Human communities have always generated, refined and passed on knowledge from generation to generation. Such “traditional” knowledge”[1] is often an important part of their cultural identities. Traditional knowledge has played, and still plays, a vital role in the daily lives of the vast majority of people. Traditional knowledge is essential to the food security and health of millions of people in the developing world. In many countries, traditional medicines provide the only affordable treatment available to poor people. In developing countries, up to 80% of the population depend on traditional medicines to help meet their healthcare needs.[2] In addition, knowledge of the healing properties of plants has been the source of many modern medicines. As we note in Chapter 3, the use and continuous development by local farmers of plant varieties and the sharing and diffusion of these varieties and the knowledge associated with them play an essential role in agricultural systems in developing countries.
Only recently, however, has the international community sought to recognise and protect traditional knowledge. In 1981, WIPO and UNESCO adopted a model law on folklore. In 1989 the concept of Farmers’ Rights was introduced by the FAO into its International Undertaking on Plant Genetic Resources and in 1992 the Convention on Biological Diversity (CBD) highlighted the need to promote and preserve traditional knowledge.[3] In spite of these efforts which have spanned two decades, final and universally acceptable solutions for the protection and promotion of traditional knowledge have not yet emerged.
The CBD also set out principles governing access to genetic resources and the knowledge associated with them, and the sharing of benefits arising from such access. We therefore consider the relationship between the IP system and the access and benefit sharing principles of the CBD in the context of both knowledge, traditional or otherwise, and genetic resources.
We also consider here, although it is largely a separate issue, whether Geographical Indications (GIs) have a role to play in promoting development, and the issues relevant to developing countries in the current discussions on this issue in the TRIPS Council.
Thus in this chapter we examine the following
questions:
·
What is the nature of traditional knowledge and
folklore and what do we mean by its protection?
·
How can the existing IP system be used to protect and
promote traditional knowledge?
·
What modifications of the IP system might improve its
protection?
·
How can the IP system support the principles of
access and benefit sharing enshrined in the Convention on Biological Diversity
(CBD)?
·
Is the protection of Geographical Indications
important for developing countries?
A number of cases relating to traditional knowledge have attracted international attention. As a result, the issue of traditional knowledge has been brought to the fore of the general debate surrounding intellectual property. These cases involve what is often referred to as “biopiracy” (See Boxes 4.1 and 4.2). The examples of turmeric, neem and ayahuasca illustrate the issues that can arise when patent protection is granted to inventions relating to traditional knowledge which is already in the public domain. In these cases, invalid patents were issued because the patent examiners were not aware of the relevant traditional knowledge. In another example, a patent was granted on a plant species called Hoodia. Here, the issue was not whether the patent should or should not have been granted, but rather on whether the local people known as the San, who had nurtured the traditional knowledge underpinning the invention, were entitled to receive a fair share of any benefits arising from commercialisation.
Box 4.1 Biopiracy
There is no accepted definition of “biopiracy.” The Action Group on
Erosion, Technology and Concentration
(ETC Group) defines it as “the appropriation of the knowledge and
genetic resources of farming and indigenous communities by individuals or
institutions seeking exclusive monopoly control (usually patents or plant
breeders' rights) over these resources and knowledge.”
The following have been described as “biopiracy”:
a)
The granting of ‘wrong’ patents. These are
patents granted for inventions that are either not novel or are not inventive
having regard to traditional knowledge already in the public domain. Such
patents may be granted due either to oversights during the examination of the
patent or simply because the patent examiner did not have access to the
knowledge. This may be because it is written down but not accessible using the
tools available to the examiner, or because it is unwritten knowledge. A WIPO
led initiative to document and classify traditional knowledge seeks to address
some of these problems.
b)
The granting of ‘right’ patents. Patents may be correctly granted according to
national law on inventions derived from a community’s traditional knowledge or
genetic resources. It could be argued this constitutes “biopiracy” on the
following grounds:
·
Patenting standards are
too low. Patents are allowed, for
instance, for inventions which amount to little more than discoveries.
Alternatively, the national patent regime (for example, as in the US) may not
recognise some forms of public disclosure of traditional knowledge as prior
art.[4]
·
Even if the patent
represents a genuine invention, however defined, no arrangements may have been
made to obtain the prior informed consent (PIC)[5]
of the communities providing the knowledge or resource, and for sharing the
benefits of commercialisation to reward them appropriately in accordance with
the principles of the CBD.
Box 4.2 Controversial Patent Cases involving Traditional Knowledge and
Genetic Resources
Turmeric
Turmeric (Curcuma longa) is a
plant of the ginger family yielding saffron-coloured rhizomes used as a spice
for flavouring Indian cooking. It also has properties that make it an effective
ingredient in medicines, cosmetics and as a colour dye. As a medicine, it is
traditionally used to heal wounds and rashes.
·
In 1995, two Indian
nationals at the University of Mississippi Medical Centre were granted US
patent no. 5,401,504 on "use of turmeric in wound healing".
·
The Indian Council of
Scientific and Industrial Research (CSIR) requested the US Patent and Trademark
Office (USPTO) to re-examine the patent.
·
CSIR argued that
turmeric has been used for thousands of years for healing wounds and rashes and
therefore its medicinal use was not novel.
·
Their claim was
supported by documentary evidence of traditional knowledge, including an
ancient Sanskrit text and a paper published in 1953 in the Journal of the
Indian Medical Association.
·
Despite arguments by the
patentees, the USPTO upheld the CSIR objections and revoked the patent.
Observations: The turmeric case was a landmark case as it was the
first time that a patent based on the traditional knowledge of a developing
country had been successfully challenged. The legal costs incurred by India in
this case have been calculated by the Indian Government to be about at US
$10,000.
Neem
Neem (Azadirachta indica) is a tree from India and other parts of South
and Southeast Asia. It is now planted
across the tropics because of its properties as a natural medicine, pesticide
and fertilizer. Neem extracts can be used against hundreds of pests and
fungal diseases that attack food crops; the oil extracted from its seeds is
used to treat colds and flu; and mixed in soap, it is believed to offer low
cost relief from malaria, skin diseases and even meningitis.
·
In 1994 the EPO granted
European Patent No. 0436257 to the US Corporation W.R. Grace and USDA for a
“method for controlling fungi on plants by the aid of a hydrophobic extracted
neem oil”.
·
In 1995 a group of
international NGOs and representatives of Indian farmers filed a legal
opposition against the patent.
·
They submitted evidence
that the fungicidal effect of extracts of neem seeds had been known and used
for centuries in Indian agricultural to protect crops, and thus was the
invention claimed in EP257 was not novel.
·
In 1999 the EPO
determined that according to the evidence “all features of the present claim
have been disclosed to the public prior to the patent application… and [the
patent] was considered not to involve an inventive step”.
·
The patent was revoked
by the EPO in 2000.
Ayahuasca
For generations, shamans of indigenous tribes throughout the Amazon
Basin have processed the bark of Banisteriopsis
caapi to produce a ceremonial drink known as "ayahuasca". The
shamans use ayahuasca (which means "vine of the soul") in religious
and healing ceremonies to diagnose and treat illnesses, meet with spirits, and
divine the future.
An American, Loren Miller obtained US Plant Patent 5,751 in June 1986,
granting him rights over an alleged variety of B. caapi he had called "Da Vine". The patent description
stated that the “plant was discovered growing in a domestic garden in the
Amazon rain-forest of South America.” The patentee claimed that Da Vine
represented a new and distinct variety of B.
caapi, primarily because of the flower colour.
The Coordinating Body of Indigenous Organizations of the Amazon Basin
(COICA) – an umbrella organisation representing over 400 indigenous groups –
learned of the patent in 1994. On their behalf the Center for International
Environmental Law (CIEL) filed a re-examination request on the patent. CIEL
protested that a review of the prior art revealed that Da Vine was neither new
nor distinct. They argued also that the granting of the patent would be
contrary to the public and morality aspects of the Patent Act because of the
sacred nature of Banisteriopsis caapi
throughout the Amazon region.
Extensive, new prior art was presented by CIEL, and in November 1999,
the USPTO rejected the patent claim agreeing that Da Vine was not
distinguishable from the prior art presented by CIEL and therefore the patent
should never have been issued. However, further arguments by the patentee persuaded
the USPTO to reverse its decision and announce in early 2001 that the patent
should stand.
Observation: Because of the date of filing of the patent, it was
not covered by the new rules in the US on inter partes re-examination.
CIEL were therefore unable to comment on the arguments made by the patentee
that led to the patent being upheld.
The San, who live around the Kalahari Desert in southern Africa, have
traditionally eaten the Hoodia cactus to stave off hunger and thirst on long
hunting trips. In 1937, a Dutch
anthropologist studying the San noted this use of Hoodia. Scientists at the South African Council for
Scientific and Industrial Research (CSIR) only recently found his report and
began studying the plant.
In 1995 CSIR patented Hoodia’s appetite-suppressing element (P57). In
1997 they licensed P57 to the UK biotech company,
Phytopharm. In 1998, the
pharmaceutical company Pfizer acquired the rights to develop and market P57 as
a potential slimming drug and cure for obesity (a market worth more than £6
billion), from Phytopharm for up to $32 million in royalty and milestone
payments.
On hearing of possible exploitation of their traditional knowledge, the
San People threatened legal action against the CSIR on grounds of “biopiracy.” They claimed that their traditional
knowledge had been stolen, and CSIR had failed to
comply with the rules of the Convention on Biodiversity, which requires the
prior informed consent of all stakeholders, including the original discoverers
and users.
Phytopharm had conducted extensive enquiries but were unable to find
any of the “knowledge holders”. The remaining San were apparently at the time
living in a tented camp 1500 miles from their tribal lands. The CSIR claimed they had planned to inform the San
of the research and share the benefits, but first wanted to make sure the drug
proved successful.
In March 2002, an understanding was reached between the CSIR and the
San whereby the San, recognised as the custodians of traditional knowledge associated
with the Hoodia plant, will receive a share of any future royalties. Although the San are likely to receive only
a very small percentage of eventual sales, the potential size of the market
means that the sum involved could still be substantial. The drug is unlikely to reach the market
before 2006, and may yet fail as it progresses through clinical trials.
Observations: This case
would appear to demonstrate that with goodwill on all sides, mutually
acceptable arrangements for access and benefit sharing can be agreed. The
importance of intellectual property in securing future benefits appears to have
been recognised by all parties including the San.
Partly as a result of these well known cases, many developing countries, holders of traditional knowledge, and campaigning organisations are pressing in a multitude of fora for traditional knowledge to be better protected. Such pressure has led, for example, to the creation of an Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore in WIPO. The protection of traditional knowledge and folklore is also being discussed within the framework of the CBD and in other international organisations such as UNCTAD, WHO, FAO and UNESCO.[6] In addition, the Doha WTO Ministerial Declaration highlighted the need for further work in the TRIPS Council on protecting traditional knowledge.[7]
How can traditional knowledge be defined? Whilst the vast majority of the knowledge is old in the sense that it has been handed down through the generations, it is continually refined and new knowledge developed, rather as the modern scientific process proceeds by continual incremental improvement rather than by major leaps forward. One of the speakers at our conference suggested that the term “folklore” be replaced by the more appropriate “expressions of culture” which represents living, functional traditions, rather than souvenirs of the past. Whilst most traditional knowledge and folklore is passed on orally, some of it, such as textile designs and Ayurveda medicinal knowledge, is codified. The groups that hold traditional knowledge are very diverse: individuals, groups or groups of communities may all be custodians. Such communities might be indigenous to the land or descendents of later settlers. The nature of the knowledge is also diverse: it covers, for example, literary, artistic or scientific works, song, dance, medical treatments and practices and agricultural technologies and techniques.
Whilst a number of definitions for traditional knowledge and folklore have been put forward, there is no widely acceptable definition for either of them. It is not only the broad scope of traditional knowledge that has confounded the debate so far. There is also some confusion about exactly what is meant by “protection” and its purpose. It should certainly not be equated directly with the use of the word “protection” in its IP sense. In its report on a series of fact-finding missions, WIPO[8] sought to summarise the concerns of traditional knowledge holders as follows:
· concern about the loss of traditional life styles and of traditional knowledge, and the reluctance of the younger members of the communities to carry forward traditional practices
· concern about the lack of respect for traditional knowledge and holders of traditional knowledge
· concern about the misappropriation of traditional knowledge including use of traditional knowledge without any benefit sharing, or use in a derogatory manner
· lack of recognition of the need to preserve and promote the further use of traditional knowledge.
Another source more succinctly classified these and other possible reasons for protecting traditional knowledge as:
· equity considerations – the custodians of traditional knowledge should receive fair compensation if the traditional knowledge leads to commercial gain
· conservation concerns – the protection of traditional knowledge contributes to the wider objective of conserving the environment, bio-diversity and sustainable agricultural practices
· preservation of traditional practices and culture – protection of traditional knowledge would be used to raise the profile of the knowledge and the people entrusted with it both within and outside communities
· prevention of appropriation by unauthorised parties or avoiding “biopiracy”
· promotion of its use and its importance to development.[9]
A single solution can hardly be expected to meet such a wide range of concerns and objectives. The type of measures required to prevent misappropriation may not be the same, indeed may not be compatible, with those needed to encourage the wider use of traditional knowledge. A multiplicity of complementary measures will almost certainly be required, many of which will be outside the field of intellectual property. Indeed, underlying the debate may be a much bigger issue such as the position of indigenous communities within the wider economy and society of the country in which they reside, and their access to or ownership of land they have traditionally inhabited. In that sense, concerns about the preservation of traditional knowledge, and the continued way of life of those holding such knowledge, may be symptomatic of the underlying problems that face these communities in the face of external pressures.
However, we intend to limit our consideration to how the intellectual property system might help address these concerns. Much has already been written on this subject and many international organisations, in particularly WIPO, have started to consider whether the existing system of intellectual property has a role to play or whether new forms of protection will be required.
As noted above, a large number of bodies including WIPO, the CBD, UNCTAD and WTO are discussing the protection of traditional knowledge. These debates have rightfully focused on understanding the issue rather than on developing international norms. Only with a deeper understanding and greater practical experience at national or regional level would it be realistic to develop an international system of protection for traditional knowledge. It is essential that all of the agencies considering the issue work together to avoid unnecessary duplication and to ensure that the debate includes as many different views as possible. In this respect it has been suggested to us that an organisation such as WIPO, which deals exclusively with intellectual property matters, may not be the most appropriate forum to consider traditional knowledge in all its aspects.[10] We believe however that no single body is likely to have the capacity, expertise or resources to handle all aspects of traditional knowledge. Indeed it is our view that a multiplicity of measures, only some of them IP-related, will be necessary to protect, preserve and promote traditional knowledge.
There is much to gain at this early stage by considering the issue in a
number of fora, while ensuring coherent approaches are developed and that
effort is not duplicated.
Making Use of the
Existing IP System to Protect and Promote Traditional Knowledge
Examples are emerging which illustrate how the current intellectual property system can be utilised to commercialise traditional knowledge or prevent its misuse. For example, Aboriginal and Torres Strait Islander artists in Australia have obtained a national certification trademark.[11] Like any other trademark, this certification mark or Label of Authenticity is intended to help promote the marketing of their art and cultural products and deter the sale of products falsely claiming to be of Aboriginal origin.
In recent surveys of the existing protection of traditional knowledge and folklore, a number of countries have provided further examples of how IP tools have been utilised to promote and protect traditional knowledge and folklore.[12] These include the use of copyright protection in Canada to protect tradition-based creations including masks, totem poles and sound recordings of Aboriginal artists; the use of industrial designs to protect the external appearance of articles such as head dresses and carpets in Kazakhstan and the use of geographical indications to protect traditional products such as liquors, sauces and teas in Venezuela and Vietnam.
The ability to extend the life of trademarks indefinitely and the possibility of collective ownership of such rights suggest that they may be especially suitable for protecting traditional knowledge. This is also the case with geographical indications, which may be used to protect traditional products or crafts if particular characteristics of such products can be attributed to a particular geographical origin. However, trademarks and geographical indications can only prevent the use of the protected marks or indications; they do not protect the knowledge, or the technologies embracing that knowledge, as such.
Other IP rights, especially those requiring some form of
novelty or those with fairly limited periods of protection, seem less appropriate
for protecting traditional knowledge.
Nevertheless it is clear from these surveys, and indeed other research,
that existing IPRs do have a role to play in protecting traditional knowledge. Whether that role is a significant one
remains to be seen. Experience
elsewhere would suggest that the impact may not be great, not least because of
the high cost of obtaining and enforcing rights. If the majority of small companies in developed countries have found the intellectual property system, particularly
the patent system, to be unattractive,[13]
then it seems unlikely that local communities in developing countries, or
individuals within such communities, will derive much benefit.
Sui Generis Protection of Traditional Knowledge
Some countries have already decided that the existing intellectual property system is not, on its own, adequate to protect traditional knowledge. A number of these have enacted or are in the process of enacting sui generis systems of protection.[14]
The Philippines has enacted legislation, and is considering further provisions,[15] giving indigenous communities rights over their traditional knowledge. These rights extend to controlling access to ancestral lands, access to biological and genetic resources and to indigenous knowledge related to these resources. Access by other parties will be based on the prior informed consent (PIC) of the community obtained in accordance with customary laws. Any benefits arising from genetic resources or associated knowledge will be equitably shared. The legislation however seeks to maintain the free exchange of biodiversity among local communities. The law also seeks to ensure that indigenous communities are able to participate at all levels of decision-making.
Whilst the primary objectives of these pieces of legislation is to recognise, protect and promote the rights of communities and indigenous people, including those relating to biological resources and associated traditional knowledge, they also recognise the potential for exploiting these resources. However, Guatemalan law also seeks to preserve and promote the wider use of its traditional knowledge by placing expressions of national culture, including for example medicinal knowledge and music, under the protection of the state.[16] Such expressions cannot under the law be sold or be subject of any remuneration. Thus, different types of models are being developed at the national level, seeking to adapt legislation and practice to local needs.
A particularly important question is the extent to which any form of protection recognises the customary laws under which the knowledge evolved. Countries such as Bangladesh, and organisations such as the AU,[17] are considering sui generis legislation that provides community-based rights over biological resources and associated traditional knowledge and are seeking to give increased recognition to the cultural and customary practices of communities. The sui generis system of protection in the Philippines also takes account of customary laws.
The Australian Federal Court has considered the relevance of customary Aboriginal laws and practices in a case of copyright infringement. Although