On Protection of Traditional Medicinal Knowledge
ABSTRACT
Traditional medicinal knowledge (TMK), especially traditional Chinese medicinal knowledge (including diverse traditional theories, methods, beliefs, and practices about illness prevention, diagnosis, or treatment), plays an increasingly significant role in developing countries like China, in terms of its social, economic and medicinal interests. Despite the fact that China has enjoyed reputation in its in-depth researches, only a small number of TMK-based patents are registered, which ascribes to weak domestic awareness to protect their TMK-based medicines or practices under the umbrella of legal system. Therefore, this paper elaborates on why and how to protect our valuable TMK. First, it briefs the existing domestic and international legislation concerned, and works out the definition and features of TMK, then specifically dwells on several strategies of TMK protection, varying with different purposes on different occasions. Among all sorts of tactics are protection of eligible TMK under the existing intellectual property right (IPR) system—such as copyright, trademark, patent, and undisclosed information—or proposal for a special sui generis system, and establishment of database for public knowledge protection. Since the sui generis system and database claim entangled in-depth consideration and efforts in respect of national policies, legislation, technology and so on, a larger part of illustration would focus on the existing legal system. Taken together, these concerns will lead to improving equity while preserving open access to traditional medicinal knowledge.
Key words: Traditional Medicinal Knowledge (TMK), Intellectual Property Right (IPR), Sui Generis System, Database
论文摘要
如今，传统医药知识，尤其是传统中医药知识（包括各种有关疾病预防、诊断、治疗的传统医学理论、方法、信仰和实践），在中国等发展中国家的社会、经济和医疗事业发展中担当着举足轻重的作用。尽管中国在传统医学的研究领域享有声誉，但由于普遍缺乏利用知识产权来保护传统医药和传统实践的法律意识，仅有少数人对这些药物或实践申请了专利。因此，该论文将详细分析研究如何保护传统医药知识。首先介绍的是当前这方面国内外的立法情况，并明确传统医药知识的定义和特征，之后将针对不同情况和不同的保护目的提出各自的保护方案。这些策略包括，现有知识产权的适用，如著作权、商标权、专利权、技术秘密等，或建立传统知识的专门制度，并成立资料库以查阅进入公众领域的传统医药知识。由于实施专门制度和资料库会涉及国家政策、立法及技术等多方面因素，需要考虑更多更复杂的问题，因此该论文将集中分析知识产权现有形式下的传统医药知识保护，以明确并改善目前情况，保证公平和保存传统知识。
关键词：传统医药知识、知识产权、专门制度、资料库
Table of Contents
1. Introduction. 1
1.1. Necessity of the Protection of Traditional Medicinal Knowledge. 1
1.1.1. The Importance of Traditional Medicinal Knowledge. 1
1.1.2. Purposes of Protection. 2
1.2. Protection under the Legal Framework. 2
1.2.1. International Instruments and Organizations in Brief 2
1.2.2. Domestic Legislation. 3
2. Conceptual Framework: What Is Traditional Medicinal Knowledge. 4
2.1. Definition of Traditional Medicinal Knowledge. 4
2.2. Features of Traditional Medicinal Knowledge. 6
3. Strategies for Protection of Traditional Medicinal Knowledge. 7
3.1. Use of the Existing IPR System.. 8
3.1.1. Justification for IP Protection. 8
3.1.2. Specific IPRs Eligible. 10
3.1.2.1. Copyrights and Related Rights. 10
3.1.2.2. Patent 11
3.1.2.3. Trademark. 14
3.1.2.4. Undisclosed Information. 16
3.2. Sui Generis System.. 17
3.3. Establishment of Database. 18
4. Conclusion. 19
References. 21
1.Introduction
Traditional Knowledge (hereinafter referred to as “TK”) and indigenous knowledge has been the focus of recent international debates—whether or not to define an explicit connotation of TK, and if possible, how to confirm an internationally recognized definition, and how to seek an effective way to protect it, etc—due to its increasing significance in vital areas such as medicine security, the development of agriculture and medical treatment. While it is true that enormous efforts have been contributed to the introduction of international legal instruments in terms of folklore[1], plant genetic resources for food and agriculture[2], no world-wide consensus on legal protection of traditional medicinal knowledge (hereinafter referred to as “TMK”) has been reached, in particular on traditional Chinese medicine, resulting in the damage of interests of TMK holders and paralyzing the development thereof. Principal rationales for the importance of protecting TMK and some possible strategies are listed in the following part. Before considering how TMK can be protected in the intellectual property (hereinafter referred to as “IP”) system, we’ll take a look at the need for TMK protection and the international definition of the core concepts, though a singular definition may not be necessary at times[3].
1.1. Necessity of the Protection of Traditional Medicinal Knowledge
1.1.1. The Importance of Traditional Medicinal Knowledge
The wide use of TM, especially in poor countries, and its rapidly growing medical and economic value have riveted global attention on its significance.
In Africa up to 80% of the population use TM to help meet their health care needs, In Asia and Latin America, populations continue to use TM as a result of historical circumstances and cultural beliefs[4]. In China, TM accounts for around 40% of all health care delivered, which can be demonstrated in the well-developed system of practices at public hospitals and official education at university level covering TM for doctors, pharmacists and nurses. Apparently, the broad use of TM in developing countries is often attributable to its accessibility and affordability among the majority who are suffering poverty. Of course, its high popularity is also embedded within the local beliefs.
Even in developed countries, TM (or CAM) has been attached increasing importance. With more concern about the adverse effects of chemical drugs, CAM have its appeal to many patients that it offers gentler means of dealing with such 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 WTO report, the percentage of the population which has used CAM at least once is 48% in Australia, 70% in Canada, 42%in USA, 38% in Belgium and 75% in France[5].
1.1.2. Purposes of Protection
The aims of TMK protection can be categorized into two groups:
(a) the grant of specific intellectual property rights (hereinafter referred to as “IPRs”) in relation to TMK, to persons including those indigenous peoples or communities who have inherited and originally mastered the traditional medicinal knowledge, so that they could enjoy their legitimate rights and interests;
(b) protection of TMK from being used by malicious persons or entities without authorization or being misappropriated, or without proper sharing of the benefits arising therefrom.
1.2. Protection under the Legal Framework
With legal tools, TMK can become the trigger point for new medicine development, because the low-cost herbal materials could substantially reduce the current soaring medicine price and explore new ways to combat incurable diseases. An IPR also protects TMK from misappropriation by outsiders, who without offering either compensation or reward have often taken it from its holders. Indicated by statistics, until now, Chinese exploiters have yielded at least 3000 patent registrations to foreign counterparts, 900 of which are traditional Chinese medicines worthy of 1 billion dollars in the potential market. They lost not only the current trade revenue, but also the expected export profits in the impeding decade as a result of non-tariff distortions and impediments to international trade[6].
1.2.1 International Instruments and Organizations in Brief
No special legal instruments on traditional medicinal knowledge are adopted in the international arena yet. But we still can make full use of several existing international bodies.
(a) The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement). With the adoption of the TRIPS Agreement in 1994[7], the patenting made a major stride forward towards global recognition and enforcement (China’s legislation also referred to most of it). It defines various types of IPRs, including protection of copyrights and related rights, trademarks, geographical indications, industrial designs, patents, and undisclosed protection, etc. However, Article 27.3(a) explicitly grants Members to exclude from patentability diagnostic, therapeutic and surgical methods for the treatment of humans or animals. Indeed, nor does the TRIPS Agreement make express reference to traditional knowledge.
(b) The World Intellectual Property Organization (WIPO). Again, WIPO has neither erected protecting mechanisms on TMK, but it compiles databases to assist national legislative efforts to protect TK on a broad sense, and has explored a consensual definition of TK, though not adopted. Indeed, it is 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.
1.2.2. Domestic Legislation
The major responsibility for identifying more precisely the scope of protectable traditional medicinal knowledge rests on national laws, for no one other than the relevant nation knows more and better about the details of traditional knowledge within countless domestic communities. And the nation could incorporate some unanimously agreed concepts and international practices into its own laws, and tailor its key concerns, in accordance with its policy objectives, to the legal protection of national heritages, like traditional medicines in China.
In China, no special laws are specifically prepared for traditional medicinal knowledge protection. And the governing laws likely to cover it, in terms of protection of intellectual activities, fall into the realm of IP 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[8] of authors, other citizens, legal entities and other organizations[9] who create the works[10] are protected.
Under Trademark law, the owner shall enjoy the exclusive right to the use of the registered trademarks, including trademarks for goods and services, collective trademarks, and certification trademarks[11]. Here, trademarks also imply “geographical indications of the goods”[12],
As for patent, the Patent Law is enacted in order to protect patent rights for inventions-creations of Chinese entities or individuals to whom the patents belong[13]. According to Article 2, “’invention-creation’ means inventions, utility models and designs.”[14]But any invention or utility model for which a patent right may be granted must possess the characteristics of novelty, inventiveness and usefulness[15]. However, “methods for the diagnosis or for the treatment of diseases” shall be granted no patent right[16].
2. Conceptual Framework: What Is Traditional Medicinal Knowledge
This paper suggests a general term-traditional medicinal knowledge-that is closely connected with the subject matter of the protection.
TMK encompasses knowledge of different types, which may be distinguished by the elements involved, the knowledge’s potential or actual applications, the form of expression, the way of possession, individual or collective, and its legal status.
TMK includes, for example, information, methods, natural plants and other materials for medical treatment or health care, in other words, medical processes and products that can be used in personal ways or industry, as well as medical services.
As for its forms, the context of some TMK appears codified while others are non-codified, such as “tribal” or “indigenous” medicine, which is passed down to generations through oral ways, based mostly on traditional beliefs, norms and practices accumulated through centuries of experiences within a family or a limited range of community,
TMK may be possessed by individuals, or members of a group/community, for example, knowledge on herbal-home remedies which is held by millions of women and the elder in China, in rural areas particularly.
2.1. Definition of Traditional Medicinal Knowledge
According to the working concept of “traditional knowledge” for the purposes of the fact-finding missions in 1998-1999 by WIPO Secretariat[17], “traditional medicinal knowledge, including related medicines and remedies”, falls into a category of traditional knowledge[18]. Before we go into the depth of defining TMK, we shall possess a clear picture of what traditional knowledge is. In this report, the term “traditional knowledge” is defined as:
“tradition-based literary, artistic or scientific works; performances; inventions; scientific discoveries; designs; marks, names and symbols; undisclosed information; and all other tradition-based innovations and creations resulting from intellectual activity in the industrial, scientific, literary or artistic fields. ‘Tradition-based’ refers to knowledge systems, creations, innovations and cultural expressions which: have generally been transmitted from generation to generation; are generally regarded as pertaining to a particular people or its territory; and are constantly evolving in response to a changing environment.”
However, we could easily find that the said definition is not a formal one precise and restrictive enough for protectable subject matter in the legal sense, but it provides essential elements of its scope and nature, in that much of the matter covered in the definition is already potentially eligible for the grant of protection under IP laws, such as patent law, trademark law and the law of undisclosed information.
Actually, no international body or domestic legislature has worked out a definite concept of TMK other than WTO. In this sphere exist traditional medicine (TM) and complementary and alternative medicine (CAM)[19] systems including traditional Chinese medicine, Indian ayurveda and Arabic unani medicine. TM/CAM therapies can be categorized as medication therapies—if they use herbal medicines[20], animal parts and/or minerals—or non-medication therapies—if carried out primarily without using medication, as in the case of acupuncture, manual therapies, qigong, tai ji, thermal therapy, yoga, and other physical, mental, spiritual and mind-body therapies (See Table1 ). Apparently, traditional medicine contains diverse and sometimes conflicting characteristics. But such a definition is far from useful.
WHO therefore defines TMK as “including diverse health practices, approaches, knowledge and beliefs incorporating plant, animal, and/or mineral based medicines, spiritual therapies, manual techniques and exercises applied singularly or in combination to maintain well-being, as well as to treat, diagnose or prevent illness”[21] (excluding new plants or plant materials).
Another similar definition could also be found in Document WHO/EDM/TRM/2000, “[T]he sum total of the knowledge, skills and practices based on the theories, beliefs and experiences indigenous to different cultures, whether explicable or not, used in the maintenance of health, as well as in the prevention diagnosis, improvement or treatment of physical and mental illnesses.”
Thus, TMK can be summarized as codified and non-codified medication therapies incorporating plant, animal (including traditional Chinese patent medicines, single or compound drug prescriptions), non-medication therapies (physical, mental, spiritual and mind-body therapies like acupuncture, qigong, tai ji), production or exploitation of Chinese herbal materials, and diverse traditional theories, practices, and experiences about illness prevention, diagnosis, or treatment.
However, a survey of existing international standards in the field of IP illustrates that a precise definition of TK is not necessarily a crucial requisite for identifying the legal elements of a mechanism for its protection[22]. The same approach could be applicable to TMK. Therefore it’s more essential to identify the legal characteristics of protectable subject matter than a shared definition, to decide whether or not they meet the conditions of protection, such as novelty, an inventive step and industrial application for patent, and distinctiveness for trademark.
2.2. Features of Traditional Medicinal Knowledge
Thus, to identify the concrete characteristics of traditional medicinal knowledge, we have to clarify first the nature of this concept.
(a)Initially speaking, TMK, contrary to a common perception, is not necessarily old. In the same vein as the above concept “tradition-based”, TMK is a process of periodic, even daily creation, evolving from time to time, as individuals and communities pass down their knowledge from generation to generation and adapt their practices to their social and physical environment with new elements or improvements. In many ways, as a result, TMK is actually contemporary knowledge, which each community has developed and maintained in its local context.
(b)Secondly, the traditional essence also gives rise to another TMK feature: non-formal or non-systematic; partly because the use of methods or medicines depends on previous experiences without any scientific tests or research, partly because TMK is passed on in an informal or cultural manner, partly because TMK may be poorly documented with some essential elements modified or not explicitly articulated. So this feature may lay a hurdle on the way of claim or description when TMK is applied for registration.
(c)Another feature of TMK is concerned with the rights claimed by indigenous groups, local communities or other TMK holders[23]. Indeed, TMK also boasts the culture or geographical distinctiveness of communities or regions pertinent to the practices in discussion.
A case in point is “Guangdong herbal tea”. Traditionally, herbal tea is taken as folk formula for clearing up internal heat and eliminating damp, due to the typical climate natural environment in the southern China. Despite the fact that some herbal-tea-based products prevail in other parts of the country since the breakup of SARS, herbal tea is indisputably culturally rooted in Guangdong, which helps define the region’s own identity.
Another example can be found in the traditional practices in some tribal groups where the shaman treats the patient with both prescription and a religious ceremony[24]. Consequently, the protection of TMK ceases to be simply a matter of pecuniary gains, but also intertwines with the cultural or geographical identification of traditional or local groups. Analogously put, special protection of TMK should be granted, as if moral rights in copyright law would be entitled to an author to prohibit others from tampering.
3. Strategies for Protection of Traditional Medicinal Knowledge
As discussed above, the protection concerns about (a) the entitlement of IPRs to protect traditional medicines, or traditional medicinal knowledge based products or services; and (b) prevention from misappropriation of TMK. For the purpose of (a), we would try to put the protection within the legal framework of the existing IPR system, to make full use of the current resources in an effective and pragmatic way. Where the existing legal system lags behind the exploitation of TMK, a sufficient sui generis system of protection of traditional knowledge[25]is suggested, which I would only give a brief on it in this paper. On the other hand, for the purpose of (b), two strategies may be employed—for general products involving TMK, applicants for patents shall be required to disclose the TMK in the application without prejudice to the benefit-sharing principle; for TMK-based products or practices in the public domain, a large database shall be established to exam patent application.
3.1. Use of the Existing IPR System
3.1.1. Justification for IP Protection
Speaking of protecting TMK, exploring possibilities of prevention under the existing IPR system is regarded as a dominant means, in that devising a new legal regime for TK/TMK protection does not conform to economic calculation. However, there still exists uncertainty in extending IPRs to traditional medicinal knowledge and TMK holders. Some informants tend to view TMK as inappropriate subject matter of IPR protection, based on the arguments that (1) TMK is vaguely defined, and difficult to be explicitly described in the application; (2) TMK fails to exhibit eligibility criteria of novelty and innovation; (3) methods for the diagnosis or for the treatment of diseases are prohibited from patent rights, and also knowledge shall not be protected as intellectual property; (4) IPRs protect individual properties whereas TMK is by and large public, collective knowledge; (5) TMK holders are often difficult to be identified due to its “tradition” feature; (6) communities often hold TMK in parallel, like similar family secret therapies, which makes it difficult to determine its holders.
While partly agreeing with these concerns, I believe that the existing IP regime could still extend its protection to most TMK-related medicines or medical services. In response to the fore-mentioned dissents, some of the reasons are briefly summarized:
(a) Despite the indefinite and informal definition of TMK, whether the protection can be afforded depends on whether the claims specifically comply with the criteria of novelty, non-obviousness and utility, for example, rather than whether it is ambiguous or not. For some family formulae which have no unanimously agreed versions of prescription, it is of great importance to describe the technical essentials, like dosage or property of drugs (sometimes herbal materials) that determine the nature and function of that formula. In case minor variations appear in the herbal materials, for instance, the applicant could also apply for a patent (of medicines of the same effect) indicating certain herbal substitutes. Indeed, it’s unnecessary to precisely define every term, because even “invention”, the object of patent protection, is defined broadly.
(b) The dispute on novelty of TMK has its root in “traditional”. As clarified in the previous part (See “Features of TMK”), “traditional” knowledge does not mean “old”, which refers to the manner of producing such medicinal knowledge, rather than the date it took shape. TMK is being produced, and will be produced as it gears itself to the surrounding. In the field of patent, even though the knowledge was produced in the past, it can still be novel[26] on some occasions, in respect that an invention is new if no other inventor has obtained a patent or published articles for the same invention. Likewise, the patent can be inventive[27] if the subject matter was not obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. A few WIPO Member States have even accepted the notion of “commercial novelty” provided those inventions have not yet been subject to commercial utilization[28]. Therefore, the decisive factor still lies in whether TMK conforms to conditions.
(c) As methods for the diagnosis or for the treatment of diseases are explicitly banned from patenting, it is suggested protect them as public knowledge to prevent them from misappropriation.
(d) Further objection rests with the seeming conflict between public-owned TMK and private IPRs. However, the definition of “intellectual property” could tackle the debate on the private nature of IPRs. It is defined in terms of specific IP rights, as well as “all other rights resulting from intellectual activity in the industrial, scientific, literary or artistic fields.”[29] Intellectual property right consists of two elements: the traditional knowledge and relating rights. While the knowledge itself falls into the public domain, those rights are private rights. For that reason, IPRs functions not only to the pecuniary end, i.e. to gain economic benefits, but also to empower TMK holders moral rights—like those of an author—and guard against misuse of the culturally-rooted TMK. Moreover, patents or other IPRs covering TMK are also granted to private persons other than the indigenous peoples or communities who have originated and legitimately controlled the knowledge.
(e) Meanwhile the recognition of TMK holders shall not be an impediment, which could be solved in the approach from Document WIPO/GRTKF/IC/2/9:
“[T]he fact that the creators/inventors of traditional knowledge are not easily identifiable does not necessarily prevent the applicability of existing intellectual property standards. Most intellectual property assets are owned by collective entities, which in many cases represent large and diffuse group of individuals. On the other hand, patent law is not necessarily about protecting inventors, but about appropriating inventions.”[30]
In fact, the protection of collective rights is already well established in the existing IP system. For example, trademark law protects collective marks. Communitarian rights of particular regions define geographical indications and appellations of origins.
(f) As for parallel rights asserted by different communities to the same or similar TMK, say, family body therapies, these groups in different regions might obtain their knowledge independently, and it is advisable for them to cooperate in assigning or transferring knowledge to companies or institutions for industrial application, or just protect their TMK as undisclosed information.
3.1.2. Specific IPRs Eligible
Beyond the patent system, several other IPRs can be applied to TMK protection. The following part would explore possibilities of the use of all these IPRs in respect of different TMK.
Generally speaking, there are three types of statutory IP rights in China—copyrights, patents and trademarks—and such non-statutory rights as “know-how”. IP rights could also be divided into six categories in terms of TRIPS Agreement: copyrights and related rights, trademarks, geographical indications, industrial designs, patents, and undisclosed information. In order to effectively classify different TMK into corresponding groups, this paper adopts the Chinese system to label TMK into three major specific IPRs, among which trademarks are sub-divided into trademarks for goods and services, collective trademarks and certification trademarks (including geographical indications), and patents sub-divided into inventions, utility models and industrial designs[31].
Apart from the above, the protection of natural herbal materials or new plants employed in traditional Chinese medicines is available in Convention on Biological Diversity and Benefit Sharing and Plant Variety Protection[32].
3.1.2.1. Copyrights and Related Rights
When it comes to copyright, TMK does not be entitled enough protection under copyright or neighboring right, since a 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 itself. Therefore, copyrights are applicable to certain sectors of TMK protection, i.e. the cultural heritage and public information. And three points will be highlighted:
(1) For TMK-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 yield the tremendous patented profits to a small sum of copyright rewards, and even submit the patent to foreign counterparts after they make some minor modification.
For example, China has deep roots in sericulture, abundant in exclusive skills and unique practices, and led the way in prevention from epidemic Antheraea pernyi (柞蚕流行病) on the competitive edge. However, on an international seminar on sericulture industry, the researches gave a public speech, and elaborated on the therapies and treatment of the epidemic on the basis of traditional practices and long-term lab research. It turned out finally that they received wide appreciation on their scientific studies, but yielded the chance of patenting[33]to another foreign company that employs and further develops China’s research results.
(2) For some non-medication therapies, that is, physical, mental, spiritual or mind-body therapies, like tai ji and qi gong, the knowledge holder may record the physical movements, and mental regulations sometimes, into books. In spite of different splits, such TMK seems unlikely to be eligible for patent or trademark application, and its prevailing popularity, especially among the senior citizens in China, has thrown it beyond the possibility of undisclosed information. Accordingly, an effective protection method for these TMK holders—who inherit the TMK of different splits— is to mark it down and bring it under the protection of copyrights. But surely enough, the works shall be “intellectual creations with originality in the literary, artistic or scientific domain”.
(3) For TMK ineligible for any IPR 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. (This will be further illustrated in 3.3.)
3.1.2.2. Patent
Patent protection includes inventions, utility models and industrial designs. The TRIPS Agreement stipulates 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, I’ll exclude TMK-based methods of diagnosis or treatment of diseases from this part, such as traditional methods of examining body: inspection of vitality, observation of the tongue coating, inquiry about chill and fever, etc.
For TM therapies which involve core technologies of TMK rich in research value, patent rights shall be, for the most part, granted so far as they tally with the application conditions, although the novelty requirement often blocks the way. But here something should be focused attention on:
(1) Objective Matter of Protection
TM therapies, in terms of the WTO definition, involve herbal medicines, animal parts and/or minerals that are new, inventive and useful. While new varieties of herbal plants are already under the protection of Plant Variety Protection (UPOV)[35], most commonly seen traditional medicines are confronted with the challenge of eligibility for protection.
First, TMK is not necessarily ancient knowledge, but for most of the time, contemporary information. As discussed in the previous part “2.2. Features of TMK”, it is “traditional” only because it is created in a manner that reflects the traditions of the communities. So the term “tradition” shall not be deemed as an obstacle against the “novelty” requirement for patent application, in the sense that the concept is merely related to the way in which the knowledge is created, preserved and disseminated.
But to meet the patentability criteria, in particular the inventiveness requirements, TMK 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 render it novel and non-obvious. For example, they can convert liquid Chinese medicines into solid granules, or mix different herbal materials or animal parts into a creative combination.
A difficult question arises when a TMK component is claimed as part of such a patent: whether the traditional medicinal information—mostly commonly used knowledge or even public knowledge in this case—encapsulated within the medicines should be eligible for patent protection. Although some scholars argue that IPRs are only limited to knowledge that can be used for commercial purposes, and TMK should be distinguished from other commercially valuable information[36], I would shed light on the object of Patent Law. When we unveil the nature of inventions, it purports to any new technical solution relating to a product, a process or improvement thereof. Whether the invention is grounded on nothing or former experiences, there must exist a new and innovative step resulting from brain-storming or intellectual efforts which deserve patent rights. Furthermore, the chances are slim that inventions take shape without reference to any traditional knowledge, which otherwise may render the majority of patents illegal. Therefore, the TMK involved in the new medicine shall not be deemed an independent part of information, but an integral element incorporated in the innovation which comprises the patent.
However, one instance is excluded from the above value-adding suggestion: some informal traditional medicinal practices generally originated in the past with few modifications, say, some folk prescriptions for disease diagnosing or treating that have not yet been officially recognized or admitted by competent authorities, shall not be labeled beyond patent protection, in condition that they do not violate the laws of the State, go against social morals or exert detriment to the public interest. And of course, these practices should also comply with the three basic application requisites for patents. Such TMK shall still be regarded as eligible patent if it is never available to the public through wide use or oral traditions, because in the field of patents, it is disclosure (or the lack thereof) that established whether the condition of novelty and inventiveness is met. This is also known as commercial novelty. The date on which the invention was realized does not necessarily lay obstruction. If it is absent with any patent for the same thing, and not obvious at the time it was made to a person having ordinary skill in the art, it is still eligible.
(2) Types of Patents
i.Inventions: Among the three patents available, only inventions could refer to product, process or improvement. Thus, inventive or improved medicines, unauthorized medical therapies or methods are applicable.
In TK protection, it is possible to grant patents on an inventive combination of two individually ‘known’ substances: in the Maca and Velvet Deer Antler[37]cases, the USPTO had correctly refused separate patent protection of Maca (a fertility boosting plant), and of 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.
In the same vein, patent can be registered even if it is developed from traditional medicines or medicinal plants. An Indian developer Tropical Botanic Garden and Research Institute exploits a new medicine named “Jeevani” from a traditional medicinal plant “arogyapaacha”[38]. 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.
ii.Utility models: It means new technical solution on the shape, structure or their combination, of a product, which is fit for practical use. As it is confined to products, particular medicines, the shapes or appearances of which are modified for convenience, match this type, such as Istis-Root Granules originating from traditional Istis-Root decoction.
iii.Industrial designs: Since this type focuses more on the aesthetic shape or pattern of a product, which has little bearing with medicines, such patents may seldom be used in TMK protection.
(3) Exception
In case a person maliciously applies for a patent on basis of TMK or information which has been obtained improperly, existing patent law allows the right holder of the knowledge or information either to have the patent cancelled or to have it transferred to his name[39]. Under such circumstances, the patent may be entitled for not meeting the patentability criteria.
(4) Disclosure Requirement
Other than the protection in the form of IPR entitlement as above, there is another method of protection to prevent misappropriation of TMK. in other words, for general products involving TMK, applicants for patents shall be required to disclose the TMK in the application in accordance with the benefit-sharing principle.
3.1.2.3. Trademark
In the trademark dispute on “LI Shizhen”, the importance of this type of IPR would never be over-emphasized[40]. Qichun, birthplace of the notable physician LI Shizhen in Hubei Province, has for long earned its reputation for “Four Medicinal Treasures”—Qi snakes, Qi turtles, Qi bamboos and Qi mugwort. It is reasonable if Qichun people promoted the regional medicinal resources through their historic figure “LI Shizhen”. Unfortunately, a Beijing trade company of medical-care products preempted the trademark by registering the name “LI Shizhen” back in 1983, which rendered Qichun people’s subsequent registration null and void. When they intend to employ their ancestor LI Shizhen as a brand name to attract foreign investments on local herbal materials, they have infringed on others’ legal rights. It is until then when they come to realize the significance of trademarks.
In domestic legislation, Article 3 of Trademark Law categorized registered trademarks into trademarks for goods and services, collective trademarks and certification trademarks. Geographical indications, a type of IPRs in TRIPS, are regarded as certification marks or collective trademarks under the Implementation Regulation[41].
Medicine manufacturers, exploiting ordinary TMK 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.
Apart from the initial example, another case in 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[42], the plaintiff who legitimately produces red-can packaged “Wang Lao Ji” Herbal Tea, lodged a lawsuit against “Twenty-four Tastes” Herbal Tea’s manufacturer, San Shui Hua Li Company. Jia Duo Bao Company firmly claims that Hua Li Company 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 TMK to unite together and form an association or organization about that TMK. Sometimes, TMK 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 TMK could be better popularized.
Meanwhile a certification trademark works in a similar way as a collective trademark, but it’s available to any individual who satisfies the criteria. It is controlled by an organization which is capable of exercising supervision over a particular kind of goods or services, and used by a unit other than the organization or by an individual for its or his goods or services. For example, “Guangdong criteria for herbal tea therapies”, initiated by Guangdong Food Industry Association[43], are being drafted with the approval of Guangdong Administration of Quality and Technical Supervision, to supervise manufacturers who employ the relevant therapies. But a certification trademark tends to certify the indications of the place of origin, raw materials mode of manufacture, quality, or other specified properties of the said goods or services.
Geographical indications[44] can also play a complementary and positive role, though they have to be registered as certification or collective marks in China[45]. Since they don’t protect specific TM knowledge or information, medicinal products or materials apparently originating from a “protective area” could be identified as geographical indications to guarantee the quality of their medicines and the credibility in the place of origin if they fulfill the criteria. On many occasions this protection is employed to safeguard special, locally grown medicinal materials to facilitate its export as well as secure its quality.
3.1.2.4. Undisclosed Information
Article 39.1 of TRIPS provides that “in the course of ensuring effective protection against unfair competition as provided in Article 10bis of the Paris Convention (1967), Members shall protect undisclosed information and data submitted to governments or governmental agencies.”
On condition that it (a) is not generally known among or readily accessible to persons within the circles which normally deal with the kind of information in question, (b) has commercial value and (c) has been subject to reasonable steps under the circumstances to keep it secret, natural or legal persons lawfully in control of the information may prevent the information from being disclosed to, acquired or used by others without their consent. So the protection is applicable to informal, secret family prescription or therapy, original medical treatment (medicines or mind-therapies) solely created by individuals. In this way, limitations are maintained on the circulation of their knowledge, innovations and practices, as famous Coca Cola Company does. A famous domestic pharmaceutical company Yun Yao Co, Ltd. also adopts this strategy in protecting its anti-bacterial ointment Yun Nan Bai Yao.
In fact, the undisclosed way of protection is far more efficient than any other IP protection, especially for traditional knowledge that is low in technology and easier to be imitated. On the one hand, undisclosed information validates a long-term protection, because different from the twenty-year tenure of patent protection, only this type of protection exerts no requirement on the term of protection. Copyrights and trademarks are also eligibly under protection for a certain period of time. On the other hand, some foreign medical companies might as well imitate the core technology of Chinese traditional medicines if Chinese applicants register their products merely in the form of trademark. But of course, the protecting responsibility rests on the companies or TMK holders themselves.
3.2. Sui Generis System
Where the existing IPR 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 generisb model. But this special system shall not only cover TMK protection, but the whole traditional knowledge. And this TK system could be developed to comprise specific features applying to specific elements of TK, such as TMK discussed in this essay. As the WTO Secretariat 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.
However, to set up an all-sided protection system, still more work is to be done, for example, identifying elements like the additional criteria, right-owner, right content, expiration[46], etc.
Even if some TK fits within a broad definition, it may need to meet distinct criteria in this specifically designed legal system. This may apply, for instance, to TMK 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 TK which have not been commercially exploited prior to the date of the filing of the database are protected (though the concept of commercial novelty is actually not foreign to existing IP mechanisms, such as UPOV’s plant variety protection).
Besides, TMK, 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 customary law, that is, recognizing communities’ customs and traditions.
When it comes to the content, TMK rights should also comprise material and moral rights, and the moral part should be considered a crucial component, because of their particular role on the protection and preservation of the cultural identity of traditional communities. And the rights could also comprise the right to assign, transfer and license those contents of TMK databases with a commercial/industrial nature.
IPRs that stimulate innovation and creation are generally limited in time. Active use of TK should also constitute the required limit of protection, the period of which will have to be determined by law. But the problem is that for TMK, a new medicine will often only be launched to the market after a number of years of research and testing, and the amount of equitable sharing of benefits cannot be properly defined during the first years of licensing. At this point, some experts suggest differentiating the licensing fees, with one charge for a period of R&D, and additional compensation to become due once the medicine reaches the market.
Considering that this might be an extremely complex issue requiring laborious efforts, I’m therefore not going to further delve into the recesses of the system in this paper.
3.3. Establishment of Database
Unlike the IPR protection for commercial exploitation, there is another kind of protection underlying the preservation and conservation of long-history customs, and the maintenance and sustainable development of the local and indigenous culture, in other words, protection for knowledge with little economic value—public knowledge.
For well-known, popular TMK—including codified traditional medicinal information ineligible for novelty, innovation, industrial application or geographical indication—that is unlikely and unsuitable to be brought under the protection of any IPR laws (in China, Copyright Law, Trademark Law and Patent Law; internationally TRIPS Agreement), it is advisable to treat it as public knowledge, under the theory that their use is not exclusive but open to others in the community, such as the original “twenty-four tastes”, a common home-used Guangdong herbal therapy (traditionally comprising twenty-four types of herbal plants) to prevent and sometimes treat common flu. Moreover, since such non-systematically used TMK is often passed down over generations by customary and informal practices, there exists a broad spectrum of variations during the practices of the same TMK, which also renders it impossible to be protected as a specific kind of IPR object matter before any new value is added.
Unfortunately, however, there are no existing protection strategies in the public TMK domain, either in domestic or global realm, but we may apply some principles available in other traditional knowledge domains to deal with ill-intentioned misappropriation of public TMK, such as implementing, through national legislation, the benefit sharing required by the Convention on Biological Diversity (hereinafter referred to as “CBD”)[47].
In addition, local patent offices shall include as much TMK in prior art searches as possible in order that the information is available to them, codify the traditional knowledge that is ineligible for IP protection into publicized literature, and establish a huge inventories, collections, compilations or simply database of all systematically documented public TMK accessible to relevant authorities who exam the patent application. All that should be completed with the involvement and consent of the local communities, that is, the TMK holders. Examples of this database management of folklore and other cultural heritages are proposed in the report of the US delegation to WIPO:
“[W]here preservation, conservation and protection are the goals rather than exploitation, a different strategy must be developed. In the United States, for example, preservation of Native American work is achieved through several legislative avenues, including the registration of official insignia of Native American Tribes... The American Folklife Center created by the Congress encompasses all aspects of folklore and folklife from this country and around the world, including over one million photographs, manuscripts, audio recordings, and moving images…”[48]
Generally speaking, it is favorable to protect some TMK as public knowledge with reasonable strategies instead of legal tools, considering its own features and objectives of conservation.
4. Conclusion
In a word, it is indispensable to strengthen our awareness of protecting traditional medicinal knowledge, in particular under the IPR framework; otherwise China will lose its medicinal advantage of tremendous historic value to developed countries that emphasize IP protection.
While it is true that no TMK protection may be efficiently implemented if we have no clear concept of what TMK is, the key lies in whether the medicinal products or practices conform to the essentials of protection, rather than the precise definition of TMK. In accordance with different circumstances, we may adopt different protection strategies that lay down different requirements.
For the IPRs entitlement to protect TMK, one solution, the most practical one 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, inventors or researchers shall be aware of the possible consequences when they release research articles in public on TMK-based new medicines that are eligible for patent application. For some non-medication therapies, like tai ji and qi gong, the knowledge holder of a distinct split may record the physical movements, and mental regulations sometimes, into books consistent with the originality basis, and enjoy copyright protection. While for TMK ineligible for any IPR protection, database establishment shall 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, but only two types may be available—inventions and utility models.
For traditional medicine manufacturers and those who share similar TM practices or locally-grown herbal materials within a region, trademark, in particular collective or certification trademark, appears to be a wiser decision.
As to undisclosed information, it is commonly applicable to informal, secret family therapies, or original medical treatments that TMK holders are reluctant to disclose and expecting for a long-term protection.
Though it seems fairly feasible to apply the existing system as the only legal solution, there exist some pending problems as to limitations of the current protection regime, such as additional criteria specifically for traditional knowledge as human heritage, reasonably identifying right-owner, supplement of right content, modification of time limit, etc. These deficiencies call for a sui generis system which needs long-term studies and international cooperation, thus laid beyond the focus of this paper.
For the purpose of guarding TMK against misuse, patent applicants shall be required to disclose the TMK in the application in accordance with the benefit-sharing principle, if it can be patented; and for TMK-based products or practices in the public domain, a large database shall be established to exam patent application.
References:
[1] 蔡吉祥(Cai, Jixiang).发表论文葬送无形资产,选自《无形资产36忌无形资产失败案例分析与研究》[M].海天出版社,2004.
[2] Carlos M Correa. Traditional Knowledge and Intellectual Property: Issues and Options Surrounding the Protection of Traditional Knowledge [M]. Quaker United Nations Office Geneva, November 2001.
[3] Thomas Cottier and Marion Panizzon. Legal Perspectives on Traditional Knowledge: The Case for Intellectual Property Protection[J]. Journal of International Economic Law. 6 (2004). Oxford University Press.
[4] WHO. WHO/EDM/TRM/2002.1..Medicine Strategy 2002-2005[R]. 2002.
[5] Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore. Document WIPO/GRTKF/IC/2/8, Elements of A Sui Generis System for the Protection of Traditional knowledge[R]. Fourth Session. Geneva, September 2002.
[6] WIPO/GRTKF/IC/3/9 Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore. Traditional Knowledge—Operational Terms and Definitions[R]. Third Session. Geneva, 2002.
[7]WIPO. Document WIPO/GRTKF/IC/3/16. Annex of Submission by the European Community and its Member States[R]. Geneva, June 2002.
[8]WIPO. Document WIPO/GRTKF/IC/4/8. Elements of A Sui Generis System for The Protection of Traditional Knowledge[R]. Geneva, September 2002.
[9] WIPO. Intellectual Property Needs and Expectations of Traditional Knowledge Holders—WIPO Report on Fact-Finding Missions on Intellectual Property and Traditional Knowledge[R]. April 2001.
[10] 思考者.法律保护中医药: http://www.biox.cn/content/20050707/24842.htm.
[11] 陈苗苗(Chen Miaomiao). 广东凉茶被认定为首批”广东省食品文化遗产”: http://www.gd.xinhuanet.com/newscenter/2005-08/31/content_5014804.htm.
[12] 陈朝晖(Chen, Chaohui),郑洪(Zheng, Hong). 如何实现中医药的全面国际保护. http://www.100md.com/html/DirDu/2005/12/05/81/87/39.htm.
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[1] A World Intellectual Property Organization-United Nations Educational Scientific and Social Organization Model Law on Folklore was adopted in 1981.
[2] Convention on Biological Diversity and Benefit Sharing. See Convention on Biological Diversity, 5 June 1992, 31I.L.M. 818 (hereinafter CBD)
[3] WIPO/GRTKF/IC/3/9 Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore. Traditional Knowledge—Operational Terms and Definitions[R]. Third Session. Geneva, 2002. at 3.
[4] WHO. WHO/EDM/TRM/2002.1..Medicine Strategy 2002-2005[R]. 2002.1.
[5] WHO. WHO/EDM/TRM/2002.1..Medicine Strategy 2002-2005[R]. 2002.2.
[6]蔡吉祥(Cai, Jixiang).发表论文葬送无形资产,选自《无形资产36忌无形资产失败案例分析与研究》[M].海天出版社,2004. 29
[7] Agreement on Trade-Related Aspects of Intellectual Property Rights, Annex 1c of the Marrakesh Agreement Establishing the World Trade Organization. WTO Secretariat. Geneva 1994 (hereinafter TRIPS Agreement).
[8] Article 10 of Copyright Law of the People’s Republic of China.
[9] Article 9 of Copyright Law of the People’s Republic of China.
[10] The term “works” includes works of literature, art, natural sciences, social sciences, engineering and technology. See Article 3 of Copyright Law of the People’s Republic of China.
[11] Article 3 of Trademark Law of the People’s Republic of China.
[12] That is, “the origin of the goods the special qualities, credibility or other characteristics of the goods and it is primarily determined by the natural factors or other humanistic factors of the place indicated”. See Article 16 of Trademark Law of the People’s Republic of China.
[13] See Article 1, Article 6, Article 7, Article 8 of Patent Law of the People’s Republic of China.
[14] “Invention” purports to any technical solution relating to a product, a process or improvement thereof; “utility model” any new technical solution relating to the shape, the structure, or their combination, of a product, which is fit for practical use; “design” any new design of the shape, pattern or their combination, or the combination of color with shape or pattern, of a product, which creates an aesthetic feeling and is fit for industrial application. See Article 2 of Rules for the Implementation of the Patent Law of the People’s Republic of China.
[15] “Novelty” means that no identical invention or utility model has been publicly disclosed in domestic or foreign publications or has been publicly used or made known to the public by any other means in the country…; “inventiveness” means the prominent and substantive distinguishing features and represents a marked improvement; “usefulness” means that the invention or utility model can be made or used and can produce positive results. See Article 22 of Patent Law of the People’s Republic of China.
[16] See Article 25 of Patent Law of the People’s Republic of China.
[17] WIPO. Intellectual Property Needs and Expectations of Traditional Knowledge Holders—WIPO Report on Fact-Finding Missions on Intellectual Property and Traditional Knowledge[R]. April 2001. at 25.
[18] “Categories of traditional knowledge include: agricultural knowledge; scientific knowledge; technical knowledge; ecological knowledge; medicinal knowledge; biodiversity-related knowledge; ‘expressions of folklore’ in the form of music, dance, song, handicrafts, designs, stories and artwork; elements of languages, such as names, geographical indications and symbol; and, movable cultural properties.”
[19] The terms “complementary” and “alternative”(and sometimes also “non-conventional” or “parallel”) are used to refer to a broad set of health care practices that are not part of a country’s own tradition, or not integrated into its dominant health care system. See WHO/EDM/TRM/2002.1..Medicine Strategy 2002-2005[R]. 2002.7.
[20] Herbal medicines include herbs, herbal materials, herbal preparations and finished herbal products that contain as active ingredients parts of plants, or other plant materials, or combinations thereof. See WHO/EDM/TRM/2002.1..Medicine Strategy 2002-2005[R]. 2002.7.
[21] See Box 1. WHO/EDM/TRM/2002.1. Medicine Strategy 2002-2005,
[22] Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore. Document WIPO/GRTKF/IC/2/8, Elements of A Sui Generis System for the Protection of Traditional knowledge[R]. Fourth Session. Geneva, September 2002. at 26.
[23] For purposes of WIPO’s work to date, WIPO has used the term “traditional knowledge holder” to refer to all persons who create, originate, develop and practice traditional knowledge in a traditional setting and context.
[24] An example of an Amazon tribe. See Document WIPO/GRTKF/IC/4/8. Elements of A Sui Generis System for The Protection of Traditional Knowledge[R]. Geneva, September 2002.15.
[25] “A proposal for traditional IP rights in traditional knowledge…We reject any activity-specific approach that would differentiate among traditional medicinal knowledge, traditional ecological knowledge, traditional and local technology knowledge, and general know-how and practices.” (Thomas Cottier and Marion Panizzon. Legal Perspectives on Traditional Knowledge: The Case for Intellectual Property Protection[J]. Journal of International Economic Law. 6 (2004). Oxford University Press. 387.)
[26] “’Novelty’ means that, before the filing date of the application, no identical invention or utility model has been publicly disclosed in domestic or foreign publications or has been publicly used or made known to the public by any other means in the country, nor has any other person previously filed with the patent administration department…”Article 22 of Patent Law of the People’s Republic of China.
[27] “’Inventiveness’ means that, compared with the technology existing before the filing date of the application, the invention has prominent and substantive distinguishing features and represents a marked improvement…”Article 22 of Patent Law of the People’s Republic of China.
[28] WIPO. Document WIPO/GRTKF/IC/4/8. Elements of A Sui Generis System for The Protection of Traditional Knowledge[R]. Geneva, September 2002.17
[29] Article 2 of the WIPO Convention provides that “‘intellectual property’ shall include the rights relating to: literary, artistic and scientific works, performances of performing artists, phonograms and broadcasts, inventions in all fields of human endeavor, scientific discoveries, industrial designs, trademarks, service marks, and commercial names and designations, protection against unfair competition, and all other rights resulting from intellectual activity in the industrial, scientific, literary or artistic fields.”
[30] Document WIPO/GRTKF/IC/2/9
[31] Article 25 of TRIPS Agreements stipulates that “[m]embers shall provide for the protection of independently created industrial designs that are new or original”.
[32] In its 1978 and 1991 Acts, the International Union for the Protection of New Varieties of Plants (UPOV) established a sui generis system of plant-related IPRs for plant breeders.
[33]蔡吉祥(Cai, Jixiang).发表论文葬送无形资产,选自《无形资产36忌无形资产失败案例分析与研究》[M].海天出版社,2004. 29
[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 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).
[36] Thomas Cottier and Marion Panizzon. Legal Perspectives on Traditional Knowledge: The Case for Intellectual Property Protection[J]. Journal of International Economic Law. 6 (2004). Oxford University Press. 390.
[37] Thomas Cottier and Marion Panizzon. Legal Perspectives on Traditional Knowledge: The Case for Intellectual Property Protection[J]. Journal of International Economic Law. 6 (2004). Oxford University Press. 395.
[38] 陈朝晖(Chen, Chaohui),郑洪(Zheng, Hong). 如何实现中医药的全面国际保护. http://www.100md.com/html/DirDu/2005/12/05/81/87/39.htm.
[39] WIPO. Document WIPO/GRTKF/IC/3/16. Annex of Submission by the European Community and its Member States[R]. Geneva, June 2002. 2~3
[40]蔡吉祥(Cai, Jixiang).发表论文葬送无形资产,选自《无形资产36忌无形资产失败案例分析与研究》[M].海天出版社,2004. 53
[41] Article 6 of Regulations for the Implementation of the Trademark Law of the PRC prescribes that “For geographical indications…, applications may be filed to register them as certification marks or collective marks…”
[42] 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.
[43]陈苗苗(Chen Miaomiao). 广东凉茶被认定为首批”广东省食品文化遗产”: http://www.gd.xinhuanet.com/newscenter/2005-08/31/content_5014804.htm.
[44] Article 16 of Trademark Law of the PRC reads’ “the geographical indication…means the origin of goods, the special qualities, credibility or other characteristics of the goods, and it is primarily determined by the natural factors or other humanistic factors of the place indicated.” Article 22 of TRIPS Agreement also defines it as “indication which identifies a good as originating in the territory of a Member, or a region or locality in that territory, where a given quality, reputation or other characteristic of the good is essentially attributable to its geographical origin.”
[45] See Article 6 of Regulations for the Implementation of the Trademark Law of the PRC.
[46] WIPO. Document WIPO/GRTKF/IC/4/8, Elements of A Sui Generis System for The Protection of Traditional Knowledge. Geneva, September 2002.22-31.
[47] According to Article 15.7 of CBD, “Each Contracting Party is bound to take legislative, administrative or policy measures with the aim of sharing in a fair and equitable way the results of research and development and the benefits arising from the commercial and other utilization of genetic resources with the Contracting Party providing such resources. Such sharing shall be upon mutually agreed terms.”
[48] General Declaration of the USA to the First Session of the WIPO Committee, May 1, 2001. A Center for Arab and Mediterranean Music was established by Tunisia in 1992. See the Report of the WIPO Committee, para35.
