RESTRICTEDWORLD TRADE
ORGANIZATIONIP/C/W/218
18 October 2000
(00-4287)
Council for Trade-Related Aspects
of Intellectual Property RightsOriginal:  English/
French/Spanish
DOCUMENT PREPARED BY THE INTERNATIONAL BUREAU OF WIPO FOR THE
MEETING ON INTELLECTUAL PROPERTY AND GENETIC RESOURCES, WHICH
TOOK PLACE ON 17 AND 18 APRIL 2000 IN GENEVA
INTELLECTUAL PROPERTY AND GENETIC RESOURCES – AN OVERVIEW
*
I. Introduction:  the genesis of the WIPO Meeting on Intellectual Property and Genetic
Resources
1. At the third session of the Standing Committee on the Law of Patents (SCP), which took
place in Geneva from September 6 to 14, 1999, the Delegation of Colombia proposed the introduction
of a new article in the draft Patent Law Treaty, as follows:
"1. All industrial property protection shall guarantee the protection of the country's
biological and genetic heritage.  Consequently, the grant of patents or registrations that relate
to elements of that heritage shall be subject to their having been acquired legally.
"2. Every document shall specify the registration number of the contract affording access
to genetic resources and a copy thereof where the products or processes for which protection
is sought have been manufactured or developed from genetic resources, or products thereof,of which one of the member countries is the country of origin."  (see document SCP/3/10).
2. Following informal consultations, the SCP agre ed to submit the following invitation to the
International Bureau:
"Recognizing the importance of biological and genetic resources, the SCP invites the
International Bureau to include on the agenda of the Working Group on Biotechnological
Inventions, to be convened at WIPO in Nove mber 1999, the issue of protection of biological
and genetic resources.  The SCP further invites the International Bureau to take steps to
convene a separate meeting involving a larger number of Member States early in 2000, to
consider that issue."  (see document SCP/3/11, paragraph 208)
The International Bureau indicated to the SCP that the meeting would determine its own
terms of reference, and any decision on how to proceed further would be a matter for the meeting
itself to decide (see document SCP/3/11, paragraph 209;  see in general paragraphs 202 to 209).
                                                     
* At its meeting of 21 and 22 September 2000, the Council for TRIPS agreed that this document be
circulated in the IP/C/W/- series of documents.  Th e symbol of the original document circulated by the
International Bureau on 24 March 2000 is WIPO/IP/GR/00/2.IP/C/W/218
Page 2
3. Those conclusions were examined by the Assemblies of the Member States of WIPO, which
met from September 20 to 29, 1999.  It was then advised that the Working Group should meet in
November to study the issue critically, and that subsequently, early the following year, the meeting on
biotechnology should take place, but without prejudging whether a separate Standing Committee was
needed (see document A/34/16, paragraph 142).
4. The Working Group on Biotechnology, at its meeting on November 8 and 9, 1999, decided to
establish a project to evaluate means of recording ownership interests in inventions arising out of
private-public collaborative research and similar undertakings.  Moreover, the Working Group
decided to establish a questionnaire for the purpose of gathering information about the protection of
biotechnological inventions, including the situation with respect to intellectual property and genetic
resources, in the Member States of WIPO.  With a view to obtaining data on recording the ownershipinterests described above and also to contribute significantly to the meeting of Member States on
April 17 and 18, 2000, it was agreed by the Working Group that the questionnaire should include
specific questions on the disclosure, in patent documents, of the origin of genetic resources and other
contributions.
5. Given the broad invitation which was communicated  by the Director General of WIPO to the
Assemblies, it is proposed that the present meeting discuss the concerned issues that generally are
raised in the context of access to and in situ preservation of genetic resources in their direct or indirect
relationship with intellectual property.  This document contains a brief overview of these issues.
II. The Protection of Traditional Knowledge and its Relationship with the International Treaties
on Intellectual Property
6. In recent years, resurgent interest in tradition-based innovation and creativity has given rise to
legal, ethical, economic and social questions.  Guided by the information gathered undersub-program 11.1 in the 1998-1999 biennium, WIPO's activities relating to traditional knowledge,
innovations and creativity are now focused on promoting their protection by exploring and developing
ways in which the existing intellectual property system, including ancillary mechanisms and practices,
can provide appropriate and equitable protection.
7. Two documents prepared by the International Bureau (both entitled "Protection of Traditional
Knowledge:  A Global Intellectual Property Issue") describe different aspects of the work of WIPO inthat field.  Document WIPO/RT/LDC/1/4, which was di stributed to the participants in the High Level
Interregional Roundtable on Intellectual Property for the Least Developed Countries, held in Geneva,
on September 30, 1999, addresses the technical, social and economic questions raised by traditional
knowledge.  This document elaborates on the mu ltifaceted notion of traditional knowledge, for it
encompasses several components, some of which are referred to by terms such as "indigenousknowledge," "folklore," "traditional medicinal k nowledge," etc.  Furthermore, it emphasizes that
traditional knowledge is not necessarily ancient, for it is being created every day, and it is evolving as
a response of individuals and communities to the challenges posed by their social and physical
environment.  In its use, traditional knowledge is also contemporary knowledge.  The paper also
argues that biodiversity, and the knowledge associated with using it in a sustainable manner, are acomparative advantage of those least developed countries that are biodiversity-rich, and that,
therefore, protection of traditional knowledge will enable those countries to participate more
effectively in global markets and improve their economic performance.  Document
WIPO/IP/TK/RT/99/2, which was distributed to the participants in the Roundtable on Intellectual
Property and Traditional Knowledge, held in Geneva on November 1 and 2, 1999, reflects the
exploratory work done by WIPO in the 1998-1999 biennium, including nine fact-finding missions
(FFMs) "to identify and explore the intellectual property needs and expectations of new beneficiaries,
including the holders of traditional knowledge, in order to promote the contribution of the intellectual
property system to their social, cultural and economic development."  These missions were intended
to enable the "study of current approaches to, and future possibilities for, the protection of intellectualIP/C/W/218
Page 3
property rights of holders of indigenous knowledg e, innovations and culture."  The nine FFMs were
undertaken to the South Pacific, South Asia, So uthern and Eastern Africa, North America, West
Africa, the Arab countries, South America, Central America and the Caribbean.1  Furthermore, that
document briefly describes four regional consultations on the protection of expressions of folklore,
which were held in 1999 for African countries in Pretoria, South Africa, for countries of Asia and thePacific in Hanoi, Viet Nam, for Arab countries in Tunis, Tunisia, and for Latin America and the
Caribbean in Quito, Ecuador.  Each of the four regional consultations adopted Resolutions or
Recommendations which include proposals for futu re work addressed to WIPO and UNESCO, on the
one hand, and to national governments of the respective regions on the other.
2
8. Traditional knowledge arises as an issue in association with genetic resources under
Article 8(j) of the Convention on Biological Diversity (CBD), which entered into force on
December 29, 1993.  Article 8(j), which applies to in situ  conservation of biological diversity,
establishes that Contracting Parties "shall, as far as possible and as appropriate […] [s]ubject to [their]
national legislation, respect, preserve and maintain knowledge, innovations and practices of
indigenous and local communities embodying traditional lifestyles relevant for the conservation and
sustainable use of biological diversity and promot e their wider application with the approval and
involvement of the holders of such knowledge, innovations and practices and encourage the equitable
sharing of the benefits arising from the utilization of such knowledge, innovations and practices."
9. The language of Article 8(j) of the CBD suggests that its implementation requires three sorts
of legislative action:
(a) definition of standards concerning the availability, scope and use of rights (which
could include intellectual property rights) in knowledge, innovations and practices of
indigenous and local communities, as well as the establishment of measures concerning the
enforcement of those rights;
(b) promotion of wide application of such k nowledge, innovations and practices with the
approval and involvement of the holders of such knowledge;  and
(c) encouragement of the equitable sharing of the benefits arising from the utilization of
such knowledge, innovations and practices.
10. There are different views on how to address the first category of issues.  Some would prefer
to explore the possibility of using the existing mechanisms of intellectual property to protect
traditional knowledge.  Others would prefer to embark immediately on an exercise of developing a
new, sui generis  system of intellectual property protection, whereby the features of the existing
mechanisms would be adapted to the particular characteristics of traditional knowledge.  Furtherdevelopments in the definition of the concept of "farmers’ rights" may also be relevant in that
context.
3
                                                     
1 A detailed report of the FFMs is being finalized by the International Bureau and it is expected to be
made publicly available in the course of first half 2000.
2 The Recommendations and other documents of the four regional consultations are available from the
International Bureau.  They also may be obtained from the WIPO website, <http://www.wipo.int> .
3 The concept of "farmers' rights" is being addressed in the Food and Agriculture Organization of the
United Nations (FAO) Global System on Plant Genetic Resources for Food and Agriculture through theInternational Undertaking on Plant Genetic Resources for Food and Agriculture.  At the present stage, theconsolidated negotiating text of the International Undertaking does not contain a definition of "farmers' rights."
These are considered a result of "the enormous contribu tion that farmers […] have made and will continue to
make for the conservation and development of plant genetic resources which constitute the basis of food andagriculture production throughout the world."  It is purported that measures to protect and promote Farmers'Rights include the right to use, exchange, and, in the case of landraces and varieties that are no longer registered,market farm-saved seeds;  the protection of traditional knowledge;  the right to equitably participate in benefitIP/C/W/218
Page 4
11. The implementation of the second and third categories depend very much on the outcome of
the debate on the first category of issues.  A wider application of traditional knowledge for the in situ
conservation of biodiversity would imply the facilitation of technology transfer by the holders of such
knowledge to potential users.  Technology transfer, however, is a process which, irrespective of themodality chosen for the transfer, comprises three different steps:  comprehension, communication and
absorption.  For that to happen, traditional knowledge must be systematically documented so that it
forms a coherent set of instructions that a potential transferee can learn and apply.  Documentation, on
the other hand, raises a particular set of intellectual property-related concerns regarding the public
disclosure of information, which, if made without the appropriate controls, may impair the protection
of traditional knowledge by the patent or the trade secret system.  Furthermore, the promotion of wide
application of traditional knowledge raises issues that are common to both traditional andnon-traditional knowledge, such as the establishment of public policies on tax incentives as well as
the recourse to the mechanism of compulsory licences.
12. The Executive Secretary of the CBD has worked extensively on the definition of an agenda
for the implementation of Article 8(j) of the Convention (see, e.g., Farmers' Rights and Rights of
Similar Groups – The Rights of indigenous and lo cal communities embodying traditional lifestyles:
experience and potential for implementation of Article 8(j) of the Convention on Biological Diversity
(UNEP/CBD/I C/2/14), Knowledge, Innovations and Practices of Indigenous and Local Communities:
Implementation of Article 8(j)  (UNEP/CBD/ COP/3/19), The Relationship Between Intellectual
property Rights and the Relevant Provisions of the Agreement on Trade-Related Aspects ofIntellectual Property Rights (TRIPS Agreement) and the Convention on Biological Diversity
(UNEP/CBD/ISOC/5), Legal and Other Appropriate Forms of Protection for the Knowledge,
Innovations and Practices of Indigenous and Local Communities Embodying Traditional Lifestyles
Relevant for the Conservation and Sustainable Use of Biological Diversity  (UNEP/CBD/WG8J/1/2).
This last document has been prepared as a background note for an ad hoc open-ended session of aWorking Group established by the CBD Secretariat to work on the implementation of Article 8(j) of
the CBD.  It presents a range of legal possibilities for the protection of traditional knowledge, such as
intellectual property rights regimes, sui generis  legislative protection for traditional biodiversity-
related knowledge, and other forms of legal protection (such as contractual agreements).  It also
discusses some aspects of common law and customary law that might help protect traditional
knowledge.  Some non-binding forms of protection are also mentioned, such as soft law (guidelines,
principles and codes of conduct), incentive measures and capacity-building measures.  The thrust ofthe document is to establish a framework for the development of case studies to be submitted to the
Conference of the Parties, yet recognizing the ne ed to avoid unnecessary duplication of effort and to
promote synergy and harmony among ongoing processes in other intergovernmental organizations.
13. The Secretariat of the WTO has also been conducting relevant work in this field.  WTO
Members, conscious of the influence of the TRIPS Agreement as a factor of improvement of
intellectual property protection, have asked various bodies of that organization, such as the Committee
on Trade and Environment (CTE), the Council for TRIPS and the General Council, to address the
issue.  In the context of the activities of the CTE, the WTO Secretariat has prepared several
documents reflecting how WTO Members’ obligations concerning non-discrimination in internationaltrade interact with the protection of traditional knowledge:  Environment and TRIPS  (WT/CTE/W/8
and W/8/Corr.1), The Convention on Biological Diversity and the Agreement on Trade-Related
Aspects of Intellectual Property Rights  (WT/CTE/W/50), The Relationship Between the Convention
on Biological Diversity (CBD) and the Agreement on Trade-Related Aspects of Intellectual Property
Rights (TRIPS);  with a Focus on Article 27.3(b)  (WT/CTE/W/125).  The thrust of these documents is
                                                                                                                                                                    
sharing;  and the right to participate in making decisi ons, at the national level, on matters related to the
conservation and sustainable use of plant genetic resources for food and agriculture.  See  Composite Draft Text
of the International Undertaking on Plant Genetic Resources, incorporating the Chairman’s Elements ,
document CGRFA-8/99/13 Annex, of the Commission on Genetic Resources for Food and Agriculture.IP/C/W/218
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that the TRIPS Agreement does not impair the protection of traditional knowledge by intellectual
property regimes, or by non-intellectual property regimes, such as contract law.  These documents
point out that several areas of intellectual property protection (including patents and protection of
undisclosed information) included in the TRIPS Agreement could be useful tools for the protection of
environmentally-sound technologies.  As far as technology that may cause serious prejudice to theenvironment is concerned, Article 27.2 of the TRIPS Agreement allows that WTO Members exclude
it from patentability, provided some additional conditions are met.
4  Document WT/CTE/W/125
comments on legislation implementing the CBD, including the Andean Community’s Common
System on Access to Genetic Resources and the Biodiversity Law of Costa Rica, which are referred to
below.
14. A number of Member States of WIPO have indicated that there is the need for the
establishment of a mechanism to examine in depth and systematically the availability of legal
mechanisms for the protection of traditional know ledge from an intellectual property approach.
Given that the WIPO Secretariat, under Sub-program 11.1, has undertaken the task of verifying the
appropriateness of the existing mechanisms of intellectual property to protect traditional knowledge,
where necessary, it may be convenient for Member States to provide the WIPO Secretariat with theappropriate guidelines for the development of further activities in that field.
III. Access to and Transfer of Technology in the Context of Access to Genetic Resources and their
Relationship with the International Treaties on Intellectual Property
15. Article 16 of the CBD recognizes that "access to and transfer of technology among
Contracting Parties are essential elements for the attainment of the objectives" of the Convention,
namely the conservation and sustainable use of biological diversity for the benefit of present and
future generations.  In this vein, Contracting Part ies undertake "to provide and/or facilitate access for
and transfer to other Contracting Parties of technologies that are relevant" to those objectives or that"make use of genetic resources and do not cause significant damage to the environment."
Accordingly, "access to and transfer of technology referred to […] above to developing countries
shall be provided and/or facilitated under fair and most favourable terms, including on concessional
and preferential terms where mutually agreed."  Where technology is "subject to patents and other
intellectual property rights, such access and transfer shall be provided on terms which recognize and
are consistent with the adequate and effective protection of intellectual property rights."
16. Article 16 of the CBD stems from the acknowledgement that conservation of biological
diversity generates opportunity costs for biodiversity-rich countries that are not in control of the
adequate and necessary technologies in order to achieve the Convention's objectives.  Article 16
establishes a legal framework that seeks to reduce those costs, yet without undermining the
international intellectual property system.  Firstly, access to and transfer of technology should takeplace under fair and most favorable terms.  The common meaning of that term indicates that
technology transfer contracts should adopt conditions prevailing on the international technology
market (unless parties mutually agree to concessional and preferential terms), without price
discrimination or market segmentation.  It is apparent that the term "mutually agreed" does not allow
for compulsory licences since a compulsory licence is, by definition, not "mutually agreed."  Where,
however, compulsory licences are granted, the remuneration paid by the country acceding to the
protected technology must be adequate in the circumstances of each case, taking into account the
economic value of the authorization.  Other conditions, as established by Article 31 of the TRIPS
Agreement and Article 5A of the Paris Convention for the Protection of Industrial Property, are also
applicable to compulsory licences of patented environmentally-sound inventions.
                                                     
4 Article 27.2:  "Members may exclude from patentability inventions, the prevention within their
territory of the commercial exploitation of which is necessary to protect ordre public  or morality, including to
protect human, animal or plant life or health or to avoi d serious prejudice to the environment, provided that such
exclusion is not made merely because the exploitation is prohibited by their law."IP/C/W/218
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17. Two documents prepared by the Executive Secretary of the CBD elaborate further on the
interface between the implementation of Article 16 of the Convention and the international protection
of intellectual property ( Ways and Means to Promote and Facilitate Access to, and Transfer and
Development of Technology , Including Biotechnology , UNEP/CBD/SBSTTA/2/6, and Promoting and
Facilitating Access to, and Transfer and Development of Technology , UNEP/CBD/COP/3/21).  These
documents elaborate on the concept of technology as referred to in the text of the CBD, comprising
conservation and sustainable-use technologies and biotechnology.  They describe the mechanisms of
technology transfer (foreign direct investment, licensing arrangements and partnerships) and capacity
building.  In addition, they contain a discussion on scientific, technical and technological cooperation.
The objective of both documents is to identify priority issues for the Conference of the Parties in
relation to the points raised that may contribute to the implementation of Article 16, such as capacitybuilding, technology, international trade and human capital, national and sectoral policies, technology
identification and assessment, scientific, technical and technological cooperation and private sector
involvement.
18. The Secretariat of the WTO has also examined that issue ( Factors Affecting Transfer of
Environmentally-Sound Technology , WT/CTE/W/22).  That paper asserts that the existence of any
technology is a prerequisite to any possibility of  access to that technology (and thus that the very
existence of intellectual property as an incentive to the generation of technology may be an essential
condition for the implementation of Article 16 of th e CBD).  It describes how intellectual property
rights covered by the TRIPS Agreement (patents and trade secrets, in particular) may impacttechnology transfer.  The paper concludes that the factors determining transfer of
environmentally-sound technology are essentially the same as those determining transfer of
technology in general.
19. Paragraphs 3, 4 and 5 of Article 16 of the CBD establish guidelines concerning legislative,
administrative or policy measures, as appropriate, with the aim that Contracting Parties, in particular
those that are developing countries, which provide genetic resources are provided access to and
transfer of technology, including technology which is protected by intellectual property rights.  It is
relevant to note that paragraph 4 of Article 16 of the CBD refers to the transfer of technology to
developing countries that is largely under the control of the private sector.  It should be noted that,
despite their different objectives, there is an apparent parallel between that provision and paragraph 2
of Article 66 of the TRIPS Agreement, which provides that developed countries shall establishincentives to enterprises and institutions in thei r territories for the purposes of promoting and
encouraging technology transfer to least-developed countries.  Furthermore, paragraph 5 of Article 16
of the CBD mandates Contracting Parties to the Convention to cooperate in order to ensure that
patents and other intellectual property rights are supportive and do not run counter to the objectives of
the Convention. This provision requires Parties to the CBD to prevent the abusive use of intellectual
property rights which might impair the attainment of the Convention's objectives.  A parallel can be
found between paragraph 5 of Article 16 of the CB D and Articles 8 and 40 of the TRIPS Agreement,
which contain principles and rules under which WTO Members may control abusive practices by
intellectual property rights holders.
20. In other fora, some WIPO Member States have addressed concerns as regards the need for
appropriate mechanisms that national laws could incorporate in order to promote the transfer of
environmentally-sound technology without impairing the private property rights of intellectual
property rights holders.  It appears that the eventual adoption of such mechanisms would entail the
legal treatment of aspects of the use of intellectual property rights that may not be supportive of andrun counter to the objectives of international conventions, such as anti-competitive practices and other
abuses of intellectual property rights.IP/C/W/218
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IV. Access to Genetic Resources and Benefit Sharing and their Relationship with the
International Treaties on Intellectual Property
21. The CBD recognizes that genetic resources, as a component of natural resources, are subject
to the sovereign rights of States (Article 15, paragraph 1).  Therefore, it is their right to establish theconditions under which access to genetic resources is granted or facilitated.  The Convention further
establishes that access to genetic resources shall be subject to prior informed consent of the
Contracting Party providing such resources, unless otherwise determined by that Party (Article 15,
paragraph 5).  The Convention also provides that legislative, administrative or policy measures shall
be established with the aim of sharing in a fair and equitable way 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 which recognize and are consistent withthe adequate and effective protection of intellectual property rights.
22. The interface between access to genetic resources and benefit sharing, on the one hand, and
intellectual property rights, on the other, has two different aspects.
23. Firstly, genetic resources, conserved either in situ  or  ex situ , may have been modified by
means of human intervention, thus acquiring characteristics that are not found in nature.  Where those
modifications are new, involve an inventive step a nd are capable of industrial application, they may
be protected by patents (depending on specific provisions in national law regarding patentable
subject-matter).
24. Plant genetic resources that consist in plant varieties that are new, distinct, sufficiently
uniform and stable may qualify for protection under national laws implemented in accordance with
the International Convention for the Protection of New Varieties of Plants (UPOV), of 1961, as
revised in 1972, 1978 and 1991, or under another sui generis  system, or a combination thereof.
25. Other modified resources that do not qualify for protection under existing intellectual
property mechanisms, such as landraces and traditional varieties, which nonetheless are of great
relevance for the subsistence of local communities and possibly for the conservation and development
of plant genetic resources, may be considered by national laws to constitute subject-matter protectable
under national laws in respect of traditional knowledge.
26. Access to genetic resources which are privately controlled will depend on authorization by
right holders and on licensing agreements.  The breeding of new varieties and the utilization of the
product of the harvest which farmers have obtained by planting, on their own holdings, the protected
variety or an essentially derived variety, fo r propagating purposes, may not depend upon the
authorization by the right holder, provided the exceptions allowed under UPOV (1991) have beenincorporated into national laws and other conditions thereby established are met.  Similar exceptions
can be found in some national laws in respect of plant propagating material and breeding stock or
other animal reproductive material which are protected by patents.
27. The second context in which intellectual property rights are relevant as a framework for the
access to genetic resources and benefit sharing is the recording of interests in inventions that arise
from access to or use of genetic resources and traditional knowledge.  A number of regional and
national laws have provided for such recordals, by means of establishing that patent documents shall
disclose the origin of the genetic resources used in the development of inventions as well as show that
prior informed consent has been obtained from th e competent authorities and traditional knowledge
holders.  The purpose of such disclosure is to provide a mechanism to verify compliance with national
laws and contracts concerning access to genetic resources and benefit sharing.IP/C/W/218
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28. Many types of biotechnological inventions draw from and build on information and
characteristics of naturally occurring plants, animals and other living organisms.  In the realm of
pharmaceutical biotechnology, research and development efforts tend to focus on use of information
derived from the study of human beings and their biological makeup.  Information derived from the
study of mammals and other animals also provides value in the process of elucidating the source of
human disorders.  In other areas of biotechnology, such as agricultural biotechnology, the focus of
efforts tends to be the alteration of the genetic makeup of plants to create new plant varieties and
species that have value to agriculture or other industrial sectors.  There is also a long history of
pharmaceutical innovation based on "natural products ."  For example, numerous chemical compounds
having value as a pharmaceutical application have been derived from naturally occurring plants and
other living organisms.  The pattern of innovation witnessed in the area of natural products chemistry
starts with isolation of an active chemical compound, but then ordinarily proceeds to identification ofmeans to synthesize the chemical compound in a manne r that can be scaled up to a commercial level.
Doing so avoids creating a dependence on raw materials to simply extract the chemical compound,
and thus, tends to be preferable from an ecological conservation perspective.
29. In recent years, a significant amount of attention has been paid to the process by which
investigation, research and development of commercial products from naturally occurring biological
materials is conducted.  Some of this attention has focused on improving the facilitation of
cooperation between organizations or individuals in a country rich in biological diversity and research
institutions, whether from the public or private sector.  Similarly, attention has been given to
interactions and collaborations between indigenous cultures that possess knowledge about local flora
and fauna and entities interested in conducting research and development using that knowledge.
Much attention has also been directed to research  efforts involving biological materials in certain
"biodiversity-rich" developing countries.  The unique capacity of these institutions to explore,
discover and characterize biological resources give s these organizations a unique position with regard
to their ability to stimulate research and development collaborations with other public and privatesector research organizations.  In many instances, these collaborations play an indispensable role in
efforts aimed at discovery and commercialization of new products based on biological resources.
30. The requirement of recording the contributions of biological materials and the knowledge of
how to use them for some practical purposes in patent documents raises several issues, which WIPO
Member States might consider to address in depth.  It appears that the requirement would apply
exclusively in the biotechnology field and only when natural resources, conserved in situ , are
employed.  Once the active components are isolated from those resources or when synthesized, the
link between the invention and the resources may become too weak to be of any significance, unless
inventors are required to record the utilization of the genetic information contained in the resources,
and not only the physical, tangible, natural materials.  In addition, where the requirement covers
genetic resources and derived products and substances as well, it also becomes relevant in thechemical field, thus covering the whole spectrum of the biotechnology-based as well as the chemistry-
based industry.  Such a requirement also appears to implicate a wide variety of industries, including
not only food and pharmaceuticals, but also cosm etics, dietary products, dyes and pigments.
31. Another issue is the consequence of non-compliance with the requirement.  One possible
approach is that the applications would be subject to refusal or rejection and patents granted in favour
of inventors who failed to comply with that  requirement might be invalidated or revoked.
Decision 391, of July 2, 1996, adopted by the Commission of the Agreement of Cartagena, and which
established a Common Regime for Access to Genetic Resources applicable to Bolivia, Colombia,
Ecuador, Peru and Venezuela, and the Biodiver sity Law of Costa Rica, nr. 7788, of April 24, 1998,
are statutory examples of such an approach.  The same criterion may be adopted in Brazil (two Bills
of Laws currently under discussion in Brazilian Congress make patentability dependent on
compliance with the requirement).  In South Afri ca, a Draft Bill on the Protection and Promotion of
South African Indigenous Knowledge, as introduced in the National Assembly, provides that "in all
printed publications, and in connection with any communications to the public, of any identifiableIP/C/W/218
Page 9
indigenous knowledge, its source shall be indicated in an appropriate manner, by mentioning the
community and geographic place from where the knowledge is utilized has been derived."  Omission
of such an acknowledgement will be subject to a fine.  The same Bill establishes further that the
acknowledgement is not required where the utilization of the knowledge has been incidental and
where the knowledge is adapted by an author so as to create an original work.
32. Since the standards concerning the availability, scope and use of intellectual property rights,
as established by the TRIPS Agreement, are relevant in the context of conditions of patentability and,
eventually, of registrability of plant varieties, some provisions of that Agreement may provide some
guidelines on how WIPO Member States which are WTO Members should address those issues.
These include, in particular, Articles 27, 29, 32 and 62 of the TRIPS Agreement.
33. The Executive Secretariat of the CBD has examined and produced recommendations on the
implementation of Article 15 (e.g., Access to Genetic Resources , UNEP/CBD/COP/3/20, Review of
National, Regional and Sectoral Measures and Gu idelines for the Implementation of Article 15 ,
UNEP/CBD/COP/4/23).  The work of the Commission on Genetic Resources for Food and
Agriculture (CGRFA), of FAO, is likewise relevant in the context of access to plant genetic resources,
and in particular in what concerns the implementation and the revision of the International
Undertaking on Plant Genetic Resources (IU).  The IU seeks to "ensure that plant genetic resources of
economic and/or social interest, particularly for agriculture, will be explored, preserved and made
available for plant breeding and scientific purposes." The IU, which is a non-legally binding
instrument, was adopted by Resolution 8/83 of the 1983 FAO Conference, and interpreted andcomplemented by three Conference Resolutions (4/89, 5/89 and 3/91), now annexed to the IU which
introduced the concepts of farmers’ rights, national sovereignty over plant genetic resources (in
compliance with the CBD), and an international fund for the implementation of farmers' rights.  The
process of revising the IU was launched in 1994 and is still underway.  Relevant information can be
found in the following documents elaborated by the Secretariat of the CGRFA, in preparation of its
Eighth Regular Session:  Revision of the International Undertaking on Plant Genetic Resources:
Legal and Institutional Options  (CGRFA/8/9/99), Report of the Chairman of the Commission on
Genetic Resources for Food and Agriculture on the Status of Negotiations for the Revision of the
International Undertaking on Plant Genetic Resources, in Harmony with the Convention on
Biological Diversity  (CGRFA-8/99/13), Composite Draft Text of the International Undertaking on
Plant Genetic Resources — Incorporating the Chairman’s Elements  (CGRFA 8/99/13 Annex), and
Revision of the International Undertaking on Plant Genetic Resources — Consolidating NegotiatingText Resulting from the Deliberations During the Fifth Extraordinary Session of the Commission on
Genetic Resources for Food and Agriculture  (CGRFA/IUND/CNT/Rev.1).
34. The various intellectual property issues that are raised in the context of access to genetic
resources and sharing of benefits derived therefrom are not clearly understood.  It appears, therefore,that there is an urgent need for such work to be undertaken, including the issues identified above, as
well as the definition of the appropriate steps to be taken by the WIPO Secretariat.
V. Scientific and Technical Cooperation in the Preservation and Sustainable Use of Biodiversity
and its Relationship with the International Treaties on Intellectual Property
35. Intellectual property rights in biotechnology innovation have been used by a number of
"public sector" research institutions to stimulate cooperation with the private sector, generate revenue,
structure relationships and protect investments.  Within certain WIPO Member States, the university
and government sectors, in particular, have had significant success in using patents to stimulate
cooperation with the private sector.  This cooperat ion is aimed at developing and delivering new
products to the market that are based on university and government innovation.  Patents have also
been instrumental in the process of forming new companies out of government or university-
sponsored research.  Since 1980, it has been estimated that over 1,200 new companies were formed inIP/C/W/218
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the United States of America through the use of pate nts and patent licensing practices.  A significant
portion of this figure is reportedly comprised of biotechnology start-up companies.
36. The success of the universities and the government in creating revenue and technology-based
opportunities through patent licensing practices in the United States of America is a relatively recent
development attributable to a series of legislative changes in the United States of America during the
1980s.  The so-called "Bayh-Dole" Act of the United States of America, in combination with other
legislation, created the foundation for the now accepted practices concerning patent licensing and
cooperation that resulted in the above cited figures.  Similar legislation and practices have been
successfully created in other WIPO Member States.
37. Many WIPO Members enjoy a strong basic research capacity in various fields of
biotechnology through their university sector a nd through their government-sponsored research
institutions. In this context, the effective implementation and operationalization of Article 7 of theTRIPS Agreement
5 might prove to be of great importance for the attainment of the objectives of
Article 19 of the CBD.
38. Recognizing this, WIPO Member States have raised questions concerning the appropriate
intellectual property mechanisms that facilitate cooperation in the scientific sector, namely by creatingincentives for the establishment of fruitful partnerships and facilitating the transfer of technology from
basic research into applied research settings, and eventually into the market.  Discussions have
covered additional issues, such as existing practices concerning international transfer of
biotechnology between public and private sector entities, particularly those involving developing
countries (as licensors, licensees and both).  Special attention might be paid to modalities used inexisting relationships that enable the effective tr ansfer and absorption of technological knowledge and
know-how, and establishment of international partnerships in the fields of research and
commercialization of biotechnological products.  Other issues which are also relevant in the context
of access to scientific and technical information are those related to limitations and exceptions to
intellectual property rights conferred.
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5 Article 7 of the TRIPS Agreement:  "The protection and enforcement of intellectual property rights
should contribute to the promotion of technological innovation and to the transfer and dissemination oftechnology, to the mutual advantage of producers and us ers of technological knowledge in a manner conducive
to social and economic welfare, and to a balance of rights and obligations."