WORLD TRADE
ORGANIZATIONIP/C/W/254
13 June 2001
(01-2916)
Council for Trade-Related Aspects
of Intellectual Property RightsOriginal:  English
REVIEW OF THE PROVISIONS OF ART ICLE 27.3(b) OF THE TRIPS AGREEMENT
Communication from the European Communities and their member States
The following communication, dated 2 April 2001, has been received from the European
Communities and their member States with the request that it be circulated to Members.
_______________
THE RELATIONSHIP BETWEEN THE CONVENTION ON BIOLOGICAL DIVERSITY AND THE TRIPS
AGREEMENT
FOREWORD
1. The relationship between the TRIPS Agreement and the Convention on Biological Diversity
(hereinafter "CBD") has become a major focus of discussion in the TRIPS Council within the context
of the review of Article 27.3(b).  It has been argued, at one end, that the instruments are incompatible
and that the TRIPS Agreement should be amended so as to bring it in line with the CBD, while at the
other end, it has been claimed that there is no conflict.
2. The European Communities and their member St ates (hereinafter "EC/MS") hold the view
that issues such as sustainable development, environmental sustainability, human development,human rights, sound economic policies and ethical norms may all have a bearing on the legitimate
exercise of intellectual property rights and should be carefully considered.  From this perspective, the
EC/MS agree that concerns voiced by developing country Members within the context of the review
of Article 27.3(b) of the TRIPs Agreement should be properly addressed.  The present review exercise
may not be a vehicle capable of producing definitive solutions to all the issues raised in this context.
3. The present communication sets forth a first set of thoughts by the EC/MS on the relationship
between intellectual property and biodiversity related matters.  It does not represent a negotiation
position on these issues.  The EC/MS is looking forward to concrete proposals from Members which
have raised specific concerns in the TRIPS Council  in the context of the review of Article 27.3(b).
PART I:  THE LEGAL RELATIONSHIP BETWEEN THE TRIPS AGREEMENT AND THE
CBD
4. The EC/MS believe that, from a legal perspective, the CBD and the TRIPS Agreement do not
conflict with each other.  They have different objectives; they do not deal with the same subject
matter and they are of a different legal nature.
5. The CBD’s objectives are:  the conservation of biological diversity;  the sustainable use of its
components; and the fair and equitable sharing of the benefits arising out of the utilisation of geneticresources.  The main objectives of the TRIPS Agr eement are to set minimum standards of intellectualIP/C/W/254
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property protection within WTO Members and to ensure that states make available to rights holders
judicial and/or administrative procedures to enforce their intellectual property rights.
6. In the same vein, the two treaties do not deal with the same subject-matter.  The CBD deals
with protection of and control over biological diversity.  The TRIPS Agreement deals with standardsof intellectual property law, not addressing the issue of commercialisation of products protected under
intellectual property law.
7. The CBD stipulates that states have sovereign rights over their genetic resources and have the
authority to determine access to their genetic resource s as well as to establish mechanisms for the fair
and equitable sharing of the benefits arising from the use of genetic resources.  It is stipulated that
access is granted on "mutually agreed terms", subject to "prior informed consent" of the supplier ofthe resources .  Biological or genetic resources can serve as a basis for the production of derived
products such as medicines or genetically modified organisms.
8. The TRIPS Agreement obliges Members to provide minimum protection to, inter alia, literary
and artistic works, trademarks, geographical indications or inventions that meet the criteria ofpatentability.  Genetic resources can serve as a basis for inventions, which may be subject to
intellectual property rights, and in particular patents, or to new plant varieties which can be protected
by plant variety rights.  It needs to be recalled th at, in principle, neither naturally occurring genetic
resources as they exist in their natural environmen t, nor related traditional knowledge, can constitute
patentable subject matter in themselves, because they do not meet the basic criteria of patentability(and in particular, novelty and inventive activity).  A patent application claiming naturally occurring
material as such in its natural state, would be liable to refusal, and if granted, to revocation, for want
of novelty and/or inventive step.  To be protected, genetic resources must be isolated from their
natural environment or produced by means of a technical process, so as to meet the criteria of
patentability.
9. The CBD provides a general framework and policy objectives within which states can act to
fulfil their objectives.  For instance, with regard to benefit sharing, the CBD is not prescriptive about
how it is to take place, except to say that it mu st be mutually agreed.  By contrast, the TRIPS
Agreement provides legal minimum standards that must be enacted in national law, with an
enforcement mechanism and sanctions available for non-compliance under WTO rules.  Each of the
agreements can be implemented through specific implementing provisions.
10. Neither treaty specifies that it is subject to the other. The CBD and the TRIPS Agreement do
not expressly refer to each other.  Article 16(5) of the CBD, however, recognises that intellectual
property rights, the subject matter of the TRIPS Agreement, "may have an influence on the
implementation" of the CBD.  It obliges states to  cooperate in order to ensure that intellectual
property rights are "supportive of and do not run counter to" the objectives of the CBD.  At the same
time, Article 16(2) states that the technology transfer  process is to be consistent with "the adequate
and effective protection of intellectual property rights". Thus, Article 16 of the CBD preserves the
entitlements of intellectual property owners as they are defined in, inter alia, the TRIPS Agreement.
11. The TRIPS Agreement does not directly refer to the subject matter of the CBD.  However, the
Preamble and Article 8 refer to principles such as developmental objectives, and Article 66.2 refers to
transfer of technology.
12. According to the analysis of the EC/MS, there is nothing in the provisions of either agreement
that would prevent a state from fulfilling its obligat ions under both.  The CBD, for example, does not
prohibit patents on inventions using genetic material. In the same vein, the principle of state
sovereignty over genetic resources in the CBD does not conflict with the TRIPS Agreement.  The
latter, in its turn, does not prevent signatories to the CBD from exercising their right to regulate access
to their genetic resources, to require prior informed  consent or to share in the benefits arising fromIP/C/W/254
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their use. Although the TRIPS Agreement does not c ontain provisions on the protection of traditional
knowledge, it does not prevent states from enacting a sui generis  protection system for traditional
knowledge.
PART II:  THE INTERACTION BETWEEN THE CBD AND THE TRIPS AGREEMENT
13. Despite their difference in coverage, there is considerable interaction between the rights
referred to in the TRIPS Agreement and the subject matter of the CBD.  There is a range of issues
upon which both agreements do have implications, such as biotechnology, plant varieties,
environmental technology relating to conservation and sustainable use, information relating to
conservation and sustainable use, traditional knowledge and benefit sharing.
14. The main area of interconnection between intellectual property rights and biodiversity-related
matters is to be found in Section 5 of the TRIPS Agreement which deals with patents.  It is clear that
implementation of patent legislation may impact on the implementation of the CBD.  In particular, to
the extent to which an invention developed on the basis of a biological resource provides a valuable
and practical means of exploiting that resource, the exercise of the rights in any patent granted onsuch an invention could have positive implications for benefit sharing.  This is the reason why
Article 16.5 of the CBD requires Parties to ensure that intellectual property rights are supportive of
and do not run counter to the objectives of the CBD.  In this regard, we would like to confirm that the
EC/MS are in favour of granting the CBD Secretaria t ad hoc observer status in the TRIPS Council.  In
the same vein, the EC/MS believe that enhanced cooperation between the WTO Secretariat and theCBD Secretariat would be very important in view  of a mutually supportive implementation of both
agreements.
15. The EC/MS believe that, from the point of view of their implementation, the TRIPS
Agreement and the CBD should not undermine each other’s objectives;  they should, accordingly, beimplemented in a mutually supportive way. It should be remembered that the Conference of the
Parties to the CBD  of 15-26 May 2000 have called for " case studies on the relationships between
intellectual property and CBD objectives, including technology transfer and benefit-sharing with
indigenous and local communities ".  Sound empirical data about the actual use of intellectual property
rights and the long run effects of that use on the objectives of the CBD would indeed be extremely
helpful in further analysing interconnections  between the CBD and the TRIPS Agreement.
16. In accordance with Decision 26 of the fifth Conference of the Parties (CoP V) to the CBD, on
5 February 2001, the EU submitted to the CBD Secretariat a paper on the relationship between
intellectual property rights (IPRs) and biodiversity.  The paper, which is annexed herewith, is not a
statement of the EU position. However, it identi fies in some detail the main aspects of the
IPR/Biodiversity debate and is a first step towards shaping such a position.  Intensive discussions onaccess and benefit-sharing took place under the CBD on 19-22 March 2001 in Montreal in a Panel of
Experts’meeting devoted to this issue.  Further discussion will be held in the near future as the Panel
will report to an Ad Hoc Open-ended Working Group which will meet in Bonn in October 2001.  The
Working Group has a broad mandate to develop guidelines or other approaches on virtually all aspects
of the access and benefit-sharing issue.  It can be  expected that the relationship between IPRs and
CBD will be one of the main elements to be discussed in the context of the broader debate on access
and benefit-sharing.  The EU and its member States intend to co-operate actively in order for the
above-mentioned Working Group to be able to develop guidelines or other approaches to be
submitted to CoP VI in April 2002.  The EC/MS attach great importance to this work and intend to
participate actively in order for the above-mentioned Working Group to be able to develop guidelinesor other approaches to be submitted to CoP VI in April 2002.
17. In themselves, the provisions of the TRIPS Agr eement appear neutral in terms of their impact
on the objectives of the CBD.  Hence the TRIPS Agreement should not in practice undermine the
achievement of the objectives of the  CBD, such as conservation, sustainable use, benefit sharing andIP/C/W/254
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protection of traditional knowledge.  In its implementation, the TRIPS Agreement can in fact be used
to support the objectives of the CBD, such as the sharing of benefits (of e.g. knowledge obtained from
research or income created by the exploitation of patented inventions).  An important objective of the
TRIPS Agreement is to promote effective and adequate protection of intellectual property rights,
including by providing incentives to inventors through the provision of exclusive rights on atemporary basis.  Intellectual property rights are instruments to ensure an adequate level of
transparency and openness regarding all kinds of inventions, including those using genetic material.
Without transparency, economic operators, research and development institutions and inventors
cannot benefit from the knowledge which can be derived from the use of genetic material in
innovative processes and activities.  Innovative creations would be kept secret and non-available to
the public because there would be no economic incitement to disclose them.  This might lead to
increased business secrecy and an anti-competitive contractual environment, e.g. by increasing the use
of secrecy agreements between commercial operators.
18. Furthermore, intellectual property rights, and in particular patents, are instruments, but not the
only ones, that can be used by providers of genetic material to obtain benefits from commercial
operators who depend on genetic material to develop new products.  Patents can be used as aninstrument between the parties to agreements on access to genetic resources to secure remuneration to
the provider country for the use of genetic resources on a long term basis.  It should, in this context,
be remembered that intellectual property is only one of many complicated aspects concerning access
to genetic resources and benefit sharing.
19. Finally, the TRIPS Agreement leaves scope to WTO Members to determine the degree of
exclusivity conferred by patents.  Members remain free to provide for exclusions allowing utilisation
of the product for research.  The same applies to plant variety protection under UPOV 91 as regards
the utilisation for further plant breeding and the farmers’ privilege.  In themselves, such provisions
contribute to the sharing of benefits arising from innovation on (plant) genetic resources.  This hasbeen acknowledged in the ongoing negotiations for the revised FAO International Undertaking on
Plant Genetic Resources.
PART III:  DISCLOSURE REQUIREMENTS
20. It has been argued by several Members within the context of the ongoing review that
Article 27 of the TRIPS Agreement should incorporate requirements in the CBD concerning accessauthorisation from the government of the country providing a genetic resource used in an invention,
prior informed consent, benefit sharing, protecti on of traditional knowledge and technology transfer.
Proponents of this measure argued that this would en sure that source countries’ laws on access and
benefit sharing and on protection of traditional knowledge would be respected by patent applicants
and would prevent abusive patenting of existing traditional knowledge by parties other than the
holders of the traditional knowledge
.  This issue was also discussed in the autumn of 2000 at the
WIPO General Assembly, which agreed to establish a special Intergovernmental Committee to
consider the relationship between intellectual property and genetic resources, as well as traditional
knowledge and folklore.  The first meeting of this Intergovernmental Committee will take place from30 April to 5 May 2001.
21. In this context, it should be noted that intell ectual property rights do not aim to regulate the
access and use of genetic resources, to regulate the terms and conditions for bioprospecting or the
commercialisation of IPR-protected goods and services .  In the same vein, patent authorities are there
to examine whether an invention meets the objective patentability criteria;  they are not there to act asan enforcement agency for a third country’s legislation on access to genetic resources.
22. Therefore, the EC does not favour incorporating into the TRIPS Agreement overly complex
requirements which would oblige patent applicants to  provide, in their patent application, an official
certificate of the source and origin of the genetic material and the related traditional knowledge used,IP/C/W/254
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evidence of fair and equitable benefit sharing and evidence of prior informed consent from
government or local communities for the exploitation of the subject matter of the patent.  It should be
borne in mind that the number of countries which have enacted legislation on access to genetic
resources is still rather limited.  Hence, only few countries are currently in a position to deliver such
certificates.  However,  the EC/MS are open to examine possible effects of the patent system and lookinto different ways of how to positively support st ates in achieving the objectives of the CBD, in
particular benefit sharing, while maintaining existing standards and level of intellectual property
protection and not unduly increasing the burden on patent applicants and taking into account the
outcome of the above-outlined negotiation process which is taking place in the framework of the
CBD.  As already mentioned above, further discussions on access and benefit-sharing will take place
under the CBD.
23. In this respect, the EC/MS are prepared to engage in a positive manner in an attempt to agree,
within the appropriate fora, on a multilateral system and/or other solutions for disclosing and sharing
information about the geographical origin of biological material relied on in patent applications.  Suchdiscussions could also address the issue of a self-standing obligation for patent applicants to disclose
the geographical origin of biological material relied on in patent applications.  Once such a system or
solution is in place, attention can then be focussed on how and to what extent it needs to be included
in the TRIPS Agreement
.
24. It should be stressed that such a system could never on its own be a satisfactory guarantee of
the sharing of benefits arising from the use of genetic resources.  In that perspective,  the disclosure of
origin should be considered as complementary to  the main legal instrument in this respect, i.e. the
enforcement of sound and effective national legislation  in the countries providing genetic resources,
laying down the conditions for access and benefit sharing and protection of traditional knowledge.  In
that respect, the EC/MS believe that national legislation on access to genetic resources and benefit
sharing should provide for easily accessible and tr ansparent application systems for access to genetic
resources, including flexible procedures for prior informed consent;  make sure that access and benefit
sharing are granted on mutually agreed terms as provided by the CBD;  and be in conformity with the
WTO obligations and other international undertakings .
25. The ability of the EC/MS to effectively address the issue of disclosure of origin would depend
in practice on the existence of sound access legislation.  The EC/MS are aware that many developing
country Members may require assistance to build their capacity to put in place and implement
appropriate and effective legislation.  The EC/MS are, if requested, prepared to provide such
assistance.
PART IV:  PROTECTION OF TRADITIONAL KNOWLEDGE
26. Article 8(j) of the CBD encourages signatories to protect traditional knowledge.  Article 8(j)
does not provide a ready-to-use framework, but is open-ended about the means that states mightemploy for the protection of such knowledge.  As said above, nothing in the TRIPS Agreement
prevents WTO Members from setting up a protection regime, either by applying their existing
intellectual property regimes to indigenous knowledge (to the extent that such regimes are adequate to
that effect) or through the enactment of a specific model of protection effectively regulating and
enforcing access to, protection of, and reward for the use of traditional knowledge.
27. The EC/MS, therefore, support the development of an international model for the legal
protection of traditional knowledge.  The EC/MS believe that a broader scope of protection including
elements of particular interest to developing countr ies, and in particular traditional knowledge, would
improve confidence in the international IP system.  It is hoped that the new WIPO Intergovernmental
Committee referred to above will take up this issue, in close co-operation with the CBD and theIP/C/W/254
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TRIPS Council.  Once a model is in place, attention can then be focussed on how and to what extent
the protection of traditional knowledge can be included in the TRIPS Agreement.
28. Meanwhile, it should be examined how to make more information available on traditional
knowledge to patent offices (through databases or registration) so as to allow patent examiners to takethem into account as prior art, in order to reduce the risk of abusive patents.
29. It should be kept in mind that, except for certain cases, traditional knowledge can, in itself,
not be patented, because it usually does not respond to the basic criteria of patentability.  Were parties
other than traditional knowledge holders to obtain patent protection for traditional knowledge, the
patent should be cancelled.  The situation is different when traditional knowledge is used as a basis
for further innovations.  In such cases, these innovations, where they meet the relevant criteria, areperfectly patentable.  The existence of a patent would, however, not override accompanying national
requirements to obtain authorisation from the owners of the traditional knowledge from which the
invention is derived and to reward them for the use of it or share the benefits of its use.
30. In the context of traditional knowledge, the EC/MS would also like to point out the
complementary role that can be played by geographical indications in protecting traditional products
under certain circumstances.  It may also be useful to examine their possible role in achieving other
goals of the CBD.  The latter recognises the existence of geographically defined areas that are
regulated to achieve conservation objectives (see the definition of “protected area” in Article 1).
Products originating from such areas may perhaps also be identified as geographical indications, ifproducers decided to link their collective production standards and related traditional knowledge to
conservation goals.
PART V:  CONCLUSION
31. The EC/MS stand ready to consider any difficulty WTO Members may meet with regard to
the relationship between the TRIPS Agreement and the CBD relating to the practical implementation
of the two.  The EC/MS are of the opinion that the search for solutions to the developing countries’
concerns expressed within the context of the review of Article 27.3(b) of the TRIPS Agreement does
not necessarily lie within the scope of that Article itself, but may rather be found:
1) in developing appropriate international instruments to achieve the objectives of the
CBD (in particular access to genetic resources, benefit sharing and protection of traditional
knowledge) and those objectives of the TRIPS Agreement which, in the view of the
developing countries, have not sufficiently been promoted by the industrialised countries ( i.e.
transfer of technology and know how);
2) in providing technical assistance to developing countries to implement the CBD
through sound an effective internal legislation; and
3) through the possible negotiation of measures within the intellectual property system
(in particular in the context of WIPO and, where and when relevant, the TRIPS Agreement)aimed at facilitating benefit sharing and protecting sovereign access rights (e.g. to insert a
provision on the disclosure of origin or to develop protection of traditional knowledge).
32. Therefore, while the EC/MS remain prepared to participate constructively and in a positive
manner in the discussion on the relationship between the TRIPS Agreement and the Convention onBiological Biodiversity within the TRIPS Council, th ey believe that the review of Article 27.3(b) may
not be a vehicle capable of producing definitive solutions to all the issues raised in this context.
Further progress can, however, be made on the basis of Article 71.1 of the TRIPS Agreement;  in
WIPO;  in the CBD;  in the FAO;   or in the context of a new round of multilateral trade negotiationsIP/C/W/254
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in the WTO.  It goes without saying that work pursued in other bodies referred to should be closely
followed by the TRIPS Council.IP/C/W/254
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ANNEX
Paper on the relationship between Intellectual Property Rights (IPRs) and Biodiversity
submitted by the EU to th e CBD Secretariat on 5 Febr uary 2001, in accordance with
Decision 26 of the fifth Conference of the Parties (CoP V) to the CBD.
This paper is not a statement of the EU position : it identifies in some detail the main aspects
of the IPR/Biodiversity debate and is a fi rst step towards shaping such a position
RELATIONSHIP BETWEEN IPRs AND ACCESS TO GENETIC RESOURCES AND
SHARING OF BENEFITS ARISING FROM THEIR USE
1. Economical, legal and institutional context
1.1 Use and benefits
The complexity of access to genetic resources (plant, animal or microbial) and of the sharing
of benefits that arise from their use is widely recognised.  This is due to a number of factors.
First, the benefits arising from the use of genetic resources are diverse, including benefits for
a) science, research, education and training; b) food, agriculture, fisheries and forestry; andc) industrial purposes, including pharmaceuticals.  Some benefits are already being shared,
independently from the provisions of the CBD, for example, the results of scientific research are
usually  published through scientific journals or through the description of innovations required when
filing for intellectual property rights.
Second, the processes through which the use of genetic resources generate benefits are also
very diverse.  Such processes differ for plant, animal or microbial genetic resources due to their
different biological features.  It is important to remember that, unless commercialised in its original
state, benefits are not generated by the genetic resource itself, nor by the IPR itself.  Benefits are
generated by a succession of stakeholders and activities which identify the features of the genetic
resource and an associated industrial application.  Where an innovative process or product is defined,
an application for protection by an IPR can be made.  This would be followed by production,distribution and commercialisation before the end product can be marketed.
Third, the end product can be living (e.g. a plant variety) or non-living (e.g. a pharmaceutical
product) biological material.  It can be scientific or technical information.  Several intellectual
property protection objects, such as a gene, a variety or a process, can contribute to the end product.Intellectual property protection can take different forms which, subject to the legal system of the
country in which protection is sought, can be patents, protected varieties, geographical indications,
etc.  Intellectual property protection can involve the material itself and/or an associated technology for
identifying or using the material and/or scientific knowledge.
Lastly, the link between the end product and the genetic resource is not always direct or
exclusive.  Different categories of industrial pr oducts and processes can require a single or severalIP/C/W/254
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genetic resources, a single or repetitive contribution of the genetic resource and, in some cases,
recourse to synthetic substitutes for the genetic resource.  The arrangements for the sharing of benefits
must take account of these complexities, and define as a first step the respective rights and
investments of the stakeholders involved with regard to the utilisation/ use of genetic resources.
1.2 Access
In the context of the CBD, IPRs are often mentioned as a possible means for achieving the
objectives of Article 15.  However, IPRs, particularly patents, were not designed to regulate access to
genetic resources or to regulate the conditions for bioprospecting, although they may have an
influence on access and benefit sharing arrangements as recognised in Article 16.5.  The CBD makes
clear that these are matters for national legislation.
IPRs, particularly patents and plant variety rights, are a crucial incentive for the creation of
some types of benefits.  They are not, as such, the mechanisms to share benefits.  Without such an
incentive, private investment in the creation of new products or processes from genetic resources
would be significantly lower, with a consequent reduction in the creation of benefits that could beshared.
A patent provides a negative, time-limited right, allowing the holder to prevent commercial
use of his invention without his permission.  A patent is not a licence for the right-holder to exploit his
invention, since any such exploitation must comply with the conditions laid  down in other relevant
legislation.  A patent cannot be obtained on a mere di scovery, even if an invention could be developed
on the basis of natural biological materials.  The granting of a patent is subject to strict criteria of
novelty, inventiveness and industrial application.
Specific legislation or other solutions have a role to play in access and benefit-sharing
arrangements.  These can include upstream measures (research inconsistent with ethics, access to
genetic resources) and downstream measures (conditions for the marketing of products from research
in biotechnology, sharing of benefits from the use of genetic resources), so that IPRs are not
detrimental to individuals, local and indigenous communities, or to the entire country of origin of the
biological resources used in the protected innovati on.  The development of national, regional or global
solutions aimed at fulfilling the objectives of the CBD needs to take account of relevant existing
legislation, particularly that in fields related to the objectives of the CBD.
The complexity of the relationship between genetic resources, generated benefits and IPRs
warrants an in-depth study, which should consider the scope of the different situations, in preparation
for the Ad Hoc Open-ended Working Group on Access and Benefit-Sharing.  This study should help
in the design of a framework for solutions enabling the fair and equitable sharing of benefits arisingfrom the use of genetic resources among all stakeholders involved in the various processes,
particularly those that have ensured the conservation and availability of genetic resources.
This preparatory work should take full account of relevant work in other fora, as recognised
by Decision V/26, in particular
:
• the negotiations being conducted in the FAO to revise the International Undertaking on
Plant Genetic Resources for Food and Agriculture, which are based on the principle of amultilateral approach to access and benefit-sharing, consistent with the IPRs relevant to
this area (especially on plant varieties), the rights of farmers and the provisions on
benefit-sharing in the CBD; and
• work which is or may be undertaken in WIPO (including the WIPO Committee on
Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore),IP/C/W/254
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OECD, WTO and UPOV following the invitation of COP V to relevant international
organisations to analyse the issue of IPRs in relation to access and benefit-sharing, and to
take into account the relevant CBD provisions in their work on IPRs.
With regard to Decision V/26 in relation to the development of guidelines and other
approaches, it may be useful to consider the following issues.
2. Main issues in the debate
2.1 Intellectual Property Rights and the Protection of Traditional Knowledge
Most existing IPR systems, in their present form, are not geared to the protection of all the
various aspects of traditional knowledge.
To properly analyse this issue, it is, first, im portant to try to establish a legal definition for
"traditional knowledge" which takes into account the potential dangers of freezing what are often
evolutionary practices within a legal framework.  Second, it needs to be determined whether suchrights should be established at the individual, collective or common level.  Third, the extent to which
existing IPRs (patents, plant varieties, geographical indications, copyright, industrial designs,
trademarks and the protection of confidential information) are able to meet the objectives of
protecting traditional knowledge could be studied, together with the possibility of establishing new sui
generis  types of property rights.
Finally, it is important to clarify how the granting of an IPR to a third person may affect local
communities and indigenous populations, directly or indirectly, in continuing to apply their historical
and customary practices.
2.2 Scope of the Protection Afforded by IPRs to Inventions using Genetic Resources
Previous documents elaborated within the CBD have identified a number of issues relating to
patents.  However, it is important also to fully consider other forms of protection including, in
particular, plant breeder’s rights and geographical indications.  It is suggested that study of the
following issues, which are not intended to be exclusive, might help clarify the debate:
– Impact of IPRs on the use of the genetic resource employed in the development of the protected
innovation, particularly traditional uses of the genetic resource.
– Limitations on the protection afforded by an IPR.  Some existing IPR legislation provides for
such limitations, for example provisions which allow free use of patented products and processesfor research (the "research exemption") and for self-sufficiency purposes (the "farmer’s
privilege").  Within the CBD, some have argued that such limitations should be extended, for
example by granting compulsory licences under favourable or preferential terms to the country or
community which supplied the genetic resource, or for biodiversity conservation purposes.
2.3 IPRs as an Instrument for the Implementation of Article 15.7 of the CBD
Within the CBD some delegations have tended to view IPRs as:
– a possible economic incentive.  It has been suggested that the filing or granting of an IPR
could be used as a trigger for benefit-sharing (through an undertaking by the developer of a
genetic resource to pay or negotiate royalties if the resultant product is protected by an IPR;
through the joint ownership of the IPR; or through fees).  Such a mechanism could be
implemented through:IP/C/W/254
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– agreements between providers and developers of genetic resources (e.g. between
partners in research programmes);
– national procedures or legislation on IPRs or on access to genetic resources.
– a legal instrument for the verification of compliance with the CBD on:
– Prior informed consent.  It has been suggested that proof of prior informed consent
should be a condition of granting an IPR.  Evidence of prior informed consent could
also be provided by means of an information system.  Other options could also be
studied.
– Mutually agreed terms.  Non-compliance could be punished through the cancelling of
any related IPR, civil action for damages or criminal proceedings.  Other options
could also be studied.
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