Protection and Promotion of Traditional Medicine - Implications for Public Health in Developing Countries
(2002; 131 pages) View the PDF document
Table of Contents
View the documentThe South Centre
View the documentPREFACE
View the documentINTRODUCTION
Open this folder and view contentsI. INTELLECTUAL PROPERTY AND TRM
Close this folderII. RATIONALE FOR PROTECTION
View the documentA. Equity
View the documentB. Preservation
View the documentC. Preventing Misappropriation
View the documentD. Promoting Self- Determination68
View the documentE. Promoting Development
View the documentF. Summary: What Can Protection Achieve?
Open this folder and view contentsIII. APPLYING EXISTING IPRS
Open this folder and view contentsIV. POLICY OPTIONS: PROTECTING AND PROMOTING TRM
View the documentV. IPRs AND PUBLIC HEALTH
View the documentVI. CONCLUSIONS
View the documentREFERENCES
 

C. Preventing Misappropriation

As mentioned, the need to protect TRM has arisen in many instances in the context of claims relating to the unauthorized appropriation of TRM-based products, processes and the biological resources on which they are based.

For example, patents have been obtained by applicants from developed countries on the production, processes and/or therapeutic uses relating to caraway (Carum carvi), amaltas (Cassia fistula) and Indian mustard (Brassica campestris) (Sharma, 2000, p. 5). A patent (US patent No. 5.401.504) was also granted to the University of Mississippi Medical Center, in March 1995, over the “Use of Turmeric in Wound Healing”. The claim covered “a method of promoting healing of a wound by administering turmeric to a patient afflicted with the wound”, such wounds including surgical wounds and body ulcers. The powder of the turmeric plant is a classic “grandmother’s remedy” in India. It has been applied to the scrapes and cuts of generations of children (Dutfield, 2000a, p. 65). On 14 August 1997, the US Patent and Trademark Office invalidated the patent upon request by India’s Council for Scientific and Industrial Research (CSIR), after ascertaining that there was no novelty.56

56 See, e.g., SUNS No. 4050, 8 August, 1997. The lack of novelty was held on the basis of a 1953 article in the Journal of the Indian Medical Association and on Ayurvedic texts (Hansen, 2002).


A further example is the patent - regarded as outrageous by indigenous communities in Amazonia - that relates to a variety of the ayahuasca57 vine (Banisteriopsis caapi). In 1986, after research in Ecuadorian Amazonia, a US citizen was granted US plant patent No. 5.751 (Garí, 2000. p. 8 p. 9). Ayahuasca is a used for many medicinal and ritual purposes and is a sacred plant for many of the indigenous peoples of Amazonia. The patent was challenged by several NGOs and was re-examined and revoked in 1999. However, it was re-instated by the US Patent and Trademark Office in 2001. Another publicized case in Latin America was the grant of US patent No. 5.304.718 to researchers of the Colorado State University on a variety of the important South American food plant quinoa. Other significant examples, although many could be mentioned, include the more than one hundred patents obtained on derivatives of the neem tree (which indigenous communities have used traditionally in India for multiple purposes)58 and the patent held by the University of Lausanne that relate to the Madagascan plant Swartzier Madagascariensis.59

57 “Ayahuasca” is the vernacular name among the Amazon Quechua people, in whose language ayahuasca means “vine of the spirits”.

58 In early 2000 a patent granted to W.R. Grace Company and US Department of Agriculture on neem oil extract used as fungicide and insecticide (EPO patent No. 436257) was revoked by the European Patent Office. However, other neem-related patents have remained active, such as a patent obtained by the same company in 1992 covering specific storage-stable pesticide compositions and methods for making them, which retained at least 80% of the active ingredient after one year when stored at a room temperature of 25 degrees Celsius. On the neem-based patents in the U.S. and India, see Karki, 2001.

59 The Panafrican News Agency reported on November 11, 2000, that “a bitter row has erupted between Zimbabwe’s traditional healers and a Swiss university over the latter’s move to patent a drug the former had submitted for trial under a research agreement. The Zimbabwe National Healers’ Association, a group of witch doctors, had submitted a plant known as Swartzier Madagascariensis to the University of Zimbabwe for medical trial on patients suffering form candida, footrot and oral thrush. But the drug was later sent to the University of Lausanne in Switzerland which patented it jointly with a US drugs company....”.


The reaction generated by these kind of patent grants, illustrate the deep differences that often exist between the Western concept of the private/public domain and the constructions of knowledge held by traditional/indigenous peoples.

Under the Western paradigm of IPRs, any information not covered by a specific form of IPRs, is a res nullius and belongs to the “public domain”. The concept of the public domain, though technically correct in the context of the IPRs legal paradigm, ignores that knowledge may be subject to special rules of appropriation under customary laws,60 that sometimes recognize certain forms of ownership or possession rights.61 According to evidence collected by WIPO, in some cases such laws include elements comparable to IPRs62. Whenever IPRs are granted over traditional knowledge components, tensions with the conceptual framework of local and indigenous communities becomes more acute. Certain communities view knowledge as an integral part of their natural environment or of their religious system and worldview. Even where there is a notion of property within the worldviews of local/indigenous communities, certain peoples do not view knowledge as a subject over which property rights can be held. In these cases, the Western concept of IPRs may violate the communities’ value systems and explain why -as in the case of ayahuasca- the communities were outraged by the granting of patent rights.

60 See, e.g. Dutfield, 2000b, p. 285.

61 See also section IV.j below.

62 See WIPO, 2001; see also Valencia, 1998.


The debate about misappropriation often confuses at least four distinct situations:

(a) Knowledge that is disclosed and firmly in the public domain (at least in a Western framework) becomes patented due to failing to identify relevant prior art in the examination of the patent application. If such prior art were brought to the attention of the respective patent office or of a court - as in the turmeric case - the patent could be revoked. The US delegation to the WIPO Committee dealing with TK mentioned above, has argued that

“if information is not written down, that information is completely inaccessible to patent examiners everywhere as prior art when they are examining patent applications. It is possible, therefore, for a patent to be issued claiming as an invention technology that is known to a particular indigenous community. The fault lies not with the patent system, however, but with the inaccessibility of the knowledge involved beyond the indigenous community” (US Statement to the First Meeting of the WIPO Committee, May 1, 2001).


While this statement acknowledges the ramifications of limitations in the examination process, it puts the burden on traditional/indigenous communities to prove their knoweldge is in the public domain, rather than on patent offices to properly establish the lack of prior art.

A large part of TRM knowledge in codified TRM systems may give rise to cases of this kind. Reaction against IPRs protection is based on the public availability of the relevant knowledge, which should remain available to all. The patent system is intended to reward contributions to the state of the art, not the appropriation of pre-existing knowledge. A possible solution to this problem, as discussed below,63 lies in gathering and publishing data on disclosed TRM so as to prevent the granting of IPRs thereon.

63 See section IV.c below.


(b) There are cases where certain knowledge, which is not publicly available (e.g. held by a small indigenous community), is acquired by an individual or a company and protected, as received, without authorization from and/or compensation to the community who held and developed the knowledge. To the extent that the community had no specific right over such knowledge recognized under the applicable national law, there is no infringement of any right, though customary law may have been violated. Moreover, since the knowledge was not technically part of the prior art, patents granted may be held valid (if an inventive step is also present). This problem thus cannot be simply addressed by challenging the patent on the basis of lack of novelty. The prior consent and benefit sharing principles enshrined in the CBD may provide, as discussed below, a possible model to deal with this situation. It may also be possible to challenge the patent on the basis of rules relating to invention, since the patent owner cannot be legally deemed the inventor.64

64 See section IV.g below.


(c) Received TRM is improved on or modified, and the outcome subject to IPRs (e.g. a synthetically produced active ingredient found in a plant or a more stable form of a known substance). In these cases, something new has been created that represents an addition to but that derives from the previously available pool of knowledge.

No significant legal questions arise when the derivative has built upon previously disclosed knowledge, as the inventor has added value to the preexisting prior art. When derivatives have been based on non-publicly available knowledge possessed by traditional/indigenous communities, the same issues as in point (b) above emerge in relation to benefit sharing.

There may be questions in such cases concerning the extent of the technical contribution made by patent holders. In some instances, the degree of inventive activity involved may be minimal, for instance, when a researcher or company claims protection over a useful characteristic of a plant that was familiar to a traditional/indigenous community, but which the latter were unable to describe in appropriate technical terms.65 In order to avoid objections to patentability, claims may be made on a purified extract or a synthetic version of the compound, but this would not dissipate doubts about the legitimacy of the appropriation (Dutfield, 2000 p.12).

65 An example could be the appetite-suppressing element found in a plant (hoodia cactus) known to the San community in South Africa, which was patented by the South African Council for Scientific and Industrial Research, and licensed to a British company. An agreement between the CSIR and the San has since been reached.


(d) In some cases commercial companies profitably exploit TRM knowledge, which is publicly available, without acquiring IPRs, and without any benefit sharing with traditional knowledge holders or cultures of origin. Examples include kava-kava from the Pacific Islands, tea tree oil from Aboriginal Australian medicine, Devil’s Claw from Namibia and South Africa, Prunnus Africana from equatorial Africa and many other herbal medicines popular in western markets. By definition, no IPRs issues are involved in these cases.

The following table summarizes the different cases described above in the light of principles of patent law.

Table 1
Typology of TRM misappropriation

Status of TRM knowledge

Appropriation

Legal situation

1. Publicly available

As received

Invalid patent (lack of novelty)

2. Undisclosed

As received

Questionable inventor-ship

3. Publicly available/undisclosed

Derivatives

Valid patents, if an inventive step proven

4. Publicly available

Commercially exploited

No patents granted

In the first three cases there is appropriation of knowledge under IPRs, but in the third case such appropriation takes place with regard to a “derivative” or modified form of the received knowledge. Cases 1 and 2, and certain IPRs granted under case 3 are often termed “bio-piracy”. The third column of the Table suggests that in the first two cases, patents could be invalidated. In these cases the “protection” of TRM is not necessarily linked to demands of benefit sharing, but aims mainly at preventing the acquisition of IPRs that should be invalid given the appropriate application of IPRs standards of novelty and invention.

Finally, there are cases in which there is merely disclosure, rather than misappropriation of TRM through publication without the consent of knowledge holders, which puts such knowledge into the public domain. Over recent years, there has been a growing trend of surveying medicinal plants, conducting screenings of their chemical constituents, and developing inventories of their traditional use in healthcare. The data has been then compiled in databases, often available for public use and, in some cases for commercial gain. The CABI medicinal plant database in Wallingford, UK, with over 3 million entries of scientific studies on medicinal plants, and the NAPRALERT database at the University of Illinois are two large commercial examples. There are many smaller databases located in national research centers around the world as well as in international and national NGO’s.66

66 Communication from Bodeker, 13 August 2001.


A recent survey indicates that publications in scientific journals generally leading to the transfer of TRM to the public domain are made both by academics in developed and in developing countries. Table 2 presents articles in 25 journals in English, French and Chinese where explicitly reference is made to ethnomedical uses of the substances described.67

67 The largest number of articles were found in the Journal of Ethnopharmacology (128 articles or 51% of the total), Pharmaceutical Biology (50 articles or 19%), Economic Botany (14 article or 6%), and Phytomedicine (12 articles or 5%).


University-based authors account for an overwhelming 81 per cent of the publications. Amongst the developing countries, the leading producers of ethnomedical publications are India (20 publications), Brazil (19), Mexico (10), Argentina (10), South Africa (9), Turkey (9) and Nigeria (6). Another 37 countries from all regions are also represented.

While those opposing IPRs over traditional knowledge may welcome the fact that publication will prevent appropriation, questions obviously arise as to the legitimacy of publishing knowledge without the consent of the knowledge holders, as is often the case. Publication without such consent certainly denies an important component of the right to self-determination (see next section). Unlike the potential invalidation of a wrongly granted patent, once publication is made there is no means to reverse or remedy the situation, unless a patent is promptly applied for by the original holders of the knowledge and fraud in the publication may be proven, certainly a too heavy burden for most TRM holders, especially those in developing countries.

Table 2
Ethnomedical Publications 1996-2001

   

First
Identification

First
Confirmation

Totals

Source

Tribal

73

39

112

 

Folk

55

85

140

Institution

University

106

98

204

 

Government

16

15

31

 

Corporation

4

5

9

 

NGO

3

5

8

Region

North

50

57

107

 

South

77

68

145

Totals

 

128

124

252

 

Source: Barsh, 2001.

 

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