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 knowledgeis 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.
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 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 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. 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.” 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.”
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.
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.
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.
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 patentingto 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.)
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.” 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), 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, 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 antlercases, 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”. 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. 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.
in the trademark dispute on “li shizhen”, the importance of this type of ipr would never be over-emphasized. 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.
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, 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, 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 can also play a complementary and positive role, though they have to be registered as certification or collective marks in china. 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.
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.
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, 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.
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”).
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…” 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.
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