs, the two principal international copyright conventions operating today, protect the works of arrangement and compilation. According to these comments “compilations of data or other material, whether in machine readable or other form, which by reason of the selection or arrangement of their contents constitute intellectual creations shall be protected as such. Such protection, which shall not extend to the data or material itself, shall be without prejudice to any copyright subsisting in the data or material itself.”[47]

Compiling the TCMK to collections and arranging and compiling the ancient TCMK books can not only protect the specific expression traditional Chinese medicine knowledge on the copyright[48] , but also prevent others from applying the patent so that obtaining the monopolization of the traditional Chinese medicine. For instance, there is a patent which is on pilatory applied by a foreign country. This pilatory is composed of abstractions of plum, pinaster leaves and bamboo leaves to treat scalp itch and promote regeneration of hair. However, in Tang Dynasty, Sun Simiao wrote a medical book “Bei Ji Qian Jin Yao Fang” (Emergency Formulas of a thousand gold worth) in which it was written that pinaster and bamboo leaves can be used for hair regeneration and plum can be used for anti-itch of scalp. Due to the detailed and cleared recordation in Chinese medicine literature, the applicant withdrew the application. However this patent has been registered in U.S. and other European countries because of lack of the knowledge of the ancient literature.

3. Establishing database

As discussed above, establishing database is an efficient means to protect the TCMK. Many people have recognized the internet being the most important invention in the last century. The exchange of information and communications has become so easy because of such invention. However, it is the expansion of the same technology makes the digital databases vulnerable to unauthorized uses and misappropriations. Therefore, intellectual property protection on those valuable databases is calling for our attention, especially in this cyber-era.[49] Many traditional Chinese medicines have been applied for patent by foreign countries, so a database can also prevent other foreign countries to infringe the Chinese patent rights.

Some countries have well documented the traditional medicines. Lao People’s Democratic Republic, for example, established the Traditional Medicines Resource Centre (TMRC). The TMRC works with local healers to document all traditional medicines detailed with in order to promote the “shared practices” in Lao People’s Democratic Republic. The TRMC also collaborates with the International Co-operative Biodiversity Group for inventing prospective medicinal products. During the collaboration the TRMC shares with all the related communities all the benefits, profits or royalties from recovering plants and knowledge.[50] In India, National Institute of Science Communication (NISCOM) and the Indian Systems of Medicine and Homoeopathy (ISM&H) collaborated to establish a traditional knowledge database. The subject of the database initially is Indian herb and the database is supposed to computerize the knowledge in public domain. The database adopts several editions in the different international languages, such as English, Spanish, Germany, French and Japanese.[51]

Now China has established hundreds of databases of TCMK including literal and factual databases by R&D organizations and universities or colleges, such as TCM database[52] , Chinese medicine information database[53] and so on. Accompanying the establishment of the database, some legal issues arise. Among them are the issues of the ownership of the information within the database, and of the access of the database.

a. Ownership of the Database

TCMK is traditional so that it is strongly intergenerational. Therefore it will be difficult to identify a “single holder” because it is often the families, even lineages that hold TCMK.[54] “In the event that individuals add value to TCMK, they could qualify for conventional modes of intellectual property protection, such as copyrights or database rights in value-adding collections of information. That the right as such is reserved for a collective entity hardly presents a new phenomenon. Most intellectual property assets are owned by collective entities, which in many cases represent large and diffuse groups of individuals.”[55] Moreover, the same TCMK may be held by different communities in different regions of the world independently from each other.[56] For example, some ancestors migrated to other neighboring countries with the books and knowledge so that different countries may own the same data. Just like some TCMK can also be seen in other Asian countries, such as Japan and Korean. In this case, they are prohibited from applying for joint ownership, because--not knowing about each other’s respective work--they do not fulfill the requirement of “aggregate efforts” and “collaboration”.[57]

In this regard, all the communities in the proposed intellectual property system should state to adopt “appropriate exceptions for collective administration of TCMK intellectual property rights”. The reason to do this is to avoid different communities competing against one another by the means of driving down the prices of their traditional knowledge. Traditional communities could be denied as “an exceptional use of monopolistic market power” under antitrust law. In this case, the initial goal to establish the rights would be undermined.[58]

b. Access of the Database

More and more researchers are depending upon digital databases in their scientific process, including those in developing countries. Usually they would encounter a situation where they have to pay to access some commercially-owned databases seeking to maximize revenues from subscriptions. Little do the researchers know, however, some of the data those commercial databases contain may be readily accessible in the public domain, some others may be collected through publicly funded research.[59]

The EU may be the most successful example of establishing and protecting database. It adopts legislation to protect the databases through sui generis protection. It prevents unauthorized access to data compilations no matter the non-original and the original. It also grants the exclusive rights to extract and use the contents of the protected database, either all the database or a substantial part of it. Similar legislation should be adopted also by China to preventing unauthorized use of database.

Usually, legal protection on the intellectual property rights of the databases is far from being adequate, although one may always argue that the database owners can contract the users into various restrictions on using the products.[60] On the contrary, in case of a database of traditional knowledge, the concern is that a sui generis form of protection might have been too strong that it chills productivity when inventors are reluctant to apply patents with the fear that the application will be denied as not novel.[61]

4. Sui Generis System

Sui generis system is a special and different system to protect “traditional knowledge or folklore” on the basis of “the special characteristics of traditional knowledge or folklore.” The protection of plant varieties and protection of databases may be the main areas which are now have been provided by Sui generis systems.[62] Where the existing intellectual property system may be usable in certain circumstances, it cannot provide for sufficient protection of traditional knowledge. The failure to protect some medicine compounds, folk secret therapies, medicinal works over generations and the like, calls for a sui generis model. But this special system shall not only cover TCMK protection, but the whole traditional knowledge. And this sui generis system could be developed to comprise specific features applying to specific elements of traditional knowledge, such as TCMK discussed here. As the WTO puts it in connection with the explanation of the sui generis system of plant variety protection, under Article 27.3(b) of the TRIPS Agreement, “Sui generis protection gives Members more flexibility to adapt to particular circumstances arising from the technical characteristics of inventions in the field of plant varieties, such as novelty and disclosure.”

Even if some traditional knowledge fits within a broad definition, it may need to meet distinct criteria in this specifically designed legal system. This may apply, for instance, to TCMK which has already entered the public domain, so the term public domain here should be clearly defined. At the same time, through the international legal network, the concept of commercial novelty can be resorted to make sure that all elements of traditional knowledge which have not been commercially exploited prior to the date of the filing of the database are protected.

Besides, TCMK, unlike other intellectual properties, is generally perceived as a matter of collective rights, but its protection may be vested in individuals. The solution, indicated in the WIPO document, must be found in accordance with common law, which is recognizing communities’ customs and traditions.[63]

C. Trademark Strategies of Protecting Traditional Chinese Medical Knowledge

1. Geographical Certification Mark

Whilst a trademark identifies the manufacturer of a product, a certification mark informs consumers that a product bearing the mark meets certain standards which can include geographic origin and quality. Certification marks certify regional or other origin, material, mode of manufacture, quality, accuracy, or other characteristics of such person’s goods or services or that the work of labor on the goods or services was performed by members of a union or other organization[64] . Since 1995, China has adopted certification marks to protect the geographical marks. Just as mentioned above, geoherbalism can be protected by certification mark and a separate Chinese GI system too.

There are several advantages to register the certification mark comparing with trademark. First, there is less liability for the mark owners. A certification mark is any word, name, symbol, or device only used by a party or parties other than the owner of the mark to certify some aspect of the third parties’ goods or services. Thus, a license agreement is essential to the function of a certification mark.[65] Unlike a trademark owner, who controls the nature and quality of the goods or services under a license agreement, a certifier is not responsible for the nature and quality of the goods or services to which the certification mark is applied. A certifier guarantees certain qualities or characteristics of the goods or services but does not guarantee the nature and quality of the goods or services themselves.[66] The trademark and service mark owners continue to be responsible for their own goods and services. Furthermore, the owner of a certification mark is compelled to license the use of the mark if the goods meet the certifier’s standards.[67] This is different from a trademark, where the owner may, but is not obligated to, license use of its mark to third parties. Secondly, it is easier to register. Typically, a governmental body or agency owns and controls the use of the mark to certify regional origin.[68] A governmental entity is often in the best position to establish and regulate standards, to control the use of the mark and to ensure that no discriminatory activity will occur. If anyone other than the appropriate entity applies to register a certification mark, registration may be refused not only on the ground that the applicant is not the owner of the mark but that the mark as employed by the applicant would not function as a certification mark. In addition, there are some grounds for refusing registration of trademarks, one of which is geographic marks. A geographic mark is not easy to administer as a trademark unless it has a secondary meaning. However certification marks may be registered without proof of secondary meaning but must be made available in a nondiscriminatory fashion to anyone who complies with the terms of the certification. A geographic certification mark can be registered without providing any secondary meaning. Third, it can bring benefit to the farmers. Often, geographic terms indicate a degree of superior quality of the goods originating from those areas, such as IDAHO for potatoes, VIDALIA for onions, COLOMBIAN for coffee and FLORIDA or CALIFORNIA for oranges and other citrus products. There is a need to distinguish such products from the same type of products grown in other geographic areas for two reasons: (1) to protect the producer in that region from outsiders using the designation, and (2) to protect the public from being misled as to the geographic source of the product.[69] In addition, all producers in a particular region should be free to use a geographic name to inform purchasers of the regional source of their goods. It is therefore imperative that the owner of a certification mark refrain from discriminatory practices which would prevent a producer from using a geographic term to describe the regional origin of its goods. A certification mark owner is obligated to permit any producer from a region to use the geographic designation provided the goods comply with the certifier’s standards.[70] Lastly, the Chinese government can obtain a healthy income. Others who want to use the certification mark must sign a Licensing Agreement with the owner of the certification mark. The cost and expenses are prescribed within the agreement, so a healthy income stream will flow into China from the licensees who use the name.

Currently, few Chinese medicinal materials have applied for the marks. However, applying certification marks can cause the medicinal materials to be famous so that they can take possession of the market and brings more incomes for Chinese government and Chinese people. Therefore, certification mark is one of the efficient methods to protect the traditional Chinese medicine resource.

2. Trademark of Product by Medicine company

Medicine manufacturers, exploiting ordinary TCMK to produce traditional Chinese medicines ineligible for patent rights, may design a distinctive sign with noticeable characteristics and apply for a trademark to distinguish their brand from counterparts in accordance with the law.

One case at point is the distinctive package pattern of “Wang Lao Ji” Herbal Tea. In the case Guangdong Jia Duo Bao Beverage and Food Co, Ltd V. San Shui Hua Li Beverage and Food Co, Ltd[71] , the plaintiff, Jiao Duo Bao Co., who legitimately produces red-can packaged “Wang Lao Ji” Herbal Tea, filled a lawsuit against “Twenty-four Tastes” Herbal Tea’s manufacturer, San Shui Hua Li Company. Jia Duo Bao Company (Jiao) firmly claims that Hua Li Company (Hua) has infringed on Jia’s IPR, in that Hua uses a slightly different product name, trademark, and package pattern from Jia’s, which indisputably misled its consumers. Both courts of the first and second instances adjudicate that Hua Li Company has committed an act of tort, and shall bear the liability for Jia’s losses of over 100,000 yuan.

As a collective trademark refers to one registered in the name of a group, association, or any other organization for use in business by its members to indicate membership, it is essential for some indigenous communities or local groups sharing the same or similar TCMK to unite together and form an association or organization about that TCMK. Sometimes, TCMK is a means of cultural identification of its holders, and its preservation is linked to distinct cultures per se. In such case, it is in the interest of all relevant groups or producers mastering similar information to employ the knowledge in medicine-manufacturing within the regional union: for one thing, their reputation is reinforced in the name of a larger and stronger industrial group; for another, the culture or TCMK could be better popularized.

The companies producing the TCM should protect their trademark. Trademark in some sense is similar to the patented product. The companies should advert the similar products or the similar trademarks to their own products or trademarks. The similar products or trademarks could make consumers confusion and dilute their own products or trademarks.

D. Trade Secret Strategies of Protecting Traditional Chinese Medical Knowledge

Some companies and individuals prefer to protect TCMK by trade secret. There are two main reasons. First, in situations where it is difficult to apply for patent protection. For companies, it will take a long time to apply the patent from handing in the application to getting the results. Time is money. The more the time cost, the more economical benefit they will lose. For individuals, applying for the patent will cost application fee and other fees, such as providing testing result. Both time and money are important for both individuals and companies. Secondly, the term of patent protection is too limited. After the term expires, others can use it for free. The value of the invention will be dramatically decreased. Therefore, sometimes trade secret is a preferred way of protection.

However, the companies or individuals must bear the risk of the inadvertent waiver of the trade secret. Once the trade secret was disclosed, it would lost its value.

V. Benefit of Protecting TCMK

A. Benefit to China

The internationalization of intellectual property began in the nineteenth century as countries started to realize that national rules to protect intellectual property rights were insufficient. With the growth of international trade, global rules were needed. For China, the most importance change is entering the WTO because TRIPs in the area of TCMK can be used to protect native interests and knowledge.

Protecting TCMK can encourage Chinese economic development in many aspects. It can promote domestic innovation, such as improving the therapies on the basic of the folk secret ones; increase the price by using Geographical Indications; and foster technology transfers, such as patent licensing, and imports. Other beneficial side effects include: job creation, an increase in tax revenue from patent licensing, related investment activity, and the development of domestic industries. The mere registration of patents, both domestic and foreign, gives domestic traditional Chinese medicine industries a foundation for future innovation and development.

B. Benefit to other Developing Countries and all the World

There is historical precedent for developing countries to “borrow” from other countries’ technologies,[72] and there are several concerns rendering them reluctant to give intellectual property (IP) its full protection. As a result, many people in the developing countries, including China, find it more desirable to copy certain types of technology rather than impose a strict regime of IP protection.

China is a more developed country in many ways than most developing countries. In this sense, as China efficiently protect the TCMK, the other developing countries can be encouraged and follow China to protect their own traditional knowledge.

The wide use of traditional medicine, especially in poor countries, improves the quality of health with low cost and high quality.

Even in developed countries, traditional medicine has been given increasing importance. With more concern about the adverse effects of chemical drugs, traditional Chinese medicine has its appeal to many patients that it offers gentler means of dealing with chronic, debilitating diseases such as heart diseases, cancer, diabetes and mental disorders. Meanwhile, traditional medicines appear as an alternative to the average therapies against the currently incurable diseases like AIDS, which may raise hope among HIV-affected individuals. According to the WHO report, the percentage of the population which has used traditional Chinese medicine at least once is 48% in Australia, 70% in Canada, 42% in USA, 38% in Belgium and 75% in France.[73]

VI. Conclusion

Traditional Chinese Medical Knowledge is intellectual treasure of Chinese folks with long history. It not only brings the economic interest, but also the symbol of the Chinese long history. China should protect TCMK efficiently; otherwise China will lose its medicinal advantage of tremendous historic value to developed countries.

The most practical strategy at the moment, is to make full use of the existing IP system to bring the protection in the fields of copyright, patent, trademark as well as undisclosed information. In respect of copyright and relating rights, Chinese inventors or researchers should be aware of the possible consequences when they release research articles in public on TCMK-based new medicines that are eligible for patent application. For some non-medication therapies, like tai ji and qi gong, the knowledge holder may record the physical movements, and mental regulations sometimes, into books consistent with the originality basis, and enjoy copyright protection. As for TCMK, which is ineligible for any protection, database establishment should be given priority. In case additional values could be attached to traditional medicines or methods to meet the three patenting requirements (novelty, inventiveness and industrial application), patent protection may be suggested. At the same time, the regulations on biodiversity and sui generis regime should be constituted.

From the analysis above, it seems that when considering protections by the patent, copyright, trademark or trade secret, none of these is the single best way to protect TCMK. The best way is to combine all the four aspects to protect TCMK.

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Footnotes

  • [1] See http://www.who.int/mediacentre/factsheets/fs134/en
  • [2] See infra Part IIA
  • [3] See http://www.kpao.net/doctor/part1/B5u42ERQ4250.html
  • [4] http://www.chinanews.com.cn/hr/hrlt/news/2007/07-23/985588.shtml
  • [5] See WHO Traditional Medicine Strategy 2002-2005, at 4
  • [6] See infra Part IIA
  • [7] See Liu Yangchi, The Essential Book of Traditional Chinese Medicine, Columbia University Press 1988
  • [8] See United Nations-Treaty Series, Vol. 1760, I-30619. Article is available online at http://www.cbd.int/doc/legal/cbd-un-en.pdf
  • [9] See Graham Dutfield, International Expert Workshop on Access to Genetic Resources and Benefit Sharing (2004).
  • [10] See http://www.chinainfo.gov.cn/data/200404/1_20040416_78591.html
  • [11] See http://www.kpao.net/doctor/part1/B5u42ERQ4250.html
  • [12] See Benjamin Liu, Past Cultural Achievement as a Future Technological Resource: Contradictions and Opportunities in the Intellectual Property Protection of Chinese medicine in China, 21 UCLA Pac. Basin L.J. 75, 80
  • [13] See Teresa Schroeder, Comment, Chinese Regulation of Traditional Chinese Medicine in the Modern World: Can the Chinese Effectively Profit From One of Their Most Valuable Cultural Resources?, 11 Pac. Rim L. & Pol'y J. 687, 688 (2002)
  • [14] Ministry of Commerce, Intellectual Property Protection in China (2004). Article is available online at http://kjs.mofcom.gov.cn/static/column/ztxx/dwmyxs/q.html/1
  • [15] See Hui Lai, On Protection of Traditional Medicinal Knowledge, http://www.law-door.com/article.asp?articleid=723
  • [16] See International Convention for the Protection of New Varieties of Plants, Paris, 2 December 1961, as revised at Geneva on 19 March 1991 (UPOV Doc. 221(E), 1996).
  • [17] Article 25 of Patent Law of PRC
  • [18] The Regulations of the People’s Republic of China on the Protection of New Varieties of Plants, Article 1. English version is available online at http://www.upov.int/en/publications/npvlaws/china/china.pdf.
  • [19] Article 2 of Regulations on the Protections of New Varieties of Plant
  • [20] See http://www.100md.com/html/DirDu/2005/12/05/81/87/39.htm
  • [21] The Regulations of the People’s Republic of China on the Protection of New Varieties of Plants, Article 6. English version is available online at http://www.upov.int/en/publications/npvlaws/china/china.pdf
  • [22] Id. at Art. 34.
  • [23] Id. at Art. 6
  • [24] Id, at Art.6.
  • [25] Id. at Art 9.
  • [26] Id at Art. 10(1).
  • [27] Y.Y. CHEN, The Trend of Plant Varieties Protection – A Point of View from the UPOV (2004), Chinese version available online at http://www.sipo.gov.cn/sipo/ztxx/nyzscqxx/t20040922_34125.htm.
  • [28] The Regulations of the People’s Republic of China on the Protection of New Varieties of Plants, Article 10(2). English version is available online at http://www.upov.int/en/publications/npvlaws/china/china.pdf.
  • [29] Id. at Art. 11.
  • [30] See http://www.feixi.gov.cn/fxda/Article_Show.asp?ArticleID=494
  • [31] See Report of Commission on Intellectual Property Rights: Integrating Intellectual Property Rights and Development Policy London September 2002
  • [32] See Bio-piracy of Traditional Knowledge, http://203.200.90.6/tkdl/LangDefault/common/Biopiracy.asp
  • [33] See Elements Of A Sui Generis System For The Protection Of Traditional Knowledge, World Intellectual Property Organization, Intergovernmental Committee On Intellectual Property And Genetic Resources, Traditional Knowledge And Folklore, 3rd Sess., 2002, WIPO/GRTKF/IC/3/8; also see Stephen A. Hansen & Justin W. VanFleet, American Association for the Advancement Science, Traditional Knowledge andIntellectual Property: A Handbook on Issues and Options for Traditional Knowledge Holders in Protecting their IntellectualProperty and Maintaining Biological Diversity 3 (2003)
  • [34] For the purposes of this Article, the terms “inventive step” and “capable of industrial application” may be deemed by a Member to be synonymous with the terms “non-obvious” and “useful” respectively.
  • [35] See Hui Lai, On Protection of Traditional Medicinal Knowledge, http://www.law-door.com/article.asp?articleid=723
  • [36] See Thomas Cottier and Marion Panizzon. Legal Perspectives on Traditional Knowledge: The Case for Intellectual Property Protection 6 Journal of International Economic Law 390, 395
  • [37] This point may be controversial after the Supreme Court decision in the case of KSR v. Teleflex (127 S.Ct. 1727). In 1966, U.S. Supreme Court conform how to value the obviousness for patent in Graham v. John Deere Co (383 U.S. 1, 86 S.Ct. 684): the scope and content of the prior art are to be determined; differences between the prior art and the claims at issue are to be ascertained; the level of ordinary skill in the pertinent art resolved; and secondary considerations.
  • [38] This is an unpublished case. The detail can be seen Hong Pei, Intellectual Property Must Be Used For Chinese Medicine Modernization, China Intellectual Property Newspaper, Jan. 24, 2007, at 8.
  • [39] See Civil Judgement of Chengxuan Zhang v. Wenzhong Yang on the dispute of copyright of one prescription, by Chengdu Intermediate People’s Court, (2006) CDIPC Initial No. 1042
  • [40] Article 2 of Implementing Regulations of the Copyright Law of the People’s Republic of China
  • [41] See 17 U.S.C.§102
  • [42] See Baker v. Selden 101 U.S. 99, 102 (1879)
  • [43] Id at 102-103
  • [44] See http://foodandwine.com/articles/new-era-of-the-recipe-burglar
  • [45] 88 F 3d 473 (7th Cir. 1996)
  • [46] See Hui Lai, On Protection of Traditional Medicinal Knowledge, http://www.law-door.com/article.asp?articleid=723
  • [47] Article 10(2) of TRIPs
  • [48] A compilation right only extends to the structuring of the components not the components themselves unless they are otherwise separately copyrightable.
  • [49] See Report of Commission on Intellectual Property Rights: Integrating Intellectual Property Rights and Development Policy London September 2002
  • [50] See Riley, M. (2000) Traditional Medicine Research Centre - A Potential Tool for Protecting Traditional andTribal Medicinal Knowledge in Laos, Cultural Survival Quarterly, vol. 24:4.
  • [51] See http://bencao.cintcm.ac.cn/tcmip/ArticleShow.asp?ArticleID=890
  • [52] http://www.cintcm.com/
  • [53] http://www.cpi.gov.cn/demo/index.html
  • [54] See David R. Downes, How Intellectual Property Could Be a Tool to Protect Traditional Knowledge, 25 Colum. J. Environmental L. (2000) 255
  • [55] See Review of the Provisions of Art. 27.3(b), Relationship between the TRIPS Agreement and the Convention on Biological Diversity and Protection of Traditional Knowledge, Information from Intergovernmental Organizations, Addendum, Convention on Biological Diversity (CBD), Council for Trade-Related Aspects of Intellectual Property Rights, Committee on Trade and Environment, WTO Document IP/C/W/347/Add. 1, WT/CTE/W/210, 10 June 2002, at ΒΆ 34. The WTO cites the example of General Motors, which owns intellectual property rights on behalf of a community of shareholders that is much larger and more diffuse than most identified traditional communities.
  • [56] See Thomas Cottier and Marion Panizzon, Legal Perspectives on Traditional Knowledge: the Case for Intellectual Property Protection, 7 J. Int'l Econ. L. 371, 389
  • [57] See Philippe Cullet, in Rights to Plant Genetic Resources and Traditional Knowledge: Basic Issues and Perspectives in Law and Policy, SDC/WTI Second Expert Workshop 27-29 April 2003, Bern, Switzerland (on file with the authors) viewing the concept of ‘joint inventorship’, as recognized by 35 US Code 116, as a likely form for defining the right holder. Adopting that concept for TK, this author proposes that the determining test be that ‘the contribution of the joint inventor must be essential in distinguishing the invention from the prior art.’
  • [58] See Stephen A. Hansen and Justin W. van Fleet, A Handbook on Issues and Options for Traditional Knowledge Holders in Protecting their Intellectual Property and Maintaining Biological Diversity (Washington, DC: American Association for the Advancement of Science, 2003), at 11
  • [59] See Report of Commission on Intellectual Property Rights: Integrating Intellectual Property Rights and Development Policy London September 2002
  • [60] See Erik B. Bluemel, Substance without Process: Analyzing TRIPs Participatory Guarantees in light of Protected Indigenous Rights, 86 J. Pat. & Trademark Off. Soc'y 671, 703
  • [61] See Lionel M. Lavenue, Database Rights and Technical Data Rights: The Expansion of Intellectual Property for the Protection of Databases, 38 Santa Clara L. Rev. 1, 36 (1997)
  • [62] See http://www.eurogeographics.org/WorkGroups/WG1/eu_directive.pdf).
  • [63] See Hui Lai, On Protection of Traditional Medicinal Knowledge, http://www.law-door.com/article.asp?articleid=723
  • [64] Lanham Act §45, 15 U.S.C. §1127
  • [65] See Terry E. Holtzman, Tips From the Trademark Examining Operation, 81 Trademark Rep. 180, 182-83 (1991)
  • [66] See In re Celanese Corp. of America, 136 USPQ 86 (TTAB 1962)
  • [67] Lanham Act §14(5)(D), 15 U.S.C. §1064(5)(D)
  • [68] 4A R. Callmann, The Law of Unfair Competition, Trademarks and Monopolies, §17:18, p 75 (4th ed 1983).
  • [69] See Terry E. Holtzman, Tips From the Trademark Examining Operation, 81 Trademark Rep. 180, at 184-185 (1991)
  • [70] Id. at 185
  • [71] See Civil Judgment of San Shui Hua Li Beverage and Food Co, Ltd V. Guangdong Jia Duo Bao Beverage and Food Co, Ltd on the dispute of packages of well-known products, by Guangdong Higher People’s Court, (2003) GDHPC3Final No 212
  • [72] M. Schiappacasse, Intellectual Property Right in China: Technology Transfers and Economic Development, 2 Buff. Intell, Prop. L.J. 164, 168.
  • [73] See WHO Traditional Medicine Strategy 2002-2005

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Last updated 4/27/2012