WORLD TRADE
ORGANIZATIONIP/C/W/369
8 August 2002
(02-4357)
Council for Trade-Related Aspects
of Intellectual Property Rights
REVIEW OF THE PROVISIONS OF ARTICLE 27.3(B)
SUMMARY OF ISSUES RAISED AND POINTS MADE
Note by the Secretariat
1. This note summarizes the issues raised and the points made by delegations in the Council for
TRIPS in regard to the review of the provisions of Article 27.3(b).  It has been prepared in response to
the request made during the TRIPS Council meeting of 5-7 March 20021 that the Secretariat prepare
short papers on, inter alia , the agenda items related to review  of the provisions of Article 27.3(b), the
relationship between the TRIPS Agreement and th e Convention on Biological Diversity (CBD) and
the protection of traditional knowledge and folklore , summarizing the relevant material presented to
the TRIPS Council, whether in written or oral form, and listing all the relevant documentation.
2. Up until this year the discussion in the TRIPS Council on these three matters has taken place
in the context of the review of the provisions of Article 27.3(b), and to a much lesser extent in the
context of the review of Article 71.1.  This note seeks to summarize those parts of this work which
relate more specifically to the review of the provisions of Article 27.3(b).  To avoid undue
duplication, cross-references to the two other notes have been made in certain places.  In accordance
with the mandate given to the Secretariat, the note only contains issues raised and points made by
delegations in the Council for TRIPS and does not cover the documentation of the Committee onTrade and Environment and of the General Council, unless the relevant paper has also been circulated
as a Council for TRIPS document.
3. It is emphasized that this note is an attempt to summarize the work done so far.  By its very
nature, it cannot include a full reflection of all the interventions made and documents submitted.  It is
structured around the issues raised rather than the positions of individual Members.  Therefore anyreader wishing to appreciate fully the position of a particular Member should consult the statements
made and any papers submitted by that Member.  As requested, such documentation is listed in the
Annex to this note.  It is also referred to in the footnotes.
4. This note is divided into three major sections.  The first concerns issues relating to the patent
provisions of Article 27.3(b), the second concerns issues relating to the sui generis  protection of plant
varieties and the third concerns issues relating to the transfer of technology.  There is also a final
                                                     
1 IP/C/M/35, paragraph 226.This document has been prepared under the Secretariat's own
responsibility and without prejudice to the positions of Members
and to their rights and obligations under the WTOIP/C/W/369
Page 2
section which provides information on national legislation, practices and experiences with respect to
this agenda item.
I. ISSUES RELATING TO THE PATENT PROVISIONS OF ARTICLE 27.3(B)
5. After summarizing some general points made about the patent provisions of Article 27.3(b),
this section summarizes points made with regard to the scope of the exceptions to patentabilitypermitted under Article 27.3(b), the ethical exceptions to patentability permitted under Article 27.2
and the way in which the conditions of patentability provided for under Article 27.1 apply to plant and
animal inventions.
A. G
ENERAL ISSUES
6. One general issue that has been discussed is the case for and against providing patent
protection for plant and animal inventions , especially from a development perspective.  One view
has favoured a broad provision of patent protection for such inventions, for the following reasons:
- plant and animal inventions should be accorded adequate patent protection, in the
same way as inventions in other fields of technology, in order to promote private
sector investment in inventive activities that contribute to solving problems in both
developed and developing countries in areas such as agriculture, nutrition, health and
the environment;2
- for this purpose to be adequately met, it is necessary to have international rules for
the protection of plant and animal inventions rather than relying on differing national
rules;3
- patent protection for plant and animal inventions facilitates the transfer of technology
and the dissemination of  the state-of-the-art research on plant and animal inventions
by providing an important incentive for the private sector to conclude licensing
agreements and by discouraging confidentiality and trade secret arrangements4 and,
instead, requiring the publication of patent applications on a global basis;5
- patent disclosure requirements and the control over exploitation given to the patent
owner can facilitate the operation of laws designed to protect public morality, health
and the environment.6
7. Another view that has been expressed is that patents on life forms give rise to a range of
concerns, including in regard to development, f ood security, the environment, culture and morality:7
These include:
- concerns relating to the implications of patent protection in the field of plants for
access to, and the cost, re-use  and exchange of, seeds, by farmers, as well as
concerns about the displacement of traditional varieties and depletion of biodiversity;8
                                                     
2 Japan, IP/C/M/32 para. 142; Switzerland, IP/C/M/30 para. 161 and IP/C/W/284, para. 4.
3 Singapore, IP/C/M/25 para. 80.
4 Australia, IP/C/M/24 para. 83.
5 Australia, IP/C/M/24 para. 83; Canada, IP/C/M/25 para. 91; EC, IP/C/M/25 para. 72; Japan, IP/C/M/29
para. 150; Switzerland, IP/C/M/30 para. 161.
6 Switzerland, IP/C/W/284.
7 India, IP/C/M/25, paragraph 70, IP/C/M/24, para. 80 and Kenya, IP/C/M/28, para. 143.
8 Kenya, IP/C/M28, para. 145.IP/C/W/369
Page 3
- concerns relating to the grant of excessively broad patents, which do not fully meet
the tests of patentability and the consequent problems of "bio-piracy" in respect of
genetic material and traditional knowledge and of the costs and burdens associated
with the revocation of such patents;
- another area of concern has been the view that present international arrangements,
which it has been said protect the interests of innovators but do not adequately protect
the countries and communities that supply the underlying genetic material and
traditional knowledge, need rebalancing, in particular to make the principles of the
CBD in regard to prior informed cons ent and benefit-sharing more effective.
8. Some of these points, especially the last two, are elaborated in the Secretariat summary notes
on the relationship between the TRIPS Agreement and the CBD and the protection of traditional
knowledge and folklore.
9. The suggestions that have been made for what action might be taken by the WTO  in regard
to the patent provisions of Article 27.3(b) in light of the mandated review can be categorized in four
categories:
- the exceptions to patentability authorized by Article 27.3(b) are unnecessary 9 and
patent protection should be extended to all patentable inventions of plants and
animals,10
- Article 27.3(b) should be maintained as it is11, with no lowering of the level of
protection.12   The provision is well-balanced, preserving Members' rights to decide
whether or not to exclude plants and animals from patentability in the light of their
specific national interests and needs.13  With regard to the process to be followed in
the review, it has been suggested that this should primarily be one of information
sharing on how Members have implemented Article 27.3(b) nationally,14
- retain the exceptions, but provide clarification or definitions of certain terms used in
Article 27.3(b), especially with a view to  clarify the differences between plants,
animals and micro-organisms,15
- amend or clarify Article 27.3(b) to prohibit the patenting of all life forms, more
specifically plants and animals, micro-organisms and all other living organisms andtheir parts, including genes as well as natural processes that produce plants, animals
and other living organisms.
16  Some proponents of this view  have also suggested that
the provision be amended along the lines of the general and security exceptions in the
other WTO agreements, using similar language.17  It has also been  suggested that the
Article should be amended to prohibit the patenting of inventions based on traditional
                                                     
9 United States, IP/C/M/29 para. 185.
10 Singapore, IP/C/M/29 para. 169.
11 Australia, IP/C/M/28 para. 152; Canada, IP/C/M/25 para. 91; Korea, IP/C/M/26 para. 70.
12 Japan, IP/C/M/32 para. 142; Singapore, IP/C/M/29 para. 169; Switzerland, IP/C/M/30 para. 161.
13 Brazil, IP/C/M/26 para. 61; Switzerland, IP/C/M/32 para. 123, IP/C/M/30 para. 161.  Mexico, IP/C/M/26
para. 76.
14 Japan, IP/C/M/28 para. 162.
15 Brazil, IP/C/M/30 para. 156 and 183, IP/C/M/25 para. 94; India, IP/C/M/26, para. 55; Peru, IP/C/M/29
para. 175; Thailand, IP/C/M/25 para. 78.
16 India, IP/C/M/29 para. 163, IP/C/W/161; Kenya, IP/C/M/28 para. 146 ; Kenya on behalf of the African Group,
IP/C/W/163.
17 Kenya, IP/C/M/28 para. 141.IP/C/W/369
Page 4
knowledge18 or those that violate Article 15 of the CBD.19  It has been suggested that
the obligation of developing countries to implement Article 27.3(b) should take effect
five years after the completion of the review of this provision.20
There have also been suggestions regarding disclosure  requirements in regard to genetic material and
traditional knowledge used in inventions.  These are dealt with in the Secretariat summary note on the
relationship between the TRIPS Agreement and the CBD.
B. SCOPE OF EXCEPTIONS TO PATENTABILITY IN ARTICLE 27.3( B)
10. Issues have been raised regarding the scope of the exceptions, including the definition of the
terms used, in Article 27.3(b).  It has been argued that the absence of clear definitions could pose
problems of legal uncertainty as regards the scope of patentability under Article 27.3(b).21
11. In regard to the definition of plants and animals , it has been suggested that it should be
made clear that parts of plants and animals are excludable from patentable subject-matter.22  I n
particular, it has been said that cells, cell lines, genes and genomes should be excluded.23
12. With regard to micro-organisms , the view has been expressed that there is no scientific or
other rationale for distinguishing between plants and animals on the one hand and micro-organisms onthe other.  Both should not be patentable, since both are living things which can only be discovered
and not invented.
24  The view has also been expressed that there is no consensus on the meaning of the
term "micro-organism" in the scientific community.25  For example, it has been questioned whether
biological material such as cell lines, enzymes, plasmids, cosmids and genes should qualify as
micro-organisms.26  It has also been said that there is no scientific basis for the distinction between
plants, animals and micro-organisms.27
13. In response, the view has been expressed that the distinctions made in Article 27.3(b) are in
accordance with the generally accepted scientific classification of organisms28 and that the notion of
categorising life-forms into plants, animals and micro-organisms is widely accepted in existing
international agreements, including the CBD.29  It has been said that the absence of a definition in the
TRIPS Agreement of the term "micro-organism" refl ects that the fact that the term has not been
defined by patent experts anywhere, not even in the Budapest Treaty on the International Recognition
of the Deposit of Micro-organisms for the Purposes of Patent Procedures.  It has also been said that
the WIPO Committee of Experts on Biotechnological Inventions and Industrial Property, which met
between 1984 and 1988, did not define the term "micro-organism", although the term was used
frequently in its discussions.  It has been said that the reason for the lack of a definition is reflected in
the Comparative Study of Patent Practices in the Field of Biotechnology Related Mainly to
Microbiological Inventions , dated 20 January 1988, prepared jointly by the European Patent Office,
the Japanese Patent Office and the US Patent and Trademark Office.  Page 3 of that document
contains the following, under the heading "Definition of Micro-organism, If Any":
                                                     
18 India, IP/C/M/25 para. 25.
19 India, IP/C/W/196.
20 Kenya on behalf of the African Group, IP/C/W/163.
21 Brazil, IP/C/M/29 para. 146; Pakistan, IP/C/M/25 para. 88., Kenya, IP/C/M/28 para. 152;  Mauritius on behalf of
the African Group, IP/C/W/206.
22 India, IP/C/W/161.
23 Kenya, IP/C/M/28 para. 152.
24 Kenya on behalf of the African Group, IP/C/W/163.
25 Brazil, IP/C/M/29 para. 146; Japan, IP/C/W/236; Sw itzerland, IP/C/W/284; Venezuela, IP/C/M/29 para. 199.
26 India, IP/C/M/25, para. 70, IP/C/W/161; Pakistan, IP/C/M/26, para. 65.
27 Kenya on behalf of the African Group, IP/C/W/163.
28 Switzerland, IP/C/W/284
29 Japan, IP/C/M/29, para. 151IP/C/W/369
Page 5
"None of the laws administered by any of the Offices contains a formal definition of
the term 'micro-organism'.  Where definitions are used in either classification
definitions or administrative guidelines, the term is defined as a non-exclusive list of
organisms which are included within the scope of that term.  As noted by the EPO, it
does not seem expedient to introduce such a definition as the rapid evolution in thefield of microbiology would necessitate its frequent updating."
Thus, it has been argued, patent experts have recognized that any definition that would be agreed
upon today would have to be updated later due to the rapid evolution of research in this field.
30  It has
been said that, if patent officials operating in more technically expert forums, have not considered it
appropriate to define the term "micro-organism" , it would not be wise for the TRIPS Council to
attempt such a task.
14. The question of how WTO Members and, if necessary, a WTO panel should interpret the term
"micro-organism" given the absence of a definition has been discussed.  One view has been that the
principles of international law regarding the interpretation of treaties, in particular Articles 31 and 32
of the Vienna Convention on the Law of Treaties, should be used.31  The Vienna Convention provides
that the basic rule of interpretation is the ordinary meaning of terms in their context and in the light ofthe agreement's object and purpose.  In this regard, it has been said that the dictionary meaning should
suffice for distinguishing plants and animals from micro-organisms for the purposes of the TRIPS
Council.
32  The Concise Oxford Dictionary defines the ordinary meaning of "micro-organism" as "an
organism not visible to the naked eye, e.g., bacterium or virus".
15. In response, it has been said that, in interpre ting the term "micro-organism", Article 31(4) of
the Vienna Convention on the Law of Treaties is more relevant, namely the negotiating history of
Article 27.3(b).  In this regard, it has been said that negotiators of the TRIPS Agreement questioned,
but did not investigate, whether patents would extend to cell-lines, enzymes, plasmids, cosmids and
genes and therefore the Agreement contained terms on the meaning of which agreement was not
reached.33  I t has also been said that a dictionary re ference is not very helpful for dealing with the
several "borderline" categories of life-forms that could be classified as either micro-organisms or as
plants and animals.  Moreover, the view has been expressed that the term is obviously intended to
have a special meaning in the context of patentability and the dictionary explanation and example of a
bacterium or virus do not necessarily concern patentable micro-organisms.34
16. With regard to what action should be taken in the WTO on the treatment of micro-organisms,
the following views have been expressed:
- micro-organisms, like other biological and living organisms, should be excluded from
patentability,35
- the coverage of the term "micro-organisms" should be clarified, in particular so as to
exclude cell-lines, enzymes, plasmids, cosmids and genes,36
- individual Members should determine and apply the term in their national
jurisdictions in accordance with Article 1.1 of the Budapest Treaty and not seek to
                                                     
30 United States, IP/C/M/35 para. 222, IP/C/M/28 para. 131.
31 US IP/C/W/209.
32 Japan, IP/C/M/29 para. 151; Korea, IP/C/M/32 para. 140; Switzerland, IP/C/M/30 para. 163, IP/C/W/284;
United States, IP/C/M/35 para. 222, IP/C/M/28 para. 131, IP/C/W/209.
33 India, IP/C/M/25 para. 70.
34 Brazil, IP/C/M/29, para. 146; India, IP/C/M/30, para. 168.
35 Kenya, IP/C/M/28, para. 152
36 Kenya, IP/C/M/28 para. 152.IP/C/W/369
Page 6
define the term.  Patent experts have a fairly clear idea of the term but the issue is
complex and therefore it is better left to each Member's patent offices and experts to
determine,37
- it should be left to national policy to decide what are patentable micro-organisms,38
- it has also been said that it is important to consider what approach has been taken in
each Member's legal framework and that such a flow of information would be useful
for a collective understanding of the nature of the terms under discussion and for
clearing up concerns or grey areas.39
17. With regard to non-biological and micro-biological processes , concern has been expressed
that Article 27.3(b) incorporates specific obligations on the patenting of such processes but does not
define these terms.40  It has been suggested that artificial distinctions between essentially biological
processes on the one side and microbiological and non-biological on the other side should be
removed41 or clarified.42  The view has been expressed that micro-biological processes are biological
processes and should be treated by the TRIPS Agreement in the same way.43
C. ETHICAL EXCEPTIONS TO PATENTABILITY AND ARTICLE 27.2
18. It has been said that the criteria and rationale for what could and could not be excluded from
patentability on the grounds that inventions are contrary to ordre public  or morality, including on
grounds of protection of life and health of humans, animals and plants, should be examined in the
review given the direct link to Article 27.3(b).44  It has been suggested that specific concerns that
should be taken into account include those relating to public health, restrictions on research
materials45, limitations on competition as in the case of gene use restriction technologies (GURTs),46
human rights, agricultural security, bio-piracy, traditional knowledge and farmers' rights.47
19. The view has been expressed that patenting of li fe forms is in itself unethical and harmful and
therefore should be unconditionally prohibited.  Article 27.2 is not sufficient for this purpose as theconditions it imposes on action to protect ordre public or morality are unnecessary and cumbersome,
48
for instance that the commercial exploitation of the invention must also be prevented.49  T h e
qualifications included in Article 27.2 amount to redefining morality for Members.50
20. In response, the view has been expressed that Article 27.2 adequately takes into account
ethical concerns as far as patent law is concerned and that other ethical issues have to be addressed
and dealt with in other laws, such as on the protection of the environment, public health or animal
                                                     
37 Korea, IP/C/M/35 para. 225.
38 India, IP/C/W/161.
39 Australia, IP/C/M/29 para. 190.
40 India, IP/C/M/24 para. 8.
41 Kenya, , IP/C/M/28, para. 146.
42 Brazil, IP/C/M/29, para. 146
43 Kenya, on behalf of the African Group, IP/C/W/163.
44 Australia, IP/C/M/28 para. 152; Brazil, IP/C/W/228; Ecuador, IP/C/M/30 para. 184, IP/C/M/25 para. 87; India,
IP/C/M/28 para. 127, IP/C/M/25 para. 70; Kenya, IP/C/M/28 para. 143; Mauritius on behalf of the African Group
IP/C/W/206; Norway, IP/C/M/25 para. 76; Pakistan, IP/C/M/24 para. 86; South Africa, IP/C/M/25 para. 79.
45 Kenya, IP/C/M/28 para. 141; Mauritius on behalf of the African Group, IP/C/W/206.
46  India, IP/C/M/28 para. 126.
47 Brazil, IP/C/W/228.
48 Kenya, IP/C/M/28 para. 143.
49 India, IP/C/W/161.
50 Kenya IP/C/M/28 para. 143IP/C/W/369
Page 7
welfare.51  In this regard, the point has been made that patents do not guarantee the patent holder
unfettered exploitation of the patented invention.  Such exploitation is subject to the national law of
the Member in question, including on matters of ethi cs, animal welfare, bio-safety etc.  A Member
might legitimately enforce its national law to prohibit patentees from exploiting patented inventions
for various reasons, including ethical ones.  There is no need to exclude inventions from patentabilityin order to prevent their exploitation.
52  Moral and ethical concerns relating to the research into life-
forms and the exploitation of the results of that research are better legislated on directly rather than
through patent laws.53  It has been said that, in fact, excluding particular subject-matter from
patentability will not in itself prevent either research or exploitation of such technology.54  Instead, it
could make it more difficult to control, for example by encouraging secrecy.55  It has also been said
that discussion on this issue is difficult because the moral and ethical concerns expressed by some
Members about patenting life forms have not been specified.56
21. In response, it has been said that, while it may be possible to restrict undesirable research by
other means, it has to be taken into account that patents have an incentive effect on research and
development.  Therefore, restriction of the grant of intellectual property rights can be a tool to
discourage research contrary to ethical, cultural or religious standards.57
D. CONDITIONS OF PATENTABILITY IN ARTICLE 27.1 AND  PLANT AND ANIMAL INVENTIONS
22. The way in which the basic criteria for patentability set out in Article 27.1, namely novelty,
inventive step (or non-obviousness) and industrial applicability (or usefulness), should be applied in
the case of micro-organisms and micro-biological  processes and other plant and animal inventions
that may be patentable under national law has been discussed.  In this regard, the view has been
expressed that the lack of clear definitions of the conditions for patentability has left grey areas, inparticular with respect to the definition of the term "invention" and the scope of patentable micro-
organisms and microbiological or non-biological processes.
58
23. One view is that, given the above, it would be  up to the domestic laws and practices of the
national patent offices to define these matters.59  However, it has been said that leaving the issue
purely to the discretion of Members could give rise to a number of concerns.60
24. One issue raised has been that the use of unduly low thresholds for novelty, inventive step
and industrial applicability .  It has been said that the lax criteria applied by some Members is
undermining the patent system as a whole.61  Concern has been expressed that some patent offices
either do not have appropriate procedures or reward their examiners on the basis of the number of
patent applications handled, thereby encouraging examiners to be less than careful in granting
patents.62  In this context it has been said that over-broad patents can restrict access to genetic
                                                     
51 EC, IP/C/M/25 para. 73; Japan, IP/C/W/236; Switzerland, IP/C/M/30 para. 162, IP/C/W/284; United States,
IP/C/M/30 para. 176.
52 Japan, IP/C/M/29 para. 153.
53 United States, IP/C/W/162.
54 United States, IP/C/W/209.
55 Switzerland, IP/C/W/284.
56 United States, IP/C/W/162.
57 Brazil, IP/C/W/228.
58 India,IP/C/W/161; IP/C/M/28 para. 128.
59 Venezuela, IP/C/M/29 para. 199.
60 India, IP/C/M/28 para. 126.
61 Brazil, IP/C/W/228.
62 Brazil, IP/C/M/29 para. 146, IP/C/W/228; India, IP/C/M/28 para. 126.IP/C/W/369
Page 8
material, restrict or raise the cost of research, thus  giving rise to questions of compatability with the
CBD.63
25. The issue of the distinction to be made between discoveries and inventions , and, in
particular, what is required to satisfy the test of inventive step  (or non-obviousness) has been raised.
It has been said that, by stipulating the patenting of micro-organisms and micro-biological processes,the TRIPS Agreement violates the basic tenet of patent law that,  while discoveries are not  patentable,
inventions are.
64  It has also been said that there is need for a clearer understanding of which stages of
research into genetic resources, including genetic parts and components, constitute "discoveries" and
which fulfill the requirements of being an invention.65  A specific point that has been made in this
connection relates to the patenting of genetic materials in their natural state.66  It has been argued that
some Members define inventions to include discovery of naturally occurring matter, or the mere
isolation of such matter, and that this has led to patents on life forms found in their natural state andon research materials.
67.  It has been questioned whether the mere act of isolation of genetic material
from its natural state would satisfy the test of non-obviousness or of the inventive step.68  The view
has been expressed that the negotiating history of the TRIPS Agreement shows that the negotiators
were not able to agree that the task of isolating a bacterium would satisfy the inventiveness test.69 It
has also been said that, however costly it may be today to isolate a micro-organism, in many instancesit may correspond better to a mere discovery than to an invention.
 70  Members should be able to limit
the grant of patents in respect of micro-organisms to those that had been transgenetically modified and
satisfy the requirements of patentability.71
26. In response, it has been said that mere discoveries, not involving human intervention, are not
considered patentable subject-matter. 72  Examples have been given to illustrate the point, relating to
ores, natural phenomena, chemical substances or micro-organisms found in nature.  Life-forms in
their natural state would not satisfy the criteria for patentability in the TRIPS Agreement.73   I t has
been elaborated that if, however, naturally occurring things, such as chemical substances or micro-
organisms, have been first isolated artificially from their surroundings in nature they are capable of
constituting an invention.  It has also been said  that the subject-matter of a patent has involved
sufficient human intervention, such as isolation or purification, and if the isolated or purified subject-
matter is not of a previously recognized exis tence, then it is considered an invention.74  P l a n t s ,
animals or micro-organisms and other genetic resources would have to be altered by the hand of man
or produced by means of a technical process to satisfy the criteria of patentability.75   
27. In regard to novelty , it has been said that some members define novelty in a manner that does
not recognize information available to the public through the use of oral traditions outside their
domestic jurisdictions.76  This point is more fully discussed in the Secretariat's summary note on the
                                                     
63 Brazil, IP/C/M/25 para. 94, IP/C/W/228.
64 Kenya on behalf of the African Group, IP/C/W/163¸Mau ritius on behalf of the African Group, IP/C/W/206.
65 Malaysia, IP/C/M/32 para. 143.
66 Brazil, IP/C/M/29 para. 146; India, IP/C/M/25 para. 70; Kenya, IP/C/M/28 para. 141; Kenya on behalf of the
African Group, IP/C/W/163; Peru, IP/C/M/29, para. 175.
67 Kenya, IP/C/M/28, para. 141.
68 India, IP/C/M/29, para. 161.
69 India, IP/C/M/29 para. 161.
70 Brazil, IP/C/W/228.
71 Brazil, IP/C/W/228.
72 Japan IP/C/M/29 para. 151, IP/C/W/236; Switzerland, IP/C/M/30 para. 164.
73 Japan, IP/C/M/29, para. 151; Switzerland, IP/C/M/30, para.164; United States, IP/C/M/28, para. 131,
IP/C/M/25, para. 71, IP/C/W/209.
74 Australia, IP/C/M/24 para. 83; EC, IP/C/W/254; Japan, IP/C/M/29 para. 151, IP/C/W/236; Malaysia, IP/C/M/30
para. 179; Switzerland, IP/C/M/30 para. 164; United States, IP/C/M/29 para. 186.
75EC, IP/C/W/254; Japan, IP/C/M/29 para. 151, IP/C/W/ 236; Switzerland, IP/C/M/30 para. 164; United States,
IP/C/M/29 para. 186.
76 India, IP/C/M/28 para. 126; Kenya, IP/C/M/28 para. 141.IP/C/W/369
Page 9
protection of traditional knowledge and folklore.  In regard to the patent obligations on micro-
organisms in the TRIPS Agreement the point has been  made that the mere fact that a micro-organism
or a gene has existed in nature does not mean that it has become known to the public and ceases to be
"new" for patent purposes.77
28.  It has been said that it is unclear that some patents claimed over micro-organisms adequately
fulfill the requirements of industrial applicability  as the usefulness of the inventions is often unclear
even to the patent applicant.78  It ahs also been said that with respect to gene sequences some
Members require the description of a function while others do not.79
29. A general point made in relation to the above concerns has been that, if the criteria for
patentability have not been properly applied, the patent system provides for opposition and revocation
procedures to remedy such situations.80  In response, concerns have been expressed about the financial
and other resource costs and delays involved in keeping track of such patents and using suchprocedures, especially where pre-grant opposition is not possible.
81
30. There has been some discussion of the patenting of genes  and, more specifically, DNA
sequences.  It has also been said that there appeared to be a number of different views among
Members on the granting of patents in regard to DNA sequences82:  it is sufficient to discover a
certain sequence of the DNA;  it is necessary also to describe the function of the DNA sequence;  adistinct diagnostic and therapeutic application should also identified for the particular DNA sequence.
In the discussion, it has been said that a gene, if isolated and purified from the originating biological
material, should be considered to be an invention as it is a particular kind of chemical substance.  This
is because micro-organisms and genes could be characterised in the patent claims by their structure,
by parameters or by other appropriate means.
83  In response it has been said that, while in some cases
the biological material is also a chemical, as in the case of artificial enzymes and hence could be
patentable as a chemical, the TRIPS Agreement does not require genes to be patentable, since they are
parts of living organisms, except if they also qualify as a micro-organism that is patentable under the
national law.84
II. ISSUES RELATING TO THE SUI GENERIS  PROTECTION OF PLANT VARIETIES
31. This section is concerned with the issues that ha ve been raised and points made with regard to
the provision of Article 27.3(b) relating to the sui generis  protection of plant varieties.  After
summarizing points made on some general issues, the section then describes the views that have been
expressed about:  first, what are the elements of an effective sui generis  system;  second, the
relationship between the TRIPS provision and the International Union for the Protection of New
Varieties of Plants (UPOV) Convention, and, third, the relationship with traditional knowledge and
farmers' rights.
A. GENERAL ISSUES WITH RESPECT TO PLANT VARIETY PROTECTION
32. This sub-section deals with the general issues raised in the discussion on the protection of
plant varieties including whether or not such protection should be accorded and whether or not the
provisions contained in Article 27.3(b) are balanced or need to be amended.
                                                     
77 Japan, IP/C/W/236.
78 Brazil, IP/C/W/228.
79 Pakistan, IP/C/M/26 para. 64.
80 Switzerland, IP/C/M/30, para. 164.
81 India, IP/C/W/161.
82 Pakistan, IP/C/M/26 para. 64.
83 Japan, IP/C/M/29, para. 151, IP/C/W/236.
84 India, IP/C/W/161.IP/C/W/369
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33. With regard to the question of why plant varieties should be protected , the point has been
made that such protection allows development of new technological solutions in the field of
agriculture.  More particularly, the point has been made that improvements in agricultural
biotechnology have resulted in the design of new plants through direct manipulation of the genome of
a plant rather than reliance upon conventional plant breeding techniques that involve a trial and errorprocess.  Advances in the area include the development of new crops with higher productivity and
yields and with disease resistance.
85
34. On the other hand, concerns have been expressed that the protection of plant varieties can
have a adverse impact upon the fulfilment of the national goals of developing countries, in particular
in regard to food security, health, rural development and equity for local communities whose
traditional knowledge systems have produced staple varieties, including varieties that have medicinal
and biodiversity value.86  It has been suggested that plant variety protection could lead to excessive
dependence on foreign commercial breeders, and that such persons could not always be relied upon.87
Concern has also been expressed about the possible adverse implications for the cooperativerelationships among neighbouring farmers that are common in developing countries and the difficulty
of traditional farmers in having the capacity or education required to use the system to protect their
own interests.
88
35. With respect to the question as to whether prov isions in the TRIPS Agreement relating to the
protection of plant varieties strike the right balance  between right holders and other interests  that
are involved, three views, not necessarily mutually exclusive, have been expressed:
- Article 27.3(b) provides a certain degree of flexibility to Members in deciding on the
most effective means of sui generis  protection for plant varieties and that the status
quo should be maintained; 89
- while preserving the flexibility in Article 27.3(b), clarification of the term "effective
sui generis  system" is needed.90
36. Specific suggestions for possible clarifications that have been made are:
- reference could be made to the UPOV Convention in Article 27.3(b);91
- a footnote should be inserted after the sentence on plant variety protection in
Article 27.3(b), stating that any sui generis  law for plant variety protection can
provide for:  (i) the protection of innovations of indigenous and local farming
communities in developing countries, consistent with the CBD and the InternationalUndertaking on Plant Genetic Resources
92;  (ii) the continuation of traditional
farming practices including the right to save and exchange seeds, and sell farmers'
harvest;  and (iii)  the prevention of anti-competitive rights or practices which
                                                     
85 Japan, IP/C/M/29 para. 152; United States, IP/C/W/162.
86 Mauritius on behalf of the African Group, IP/C/W/206; Peru, IP/C/M/29 para. 175.
87 Kenya, IP/C/M/28 para. 145.
88 India, IP/C/M/28 para. 125.
89 Brazil, IP/C/M/29 para. 147; EC, IP/C/M/35 para. 214; Egypt, IP/C/M/25 para. 92; Malaysia, IP/C/M/29 para.
206; Mexico, IP/C/M/26 para. 76; Peru, IP/C/M/29 para. 175; Venezuela, IP/C/M/29 para. 200.
90 Brazil IP/C/W/228; India, IP/C/M/25 para. 70;  Kenya, IP/C/M/28 para. 146, Kenya on behalf of the African
Group, IP/W/163; Thailand, IP/C/M/25 para. 78;  EC, IP/C/M/35, para. 214.
91 EC, IP/C/M/25 para. 74.
92 Now the International Treaty on Plant Genetic Resources for food and Agriculture (2001) adopted on 3
November 2001 in Rome. See www.fao.org/biodiversity/doc_en.aspIP/C/W/369
Page 11
threaten the food sovereignty of developing countries, as is permitted by Article 31 of
the TRIPS Agreement;93
- provisions permitting specific exceptions to plant variety rights should be included in
the TRIPS Agreement covering, as a minimum, farmers' rights, in particular to sowand share harvested seed of a protected variety, communities' rights and compulsory
licensing where plant varieties are not available on reasonable commercial terms, in
times of national emergency and in cases of public non-commercial use.
94
37. The views that have been expressed in respon se to these suggestions are set out in the
discussion below
B. "EFFECTIVE SUI GENERIS SYSTEMS " OF PROTECTION
38. The question has been raised as to what constitutes an "effective" system of sui generis
protection for plant varieties for the purposes of Ar ticle 27.3(b).  In this respect, two views have been
expressed:
- there are specific criteria available to judge the effectiveness of a sui generis
system;95
- the TRIPS Agreement does not specify criteria by which to judge whether a sui
generis  system is effective and therefore this should be left to Members to decide.96
These views and responses made to specific points are elaborated below.
39. The view has been expressed that, in order to be effective, a sui generis system of protection
should possess the same basic characteristics as those that generally apply in relation to the protection
of property rights, whether real, tangible or intangible:  the nature of the subject-matter must be
identified clearly enough to enable a distinction to  be drawn between what falls within and what is
beyond the scope of the law;  who is entitled to obtain property rights must be established;  thecircumstances in which the rights exist and the limitations that apply must be spelt out;  the period
during which the rights are in force and the circumstances, if any, under which the rights expire early
or under which they can be extended must be specified;  and the legal action available to the right
holder to enforce its rights along with the remedies available must be indicated, unless these are
provided for in other laws such as a code of civil procedure.
97
40. In regard to the subject-matter that should be protected , the view has been expressed that,
for a sui generis  system to be considered effective, protection should apply to all plant varieties
throughout the plant kingdom.98  It has been pointed out that, unlike the English and French versions
of the text of the TRIPS Agreement, the Spanish version, which is as authentic as the English and
French versions, makes it clear that all plant varieties are to be protected.99  In response, the point has
been made that Article 27.3(b) only speaks of a sui generis  system without providing specific details
as to the plant varieties that should be protected.100   Further, it has been pointed out that some existing
                                                     
93 Kenya on behalf of the African Group, IP/C/W/163.
94 Thailand, IP/C/M/25 para78.
95 United States, IP/C/W/209.
96 India, IP/C/M/25 para. 70.
97 United States, IP/C/W/209.
98 Uruguay, IP/C/M/28 para. 132.
99 Uruguay, IP/C/M/28 para. 132.
100 Peru, IP/C/M/32 para. 128.IP/C/W/369
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sui generis systems, such as in the UPOV, which appear to be considered effective models given their
long-standing use, do not require protection of the entire plant kingdom.101
41. In regard to conditions for protection , it has also been suggested that, in order to be eligible
for protection, a variety should be: new, i.e., the variety's propagating or harvested material should not
have been sold or otherwise made available for purposes of exploitation of the variety;  it should beclearly distinguishable from other known varieties;  it should be uniform in that it does not vary
beyond what would normally be expected;  and the characteristics of the variety should not change
through repeated propagation.
102  In response it has been said that the suggested determinants of
entitlement to protection, namely novelty, distinctiveness, uniformity and stability, go beyond the
determinants contained in existing models.  For example, under the UPOV system, novelty is strictly
speaking not a criterion.  Further, protection under the International Undertaking on Plant Genetic
Resources for Food and Agriculture103 or the CBD may entitle a farmer's variety to protection, even
though such a variety might not be new. 104
42. With respect to who is entitled to obtain rights  under a sui generis  system of protection for
plant varieties, the view has been expressed that an effective system should ensure that protection for
plant varieties is granted only to breeders or others specifically entitled to protection either through
contract or law of succession.105   In response, it has been said that this would mean that, for example,
farmers' rights that have arisen through traditi on and not through contracts or succession cannot be
protected. 106  In turn, it has been said that this would not prevent Members from protecting farmers
rights through other means;  it only meant that such protection would not be an obligation under the
TRIPS Agreement.107
43. In regard to exceptions to the rights conferred , the scope of farmers' privilege and the
breeders' exemption has been discussed.  While the view has been expressed that these exceptions
provide for a balance between the interests and needs of plant breeders and farmers108 and may ensure
biodiversity in accordance with the CBD109, it has also been said that it is not clear that there is a
commonality of views on the definition of these terms.  With regard to the breeders' exemption,  it
has been said that it allows breeders to freely use plant varieties protected by plant breeders' rights intheir breeding activities.
110  However, the question has been raised as to whether it is clearly
understood that breeders are able to innovate around protected varieties without overly restrictive or
prohibitive compensatory conditions in favour of the holders of rights in such varieties.111  I n
response, the view has been expressed that the breeder's exemption as contained in the UPOV
Convention adequately deals with this concern.112
44. With regard to farmers' privilege , it has been stated that this allows farmers to replant on
their own holdings propagating material of protected plant varieties that they have harvested on theirown holdings.
113  It has been said that the issue of whether remuneration must be paid in relation to
                                                     
101 India, IP/C/M/29 para. 162; Thailand, IP/C/M/25 para. 78.
102 United States, IP/C/W/209.
103 Now the International Treaty on Plant Genetic Resources for food and Agriculture (2001) adopted on 3
November 2001 in Rome. See www.fao.org/biodiversity/doc_en.asp.
104 India, IP/C/M/29 para. 162.
105 United States, IP/C/W/209.
106 India, IP/C/M/29 para. 162.
107 Switzerland, IP/C/M30, para. 166, IP/C/W/284.
108 Japan, IP/C/W/236 ; Switzerland, IP/C/W/284.
109 Kenya, IP/C/M/28 para. 142.
110 Switzerland, IP/C/W/284.
111 Mauritius, on behalf of the African Group IP/C/W/206
112 Switzerland, IP/C/W/284.
113 EC, IP/C/M/25 para. 74; Switzerland, IP/C/M/29 para. 179; United States, IP/M/25 para. 71, IP/C/W/162.IP/C/W/369
Page 13
the exercise of the farmers' privilege is left to the national legislator.114  In response it has been said
that the farmers privilege should not be limited to saving and re-planting the material only on a
farmer's own holdings.115  Views have also been expressed about the way in which the issue of
farmers' privilege is treated in UPOV 1991;  these are summarized in paragraph 53 below.
45. In regard to the duration of rights , the view has been expressed that the right holder should,
for a period of at least 20 years from the date rights are granted, be entitled to prevent others from
commercializing or taking steps to commercialize the protected variety without the authorization of
the right holder.  A period of 25 years should apply in relation to new varieties of trees and vines
given that the development and commercialisation of  such new varieties requires a longer period of
time than that for other plant varieties.116  In response it has been said that the suggested term of
protection of at least 20 years, which applies to patents in Section 5 of Part II of the TRIPS
Agreement, does not apply to plant variety protection.  Effective sui generis  models, such as the
UPOV system, may have a different term of protection. 117
46. In regard to procedural requirements , the view has been expressed that the procedures to be
followed by potential right holders to obtain rights , and any fees that are involved, should be provided
for in a comprehensive and transparent way and should apply to foreign nationals on a national
treatment basis, as required by Article 3 of the TRIPS Agreement, with a provision for claiming apriority filing date based on filing in the right holder's own country similar to that applicable to
patents in the Paris Convention.
118  In response it has been said that sui generis  models that reflect the
practice of reciprocity rather than national treatment should not be deemed to be lowering the level of
protection or the effectiveness of the sui generis  system.119
47. In regard to the enforcement of rights,  the view has been expressed that effectiveness
depends upon the enforceability of a right within a national legal system.120  More particularly, it has
been suggested that the legal actions that must be available to a right holder to enforce rights and the
remedies that judicial and administrative authorities must be able to impose on infringers should be
those that are currently provided for in the TRIPS Agreement.121
48. The view has also been expressed that what can constitute "effective protection" as it relates
to the protection of plant varieties, under the TRIPS Agreement, is left to Members to determine.122
In this respect, the view has been expressed that the concept of a " sui generis " system is inconsistent
with a prescription of rights and duration or even models to be imposed on all WTO Members.123  It is
the responsibility of each Member to create a system that gives sufficient protection for the parties
involved.124  The view has also been expressed that the standards for patents might not necessarily be
applicable, particularly for countries that have opted to create a sui generis  system rather than relying
upon patents or a combination of systems including patents. 125
                                                     
114 Switzerland, IP/C/W/284.
115 Kenya, IP/C/M/28 para. 145.
116 United States, IP/C/W/209.
117 India, IP/C/M/29 para. 162.
118 United States, IP/C/W/209.
119 India, IP/C/M/29 para. 162.
120 India, IP/C/M/25 para. 70.
121 United States, IP/C/W/209.
122 Kenya, IP/C/M/28 para. 142; Kenya highlighting African Group submission, IP/ C/M/25 para. 75.
123 Kenya, IP/C/M/28 para. 142.
124 Norway, IP/C/W/293.
125 India, IP/C/M/29 para. 162.IP/C/W/369
Page 14
C. RELATIONSHIP BETWEEN THE TRIPS REQUIREMENT TO HAVE AN EFFECTIVE SUI GENERIS
SYSTEM AND THE UPOV C ONVENTION
49. Views have been expressed as to whether the systems of plant variety protection provided for
under UPOV constitute effective sui generis  systems for the purposes of Article 27.3(b).  One view
has been that, while it is recognized that the TR IPS Agreement does not specifically call for a UPOV
model to be followed, UPOV does provide for an effective sui generis  system as required by Article
27.3(b).126  Several arguments have been made to support this view and in favour of widespread use of
UPOV:
- the UPOV system is the most favourable for encouraging development of new plant
varieties in all WTO Members' territories;127
- with respect to concerns that have been expressed about the impact of the UPOV
system on farmers and plant breeders especially in developing countries, the UPOV
system is flexible enough to allow Members to adequately address such concerns
through, for example, the farmers' privilege and the breeders' exemption;128
- recognizing the difficulties associated with the creation and administration of sui
generis  systems for the protection of plant varieties, the most efficient and rapid way
to implement Article 27.3(b) would be to rely on existing harmonised plant variety
systems with possible adaptations to ensure special national needs.129
50. In response, the view has been expressed that a reference to UPOV would not be
appropriate130, for the following reasons:
- Article 27.3(b) does not bind Members to use UPOV as a model in providing
protection for plant varieties, although UPOV may be an important point of
reference.131   More particularly, Members are free to choose a model other than
UPOV, such as those based on FAO's International Undertaking on Plant GeneticResources or the CBD, if they so desire;
132
- incorporation of a reference to UPOV into Article 27.3(b) could damage the delicate
balance already established in that provision;133
- there is no authoritative interpretation as to whether UPOV satisfies the requirements
contained in Article 27.3(b);134
- UPOV is premised on the protection of plant breeders in industrialized countries
rather than the needs of users in developing countries, although the 1978 Act of
UPOV allows the recognition of farmers’ privilege to re-sow farm-saved seeds.135
                                                     
126 EC, IP/C/M/25 para. 74; Japan, IP/C/W/236; Switzerland, IP/C/M/30 para. 166; United States, IP/C/W/162;
Uruguay, IP/C/M/28 para. 132.
127 United States, IP/C/M/30 para. 175.
128 Japan IP/C/W/236;  Switzerland, IP/C/M/32 para. 123.
129 EC, IP/C/M/25 para. 74.
130 Norway, IP/C/M/25, para. 76.
131 Brazil, IP/C/M/30 para. 183, IP/C/M/25 para. 94; India, IP/C/W/161, page 4; Malaysia, IP/C/M/29 para. 206,
IP/C/M/25 para. 83; Mexico, IP/C/M/26 para. 76; Zambia, IP/C/M/28 para. 147.
132 Brazil, IP/C/M/30 para. 183; India IP/C/W/161; Zambia, IP/C/M/28 para. 147.
133 Brazil, IP/C/M/26 para. 60.
134 India, IP/C/M/25 para. 70; Thailand, IP/C/M/25 para. 78.
135 India, IP/C/W/161.IP/C/W/369
Page 15
51. In response, it has been said that the reason why a reference to UPOV does not appear in
Article 27.3(b) is because of its limited geographic coverage at the time the TRIPS Agreement was
being negotiated.136  While there might be sui generis  systems for the protection of plant varieties
other than that provided for under UPOV that meet the requirements of Article 27.3(b), such systems
would have to be judged on their merits on a case by case basis.137
52. Differing views have been expressed about the merits of the various UPOV conventions and
their relationship to the TRIPS Agreement.  In regard to UPOV 1991 , one view has been that it
achieves a proper balance of rights and obligations which work to the benefit of all countries and that
UPOV 1991 provides the most appropriate system and level of protection.138  In this regard, the point
has been made that the 1991 Act of UPOV does not permit contracting parties to limit the eligibility
for protection of varieties by species of plant.  This means that newly developed varieties of species of
plant that would not have been eligible for protection under the 1978 Act are now eligible forprotection under the 1991 Act.  However, under UPOV 1991, contracting parties can limit rights so as
to permit farmers to save seeds harvested from their own plantings for replanting in subsequent
years.
139  The point has also been made that most Members that responded to the questionnaire on the
implementation of Article 27.3(b) have adopted the 1991 Act140 and that many of those that had
originally become signatories to the 1978 Act were in the process of ratifying the 1991 Act.141
53. In response, it has been said that, while membership of the 1991 Act of UPOV is increasing, a
large number of developing countries are resisting signing the instrument given its limited flexibility
as compared with the 1978 Act .  In this regard the view has been expressed that UPOV 1978 allows
farmers to save, exchange and, to a limited degree, sell seeds of protected varieties, whereas UPOV
1991 turns these actions into privileges and exceptions, giving the government discretion as towhether to permit farmers to save seeds for us e on their own holdings and making it subject to
"reasonable restrictions" and the protection of the "legitimate interests" of the breeder.  Further, the
exception only applies to saved material that has been harvested on the same holdings.
142  Since the
food security of local communities in most developing countries depends largely on their saving,
sharing and replanting seeds from the previous harvest, the possibility of having to pay fees forengaging in such activities, as is permitted under UPOV 1991, would negatively affect small rural
producers and result in social imbalances.
143  Further, UPOV 1991 limits exhaustion of the right to
sell or otherwise market plant varieties made within the national territory of the contracting party
concerned, which might disturb the negotiated balance struck by Article 6 of the TRIPS Agreement.144
The view has been expressed that, from the perspective of developing country Members, the 1978UPOV Act remains a useful reference for discussions, even if that instrument is no longer open for
membership.
145  Legislation based upon UPOV 1978 should be regarded as providing effective
protection for plant variety rights for the purposes of Article 27.3(b).146
                                                     
136 Switzerland, IP/C/M/25 para. 82.
137 Switzerland, IP/C/M/30 para. 166; United States, IP/C/W/162.
138 EC, IP/C/M/25 para. 74; Switzerland, IP/C/M/24 para. 79; United States, IP/C/M/25 para. 71, IP/C/W/162.
139 EC, IP/C/M/25 para. 74; United States, IP/C/M/25 para. 71, IP/C/W/162.
140 Switzerland, IP/C/M/24 para. 79; United States, IP/C/M/24 para. 76.
141 Switzerland, IP/C/M/24 para. 79.
142 Kenya, IP/C/M/28 para. 145.
143 Brazil, IP/C/W/228.
144 Brazil, IP/C/W/228.
145 Brazil, IP/C/M/26 para. 60.
146 Mexico, IP/C/M/25 para. 90.IP/C/W/369
Page 16
D. RELATIONSHIP BETWEEN  SUI GENERIS PROTECTION OF PLANT VARIETIES AND TRADITIONAL
KNOWLEDGE AND FARMERS ' RIGHTS
54. The view has been expressed that laws and measures on the protection of plant varieties
directly affect traditional knowledge and farmers' rights.147  In this respect, it has been noted that
staple or medicinal plants would not qualify for protection under UPOV given their long-standingexistence, thus not protecting the traditional knowledge relating to their use.
148  The point has been
made that such traditional knowledge has b een recognized under a number of international
instruments, such as the CBD, the FAO Interna tional Undertaking on Plant Genetic Resources, and
the OAU model law.149  The view has been expressed that systems for the protection of plant varieties
may support or harm such rights, depending on whether or not the laws and measures strike a balance
between the various key interests and whether or not  farmers' rights and traditional knowledge are
duly recognized and provided for.150  It has been suggested that the flexibility provided in Article
27.3(b) should therefore be retained and construed consistently with the aforementioned
instruments.151  More particularly, the view has been expressed that the protection of plant varieties
should recognize the contribution of farming and indigenous communities to genetic resource
conservation and enhancement,152 should be equitable and should ensure biodiversity.153
55. In response, the view has been expressed that, although the TRIPS Agreement does not
specifically determine the subject matter to be protected by the sui generis  system of protection and
does not define the term "plant variety," the results of commercial plant breeding are likely to be the
primary subject matter to be protected by a sui generis  system, taking into consideration the overall
objectives of the TRIPS Agreement.154  Reference has been made in this respect to the definition of
the term "plant variety" contained in Article 1(vi) of the 1991 Act of the UPOV Convention.155
Nevertheless, it has been stated, the TRIPS Agreement does not preclude Members from
implementing a sui generis  system of protection for farmers' varieties or so-called "landraces," which
generally have characteristics that differ from commercial plant varieties and might, therefore, require
their own system of protection.156  Thus Members are free to protect farmers' rights as defined in
Article 15.2 of the draft for a revised International Undertaking on Plant Genetic Resources for Foodand Agriculture.
157  However, farmers' rights as currently defined in the International Undertaking
cover plant genetic resources and not plant varieties.  Furthermore, the definition of farmers' rights is
not specific enough to be "an effective sui generis  system" as required by Article 27.3(b) of the
TRIPS Agreement.  Therefore, the view has been expressed that national legislation would have to
further define farmers' rights in order to satisfy the requirement of "an effective sui generis  system"
under Article 27.3(b).158  It has been said that the provisions of the International Undertaking and the
CBD, on the one hand, and the TRIPS provisions regarding sui generis  protection of plant varieties
can and should be implemented in a mutually supportive way.159  The view has also been expressed
                                                     
147 Mauritius on behalf of the African Group, IP/C/W/206.
148 Kenya, IP/C/M/28 para. 145.
149 Kenya, IP/C/M/28 para. 145; Mauritius on behalf of the African Group, IP/C/W/206.
150 Mauritius on behalf of the African Group, IP/C/W/206.
151 Kenya, IP/C/M/28 para. 145; Mauritius on behalf of the African Group, IP/C/W/206;.
152 Zambia, IP/C/M/28 para. 147
153 Kenya, IP/C/M/28 para. 142.
154 Switzerland , IP/C/W/284.
155 Switzerland, IP/C/W/284.
156 Switzerland, IP/C/M/30 para. 166, IP/C/W/284.
157 Now the International Treaty on Plant Genetic Resources for Food and Agriculture (2001) adopted on 3
November 2001 in Rome. See www.fao.org/biodiversity/doc_en.asp.
158 Switzerland, IP/C/W/284.
159 Switzerland, IP/C/W/284.IP/C/W/369
Page 17
that farmers' rights are part of a much broader issue and are appropriately being dealt with in other
organisations, in particular the FAO.160
III. TRANSFER OF TECHNOLOGY
56. In the work of the Council for TRIPS, the issue of the implications of patent protection in
respect of life forms and sui generis  plant variety protection for access to, and transfer and
dissemination of, technology has been discussed.  This discussion has taken place in a number of
contexts, including in relation to developmental matters and the relationship between the TRIPS
Agreement and the objectives and provisions of the CBD concerning access to and the transfer of
technology.  It has been recalled that Article 7 of the TRIPS Agreement includes the transfer and
dissemination of technology as one of the basic objectives of the protection of intellectual property
rights and the need for measures to effectively operationalize this has been referred to.161
57. In the discussion, one view has been to put em phasis on the concern that intellectual property
rights in respect of life forms and genetic material could impede access to, and raise the cost of
technology in this area, by virtue of the exclusive rights given to right holders to prevent others from
using the protected technology.  It has been said that the issue of whether and how IPRs such as
patents and plant breeders' rights lead to the relocation of investment, transfer and dissemination of
technology and research and development in developing countries needs to be examined.162
58. In response, it has been said that full implementation of TRIPS provisions, including those in
Article 27.3(b) by developing countries, would build confidence among investors, both domestic and
foreign, stimulating investment in innovative and creative businesses in these countries.163  It has been
said that where technology is in the hands of the private sector, it can be transferred most effectively
through market mechanisms such as licensing and that for licensing agreements adequate intellectualproperty protection is an important premise.  Experience shows that the benefits to recipients and
users of technology exceed the cost of acquiring that technology and that they can in time themselves
become producers of follow-up technology.
164  The importance of the patent system for discouraging
secrecy and its disclosure requirements for facilitating the dissemination of technological and
scientific knowledge has already been referred to.165
59. Concern has been expressed that excessively broad patent rights in the area of biotechnology
may impede the use of micro-organisms and genetic material by others for research purposes.166  In
response, it has been said that the TRIPS Agreement leaves scope to WTO Members to provide for
exclusions from patent rights to allow use for research  purposes and that this is also the case for sui
generis plant variety protection, as made clear by the breeders' exception required under UPOV 1991.
The point has been made that this access to protected technology for research purposes should be
considered part of benefit-sharing, as was recogniz ed in the work underway in  the context of the FAO
International Undertaking on Plant Genetic Resources. 167
60. In regard to benefit-sharing, reference ha s been made to the requirements in the CBD
regarding the provision of access to and transfer of technology to developing countries, especially that
which makes use of genetic resources that they have provided.  This discussion is summarized in the
note on the relationship between the TRIPS Agreement and the CBD.
                                                     
160 EC, IP/C/M/35 para. 215.
161 Mauritius on behalf of the African Group, IP/C/W/206.
162 Mauritius on behalf of the African Group, IP/C/W/206.
163 United States, IP/C/W/257, IP/C/M/29, para. 184.
164 Japan, IP/C/W/236.
165 Switzerland, IP/C/W/284.
166 Brazil, IP/C/W/228.
167 European Communities, IP/C/W/254.IP/C/W/369
Page 18
IV. INFORMATION ON NATIONAL LEGISLATION, PRACTICES AND
EXPERIENCES
61. At its meeting in December 1998, the Council for TRIPS invited Members that were already
under an obligation to apply Article 27.3(b) to provide information on how the matters addressed in
this provision were treated in their national law.  Other Members were invited to provide suchinformation on a best endeavour basis.  A questionnaire was circulated by the Secretariat in document
IP/C/W/122 and an alternative questionnaire was circulated by Canada, the European Communities,
Japan and the United States in document IP/C/W/126.  Information has been provided by 37 Members
so far as set out in List C of the Annex.  These are Australia;  Bulgaria;  the Czech Republic;
European Communities and its Members states;  Estonia;  Hong Kong, China;  Hungary;  Iceland;
Japan;  Korea;  Morocco;  New Zealand;  Norway;  Poland;  Romania;  Slovak Republic;  Slovenia;
South Africa;  Switzerland;  Thailand;  United States;  and Zambia.  The information provided bythese countries, except for that provided by Estonia, Thailand and Hong Kong, China, has been
summarized by the Secretariat in the synoptic tables in document IP/C/W/273.  A revision of this
document reflecting the additional information provided will be circulated shortly.
62. At the last meeting of the Council, the Chairperson urged those Members that had not already
done so to provide such information by 1 June 2002.  It was noted that this could be done either byproviding responses to the illustrative list of que stions contained in Annex I of document IP/C/W/273
(originally circulated as document IP/C/W/122) or as responses to the questionnaire in document
IP/C/W/126 which some Members have used as a format for their responses, or by filling out the
boxes contained in the synoptic tables of information provided by Members prepared by the
Secretariat as contained in Annex II of document IP/C/W/273.
_______________IP/C/W/369
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ANNEX
DOCUMENTS OF THE TRIPS COUNCIL WITH RESPECT TO THE REVIEW OF THE
PROVISIONS OF ARTICLE 27.3(B), THE RELATIONSHIP BETWEEN TRIPS AND
THE CONVENTION ON BIOLOGICAL DIVERSITY AND THE PROTECTION
OF TRADITIONAL KNOWLEDGE AND FOLKLORE
The TRIPS Council held 15 formal meetings during the period January 1999 to March 2002.
The reports on these meetings (IP/C/M/21-35) reflect the work done so far in the TRIPS Council
pursuant to inter alia  the mandated review of the provisions of Article 27.3(b).  The substantive
discussions in the TRIPS Council on these issues have been recorded in the reports of the meetings
held from August 1999 to March 2002 (IP/C/M/24-35).
Other documents that have been made available include:
- Members' submissions relating to specific issues.  Over the period December 1998 to
October 2001, 22 papers have been submitted by Members or groups of Members
(List B).
- Information on national legislation, practices and experiences submitted by four
Members;  and the responses to the questionnaire on Article 27.3(b) from
23 Members (List C).
- Information provided on work in intergovernmental organizations (List D).
- Notes by the Secretariat on relevant issues under discussion in the TRIPS Council
(List  E).IP/C/W/369
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LIST A – Records of the work of the TRIPS Council
  IP/C/M/21-35 Minutes of the TRIPS Council Meetings 22 January 1999 –
22 March 2002
LIST B - Members' submissions relating to the agenda items
2001
 Australia   IP/C/W/310 Communication from Australia:  Review of
Article 27.3(b)   2 October 2001
 EC   IP/C/W/254 Review of the Provisions of Article 27.3(b) of the
TRIPS Agreement:  Communication from the
European Communities and their Member States   13 June 2001
 Norway   IP/C/W/293 Communica tion from Norway:  Review of
Article 27.3(b) of the TRIPS Agreement:  TheRelationship between the TRIPS Agreement and
the Convention on Biological Diversity   29 June 2001
 Switzerland   IP/C/W/284 Communication from Switzerland:  Review of
Article 27.3(b):  The View of Switzerland   15 June 2001
 United States   IP/C/W/257 Communication from the United States - Views of
the United States on the Relationship between the
Convention on Biological Diversity and the TRIPS
Agreement   13 June 2001
2000
 Brazil   IP/C/W/228 Review of Article 27.3(b) – Communication from
Brazil   24 November 2000
 India   IP/C/W/195 Communication from India    12 July 2000
 India   IP/C/W/196 Communication from India    12 July 2000
 India   JOB(00)/6091 Non-paper by India    5 October 2000
 Japan   IP/C/W/236 Review of the provisions of Article 27.3(b) -
Japan's view   11 December 2000
 Mauritius   IP/C/W/206 Communication from Mauritius on behalf of the
African Group   20 September 2000
 Singapore   JOB(00)/7853 Non-paper by Sing apore - Article 27.3(b)    11 December 2000
 United States   IP/C/W/209 Review of the Provisions of Article 27.3(b) -
Further Views of the United States –Communication from the United States   3 October 2000
1999
 Andean
 Group  IP/C/W/165 Review of the Provisions of Article 27.3(b) -
Proposal on the Intellectual Property RightsRelating to the Traditional Knowledge of Local
and Indigenous Communities – Communication
from Bolivia, Colombia, Ecuador, Nicaragua and
Peru   3 November 1999
 Canada, EC,
 Japan and
 USA  IP/C/W/126 Review of the Provisions of Article 27.3(b) -
Communication from Canada, the European
Communities, Japan and the United States   5 February 1999IP/C/W/369
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 Brazil   IP/C/W/164 Review of the Provisions of Article 27.3(b) -
Communication from Brazil   29 October 1999
 Cuba,
 Honduras,
 Paraguay and
 Venezuela  IP/C/W/166 Review of Implementation of the Agreement under
Article 71.1:  Proposal on the Intellectual Property
Rights of the Traditional Knowledge of Local and
Indigenous Communities   5 November 1999
 India   IP/C/W/161 Review of the Provisions of Article 27.3(b) -
Communication from India   3 November 1999
 Kenya   IP/C/W/163 Review of the Provisions of Article 27.3(b) –
Communication from Kenya on behalf of the
African Group   8 November 1999
 Norway   IP/C/W/167 Review of the Provisions of Article 27.3(b) -
Communication from Norway   3 November 1999
 United States   IP/C/W/162 Review of the Provisions of Article 27.3(b) –
Communication from the United States   29 October 1999
1998
 Mexico   Job No. 6957 Non-paper from Mexico:  Application of
Article 27.3(b)    8 December 1998
LIST C - Information on national legislation, practices and experiences
2002
 United States   IP/C/W/341 Technology transfer practices of the US
National Cancer Institute’s departmental
therapeutics programme – Communication
from the United States   25 March 2002
2001
Australia   IP/C/W/310 Communication from Australia:  Review of
Article 27.3(b)   2 October 2001
Czech 
RepublicIP/C/W/125/Add.8/Suppl.1 Review of the Provisions of Article 27.3(b) -
Information from Members - Supplement   18 September 2001
Estonia   IP/C/W/125/Add.20 Review of the Provisions of Article 27.3(b) -
Information from Members – Addendum   2 July 2001
Hong Kong,
China  IP/C/W/125/Add.22 Review of the Provisions of Article 27.3(b) -
Information from Members - Addendum   10 August 2001
Thailand   IP/C/W/125/Add.21 Review of the Provisions of Article 27.3(b) -
Information from Members - Addendum   10 July 2001
Peru   IP/C/W/246 Communication from Peru:  Peru's
Experience of the Protection of Traditional
Knowledge and Access to Genetic
Resources   14 March 2001
2000
Iceland   IP/C/W/125/Add.19 Review of th e Provisions of Article 27.3(b) -
Information from Members - Addendum   17 July 2000
India   IP/C/W/198 Protection of Biodiversity and Traditional
Knowledge – The Indian Experience   14 July 2000IP/C/W/369
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1999
Australia   IP/C/W/125/Add.13 Review of the Provisions of Article 27.3(b) -
Information from Members - Addendum   16 March 1999
Bulgaria - 
(Republic 
of)  IP/C/W/125 Review of the Provisions of Article 27.3(b) -
Information from Members   3 February 1999
Canada   IP/C/W/125/Add.12 Review of th e Provisions of Article 27.3(b) -
Information from Members - Addendum   12 March 1999
Czech 
Republic  IP/C/W/125/Add.8 Review of the Provisions of Article 27.3(b) -
Information from Members - Addendum   16 February 1999
  European
 Communities  IP/C/W/125/Add.4 Review of the Provisions of Article 27.3(b) -
Information from Members - Addendum   10 February 1999
Hungary   IP/C/W/125/Add.1 Re view of the Provisions of Article 27.3(b) -
Information from Members - Addendum   16 February 1999
Japan   IP/C/W/125/Add.7 Review of the Provisions of Article 27.3(b) -
Information from Members - Addendum   12 March 1999
Korea 
(Republic 
of)  IP/C/W/125/Add.9 Review of the Provisions of Article 27.3(b) -
Information from Members - Addendum   16 February 1999
Morocco   IP/C/W/125/Add.14 Review of the Provisions of Article 27.3(b) -
Information from Members - Addendum   20 April 1999
New 
Zealand  IP/C/W/125/Add.2 Review of the Provisions of Article 27.3(b) -
Information from Members - Addendum   12 February 1999
Norway   IP/C/W/125/Add.17 Re view of the Provisions of Article 27.3(b) -
Information from Members - Addendum   19 May 1999
Poland   IP/C/W/125/Add.11 Review of the Provisions of Article 27.3(b) -
Information from Members - Addendum   12 March 1999
Romania   IP/C/W/125/Add.6 Review of th e Provisions of Article 27.3(b) -
Information from Members - Addendum   16 February 1999
Slovak 
Republic  IP/C/W/125/Add.18 Review of the Provisions of Article 27.3(b) -
Information from Members - Addendum   27 July 1999
Slovenia   IP/C/W/125/Add.10 Review of the Provisions of Article 27.3(b) -
Information from Members - Addendum   16 February 199
 South 
AfricaIP/C/W/125/Add 16/Corr.1 Review of th e Provisions of Article 27.3(b) -
Information from Members - Corrigendum   25 May 1999
 South 
Africa  IP/C/W/125/Add.16 Review of the Provisions of Article 27.3(b) -
Information from Members - Addendum   21 April 1999
Switzerland   IP/C/W/125/A dd.15 Review of the Provisions of Article 27.3(b) -
Information from Members - Addendum   13 April 1999
United 
States  IP/C/W/125/Add.5 Review of the Provisions of Article 27.3(b) -
Information from Members - Addendum   20 April 1999
Zambia   IP/C/W/125/Add.3 Review of the Provisions of Article 27.3(b) -
Information from Members - Addendum   10 February 1999IP/C/W/369
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LIST D  - Information on the work of intergovernmental organizations
2002
UPOV   IP/C/W/347/Add.3 Review of th e Provisions of Article 27.3(b) -
Relationship between the TRIPS Agreement and
the Convention on Biological Diversity and
Protection of Traditional Knowledge and Folklore   7 June 2002
UNCTAD   IP/C/W/347/Add.2 Review of th e Provisions of Article 27.3(b) -
Relationship between the TRIPS Agreement and
the Convention on Biological Diversity and
Protection of Traditional Knowledge and Folklore   7 June 2002
CBD   IP/C/W/347/Add.1 Review of the Provisions of Article 27.3(b) -
Relationship between the TRIPS Agreement andthe Convention on Biological Diversity and
Protection of Traditional Knowledge and folklore   7 June 2002
FAO   IP/C/W/347 Review of the Provisions of Article 27.3(b) -
Relationship between the TRIPS Agreement and
the Convention on Biological Diversity and
Protection of Traditional Knowledge and Folklore   7 June 2002
2001
WIPO   IP/C/W/242 Statement by the World Intellectual Property
Organization (WIPO) on intellectual property,
biodiversity and traditional knowledge   6 February 2001
2000
UNCTAD   IP/C/W/230 Document prepared by the UNCTAD Secretariat
for the expert meeting on systems and national
experiences for protecting traditional knowledge,
innovations and practices which took place from30 October to 1 November 2000 in Geneva:
Outcome of the expert meeting   14 December 2000
International
Bureau of
WIPO  IP/C/W/218 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   18 October 2000
International
Bureau ofWIPO  IP/C/W/217 Document prepared by the International Bureau of
WIPO for the round table on Intellectual Propertyand traditional knowledge, which took place on
1 and 2 November 1999 in Geneva:  Protection of
Traditional Knowledge:  A Global Intellectual
Property Issue   18 October 2000
1999
CBD   IP/C/W/130/Add.1 Review of the Provisions of Article 27.3(b) –
Information from Intergovernmental Organizations
- Addendum   16 March 1999
FAO   IP/C/W/130/Add.2 Revi ew of the Provisions of Article 27.3(b) –
Information from Intergovernmental Organizations
- Addendum   12 April 1999
UPOV   IP/C/W/130 Review of the Provisions of Article 27.3(b) –
Information from Intergovernmental Organizations   17 February 1999IP/C/W/369
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LIST E – Notes by the Secretariat
2001
  Job No. 2689
  IP/C/W/273Review of the Provisions of Article 27.3(b):  Synoptic
Tables of Information provided by Members – Informal
Note by the Secretariat   5 June 2001
2000
  JOB(00)/7517 The Relationship between the Convention on Biological
Diversity and the TRIPS Agreement:  Checklist of Points
Made – Note by the Secretariat   23 November 2000
  Job No. 2627 UPOV-WIPO-WTO joint symposium on the protection of
plant varieties under Article 27.3(b) of the TRIPS
Agreement: Texts of presentations   7 May 1999
1998
  IP/C/W/122 Illustrative Questions:  Review of the Provisions of
Article 27.3(b)   22 December 1998
__________