RESTRICTEDWORLD TRADE
ORGANIZATIONIP/C/W/228
24 November 2000
(00-5027)
Council for Trade-Related Aspects
of Intellectual Property RightsOriginal:  English
REVIEW OF ARTICLE 27.3(b)
Communication from Brazil
By means of a communication, dated 22 November 2000, the attached paper has been
received from the Permanent Mission of Brazil with the request that it be circulated to Members.
_______________
1. At the TRIPS Council meeting held on 21 March 2000, the Chair set out a list of issues to
structure discussions on the review of Article 27.3(b) of the TRIPS Agreement.  The list of issues is
the following:
• The link between the provisions of Article 27.3(b) and development;
• Technical issues relating to patent protection under Article 27.3(b);
• Technical issues relating to sui generis  protection of plant varieties;
• Ethical issues relating to patentability of life forms;
• The relationship to the conservation and sustainable use of genetic material;  and
• The relationship with the concepts of traditional knowledge and farmers' rights.
2. We consider that the establishment of a list of issues is most important as a means of
facilitating the discussions and moving forward the review of Article 27.3(b) of the TRIPS
Agreement.  Such a list should not be exhaustive and should be without prejudice to the position of
individual countries on those issues.
3. Brazil would like to refer to the issues of th e checklist, taking into account the discussions
undertaken so far at the TRIPS Council as well as possible elements for future discussion.  Thisdocument is a first contribution of Brazil to the review of Article 27.3(b).  Taking into account the
developments in the exercise of review, we may bring further clarifications and complements to the
issues contained in this document.
I. THE LINK BETWEEN THE PROVISIONS OF ARTICLE 27.3(b) AND
DEVELOPMENT
4. The first item of that checklist (" The links between the provisions of Article 27.3(b) and
development ") relates to cross-cutting issues that will be elaborated in more detail in the further itemsIP/C/W/228
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and future discussion.  The generic nature of this item should serve to ensure that the progress in the
review takes into account the needs of developing countries, having in mind the decision by the
General Council in February 2000 that the mandated reviews, including those of the TRIPS
Agreement, give due consideration to the impact on development.  A good basis for discussion on this
topic has already been provided by the African Group (IPC/C/W/206) and by India1.
II. TECHNICAL ISSUES RELATING TO PATENT PROTECTION UNDER ARTICLE
27.3(b)
5. Brazilian legislation excludes from patentability all or part of plants and animals, except
transgenic micro-organisms that satisfy the three requirements of patentability – novelty, inventive
step and industrial application – and which are not mere discoveries.  The same provision establishes
that " for the purposes of this Law, transgenic microorganisms are organisms, except for all or part of
plants or animals, that express, by means of dir ect human intervention in their genetic composition, a
characteristic normally not attainable by the species under natural conditions ".2
6. Brazil considers that the review of Article 27.3(b) should preserve Members' flexibility to
exclude plants and animals from patentability.  Such a review, however, demands clarification on thescope of the exceptions set out in that Article.
7. As suggested by other Members, we are open to consider a definition of the term
"microorganisms", as well as "essentially biolog ical" and "non-biological and micro-biological".
Such definition would be useful to ensure a clear distinction between plants and animals exemptedfrom patentability in the TRIPS Agreement.  It has been suggested that Article 27.3(b) establishes an
artificial distinction between plants and animals, on the one hand, and microorganisms, on the other.
In document IP/C/W/209, the United States considers that a quotation from an English dictionary
3
would be sufficient to provide a definition of the term "microorganism".  We consider that a moreprecise and scientific definition is required – not merely for the sake of establishing "what name isgiven the biological material on which the invention is based", as suggested by the United States, but
for the purposes of providing a clear definition of the scope of exceptions to patentability set out in
Article 27.3(b).
8. The US paper also affirms that " the key to what should be patentable as a microorganism is
(…) the subject matter claimed; is that subject matter new, does it involve an inventive step, and is it
capable of industrial application " and that " to be patentable, a microorganism cannot be as it exists
in nature ".  Nevertheless, there is evidence that patent offices in some developed countries do not
necessarily follow such a policy and they tend to accept overly broad claims on genetic resources that
could lead to the grant of patents with a broad scope. In such cases, for instance, the process of
isolation of a naturally occurring microorganism can often be accepted as a fulfilment of the three
conditions established in Article 27.1 to grant patents over them.  However costly it may be today toisolate a microorganism, in many instances it may correspond better to a mere discovery than an
invention.  Furthermore, it is unclear that some patents claimed over microorganisms, for instance,
adequately fulfill the requirement of industrial application, as the usefulness of the "invention" is
often unclear even to the patent applicant.
9. Such "broad patents" over microorganisms pose a series of other problems.  Loose criteria to
establish novelty, inventive step and industrial application undermine the patent system as a whole,
since they yield legal uncertainty.  Furthermore, while some countries argue that patents on
                                                     
1 Non-paper JOB(00)/6091.
2  Law no 9,279 of May 14, 1996, Article 18, II.
3 The Concise Oxford English Dictionary : “an organism not visible to the naked eye, e.g., bacterium or
virus”.IP/C/W/228
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microorganisms are an important element to encour age research in biotechnology, too broad patents
may actually restrict research, as the patent holder has the exclusive rights to exploit the genetic
material.  Research institutions, for instance, would have to pay licensing fees to work on the genetic
material, thus limiting the access to it.  Finally, but not less important, broad patents over genetic
material from another country may result in conflicts between the TRIPS Agreement and theConvention on Biological Diversity (this element is elaborated below in more detail under items V
and VI).
10. Consequently, as part of the review of Article 27.3(b), we consider that discussions on
definitions and on criteria to clarify the scope of the term "microorganism" would be relevant to
ensure greater legal certainty in the application of  the TRIPS Agreement as the use of those terms is
different, according to whether they are used in scientific, legal or market contexts.
III. TECHNICAL ISSUES RELATING TO SUI GENERIS  PROTECTION OF PLANT
VARIETIES
11. Brazil considers that the review of Article 27.3(b) should preserve Members' flexibility to
decide on the most effective means of sui generis  system for protection of plant varieties.  Brazil
established a Law on the Protection of New Varieties of Plants in 1997 and has recently adhered to
the 1978 Act of the Convention on the Protection of New Varieties of Plants (UPOV 1978).  The
sui generis protection resulted in an effective protection of new plant varieties that have been
developed in Brazil.  Although we are of the opini on that the UPOV system could be considered as a
reference under the review of Article 27.3(b), it does not follow that this system should be consideredas the only one to fulfill the criterion of effectiveness set out in Article 27.3(b).
12. While membership in the 1991 Act of UPOV is increasing, it is a well-known fact that a large
number of developing countries are resisting this instrument on account of its less flexible elements
than the previous Act.  Such inflexibility could result in conflicts with governments' public policy
objectives.  One of the main points of concern is related to farmers' rights: UPOV 1978 allowsfarmers' traditional practice of saving, exchanging, and to a limited degree selling seeds of protected
varieties.  UPOV 1991 turns these actions into privileges and exceptions, at the discretion of
governments' decision on whether or not to permit fa rmers to save seed for use on their own holdings.
The food security of local communities in most developing countries depends largely on their saving,
sharing and replanting seeds from the previous harvest.  These communities may constitute a large
part of the population in developing countries and are basically rural.  Consequently, for many of
those countries, the possibility of requiring the payment of fees for the purpose of saving seeds forreplanting, as permitted in UPOV 1991, would affect negatively small rural producers and result in
social imbalances.  On the other hand, UPOV 1991 limits exhaustion of rights to sales or otherwise
marketing made within the national territory of the Contracting Party concerned, which might disturb
the negotiated balance of Article 6 of the TRIPS Agreement.
13. Other international instruments are also relevant as references in the review of the issue of
plant variety protection.  The International Undertaking (IU) of the Food and Agriculture
Organization (FAO) is an important reference to ensure that sui generis  systems for plant variety
protection take into account international commitments on farmers' rights.  In light of the fact that the
FAO International Undertaking is to become a le gally binding instrument, consistency between the
TRIPS Agreement and the IU is particularly important.  The Convention on Biological Diversity is
another important reference, as it also relates to the biological materials contained in seeds and
establishes the principles of benefit sharing and prior informed consent.  Currently, the FAO
International Undertaking is being reviewed in order to bring it into harmony with the CBD.  We
understand that the review of Article 27.3(b) should be part of the international effort to establish acoherent and harmonious relationship among those instruments.IP/C/W/228
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IV. ETHICAL ISSUES RELATING TO PATENTABILITY OF LIFE FORMS
14. Brazil considers that ethical, cultural and religious concerns relating to patentability of life
forms are an important element to ensure that public interest is adequately reflected in the context of
the review of Article 27.3(b).  This element would be consonant with the Principles of the TRIPS
Agreement set out in Article 8.1.  The issue also relates to Article 27.2, which allows for exclusion ofpatentability of " inventions, within their territory of the commercial exploitation of which is necessary
to protect ordre public or morality  (…)".
15. Ethical, cultural and religious beliefs concerning patents on life forms vary among countries –
and often even within a country – and therefore should be taken into account in the review process.
Property rights over life forms are accepted in most  cultures or religions, through private ownership of
individual animals and plants – such as cattle, domestic animals, crops etc.  Patents over life forms,
including microorganisms, however, do not limit control over individual living beings, but over thewhole group of specimen, which may be considered morally wrong for some cultures.
16. Some developed country Members have argued in previous meetings that moral and ethical
consequences of inventions are better dealt with directly – that is, by inhibiting the development of the
technologies themselves instead of creating obstacles to their patentability.  A great number of
developed country Members emphasize that intellectual property rights aim at encouraging researchand development of new technologies.  Whenever a Member considers that some specific
technologies related to patents on technology are cont rary to ethical, cultural or religious standards,
Article 27.3(b) should consider the possibility of providing flexibility for Members to limit or to deny
intellectual property rights over such technologi es, in order to prevent that their development is
encouraged.
17. Finally, this item is also related to issues discussed under other items of the checklist, such as
biopiracy, protection of traditional knowledge and farmers' rights.  Future discussions on this item
could also take into account health, human rights and agricultural concerns.  We may bring future
contributions in this respect in the review process.
V. THE RELATIONSHIP TO THE CONSERVATION AND SUSTAINABLE USE OF
GENETIC MATERIAL
18. Brazil attaches particular importance to this item, which enshrines several issues concerning
the relationship between the Convention on Biological Diversity and the TRIPS Agreement that
demand clarification by the Council for TRIPS.  Clarification on the relationship of both agreements
will be one of the key elements of the review of Article 27.3(b).
19. Article 15.1 ("Access to Genetic Resources") of the Convention on Biological Diversity states
that " Recognizing the sovereign rights of States over their natural resources, the authority to
determine access to genetic resources rests with the national governments and is subject to national
legislation ".  Further, Article 16.5 ("Access and Transfer of Technology") of the Convention also
establishes that " The Contracting Parties, recognizing that patents and other intellectual property
rights may have an influence on the implementation of  this Convention, shall cooperate in this regard
subject to national legislation and international law in order to ensure that such rights are supportive
of and do not run counter to its objectives " (emphasis added).
20. We believe that such provisions, along with other relevant provisions of the CBD (such as
Article 8(j), which will be discussed in more detail  in item VI), are closely connected to the scope of
the TRIPS Agreement in general and to the review of Article 27.3(b) of the Agreement in particular.IP/C/W/228
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21. Brazil considers that TRIPS and the CBD should be mutually supportive and promote the
sustainable use of resources.  At the implementation level, however, conflicts could arise, for instance,
in the case of patents claimed over naturally-occurring genetic resources, which are protected by the
CBD.  Some examples are already well known to the general public:  in its paper on " Protection of
Biodiversity and Traditional Knowledge " (IP/C/W/198),  for instance, India reports its experience with
cases of patents claimed over turmeric, karela, basmati and the neem tree; another example is the case
of the ayahuasca vine (a native plant of the Amazonian rainforest used by thousands of indigenous
peoples of the Amazon for sacred religious and healing ceremonies).  Broad patents over
microorganisms, plants and animals may result in monopoly rights for the exploitation of the patent's
subject matter, thus restricting exploitation of such resources.  Additionally, patents over a Member's
genetic resource, but granted outside its territory raises the issue of potential conflict with the
principle of the sovereignty of the Contracting Parties of the CBD over their own genetic resources.Such patents claimed over genetic resources are generally obtained without the prior informed consent
of the government or of the traditional commun ity that holds the knowledge on that material.
Moreover, no fair and equitable benefit sharing from the exploitation of the subject matter is
established by the right holder of the patent.
22. In the absence of clear standards defining the scope of patentability of micro-organism (as
discussed above) and a framework in TRIPS that clarifies the relationship of that Agreement with
Members' obligations under the CBD, implementation of the TRIPS Agreement may result in
conflicts with the Convention.  With a view to avoiding conflicts in the implementation of both
instruments – and what is more, to ensure a mutually supportive relationship – Brazil considers thatamending Article 27.3(b) of the TRIPS Agreement to accommodate principles of the CBD will be a
necessary outcome of the review of that Article.  Fa ilure to clarify this relationship may turn out to be
detrimental to both instruments.
23. In order to explore a mutually beneficial relationship, one important step would be to ensure
that patenting of genetic resources – plants, animals or microorganisms – does not run counter to the
basic principles of the CBD.  Some of those principles are the sovereignty of the Contracting Parties
of the CBD over their genetic resources; the principle of benefit sharing;  and the principle of prior
informed consent.  The CBD also has the objective of ensuring protection, at the national level, of
traditional knowledge.  Today, several countries have to tackle the problem of unauthorized
bioprospection and patenting of genetic resources over which, according to Article 15.1 of the CBD,
they have sovereign rights.  Several countries today are putting in place legislation to regulate accessto genetic resources
4, many of which may contain intellectual property-related provisions, in line with
Article 16 of that Convention.  In Brazil, for instance, in June 2000, legislation entered in force to
regulate the access to genetic resources, protection and access to associated traditional knowledge,
sharing of benefits and access to and transfer of technology for its conservation and use, among other
provisions.
24. We fully agree with the arguments expressed by India in its paper (IP/C/W/198)  that it would
be less cost-effective to establish an internationally accepted solution to prevent biopiracy than to
divert national resources to expensive judicial processes for the revocation of patents that include
illegal genetic resources.  Developing countries do not have the resources to follow each and everypatent issued outside their territories on the use of their resources.
25. In this connection, Brazil considers that Article 27.3(b) should be amended in order to include
the possibility of Members requiring, whenever appropriate, as a condition to patentability:  (a) the
identification of the source of the genetic material;  (b) the related traditional knowledge used to
                                                     
4 An informal survey by IUCN of 1998 identifie s 30 countries considering legislation on access to
genetic resources – see Glowka, Lyle: A Guide to Designing Legal Frameworks to Determine Access to Genetic
Resources . Gland, Switzerland: IUCN.IP/C/W/228
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obtain that material;  (c) evidence of fair and equitable benefit sharing;  and (d) evidence of prior
informed consent from the Government or the tr aditional community for the exploitation of the
subject matter of the patent.  An interpretative note to Article 27.3(b) should also be made in order to
clarify that discoveries or naturally occurring material shall be excluded from patentability.
26. For the sake of legal consistency, such amendments would be necessary to ensure
compatibility between the TRIPS Agreement and the Convention on Biological Diversity.  Several
countries already establish the abovementioned requirements in their national legislation as a means
of implementing the CBD.
27. Concerning similar suggestions made in other fora, the United States has mentioned in its
document that requirements to identify the source of the genetic resource in the patent application
would be " a legal and administrative nightmare ".  We are of the view that such concern is
exaggerated and unjustified. Fulfilling such requirements, besides addressing a crucial problem of
coherence between two binding international agr eements, would not be any more burdensome than
any other regular requirement in the already existing patent application procedures.  Furthermore,
evidence of the legitimacy of the access to biological resources and/or to associated traditional
knowledge should be imposed only where the Administration has reasonable grounds to suspect thatnational legislation on the protection of biodiversity has been violated by the patent applicant.  This
element would restrict the application of the requirement to a few patent applications and would
represent a mechanism of biodiversity law enforcement.  The burden, therefore, would not normally
be imposed on law-compliant companies and individuals.  The US also questions whether such a
system would actually ensure benefit sharing from the exploitation of any product or process thatmight be developed from the resource or knowledge.  In this respect, Brazil is of the view that once
Article 27.3(b) is amended as proposed in paragraph 25, the TRIPS Agreement itself would provide
the adequate enforcement of such requiremen ts through its dispute settlement mechanism.
28. The proposed amendment would have the clear benefit of providing a predictable
environment for Governments, investors, traditional communities and researchers.  As a consequence,research and development in biotechnology in developing countries would be encouraged, which
would be in line with the objectives of the TRIPS Agreement to promote technological innovation and
the transfer and dissemination of technology.
VI. THE RELATIONSHIP WITH THE CONCEPTS OF TRADITIONAL KNOWLEDGE
AND FARMERS' RIGHTS
29. Discussions among Members under the review of Article 27.3(b) have already demonstrated
that traditional knowledge may bring significant benefits for several industrial sectors, in particularthe pharmaceutical and agricultural sectors.  It is a well-known fact that traditional knowledge may
bring significant contributions for several industrial sectors.  Particularly in the pharmaceutical sector,
for instance, traditional knowledge may play a key role in the pre-scanning phase to identify the active
substances of medicines.  If such active substances were to be developed synthetically, it would take
years and large amounts of investment in research and development in laboratories.
30. Article 8(j) of the Convention on Biological Diversity establishes that " each Contracting
Party shall, as far as possible and as appropriate, (…) subject to its national legislation, respect,
preserve and maintain knowledge, innovations and practices of indigenous and local communities
embodying traditional lifestyles relevant for th e conservation and sustainable use of biological
diversity and promote 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. "IP/C/W/228
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31. The issue of protection of traditional knowledge is addressed under the review of
Article 27.3(b) based on several issues:  (a) prevention of unauthorized patenting of traditional
knowledge;  (b) sui generis frameworks for the protection of traditional knowledge;  and (c)
documentation of traditional knowledge.  Below are our views on these issues:
(a) Preventing unauthorized patenting of plants, animals and microorganisms related to
traditional knowledge
32. This issue is closely related to item V ("The relationship to the conservation and sustainable
use of genetic material"), as it addresses the relationship between the TRIPS Agreement and the
Convention on Biological Diversity.  We consider that the TRIPS Agreement does not ensure that
Members may prevent patents claimed without due regard to the provisions set out at the Convention
on Biological Diversity, in particular the requirements of benefit sharing and prior informed consentset out in Article 8(j) of the CBD.
33. In this context, an amendment to Article 27.3(b) of the TRIPS Agreement, as suggested in
paragraph 25, would be a necessary step to prevent biopiracy of genetic resources related to the use of
traditional knowledge.  As noted among the "Recommendations at the Multilateral Level" of theExpert Meeting on Systems and National Experiences for Protecting Traditional Knowledge,
Innovations and Practices, held in UNCTAD from 30 October to 1 November, 2000, " exclusion from
patentability of TK [traditional knowledge]-based products in one country, for instance, would not
exclude others from granting it a patent "
5.
(b) Framework for the protection of traditional knowledge
34. Some developed country Members have argued at the TRIPS Council that the status quo
already provides for different means of protecting traditional knowledge.  Today, for instance,
companies can establish inter partes contracts with traditional or indigenous communities.  In the
absence of any other legal framework to protect such  knowledge, we recognize that bilateral contracts
can be a possible means of ensuring the prior cons ent of traditional communities and benefit sharing
of their use.  Such contractual modalities of protection, however, are not sufficient to protect
traditional knowledge, as they are not easily enforceable and are subject to the direct negotiations
between the parties involved.  Consequently there is  no way to ensure that the prior consent obtained
from these communities will actually be an informed one.  There is no way to ensure, either, that the
benefit sharing between a company and a community w ill actually be fair and equitable.  In market,
free-enterprise economies, only a proprietary protection of traditional knowledge, even a sui generis
one, will ensure that market forces will operate to generate fairness and equity.  In addition, a
contractual approach, unlike a proprietary one, does not provide protection erga omnes , in the sense
that if the knowledge is by some way publicly disclosed, there would be no mechanisms available to
prevent their use by innocent third parties.  As a matter of course, to oblige the guilty party to
compensate the community for damages would not enab le the latter to compensate it.  In conclusion, a
contractual approach is clearly insufficient and could protect only some residual aspects of traditional
knowledge transfer.  Similar problems arise with other schemes, such as voluntary guidelines to be
followed by bioprospecting companies; however constructive the intent to establish such guidelines
might be, they may end up being ineffective due to their voluntary nature.
35. Brazil notes that nothing in the TRIPS Agreement prevents Members from protecting
traditional knowledge at the national level, in accordance with Article 8(j) of the Convention on
Biological Diversity.  To a limited extent, even the existing legal framework of intellectual property
                                                     
5 Expert Meeting on Systems and National Experiences for Protecting Traditional Knowledge,
Innovations and Practices: Outcome of the Expert Meeting , held in UNCTAD from 30 October to
1 November 2000.IP/C/W/228
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rights could provide some protection to traditional knowledge.  However useful it may be to explore
such options, they are generally considered to be insufficient to provide adequate protection to
traditional knowledge.
36. Protection provided by the conventional IPR regime is limited by operational factors – lack of
adequate education, awareness and resources, for example – and, most importantly, by conceptual
factors, since certain aspects of the knowledge produced in most traditional communities are not
necessarily within the scope of the TRIPS Agreement.  Traditional knowledge is often held
collectively, which makes it difficult to determine its title holders.  It may also be intergenerational,
which may not fit adequately the requirement of novelty.  Dissemination of traditional knowledge is
often made orally, which makes it difficult to constitute documented prior art.
37. In this respect, we fully endorse the "Recommendations at the Multilateral Level" of the
above mentioned UNCTAD Expert Meeting on Systems and National Experiences for Protecting
Traditional Knowledge, Innovations and Practices, which established that " National sui generis
systems by themselves will not be sufficient to adequately protect TK [traditional knowledge] ." (…)
"Therefore, there is a need for exploring an inte rnational mechanism for protecting TK, which may
explore minimum standards of an international sui generis  system for TK protection.  Traditional,
local and indigenous communities should be invol ved in building an international framework for
collective rights. "
38. We recognize that further discussion is necessary to consider adequate means for the
multilateral protection of traditional knowledge.  Synergies between other organizations – such as the
CBD, WIPO, FAO and UNCTAD, for instance – are most  relevant to build up a better understanding
and consider developments of a framework on this issue.  In this context, in light of its link with
development, Brazil considers that the review of Ar ticle 27.3(b) is an appropriate exercise to discuss
the possibility of establishing minimum standards of protection for traditional knowledge at themultilateral level.
39. Some countries might argue that so far relatively few countries have already established
legislation on the issue, which would make it difficult to establish an internationally recognized
regime to secure benefits arising out of the use of traditional knowledge.  It should be recalled,
however, that a large number of WTO Members who negotiated the minimum standards of
intellectual property rights set out by the TRIPS Agreement have not yet incorporated such minimumstandards at their national levels.  Consequently, the absence of protection at the national level did not
deter WTO Members from negotiating and establishing one of the most ambitious international
treaties on intellectual property rights.  Bearing this precedent in mind, we consider that Members
should not be discouraged from discussing minimum international standards for the protection of
traditional knowledge, whatever the forum in which they might be developed.
(c) Documentation of traditional knowledge
40. Brazil considers that documentation of traditional knowledge would have the clear benefit of
providing documentation for patent offices to determine prior art and check against patent claims that
are filed without the consent of the holders of tradi tional knowledge.  It should be noted that different
Members – such as Switzerland (IP/C/M/25, paragr aph 81), India (IP/C/W/198, paragraphs 16 to 23)
and the United States (IP/C/W/209, paragraph 3 of item 4) – have already agreed on the usefulness of
documenting traditional knowledge.  In this cont ext, we consider that the TRIPS Council should
explore further the means of establishing databases to this end.
41. It should go without saying that information that belongs to traditional and indigenous
communities should never be disclosed in those databanks without their prior informed consent, in
accordance with the Convention on Biological Diversity.  The establishment of databases and theIP/C/W/228
Page 9
process of documentation should not be burdensome or costly.  Further consideration needs to be
given, however, to the best ways in which determine the final use of information contained in such
databases, in order to avoid that they result in the facilitation of biopiracy.
VII. CONCLUSION
42. Brazil considers that the review of Article 27.3(b) raises several issues that relate to the
clarification of its scope as well as to its relationship with obligations undertaken by Members in other
international binding agreements, in particular the Convention on Biological Diversity.
43. The link of Article 27.3(b) to development issues merits further discussion in order to ensure
that its review takes into account the needs of developing country Members.
44. We believe that Article 27.3(b) should preserve Members' flexibility to exclude patentability
of plants and animals.  Clarification may be necessary, however, to establish a more precise definition
on terms such as "micro-organism" in order to determine the scope of patentability of Article 27.3(b).
45. Article 27.3(b) should also preserve the flexibility of Members to decide on the most effective
sui generis  systems for plant varieties protection.  International instruments, such as UPOV (1978 and
1991), FAO and the CBD, as well as national systems, are references for sui generis systems of
protection of plant varieties.
46. The review of Article 27.3(b) should take into account Members' concerns over ethical issues
on patentability of life forms.
47. Brazil believes that the TRIPS Agreement and the CBD should be mutually supportive and
ensure sustainable use of genetic resources.  In order to avoid conflicts in the implementation of both
agreements, Brazil proposes to amend Article 27.3(b) to include the requirements of:  (a) theidentification of the source of the genetic material;  (b) the related traditional knowledge used to
obtain that material;  (c) evidence of fair and equitable benefit sharing;  and (d) evidence of prior
informed consent from the Government or the in digenous community for the exploitation of the
subject matter of the patent.
48. We are open to discuss adequate ways of protecting traditional knowledge at the multilateral
level. In light of its link with development, the review of Article 27.3(b) is an adequate exercise todiscuss the establishment of sui generis protection systems.  Synergies between the TRIPS Council
and other fora, such as the CBD, WIPO, FAO and UNCTAD are necessary and should be furthered in
concrete ways.
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