WORLD TRADE  
ORGANIZATION  IP/C/W/368/Rev.1 
8 February 2006 
 
 (06-0534) 
Council for Trade-Related Aspects  
of Intellectual Property Rights   
 
  
THE RELATIONSHIP BETWEEN THE TRIPS AGREEMENT AND 
THE CONVENTION ON BIOLOGICAL DIVERSITY 
 
SUMMARY OF ISSUES RAISED AND POINTS MADE 
 
Note by the Secretariat
 
 
Revision  
 
     
 
TABLE OF CONTENTS        Page No. 
 
I.
 INTRODUCTION ................................................................................................................... .3 
II. GENERAL VIEWS ON THE RELATIONSHIP BETWEEN THE 
TRIPS AGREEMENT AND THE CBD .................................................................................3  
III. PATENTABILITY OF GENETIC MATERIALS AND THE CBD....................................9  
IV. THE TRIPS AGREEMENT AND PRIOR INFORMED CONSENT/BENEFIT 
SHARING........................................................................................................................ ........13  
A. NATIONAL -BASED APPROACH ...................................................................................................14  
1. Proponents' description of the national-based approach....................................................14  
(a) Prior informed consent and benefit sharing ..............................................................................14  
(b) Legal effects of non-compliance...............................................................................................1 5 
(c) Erroneously granted patents.................................................................................................... ..16 
(d) Claimed advantages of the national-based approach ................................................................16  
(e) Examples given of experiences with us e of the national-based approach ................................18  
2. Discussion of the national-based approach...........................................................................23  
(a) Transboundary use of genetic r esources and traditional knowledge ........................................23  
(b) Bargaining power of par ties to the contract ..............................................................................25  
(c) Transaction costs.............................................................................................................. .........26  
(d) Effectiveness of remedies proposed..........................................................................................27  This document has been prepa red under the Secretariat's own 
responsibility and without prejudice to the positions of Members 
and to their ri ghts and obli gations under the WTOIP/C/W/368/Rev.1 
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  B.
 DISCLOSURE APPROACH ............................................................................................................27  
1. Proponents' description of the disclosure approach............................................................28  
(a) Main features of the proposed disclosure requirements............................................................28  
(b) Claimed advantages of the disclosure approach .......................................................................34  
(c) Examples given of experience with use of the disclosure approach.........................................36  
2. Discussion of the disclosure approach...................................................................................40  
(a) Disclosure of origin and/or source of ge netic resources and tr aditional knowledge ................40  
(b) Disclosure of evidence of prior inform ed consent and benefit sharing ....................................44  
(c) Remedies for non-compliance with disclosure requirements, including patent 
revocation..................................................................................................................... .............47  
(d) Trigger for disclosure......................................................................................................... .......50  
(e) Use of terms:  biopiracy and misappropriati on, genetic material or genetic resources 
and traditional knowledge or knowledge , innovations and practices .......................................51  
(f) Relationship with the Patent Co-ope ration Treaty, Patent Law Treaty ....................................53  
(g) Relationship with the TRIPS Agreement..................................................................................53  
(h) Relationship with the CBD ...................................................................................................... .55 
(i) Implications for prior informed consent and benefit sharing....................................................56  
(j) Implications for preventing e rroneously granted patents..........................................................60  
(k) Implications for the patent system ............................................................................................6 1 
 
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..........................................................................68   IP/C/W/368/Rev.1 
 Page 3 
 
 
  I. INTRODUCTION 
1. At its meeting of 17-19 September 2002, the C ouncil for TRIPS requested the Secretariat to 
periodically update its summary notes on issues rais ed and points made in the Council's work on three 
items of its agenda:  namely the review of the pr ovisions of Article 27.3(b);  the relationship between 
the TRIPS Agreement and the Convention on Biological Diversity (CBD);  and the protection of 
traditional knowledge and folklore.  It was requested  that this be done not after every meeting, but 
when significant new material had been presented.  The present document, which replaces the earlier 
summary note in IP/C/W/368, responds to this re quest with respect to the relationship between the 
TRIPS Agreement and the CBD. 
2. This note, like the original note, seeks to su mmarize the relevant material presented to the 
TRIPS Council, whether in written or oral form, and lists all the relevant doc umentation tabled in the 
Council since 1999.  To avoid undue duplication, cr oss-references to the other two notes or to other 
sections of this note have been made in certain pl aces.  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 th e Committee on Trade and Environment and of the 
General Council, unless the relevant paper has also been circulated as a Council for TRIPS document. 
Nor does it cover the discussions in the Direct or-General's consultative process on outstanding 
implementation issues. 
3. The TRIPS Council documentation rele vant to its work on all the three issues is listed in the 
Annex to this note.  Specific documents are also re ferred to in the footnotes which reflect the sources 
for the points made in the compilation.  In many cases,  the same point has been made more than once;  
the footnotes do not purport to contain references to  all such occasions.  Where a group of delegations 
has made submissions, the footnotes use an abbrevia ted reference rather than listing the sponsoring 
delegations in full.  The full lists can  be found in the Annex to this note. 
4. 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 in terventions made and documents submitted.  It is 
structured around the issues raised rather than the positions of individual Members.  Therefore any 
reader wishing to appreciate fully the position of a particular Member should consult the statements 
made and any papers subm itted by that Member. 
5. This note is divided into three major sections .  The first concerns general views on the 
relationship between the TRIPS Agreement and the CBD, the second concerns patentability of genetic 
resources and the CBD, and the third concerns the TRIPS Agreement and prior informed consent/ 
benefit sharing. 
II. GENERAL VIEWS ON THE RELATIONSHIP BETWEEN THE 
TRIPS AGREEMENT AND THE CBD 
6. Two general issues concerning the overall rela tionship between the TRIPS Agreement and the 
CBD that have been raised in the discussion are: 
 - whether or not there is conflict be tween the TRIPS Agreement and the CBD; 
  - whether something needs to be done, at least on the TRIPS side, to ensure that the 
two instruments are applied in a non-conflicting and mutually supportive way, and if so, what. IP/C/W/368/Rev.1 
Page 4  
 
  7. With regard to these two questions, the view s expressed appear to fall into four broad 
categories: 
 - there is no conflict between the two Ag reements and governments can implement the 
two in a mutually supportive way through national measures; 
 
 - there is no conflict between the two Agreements and, while governments can 
implement the two in a mutually supportive way through national measures, further study is required to determine whether an y international action in relation to the 
patent system is called for; 
 
 - there is no inherent conflict between the two Agreements but there is a case for 
international action in relation to the patent system in order to ensure or enhance, in 
their implementation, the mutual suppor tiveness of both Agreements.  There are 
differences of view on the exact nature of  the international action needed, including 
on whether or not an amendment is needed to the TRIPS Agreement, to promote the 
objectives of the CBD as discussed in Section IV.B below; 
  - there is inherent conflict between the two instruments, and the TRIPS Agreement 
needs to be amended to remove such conflict. 
 8. With regard to the first category of views, th e following are the main reasons that have been 
put forward in support of the view that there is  no conflict between the TRIPS Agreement and the 
CBD and little or no likelihood of a conf lict in practical implementation: 
 - the TRIPS Agreement and the CBD have  different, non-conflicting objectives and 
purposes and deal with different subject-m atter and can and should be implemented 
in a mutually supportive manner at the national level
1; 
 
 - correctly applying the criteria for patentability will ensure the grant of valid patents 
over inventions that use genetic materia l;  such patents do not prevent compliance 
with the provisions of the CBD regarding the sovereign right of countries over their 
genetic resources, prior informed  consent and benefit sharing2;  and  
 
 - no specific examples of conflict have been cited.3 
 9. Pursuant to these views, it has been said that no change is required to the TRIPS Agreement 
to accommodate the implementation of the CBD and that implementation of each should be pursued 
in separate frameworks.
4  In fact, implementation of the TRI PS Agreement is supportive of measures 
that would implement the obligations of the CBD mo st effectively:  for example, patents can be 
instrumental in the sharing of benefits and the con servation of biological diversity based on voluntary 
                                                      
1 Australia, IP/C/W/310, IP/C/M/47, para. 55, IP/C/M/46, para. 62, IP/C/M/40, paras. 100-101, 
IP/C/M/38, para. 236, IP/C/M/36/Add.1, para. 222;  Canada, IP/C/M/47, para. 66, IP/C/M/40, para. 115, 
IP/C/M/37/Add.1, para. 232,  IP/C/M/36/Add.1, para. 229;  Japan, IP/C/W/236, IP/C/M/47, para. 69, IP/C/M/39, 
para. 137, IP/C/M/26, para. 77, IP/C/M/25, para. 93;  Ko rea, IP/C/M/46, paras. 52-53, IP/C/M/42, para. 104;  
United States, IP/C/W/434, IP/C/W/257, IP/C/W/209, IP/C /W/162, IP/C/M/43, para. 55, IP/C/M/42, para. 109. 
2 United States, IP/C/W/209, IP/C/W/162, IP/C/M/46, para. 24, IP/C/M/25, para. 71. 
3 United States, IP/C/W/209, IP/C/W/162, IP/C/M/29, para. 181. 
4 Australia, IP/C/W/310, IP/C/M/46, para. 62, IP/C/M/42, para. 118, IP/C/M/40, para. 100, 
IP/C/M/36/Add.1, para. 222;  Japan, IP/C/W/236;  Korea , IP/C/M/28, para. 164;  Singapore, JOB(00)/7853, 
IP/C/M/49, para. 147, IP/C/M/29, para. 168;  Switzerland, IP/C/W/400/Rev.1, IP/C/M/43, para. 59;  United States, IP/C/W/434, IP/C/W/257, IP/C/M/47, pa ra. 42, IP/C/M/46, para. 23, IP/C/M/45, para. 44, 
IP/C/M/43, para. 55, IP/C/M/40, para. 122, IP/C/M/30, para. 154.  IP/C/W/368/Rev.1 
 Page 5 
 
 
  contracts;  the requirements of the patent system material to patentability and inventorship can help 
prevent bad patents;  the control over production a nd distribution given to pa tent owners and their 
licensees can facilitate the sharing of technology;  an d the protection of undisclosed information could 
help the implementation of biosafety and benefit-sharing rules.5  Benefit sharing provisions of the 
CBD can also be implemented throug h governmental fund-granting activities6 and the financial 
mechanism provided for under Articles 20 and 21 of the CBD.7 
10. The view has been expressed that Members a ppear to share several broad policy objectives, 
including those of ensuring authorized access to ge netic resources, achieving equitable sharing of 
benefits arising from the use of traditional knowle dge and genetic resources and preventing the grant 
of erroneously issued patents, and that the most effective means to achieve these objectives is through 
tailored national solutions, including contracts, to meet practical concerns and actual needs.8 
11. In support of the second category of views, that there is no conflict between the two 
Agreements and that further study is necessary to  determine whether any international action in 
relation to the patent system is called for, it has been said that: 
 - no conflict between the TRIPS Agreement and the CBD has been demonstrated nor 
has it been shown that there is any crisis in the existing patent system9;   
  - there is very little concrete evidence at th is stage that national systems for regulating 
access to genetic resources and benefit sharing are per se  insufficient to deal with 
so-called misappropriation of such resources.  More analysis and sharing of national 
experiences is necessary in order for Memb ers to better understand the implications 
of some of the legal and theoretical con cepts before any action is taken at the 
international level to ensure that th e two Agreements are mutually supportive
10; 
  - there are other options, short of amending the TRIPS Agreement, that could be used 
to address the problem and which requi re the strengthening of legal and 
administrative regimes outside the field of intellectual property.  These options 
include information sharing between patent offices or mechanisms to improve disclosure of relevant information, such as establishment of databases
11;   
  - the importance of both the prevention of  biopiracy and misapp ropriation of genetic 
resources and traditional knowledge, as well as the promotion of a balanced patent 
system that benefits patent  applicants and the public in terest should be recognized.
12   
 12. The proponents of the first two categories of views have sugg ested that discussion in the 
TRIPS Council should be fact-based, review past  national experiences and situations that have 
                                                     
 
5 United States, IP/C/W/434, IP/C/W/257, IP/C/M/30, para. 154. 
6 Japan, IP/C/W/236. 
7 United States, IP/C/W/257. 
8 Australia, IP/C/M/46, para. 62;  United States, IP/C/W/434, IP/C/W/257, IP/C/W/209, IP/C/M/46, 
paras. 30-32, IP/C/M/43, para. 55,  IP/C/M/42, para. 109, IP/C/M/40, paras. 122 and 124, IP/C/M/39, 
paras. 129-130, IP/C/M/38, para. 234, IP/C/M/37/Add.1,  paras. 234-235 and 250, IP/C/M/36/Add.1, para. 231.  
9 Australia, IP/C/M/48, paras. 84 and 86, IP/C/M/46, para. 65, IP/C/M/40, para. 101;  Canada, 
IP/C/M/47, para. 66, IP/C/M46, para. 55, IP/C/M/40, para . 115;  New Zealand, IP/C/M/47, para. 54, IP/C/M/46, 
para. 61. 
10 Australia, IP/C/M/46, para. 65, IP/C/M/40, para. 101;  Canada, IP/C/M/47, para. 66, IP/C/M46, 
para. 55, IP/C/M/40, para. 115;  New Zealand, IP/C/M/47, para. 54, IP/C/M/46, para. 61. 
11 Australia, IP/C/M/40, para.101;  Canada, IP/C/M/40, para. 115. 
12 Canada, IP/C/M/48, para. 69. IP/C/W/368/Rev.1 
Page 6  
 
  prompted various concerns
13 and consider how each proposed approach could have been used to 
provide appropriate solutions.14  For example, it may be helpfu l for those Members with access and 
benefit-sharing systems currently in place to iden tify the perceived problems, in particular with 
respect to monitoring and enforcement under such sy stems, in order to have a fact-based discussion in 
the WTO.15  There have been questions raised by so me who, while welcoming the discussion on the 
proposals made in terms of the supporting role that intellectual property systems could play in 
achieving the objectives of the CBD, have sought more clarity.16 
13. In support of the third category of views, it has been said that, while there may be no inherent 
conflict between the two Agreements, there is a case for enhanced international action in relation to 
the patent system to ensure or enhance, in th eir implementation, the mutual supportiveness of both 
Agreements and avoid potential conflic t in their application in practice.17 
14. It has been suggested by those who take this vi ew that some international action is needed to 
require patent applicants to disclose the source and/ or country of origin of any biological resources or 
traditional knowledge used in inventions.  Three proposals have been discussed in this regard: 
 
 
     
                                                     
 
13 Switzerland, IP/C/M/47, para. 75. 
14 Australia, IP/C/M/46, para. 65;  Canada, IP/C/M/46, para. 55;  Japan, IP/C/M/46, para. 77;  
New Zealand, IP/C/M/47, para. 54, IP/C/M/46, para. 61;  Singapore, IP/C/M/49, para. 147;  United States, 
IP/C/W/434, IP/C/M/48, para. 34, IP/C/M/47, para. 48, IP/C/M/46, para. 36. 
15 United States, IP/C/M/48, para. 34. 
16 Chinese Taipei, IP/C/M/46, para. 71;  Hong Kong, China, IP/C/M/46, para. 88;  Malaysia, 
IP/C/M/45, para. 37, IP/C/M/44, paras. 40-41, IP/C/M/3 9, para. 138;  New Zealand, IP/C/M/49, para. 119, 
IP/C/M/47, para. 52, IP/C/M/46, para. 60, IP/C/M/44, para. 45 . 
17 Andean Community, IP/C/M/37/Add.1, para. 231;  Brazil, IP/C/W/228, IP/C/M/48, para. 35, 
IP/C/M/32, para. 128, IP/C/M/29, paras. 146, 148 and 234, IP/C/M/28, para. 135, IP/C/M/27, para. 122;  Brazil 
et al, IP/C/W/429/Rev.1, IP/C/W/356, para. 10;  China, IP/C/M/47, para. 57, IP/C/M/42, para. 119, IP/C/M/39, 
para. 132, IP/C/M/38, para. 239, IP/C/M/37/Add.1, para. 229, IP/C/M/36/Add.1, paras. 227-228;  Colombia, IP/C/M/46, para. 57, IP/C/M/36/Add.1, para. 209;  Ecuador, IP/C/M/47, para. 49, IP/C/M/25, para. 87; EC, 
IP/C/W/383, IP/C/W/254, IP/C/M/48, para. 62, IP/C/M/39,  para. 127, IP/C/M/37/Add.1, para. 226, IP/C/M/35, 
para. 233;  Egypt, IP/C/M/37/Add.1, paras. 203-204, IP/C/M/36/Add.1, para. 215;  India, IP/C/W/198, IP/C/W/195, IP/C/M/48, para. 53, IP/C/M/38, para. 23 2, IP/C/M/36/Add.1, para. 212, IP/C/M/30, para. 169, 
IP/C/M/24, para. 81;  Indonesia, IP/C/M/47, para. 51, IP/C/M/36/Add.1, para. 217, IP/C/M/32, para. 135;  
Kenya, IP/C/M/47, para. 68, IP/C/M/36/Add.1, para. 233, IP/C/M/28, para. 144;  Norway, IP/C/W/293, IP/C/M/38, paras. 241-242, IP/C/M/32, para. 125;  Pakistan, IP/C/M/36/Add.1, para. 211;  Peru, IP/C/M/48, 
paras. 92-93, IP/C/M/36/Add.1, para . 203;  Philippines, IP/C/M/47, paras.  79-80;  Switzerland, IP/C/W/433, 
IP/C/W/423, IP/C/W/400/Rev.1, IP/C/M/48, para.16;  Thailand, IP/C/M/48, para. 61, IP/C/M/42, para. 105, 
IP/C/M/25, para. 78;  Turkey, IP/C/M/47, para. 63, IP/C/M/27, para. 132;  Venezuela, IP/C/M/40, para. 102, 
IP/C/M/36/Add.1, para. 208, IP/C/M/32, para. 136, IP/C/M/28, para. 165.  IP/C/W/368/Rev.1 
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  - that the TRIPS Agreement should be amende d to incorporate certain requirements of 
the CBD.  In particular, a suggestion has been  made that patent applicants should be 
required to disclose the source and country of origin of any biological resources or traditional knowledge used in inventions, a nd to demonstrate that they had obtained 
prior informed consent from the competent authority in the country of origin and 
entered into fair and equitabl e benefit-sharing arrangements
18 or that they followed 
national legal requirements19; 
- that the Regulations of the PCT of WIPO s hould be amended so as to explicitly enable 
countries to require patent applicants to disclose the source of genetic resources and traditional knowledge, if the inventions are directly based on these resources or this 
knowledge;  the proposals would also grant applicants the possibility of satisfying this 
requirement at the time of filing an internati onal patent application, or later during the 
international phase.  This declaration of s ource would be included in the publication of 
the international patent application in orde r to render it accessible to the public at the 
earliest stage possible
20; 
- that a mandatory disclosure requirement shoul d be established relating only to origin or 
source of genetic materials for all patent applicants at the national, regional and 
international levels, with penalties for non-compliance outside the patent system.21  
Work on these ideas should be pursued in WIPO, CBD and FAO and, where and when 
relevant, in the TRIPS context to ensure po licy coherence in all forums dealing with 
issues relevant to the interplay between TRIPS and CBD in order to facilitate an 
integrated approach across institutions.22 
15. In respect of the fourth category of views, two main reasons have been put forward to support 
the view that there is an inherent conf lict between the TRIPS Agreement and the CBD: 
- the TRIPS Agreement, by requiring that cer tain genetic material  be patentable or 
protected by sui generis  plant variety rights and by not preventing the patenting of other 
genetic material, provides for the appropria tion of such genetic resources by private 
                                                      
18 Andean Community, IP/C/M/37/Add.1, para. 231;  Brazil et al, IP/C/W/429/Rev.1, IP/C/W/403, 
IP/C/W/356;  Brazil, IP/C/W/228, IP/C/M/49, para. 154, IP/C/M/46, para. 81, IP/C/M/42, para. 101, IP/C/M/39, 
para. 126, IP/C/M/38, para. 230, IP/C/M/37/Add.1, para. 237, IP/C/M/36/Add.1, para. 219, IP/C/M/33, 
para. 121, IP/C/M/32, para. 128, IP/C/M/29, paras. 14 6, 148, IP/C/M/28, para. 135, IP/C/M/27, para. 122;  
China, IP/C/M/47, para. 57, IP/C/M/37/Add.1, para. 229, IP/C/M/36/Add.1, paras. 227-228;  Colombia, IP/C/M/46, para. 57, IP/C/M/42, para. 119, IP/C/M/40, pa ra. 121, IP/C/M/38 para. 239;  Ecuador, IP/C/M/47, 
para. 49, IP/C/M/25, para. 87;  India, IP/C/W/198, IP/C/W/195, IP/C/M/49, paras. 86-90 and 134-146, 
IP/C/M/45, para. 25, IP/C/M/42, para. 113, IP/C/M/40, paras. 81-82; IP/C/M/36/Add.1, paras. 212 and 214,  IP/C/M/30, para. 169, IP/C/M/24, para. 81;  Indonesia, IP/C/M/49, para. 159, IP/C/M/47, para. 51, 
IP/C/M/36/Add.1, para. 217;  Kenya, IP/C/M/47, pa ra. 68, IP/C/M/46, para. 67, IP/C/M/42, para. 114, 
IP/C/M/40, para. 107, IP/C/M/37/Add.1, para. 239, IP/C/M/36/Add.1, para. 233, IP/C/M/28, para. 144;  Pakistan, IP/C/M/36/Add.1, para. 211;  Peru, IP/C/M/40, para. 84, IP/C/M/36/Add.1, para. 203;  Philippines, 
IP/C/M/47, paras. 79-80;  Thailand, IP/C/M/42, para. 105, IP/C/M/25, para. 78;  Turkey, IP/C/M/47, para. 63, 
IP/C/M/27, para. 132;  Venezuela, IP/C/M/40, para. 102, IP/C/M/36/Add.1, para. 208, IP/C/M/32, para. 136, IP/C/M/28, para. 165. 
19 African Group, IP/C/W/404, IP/C/W/206, IP/C/W/163, IP/C/M/40, paras. 76-79. 
20 Switzerland, IP/C/W/433, IP/C/W/423, IP/C/W/4 00/Rev.1, IP/C/M/49, para. 115, IP/C/M/46, 
para. 22, IP/C/M/45, paras. 47-48,  IP/C/M/44, para. 25, IP/C/M/42, paras. 97 and 99, IP/C/M/40 para. 71. 
21 EC IP/C/W/383, IP/C/M/49, paras. 123-124, IP/C/M/46, paras. 43-49;  Norway, IP/C/W/293, 
IP/C/M/47, paras. 64-65. 
22 EC, IP/C/W/383, IP/C/W/254, IP/C/M/35, para. 234, IP/C/M/30, paras. 144 and 146;  Norway, 
IP/C/W/293, IP/C/M/47, para. 65, IP/C/M/32, para. 125. IP/C/W/368/Rev.1 
Page 8  
 
  parties in a way that is inconsistent with  the sovereign rights of countries over their 
genetic resources as provided for in the CBD
23; 
 - the TRIPS Agreement provides for the pa tenting or other intellectual property 
protection of genetic material without ensuring that the provisions of the CBD, 
including those relating to prior informed consent and benefit sharing, are respected.
24 
Similar points have been made about the rela tionship between the TRIPS Agreement and the 
provisions of the CBD relating to the traditi onal knowledge of indigenous peoples and local 
communities. 
16. It has been suggested by those who hold the fourth category of views that Article 27.3(b) of 
the TRIPS Agreement be amended so as to oblige all Members to make life forms and parts thereof 
non-patentable.25  If this were not possible, at least patent s for those inventions based on traditional or 
indigenous knowledge and essentia lly derived products and pro cesses should be excluded and the 
TRIPS Agreement should be amended so that patents inconsistent w ith Article 15 of the CBD are not 
granted.26  With respect to the protection of plant vari eties, it has been proposed that a balance be 
struck between the interests of the community as a whole and protecting farmer s' rights and traditional 
knowledge and ensuring the preservation of biological diversity.27  (These views have been contested 
by others.  See Section III of this note and the summary of discussion on these issues in IP/C/W/369/Rev.1 and IP/C/W/370/Rev.1).  The proponents of this view have supported the 
disclosure proposal outlined in the first indent of paragraph 14 above. 
17. On the issue of which is the appropriate foru m to discuss this issue, it has been said that, 
while the mandate given at Doha to the WT O is recognized, WIPO, in particular the 
Intergovernmental Committee on Genetic Resources, Traditional Knowledge and Folklore (IGC) or 
the Working Group on PCT reform
28, provides the more appropriate forum since it has more technical 
expertise on these issues, and duplica tion of work should be avoided.29  In response it has been said 
that, given the mandate in paragraph 19 of the Doha Ministerial Declaration, particularly with regard 
to fully taking into account the development dimens ion, it is the TRIPS Council that provides a fully 
appropriate forum to examine this issue further a lthough the work in other relevant international 
                                                      
23 African Group, IP/C/W/404, IP/C/W/206, IP/C/W/163 , IP/C/M/40, paras. 76-79;  Kenya, IP/C/M/47 
para. 68, IP/C/M/36/Add.1, para. 233, IP/C/M/28, para. 144. 
24 African Group, IP/C/W/404, IP/C/W/206, IP/C/W/163;  Brazil, IP/C/W/228, IP/C/M/48, para. 37,  
IP/C/M/29, paras. 146 and 148; IP/C/M/28, para. 135, IP/C/M/27, para. 122;  Brazil et al, IP/C/W/429/Rev.1, 
IP/C/W/356;  Colombia, IP/C/M/46, para. 57, IP/C/M/ 36/Add.1, para. 209;  Ecuador, IP/C/M/47, para. 49, 
IP/C/M/25, para. 87;  EC, IP/C/W/383, IP/C/W/254 , IP/C/M/48, para 63, IP/C/M/39, para. 127, 
IP/C/M/37/Add.1, para. 226, IP/C/M/35, para. 233;  India, IP/C/W/198, IP/C/W/195, IP/C/M/48, para.52, IP/C/M/36/Add.1, para. 212, IP/C/M/30, para. 169, IP/C/M/24, para. 81;  Indonesia, IP/C/M/47, para. 51, 
IP/C/M/36/Add.1, para. 217;  Peru, IP/C/W/447, IP/C/M /48, paras. 18-19;  Thailand, IP/C/M/48, para. 61, 
IP/C/M/25, para. 78;  Turkey, IP/C/M/47, para. 63, IP/C /M/27, para. 132;  Venezuela, IP/C/M/40, para. 102, 
IP/C/M/36/Add.1, para. 208, IP/C/M/32, para. 136, IP/C/M/28, para. 165. 
25 African Group, IP/C/W/404, IP/C/W/206, IP/C/W/163, IP/C/M/40, paras. 76 and 107, 
IP/C/M/36/Add.1, para. 233, IP/C/M/28, para. 144;  Bangladesh, IP/C/M/42, para. 103;  Zambia, IP/C/M/28, para. 147. 
26 India, IP/C/W/196, IP/C/M/37/Add.1, para. 224, IP/C/M/25, para. 70. 
27 African Group, IP/C/W/404. 
28 Switzerland, IP/C/W/400/Rev.1, IP/C/M/47, para. 75, IP/C/M/46, para. 76, IP/C/M/44, para. 26, 
IP/C/M/42, para. 99, IP/C/M/40, para. 73. 
29Australia, IP/C/M/46, para. 64, IP/C/M/39, para. 140;  Canada, IP/C/M/47, para. 67, IP/C/M/46, 
para. 54, IP/C/M/42, para. 116, IP/C/M/40, para. 116, IP/C/M/36/Add.1, para. 229;  EC, IP/C/W/383, 
IP/C/W/254, IP/C/M/44, para. 28, IP/C/M/43, para. 41, IP/C/M/37/Add.1, para. 242, IP/C/M/35, paras. 238-239;  
Japan, IP/C/M/48, para. 64, IP/C/M/45, para. 46, IP/C/M /43, para. 48, IP/C/M/40, para. 96, IP/C/M/37, para. 
216, IP/C/M/36/Add.1, para. 226;  Korea, IP/C/M/46, para. 52;  New Zealand, IP/C/M/46, para. 61;  
United States, IP/C/M/40, para. 123, IP/C/M/35, paras. 241-242.  IP/C/W/368/Rev.1 
 Page 9 
 
 
  organizations should be taken into account.30  The view has also been expressed that solutions to the 
concerns raised about the TRIPS Agreement shoul d be found in the WTO, and "forum shopping" 
should be avoided.31  This discussion is set out more fully in the Secretariat's revised summary note 
on the protection of traditional knowledge and folklore (IP/C/W/370/Rev.1). 
18. The issue of what can be learnt about the re lationship between the TRIPS Agreement and the 
CBD from the way in which the CBD refers to intellectual property matters and other international 
agreements has also been discussed: 
 - one view is that Article 16.5 of the CBD itself acknowledges a conflict between the 
objectives of protecting intellectual property rights and those of the conservation of biological diversity when it states that "[ t]he Contracting Parties, recognizing that 
patents and other intellectual property rights may have an influence on the 
implementation of this Convention, shall coope rate 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"
32;  thus, patent rights are not to be enjoyed at 
the expense of violating the provisions of national-level regimes for implementing the 
objectives of the CBD.33  Indeed, the Bonn Guide lines on Access to Genetic 
Resources and Fair and Equitable Sharing of the Benefits Arising out of their Utilization (hereinafter the Bonn Guidelines) , which serve as inputs when developing 
and drafting legislative, administrative or policy measures on access and benefit sharing, urge contracting parties of th e CBD to take specific measures in this 
context
34; 
 
 - another view is that the mere fact that  the CBD refers to the possibility of conflict 
does not mean that one exists.  Moreover, the CBD itself recognizes, in Article 16.2, the need for adequate and effective protec tion of intellectual property rights.  This 
demonstrates that the two instruments are not in conflict.
35  Further, Article 22.1 of 
the CBD states that "provisions of this Convention shall not affect the rights and 
obligations of any Contracting Party de riving from any existing international 
agreement, except where the exercise of those rights and obligations would cause 
serious damage or threat to biological diversity".36  Indeed  rather than conflicting, the 
provisions of the TRIPS Agreement are s upportive of measures that would implement 
the obligations of the CBD most effectively.37 
 
III. PATENTABILITY OF GENETIC MATERIALS AND THE CBD 
19. As indicated in the previous Section, one view  that has been expressed about the relationship 
between the TRIPS Agreement and the CBD is that allowing patents to be granted in respect of 
                                                      
30 Brazil, IP/C/M/49, para.155, IP/C/M/42, para. 101, IP/C/M/36/Add.1, para. 199;  India, IP/C/M/49, 
para. 86, IP/C/M/47, para. 87, IP/C/M/43, para.67, IP/C /M/42, para. 113;  Pakistan, IP/C/M/42, para. 112;  
Venezuela, IP/C/M/44, para. 44, IP/C/M/36/Add.1, para. 208. 
31 Brazil, IP/C/M/47, paras. 32 and 86, IP/C/M/36/Add.1, para. 219;  Brazil et al, IP/C/W/443, 
IP/C/W/429;  Pakistan, IP/C/M/42, para. 112;  Peru, IP/C/M/47, para. 16. 
32 Brazil, IP/C/M/47, para. 84, IP/C/M/26, para. 62;  China, IP/C/M/36/Add.1, para. 227;  India, 
IP/C/M/48, para. 49.  
33 India, IP/C/M/37/Add.1, para. 224. 
34 Brazil et al, IP/C/W/356;  EC, IP/C/W/383. 
35 United States, IP/C/M/29, para. 193. 
36 United States, IP/C/W/434, IP/C/W/257, IP/C/M/30, para. 154. 
37 United States, IP/C/W/257. IP/C/W/368/Rev.1 
Page 10  
 
  genetic material is in itself inconsistent with  the CBD because they lim it access to such genetic 
material and can conflict with the sovereign rights of countries over their genetic resources.
38 
20. It has also been said that problems of consistency with the CBD can arise more particularly 
where Members do not follow closely enough the criteria for patentability laid down in the TRIPS Agreement, namely those of novelty, inventive step (or non-obviousness) and industrial applicability 
(or usefulness) and grant over-broad patents.
39 
21. In this regard, concern has been expressed about: 
 - the granting of patents covering genetic mate rial in its natural state.  A concern has 
been expressed that the TRIPS obligation to provide patent protection for micro-organisms could mean the patenting of  a range of genetic materials in their 
natural state
40,  particularly because some Members define inventions to include 
discovery of naturally occurring matter41; 
  - the granting of patents in respect of genetic material that has been merely isolated 
from nature and not otherwise modified.  In this connection, the view has been 
expressed that for a micro-organism to be patentable in a way that would avoid 
conflict with the CBD, it should have unde rgone some genetic modification at the 
hands of man
42; 
 
- the granting of erroneous patents on inventi ons based directly or indirectly on genetic 
resources or traditional knowledge that do not  qualify as being novel or inventive.  It 
has been said that the patent system, as currently operated, frequently gives rise to 
situations in which inventions pass the novelty or inventiveness tests when they 
should not do so.43   
22. Concern has also been expressed that the grant of overly broad patents could impede access to 
and use of genetic resources in a way which giv es rise to questions of compatibility with the CBD.44  
A related concern has been expressed about patent ri ghts over genetic resources that restrict research 
by third parties.45 
23. In response, it has been said that: 
 - the granting of patents on inventions which use genetic resources does not stand in 
the way of fulfilling the provisions of the CBD relating to the sovereign right of 
                                                      
38 African Group, IP/C/W/163;  Brazil et al, IP/C/W/356. 
 39 Brazil, IP/C/W/228;  Peru, IP/C/W/447. 
40 Kenya, IP/C/M/28, para. 141;  Peru, IP/C/M/29, para. 175. 
41 Kenya, IP/C/M/28, para. 141. 
42 Brazil, IP/C/W/228. 
43 Brazil, IP/C/W/228, IP/C/M/48, para. 37, IP/C/M/32, para. 128, IP/C/M/29, paras. 146 and 148, 
IP/C/M/28, para. 135, IP/C/M/27, para. 122;  Brazil et al, IP/C/W/429/Rev.1, IP/C/W/356;  Colombia, IP/C/M/46, para. 57, IP/C/M/36/Add.1, para. 209;  Ecuador, IP/C/M/47, para. 49, IP/C/M/25, para. 87;  India, 
IP/C/W/198, IP/C/W/195, IP/C/M/48, paras. 57-59, IP/C /M/30, para. 169, IP/C/M/24, para. 81;  Indonesia, 
IP/C/M/47, para. 51, IP/C/M/36/Add.1, para. 217;  Peru , IP/C/W/447;  Thailand, IP/C/M/25, para. 78; Turkey, 
IP/C/M/47, para. 63, IP/C/M/27, para. 132;  Venezuela, IP/C/M/40, para. 102, IP/C/M/32, para. 136, IP/C/M/28, 
para. 165. 
44 Brazil, IP/C/W/228, IP/C/M/29, para. 146;  India, IP/C/M/28, para. 126;  Singapore, 
IP/C/M/37/Add.1, para. 219. 
45 African Group, IP/C/W/206;  Kenya, IP/C/M/28, para. 141.  IP/C/W/368/Rev.1 
 Page 11 
 
 
  countries over access to genetic resources in their territories and prior informed 
consent as a condition of such access 46; 
  - holding a patent on isolated or modi fied genetic materials does not amount to 
ownership of the genetic materials them selves, nor does it provide property rights 
with regard to the source from which the orig inal material is obtained.  A patent on an 
isolated, identified and modified gene provides the patentee only with the ability to prevent others from producing, marketing a nd using the modified gene.  The source 
from which the gene is taken w ould be unaffected by the patent
47; 
 
 - life forms in their natural state would not satisfy the criteria for patentability in the 
TRIPS Agreement.  However, if the subject-m atter of a patent has involved sufficient 
human intervention, such as production by me ans of a technical process or isolation 
or purification, and if the isolated or purifie d subject is not of a previously recognized 
existence, then it is capable of constituting an invention48; 
 
- when the criteria for patentability are properl y applied, most concerns raised in this 
context would be avoided49, but occasions do arise where patents are granted for 
inventions that do not fully meet the tests for patentability set out in the TRIPS Agreement, notably because of inadequate  information available to the patent 
examiner.  While patent offices around the world do face significant workload 
burdens, the patent system, in fact, works quite well and erroneously granted patents 
are the rare exception rather than the rule
50; 
- implementation of post-grant opposition or re -examination proceedings could be used 
to rectify those rare cases when patents ar e issued erroneously.  These procedures are 
far less costly than litigation and could alert national patent authorities to new 
information that is relevant to the patentab ility of the invention.  A number of granted 
patents have been successfully challe nged when it was demonstrated, through 
opposition processes, that they should not ha ve been granted, including patents 
relevant to turmeric and neem in the Un ited States and European patent offices.  
Indeed, the perceived instances of misappropr iation often cited in the TRIPS Council 
as involving a wrongful determination of inve ntorship or prior art could have been 
satisfactorily addressed by existing procedures in the patent system51; 
- in order to prevent the grant of erroneous ly issued patents, requirements regarding 
information material to patentability a nd organized, searchable databases of the 
knowledge, innovations and prac tices of indigenous and local communities could be 
established to improve examination of patent  applications in order to ensure that 
inventions that are granted patents meet the criteria of patentability.52  P a t e n t  
examiners worldwide could use such data bases of genetic resources and traditional 
knowledge when examining patent applications .  This could aid in the discovery of 
                                                      
46 EC, IP/C/W/254, IP/C/M/30, para. 143;  United States, IP/C/M/40, para. 122. 
47 United States, IP/C/W/209, IP/C/W/162, IP/C/M/46, para. 24, IP/C/M/25, para. 71. 
48 EC, IP/C/W/254;  Japan, IP/C/W/236, IP/C/M/29, para. 151. 
49 Switzerland, IP/C/M/30, para. 164. 
50 United States, IP/C/W/449, IP/C/W/434, IP/C/M/46, para. 35, IP/C/M/32, para. 131. 
51 United States, IP/C/W/449, IP/C/W/434, IP/C/M/46, para. 35, IP/C/M/32, para. 131. 
52 EC, IP/C/W/383, IP/C/M/43, para. 39, IP/C/M/40, para. 94, IP/C/M/37/Add.1, para. 242, IP/C/M/32, 
para. 137;  India, IP/C/W/198, IP/C/M/37/Add.1, para 253;  Japan, IP/C/M/48, para. 76, IP/C/M/29, para. 157, 
IP/C/M/32, para. 142;  Switzerland, IP/C/W/400/Rev .1, IP/C/W/284, IP/C/M/42, para. 98, IP/C/M/30, 
para. 164;  United States, IP/C/W/449, IP/C/W/434, IP /C/W/257, IP/C/W/209, IP/C/M/48, para. 33, IP/C/M/46, 
para. 34. IP/C/W/368/Rev.1 
Page 12  
 
  relevant prior art and thereby improve exam ination of patent applications in the 
relevant fields
53; 
- databases would also create sources of in formation that could be used by potential 
licensees searching for knowledge, innovations an d practices that might relate to their 
field of work and could indicate contact points, qualifications for licensees, 
conditions for licensing, etc.  This woul d go toward meeting the second and third 
objectives of Article 8(j) of the CBD, i.e., to promote the wider application of the 
knowledge, innovations and practices of indigenous and local communities 
embodying traditional lifestyles relevant for the conservation and sustainable use of biological diversity with the approval a nd involvement of such communities, and 
would encourage the equitable sharing of the benefits arising from the utilization of 
such knowledge, innovations and practices.
54 
24. In response to this, it has been said that: 
- the basis for the "rare exception" claim fo r erroneously granted patents is not known 
but examining the numerous patent app lications and grants to check whether 
inappropriate patents are being applied for or granted and then taking action to revoke 
them is a burdensome and expensive pro cess, especially for developing countries55; 
- post-grant opposition or re -examination proceedings are costly and burdensome 
because holders of genetic resources or trad itional knowledge woul d have to initiate 
them in different jurisdictions.  Moreove r, these are curative mechanisms for the 
problem of the issue of bad patents, un like the suggested disclosure requirement 
which is a preventive step56; 
- although misappropriation of traditional know ledge through the grant of bad patents 
is a well-acknowledged problem, revocation of  these patents has been sought in only 
very few cases.  Challenges to patents granted could be sustained in the turmeric and neem cases owing to the engagement of  the government in the first case and a 
consortium of non-governmental organizations in the second case.
57 
25. With respect to databases, it h as been said in response that: 
- while these could play a key but compleme ntary role in facilitating the work of a 
patent examiner58, given the vast breadth and depth of such knowledge, the inherent 
limitation of such documentation is that it cannot be comprehensive of all traditional 
knowledge available in a country, particularly  where such knowledge is based on oral 
                                                      
53 Chinese Taipei, IP/C/M/43, para. 58;  EC, IP/C/M/ 37/Add.1, para 242;  United States, IP/C/W/434;  
Venezuela, IP/C/M/37/Add.1, paras. 243-244. 
54 United States, IP/C/W/257. 
55 Bolivia, IP/C/M/48, para. 83;  Brazil, IP/C/M/48, para. 37, IP/C/M/39, para. 126, IP/C/M/28, 
para. 135;  Brazil et al, IP/C/W/403, IP/C/W/356;  India, IP/C/M/48, para. 51, IP/C/M/28, para. 126;  Indonesia, IP/C/M/36/Add.1, para. 217;  Pakistan, IP/C/M/36/Add.1, para. 211, IP/C/M/28, para. 157;  Peru, IP/C/M/46, 
para. 51, IP/C/M/43, para. 44. 
56 Brazil et al, IP/C/W/459, IP/C/W/403;  Indonesia, IP/C/M/36/Add.1, para. 217;  Peru, IP/C/M/46, 
para. 51. 
57 India, IP/C/M/48, para. 60. 
58 African Group, IP/C/W/404;  Br azil, IP/C/W/228, IP/C/M/37/Add.1, para. 255;  Brazil et al, 
IP/C/W/403;  China, IP/C/M/36/Add.1, para. 228;  Venezuela, IP/C/M/37/Add.1, para. 243;  Zimbabwe, 
IP/C/M/36/Add.1, para. 201.  IP/C/W/368/Rev.1 
 Page 13 
 
 
  traditions or documented only in local languages.59  Databases are still incomplete 
and compilation is an ongoing process.  Such efforts would still not amount to an effective international regime, thus re quiring every Member individually and 
collectively to enforce international oblig ations to prohibit and take measures to 
prevent misappropriation
60; 
- based on experience so far, the use of data bases and sharing of information before the 
grant of patents has not been effective in combating cases of misappropriation of genetic resources or traditional kn owledge used in inventions.
61  In cases such as 
those relating to turmeric, neem tree, hodia and ayahuasca, absence of the relevant prior art has been used to justify improper determination of patentability
62; 
- reference to databases by patent examiners is voluntary and there is no guarantee that, 
in fact, patent examiners in different c ountries would consider this information in 
prior art searches63; 
- the appropriateness of use of databases can be questioned for reasons of high cost and 
loss of confidentiality of the traditional knowledge which is not in the public 
domain.64 
26. A suggestion has been made to establish ob ligations, guidelines or recommendations to 
improve and substantially tighten up the search system s in respect of information that is relevant to 
genetic resources and traditional kn owledge so as to evaluate novelty and inventiveness.  It has also 
been suggested that patent offices could be requi red to observe much stricter procedures when 
conducting searches for the assessment of novelty a nd inventiveness and that lack of candour in the 
provision of information could be sanctione d by non-application of the right granted.65 
27. See also the revised summary notes on the review of the provisions of Article 27.3(b) 
(IP/C/W/369/Rev.1) and on the protection of traditi onal knowledge and folklore (IP/C/W/370/Rev.1). 
IV. THE TRIPS AGREEMENT AND PRIOR INFORMED CONSENT/BENEFIT 
SHARING 
28. As indicated in Section II of this paper,  concern has been expressed that the TRIPS 
Agreement allows the granting of patents for inven tions that use genetic material without requiring 
that the provisions of the CBD in relation to prior informed consent and benefit sharing are respected.  
Two approaches, not necessarily mutually exclusive, have been taken by Members in addressing these 
and other concerns regarding the mutual supportiveness of the two Ag reements.  One approach is to 
use national solutions, including legislation on acces s and benefit sharing and contracts (hereinafter 
referred to as the "national-based approach");  the discussion on this is contained in sub-section A 
below.  The other approach is to advocate some ki nd of "disclosure" requirement on patent applicants 
as a supplementary measure to national legislation and contracts (hereinafter referred to as the 
"disclosure approach"), including in international fo rums other than the WTO;  the discussion on this 
is contained in sub-section B below.   
                                                      
59 African Group, IP/C/W/404;  Brazil, IP/C/M/48, para. 39;  Brazil and India, IP/C/W/443;  Brazil et 
al, IP/C/W/403;  India,  IP/C/M/39, para. 123, IP/C/M/37/Add. 1, para. 253. 
60 African Group, IP/C/W/404;  Peru, IP/C/M/48, para. 18. 
61 Peru, IP/C/M/46, para. 51. 
62 Brazil, IP/C/M/48, para. 39. 
63 African Group, IP/C/W/404;  India, IP/C/M/45, para. 20. 
64 Brazil, IP/C/M/37/Add.1, para. 225;  Brazil et  al, IP/C/W/403;  Venezuela, IP/C/M/37/Add.1, 
paras. 243-244. 
65 Peru, IP/C/W/447. IP/C/W/368/Rev.1 
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  A. 
NATIONAL -BASED APPROACH  
1. Proponents' description of the national-based approach 
29. The proponents of the national-based approach  have made suggestions for achieving what 
they consider to be the widely shared policy objectives of:  ensuri ng authorized access i.e., that prior 
informed consent is obtained;  achieving equitable sharing of benefits arising from the use of 
traditional knowledge and genetic resources;  and preventing th e issuance of erroneously granted 
patents.  They are of the view that the concerns  expressed on these matters could most efficiently be 
addressed through tailored national solutions outside th e intellectual property system that directly and 
effectively regulate the conduct in question.  In accordance with the CBD, countries could incorporate 
in their national legislation requirements for th e conclusion of contracts between the authorities 
competent to grant access to genetic resources and any related traditional kn owledge and those who 
wish to make use of such resources and knowledge.66  Indeed, national regimes could have many 
components, including the use of permits, contra ctual obligations, visa systems and civil and/or 
criminal penalties for non-compliance.67  With regard to concerns of  erroneously granted patents, 
solutions are available in the patent system itsel f such as the requirement to provide information 
material to patentability, post-grant opposition, re -examination and revocation proceedings as well as 
the establishment of databases of traditional knowle dge so as to strengthen the prior art resources 
available to patent examiners.68 
(a) Prior informed consent and benefit sharing 
30. With respect to the realization of the objectives in regard to prior informed consent and fair 
and equitable benefit sharing, it has been said that  the suggested national-based approach could have 
the following features: 
- contractual arrangements could be used to  establish the rights and obligations of the 
entities involved prior to any access to genetic resources;  this would ensure that prior informed consent is achieved
69; 
- countries could also establish permit systems that impose civil and/or criminal 
penalties for extracting genetic resources without a permit, where the permit would 
serve as evidence of prior informed consent70; 
- a contract-based system would provide a mechanism to transfer benefits as it could be 
used to effectively control the collecti on of resources and ensure the sharing of 
benefits from their use71; 
- contracts could include requirements on mandatory disclosure to appropriate 
authorities of any future commercial app lication utilizing the relevant traditional 
knowledge or genetic resource, whether or not  a patent is filed or granted over the 
relevant application 72; 
                                                      
66 EC, IP/C/W/383;  United States, IP/C/W/434, IP/C/W/257, IP/C/M/48, para. 26, IP/C/M/42, 
para. 109, IP/C/M/40, para. 122, IP/C/M/39, paras. 129- 131, IP/C/M/38, para. 234, IP/C/M/37/Add.1, para. 234, 
IP/C/M/36/Add.1, para. 231. 
67 United States, IP/C/M/42, para. 109, IP/C/M/39, para. 129, IP/C/M/38, para. 234. 
68 United States, IP/C/W/449, IP/C/W/434, IP/C/M/46, para. 35, IP/C/M/32, para. 131. 
69 United States, IP/C/W/434, IP/C/M/46, para. 31, IP/C/M/37/Add.1, para. 235. 
70 United States, IP/C/W/434. 
71 United States, IP/C/W/434, IP/C/M/46, para.31. 
72 United States, IP/C/W/434, IP/C/M/46, para.31, IP/C/M/37/Add.1, para. 235.  IP/C/W/368/Rev.1 
 Page 15 
 
 
  - points of contact, such as the governme nt and/or indigenous representatives 
authorized to provide access to materials, could be clearly delineated before a party seeks to use or collect traditional knowledge or genetic resources since a researcher or collector needs to know where to go, who to contact and which persons are 
authorized to grant approval in order to receive prior informed consent
73; 
- within the contract, a party could require the researcher or other party accessing the 
genetic resources and traditional knowledge to report regularly to the point of contact 
regarding progress of his research74; 
- a party to any access agreement could be obliged to notify the appropriate authorities 
in the event that an invention is develope d using genetic materials collected under the 
contract and to share the benefits that ar ise from the utilization of genetic resources 
for both commercial and non-commercial purposes75; 
- applicants could be required to disclose the relevant contract in any patent application 
filed that claims an invention that u ses genetic resources or traditional knowledge.76 
(b) Legal effects of non-compliance 
31. With regard to the legal effects of non-complia nce with contractual obligations or national 
measures, the view has been expressed that: 
- criminal and/or civil liability provisions  could be used to directly regulate and 
effectively enforce regimes for access and benefit sharing as is done in the case of 
other distinct regulatory systems.  Such provi sions could be part of civil and criminal 
codes specifically designed to enforce access and benefit-sharing laws77; 
- successful suits for breach of contract against those who fail to follow the terms of 
contracts entered into could result in court orders for specific performance or damages, including punitive damages
78; 
- choice of law provisions can also be specifi ed in contracts with third parties licensed 
to make use of genetic resources or trad itional knowledge, so that all parties are 
aware of the law that will apply should dis putes arise.  Contracts can be litigated in 
the specified jurisdiction and judgments enforced around the world under international agreements regard ing the recognition of judgments
79; 
- contracts could also be associated with Members' visa systems so that domestic law 
would be respected by foreign nationals seeking to collect such materials.80 
                                                      
73 United States, IP/C/W/434. 
74 United States, IP/C/W/434. 
75 United States, IP/C/W/434, IP/C/M/46, para. 31, IP/C/M/37/Add.1, para. 235. 
76 Japan, IP/C/M/29, para. 155;  Korea, IP/C/M/30, para. 171;  United States, IP/C/M/30, para. 177. 
77 United States, IP/C/W/434, IP/C/M/42, para. 109, IP/C/M/40, para. 122, IP/C/M/39, para. 130-131, 
IP/C/M/37/Add.1, para. 235. 
78 United States, IP/C/W/434, IP/C/M/42, para. 109, IP/C/M/40, para. 122, IP/C/M/39, paras. 130-131, 
IP/C/M/37/Add.1, para. 235. 
79 United States, IP/C/W/434, IP/C/W/257, IP/C/M/39, para. 130, IP/C/M/37/Add.1, para. 235.  
80 United States, IP/C/W/434, IP/C/M/39, para. 129, IP/C/M/38, para. 234. IP/C/W/368/Rev.1 
Page 16  
 
  (c) Erroneously granted patents 
32. With respect to concerns raised about err oneously granted patents, the view has been 
expressed that
81: 
- while there are valid concerns regarding erroneously granted patents, there are 
effective solutions to directly address th ese concerns such as post-grant opposition, 
re-examination and revocation proceedings as well as the establishment of databases 
of traditional knowledge so as to increase th e information on prior art available to 
patent examiners82; 
- Members could consider introducing in th eir patent legislation a requirement for 
patent applicants to disclose any information known by the applicant to be material to 
patentability, that is to say to determining prior art, to ascertaining inventorship and to 
preventing mistakenly granted patents.  For example, in the United States, the patent law requires inventorship for entitlement to a patent to be determined and 
determinations of inventorsh ip would be directly enhanced by such a requirement. 
(See further discussion in Section III above.) 
(d) Claimed advantages of the national-based approach 
33. Advantages of the national-based approach, other than those mentioned above, have been said 
to be that: 
- a contract system would provide the necessary flexibility to take account of 
differences in interests in the negotiations
83 and a balance between the value 
attributable to the genetic resources and that attributable to the efforts of the inventors 
and developers could be ensu red.  This would take into  account situations where the 
economic value of inventions resulting fro m the exploitation of the biological 
resource might be largely attributable to the inventive efforts of the inventor and the commercialization efforts of the patent owner and not so much to the biological resource as such.
84  Where genetic resources could be obtained from a number of 
sources, the party seeking access would be  likely to seek the resources from the 
territory that provides the most favourable terms85; 
- a system of access and benefit sharing based on contracts could be put in place 
immediately, based on existing contract la w, and therefore would not require waiting 
for the outcome of discussions in the TRIPS Council or other bodies86; 
- the system would provide for penalties against those few who might take genetic 
resources without entering into an access  agreement with the required party87; 
- the system could be appropriately tailor ed so as not to have unintended, negative 
consequences on the intellectual property system88; 
                                                      
81 United States, IP/C/W/434. 
82 Switzerland, IP/C/W/400/Rev.1. 
83 United States, IP/C/M/47, para. 44, IP/C/M/46, para. 31, IP/C/M/39, para. 130. 
84 Japan, IP/C/W/236, IP/C/M/29, para. 156;  United States, IP/C/W/257. 
85 Japan, IP/C/W/236, IP/C/M/29, para. 156;  United States, IP/C/W/257. 
86 United States, IP/C/M/37/Add.1, para. 234. 
87 United States, IP/C/W/434, IP/C/M/46, para. 31, IP/C/M/42, para. 109, IP/C/M/40, para. 122, 
IP/C/M/39, paras. 130-131, IP/C/M/37/Add.1, para. 235.  IP/C/W/368/Rev.1 
 Page 17 
 
 
  - contracts granting access could clarify the defi nition of terms that may not be so clear 
otherwise, such as the definition of the term "genetic resources", and this could clarify rights and obligations on both sides at the outset and help to avoid misunderstanding and confusion
89; 
 
- contracts could be used to effectively c ontrol the collection of resources and ensure 
the sharing of benefits from their use90; 
  - a contract-based system could be easily ad aptable to each country's legal system and 
could provide countries the flexibility to prot ect their traditional knowledge or genetic 
resources without the risks of undermining the economic development incentives of 
strong intellectual property protection and without the risk of undermining benefit 
sharing in the cases where the products based on genetic resources or traditional knowledge are not covered by patents
91; 
 
 - Article 19 of the CBD on the handling of biotechnology and the distribution of its 
benefits could also be implemented most  effectively through contractual means.92 
 34. In regard to why the national-b ased approach is the desirable wa y to achieve the objectives of 
prior informed consent and benefit sharing,  the following views have been expressed: 
- only contractual arrangements can establish the rights and obligations of the entities 
involved prior to any access to genetic res ources and can ensure that prior informed 
consent is achieved
93; 
- contracts could ensure the sharing of be nefits arising from the commercialization of 
the results of research and development based on materials to which access has been 
provided, whether or not these results are th e subject of a patent.  In other words, 
benefits could be shared whether or not  any invention has been developed that 
qualifies for patent protection and whether or not the commercial application results 
in a patent application being filed94; 
- contractual arrangements could provide for benefits in both monetary and non-
monetary form to be shared.  For inst ance, those seeking access to genetic resources 
for research and development could be requi red to share the benefits flowing from 
any patents that might be granted for i nventions developed from those genetic 
resources, including by prov iding access to the technology95; 
- the addition of a reporting requirement w ould keep the authorities informed of how 
the relevant traditional knowle dge or genetic resource is being used and would keep 
communication channels open.96 
                                                                                                                                                                     
88 United States, IP/C/W/434, IP/C/M/46, para. 31, IP/C/M/42, para. 109, IP/C/M/40, para. 122, 
IP/C/M/39, paras. 130-131, IP/C/M/37/Add.1, para. 235. 
89 United States, IP/C/W/257. 
90 United States, IP/C/W/434, IP/C/M/46, para. 31, IP/C/M/39, para 130. 
91 United States, IP/C/W/434, IP/C/M/46, para. 31. 
92 United States, IP/C/W/257. 
93 United States, IP/C/W/434, IP/C/M/46, para. 31, IP/C/M/37/Add.1, para. 235. 
94 United States, IP/C/W/434, IP/C/M/46, para. 31, IP/C/M/37/Add.1, para. 235. 
95 United States, IP/C/W/434, IP/C/M/48, para. 29, IP/C/M/40, para. 122. 
96 United States, IP/C/W/434. IP/C/W/368/Rev.1 
Page 18  
 
  (e) Examples given of experiences with use of the national-based approach 
35. To illustrate how its suggestions can be implemented, the United States submitted two 
documents: 
- one, describing the practices of the US National Cancer Institute's Departmental 
Therapeutics Programme (NCI-DTP), i.e. its drug discovery programme, in collecting 
genetic materials for screening for potential therapeutic uses related to cancer, as well 
as describing the policies of the US Na tional Institutes of Health-Office of 
Technology Transfer (NIH-OTT)
97;  and 
- another, describing the regime for access to genetic materials in US national parks.98 
This sub-section describes the main points made in these documents.  Further detail can be found in 
the documents themselves. 
36. According to the first document, the NCI-DTP,  as it investigates the potential of natural 
products in drug discovery and development, see ks to promote the conservation of biological 
diversity, and recognizes the need to collaborat e with source country organizations in the 
development of any drug from an organism collect ed within a source country's borders from source 
country organizations and peoples and, in the event of commercialization of an y drug so developed, to 
provide compensation or other benefits resulting from  that commercialization.  Most of the sample 
materials screened by NCI-DTP have  been obtained under Letters of  Collection (LOC) or Memoranda 
of Understanding (MOU) negotiated with  or involving the source countries.99 
37. The NCI-DTP screens synthetic compounds a nd natural product materials derived from 
plants, marine macro-organisms and microbes as pot ential sources of novel anti-cancer drugs.  Since 
1986, the Natural Products Branch of the NCI-DTP  has acquired 53,000 plant and 13,000 marine 
invertebrate samples, in addition to 3,000 marine plants and 25,000 fungal extracts from more than 30 
tropical or sub-tropical source countries or their s ource country organizations.  Aqueous and organic 
extracts (methylene chloride/methanol) of each of these materials have been prepared and are now 
available for high throughput screening in 1,650 micr otiter plate maps (88 extracts per plate).  In 
addition, taxonomy is available for each specim en.  The chief use for screening such a unique 
resource is to isolate, identify and characterize a lead compound whose activity can be further developed through combination with other com pounds or other synthesizing methodologies.  The 
extracts are available (under a Natural Products Re pository-Material Transfer Agreement, NPR/MTA) 
to other scientific laboratories for screening against all diseases. 
38. It was said that the NCI recognizes the value of the natural resources (plant, marine, 
microbial) being investigated and of the significant contributions made by source country 
organizations and indige nous peoples to the NCI programmes, and because of this it has established 
policies that facilitate collaboration with and compen sation of countries participating in the NCI drug 
discovery programme.  NCI-NPB complies with the principles of the Convention on Biological Diversity by providing in its negotia ted agreements that source countries share, in a fair and equitable 
way, in the results of research and development a nd in any benefits arising from commercial and other 
use of their genetic resources.  In addition, the agreements provide that source country people and 
                                                     
 
97 United States, IP/C/W/341. 
98 United States, IP/C/W/393. 
 99 Copies of the basic Natural Products Repository -Material Transfer Agr eement, the Letters of 
Collection, and the Memorandum of Understanding were included as annexes to IP/C/W/341.   IP/C/W/368/Rev.1 
 Page 19 
 
 
  organizations are to be compensated if a drug (whi ch originated from natura l materials or compounds 
submitted to the NCI) is commercialized by a potential licensee. 
39. Both the NCI and the NIH-OTT require licen sees to negotiate agreements with source 
countries or source country organizations that a ddress concerns of both parties, ensuring that, 
inter alia, pertinent agencies, institutions and/or pe rsons receive royalties and other forms of 
compensation, as appropriate.  The royalties payable to any source country depend upon the 
relationship of the marketed drug to the original l ead from the extract.  To increase the efficacy of 
source country compensation, generally the licensee is  expected to begin and complete negotiations 
with the source country or source country organizati on as soon as possible (typically within one year 
of signing the licensing agreement).  In no case, ho wever, may a licensee initiate negotiations later 
than the commencement of clinical trials, or complete negotiations later than the 
commercialization/sale of a drug.  To ensure th at potential licensees understand these obligations, the 
NIH-OTT, in disseminating licensing announcements in the US Federal Register concerning such 
natural product materials, includes the following language:  "Since [compound] was originally isolated 
from flora primarily located in [location], the NIH is concerned that the collection and utilization of 
the natural material comport with all applicable Fede ral and [location] policies related to biodiversity.  
In order to comport with such policies, the successful  applicant will also be required to negotiate and 
enter into agreements with the appropr iate [location] Government agencies". 
40. In instances in which additional supplies of a naturally occurring material or compound are 
required, they must be sought first in the original source country, if possible, in order to promote development of the agent within that source c ountry.  NCI-DTP also seeks to transfer knowledge, 
expertise, and technology related to drug di scoveries and development to source country 
organizations, subject to the provision of mutually acceptable guarantees for the protection of any patented technology.  NCI sponsors a programme wh ereby source country scientists are able to work 
as guest researchers at NCI or other mutually acceptable organizations for up to one year.  While in the past, NCI-DTP scientists had predominantly isol ated and characterized the biologically active 
extract constituents, under the MOU, qualified source country organizations are encouraged to isolate 
and characterize biologically-active constituents them selves and patent the active agents solely or 
jointly.  The NCI-DTP would collaborate with the source country organization through pre-clinical 
development of a drug.  Under a MOU, joint patent s may be sought on all inventions made by the 
source country organization and NCI working join tly with inventorship being determined in 
accordance with the relevant patent laws. 
41. For compounds determined to possess significa nt anti-cancer potential and, therefore, 
scheduled for clinical trials, the United States Government receives a royalty-free, irrevocable, 
non-exclusive licence to manufacture and/or use, by or for the United States Government, the invention(s) or process(es) claimed in any patent(s ) obtained, or that may be obtained by a source 
country organization on such compounds.  Such  licences are limited to compounds relying on 
NCI-DTP anti-cancer screening data, and are only fo r purposes of medical research related to or 
connected with cancer therapi es and not for commercial use. 
42. NCI has MOU agreements for direct collabora tion with the following entities:  Australia - 
Australian Institute of Marine Sciences, Townsville , Queensland;  Bangladesh  - the University of 
Dhaka;  Brazil - Fundacao Oswaldo Cruz – FIOCRUZ, Rio de Janeiro, South American Organization for Anti-cancer Drug Development, Porto Alegre, Univ ersidade do Paulista, Sao Paulo, Universidade 
Federal do Parana, Universidade Federal do Ceara, Forteleza;  China - Hong Kong University of 
Science and Technology, Kunming Institute of Bo tany, Yunnan, Peking University and State Key 
Laboratory, Beijing;  Costa Rica - Instituto Nacional de Biodiversidad (INBio);  Fiji - University of the South Pacific, Suva;  Iceland - the University  of Iceland, Reykjavik;  Korea - Korean Research 
Institute of Chemical Technology (KRICT);  Mexi co - Instituto de Quimica, Universidad Nacional 
Autonoma de Mexico, Mexico City;  New Zealand - National Institute of Water and Atmospheric IP/C/W/368/Rev.1 
Page 20  
 
  Research (NIWA), Wellington;  Nicaragua - Univer sidad Nacional Autonoma de Nicaragua, Leon;  
Pakistan - HEJ Research Institute of Chemistr y, University of Karachi;  Papua New Guinea - 
University of Papua New Guinea, Port Moresby;  Panama - University of Panama;  South Africa - 
Council for Scientific and Industrial Research (C SIR), Division of Food, Biological and Chemical 
Technologies (BIO/CHEMTEK), Pretoria, Rhodes Un iversity, Grahamstown;  and Zimbabwe - 
Zimbabwe National Traditional Healers Associatio n (ZINATHA).  In addition, negotiations for 
MOUs are currently in progress with the following organizations:  Brazil - Centro Pluridisciplinar 
Pesquisas Quimicas, Universidade do Campinas (UNICAMP);  Egypt - National Research Center, Cairo (under negotiation);  Jamaica - University of the West Indies;  and Ru ssia - Cancer Research 
Center, Russian Academy of Medical Sciences, Moscow. 
43. The NCI has LOC agreements for collaboration in the collection of plants and marine 
organisms with the following:  Bangladesh - Ba ngladesh National Herbarium, Dhaka;  Cambodia -
Forest and Wildlife Research Institute, Department of  Forestry and Wildlife, Phnom Penh;  Ecuador -
the AWA Peoples Federation;  Gabon - Centre Na tional de la Recherche Scientifique et 
Technologique (CENAREST), Libreville;  Ghana - Un iversity of Ghana, Legon;  Laos - Research 
Institute of Medicinal Plants, Ministry of Public  Health, Vientiane;  Madagascar - Centre national 
d'application des recherches pharmaceutiques, Anta nanarivo;  Papua New Guinea - University of 
Papua New Guinea, Port Moresby;  Philippines - Philippines National Museum, Manila;  Malaysia - 
State Government of Sarawak, State Department of Forests;  Tanzania - Traditional Medicine 
Research Institute, Muhumb ili University College of Health Sciences, University of Dar Es Salaam;  
and Viet Nam - Institute of Ecology and Biologi cal Resources, National Center for Natural Science 
and Technology, Hanoi. 
44. NCI collections have also been performed in a number of other countries, which have not, as 
yet, signed official LOC agreements.  NCI, howev er, is totally committed to the terms of the LOC 
irrespective of whether or not an official agreemen t has been signed.  These countries were:  Bahrain, 
Belize, Bolivia, Cameroon, Central African Re public, Colombia, Dominica, Dominican Republic, 
Federated States of Micronesia (Chuuk, Yap etc. ), Guatemala, Guyana, Honduras, Indonesia, 
Malaysia, Maldives, Marshall Islands , Martinique, Mauritius, Nepal, Palau, Paraguay, Peru, St. Lucia, 
Thailand, Tonga. 
45. With regard to the regime established for access to  genetic materials in US national parks, the 
second document submitted by the United States explains  that the collection of biological specimens 
for scientific research in US national parks is not ne w, since the first research permit in the national 
park system, which authorized collection of micr obial specimens from hot springs at Yellowstone 
National Park, was issued over a century ago.  Over the years, research permits have continued to be 
granted authorizing collection of specimens from the parks. 
46. In 1916, legislation was enacted creating the US  National Park Service to administer US 
national parks, in particular to "conserve the scener y and the national and hist oric objects and the wild 
life therein and to provide for the enjoyment of th e same in such manner and by such means as will 
leave them unimpaired for the enjoyment of future generations".  Over the years, research permits 
have continued to be granted authorizing collecti on of specimens from the parks.  The National Park 
Service's current regulations governing the collection of specimens for scientific research were put in 
place in 1983. 
47. In order to illustrate the public benefits of permitting access to genetic resources, the 
document describes a case study.  In 1966, Thomas Brock was studying micro-organisms living in 
Yellowstone's hot spring pools.  In the laboratory,  he named one of the curious organisms he had 
discovered Thermus aquaticus
 and submitted a living sample for safekeeping to the American Type 
Culture Collection, an organization that collects a nd maintains micro-organisms.  Two decades after 
Dr. Brock's academic work in Yellowstone, his di scoveries produced a practical application that he  IP/C/W/368/Rev.1 
 Page 21 
 
 
  had never imagined.  In 1985, a biotechnology company named Cetus Corporation was seeking to 
develop a new way to duplicate genetic material.  At the time, chromosomes were very difficult to 
study because they are made of genes and genes are composed of DNA, but DNA is too small to study effectively.  Dr. Kary Mullis, a Cetus scien tist, invented a useful method for DNA duplication, 
called Polymerase Chain Reaction (PCR), but, unfor tunately, the high temperatures required by PCR 
destroyed the polymerase enzymes, requiring laboratory technicians to add fresh enzymes throughout 
the PCR process, making that process tedious and resource intensive. 
48. Other scientists at Cetus added an enzyme, na med Taq polymerase, to the PCR, which was 
isolated from a sample of Thermus aquaticus  obtained from the American Type Culture Collection.  
Taq polymerase had the unusual ability to keep working even at high temperatures.  The scientists 
learned to reproduce the enzyme in the laboratory so  that it would not be necessary to use original 
samples.  The PCR using Taq polymerase was so effective that a whole new scientific field flourished as scientists finally had a convenient way to reproduce and study DNA.  The DNA copying process, 
made practical because of the study of a Yellowsto ne micro-organism, has now become a major part 
of DNA studies around the world.  Taq polymerase help ed permit the uses of DNA that are so familiar 
today – from matching DNA in criminal investigations, to medical diagnoses or cures, bioremediation 
of toxic wastes, and research into the basic building blocks of life. 
49. While the results of such research on material s collected from national parks flowed to the 
world, there was no provision for ensuring that benef its flowed back to the parks that supplied the 
original materials.  The National Parks Omnibus Management Act of 1998 expressly authorizes "negotiations with the research community and privat e industry for equitable, efficient benefit-sharing 
arrangements" in connection with research conduc ted in national parks.  The Act also mandates 
increased scientific research in the national park s and the use of science in park management 
decisions.  The law encourages the national parks to be places for scientific study by public as well as 
private sector researchers, and mandates long-te rm inventory and monitoring programmes that 
provide baseline information, and document trends  relating to the condition of park resources. 
50. A lawsuit in 1998 challenged the legality of  a cooperative research and development 
agreement (CRADA) negotiated betw een the Yellowstone National Pa rk (Yellowstone) and Diversa 
Corporation (Diversa), a biotechnology company th at develops new technologies for discovering and 
modifying genes.  The judge dismissed the case with  prejudice to the plaintiff, ruling that benefit-
sharing CRADAs are consistent with the National Park Service Organic Act and the Yellowstone 
National Park enabling act. 
51. As an example of benefit sharing under the CRADA between Diversa and Yellowstone, 
Diversa, in 1999, at no charge to the fede ral government, developed a DNA pedigree for the 
endangered Yellowstone wolves, the first such pedi gree ever established.  This pedigree, which the 
Yellowstone National Park could not have afforded to pay for, help s in understanding the dynamics of 
the wolf population, assessing the genetic health of the park's wolf population, identifying wolves that 
are killed illegally, detecting when wolves from othe r areas immigrate to Greater Yellowstone, and 
documenting breeding in the wild.  This knowledge is used by Yellowstone staff in carrying out their 
charge to conserve the wildlife in the park so that  it can be enjoyed by this and future generations. 
52. The National Park Service has separate require ments for collecting research materials from 
parks, depending on the use to which the research is to be put.  For collections aimed solely at basic 
research and education, the superintendent of each  national park has the authority to issue research 
permits addressing the resources and needs of the pa rk the superintendent oversees.  A Scientific 
Research and Collecting Permit is required for most scientific activities involving fieldwork or 
specimen collection, particularly if the research has the potential to disturb resources or visitors.  In 
some instances, other federal or state agency pe rmits or approvals may al so be required to be 
submitted with the application for a Scientif ic Research and Collecting Permit before the IP/C/W/368/Rev.1 
Page 22  
 
  superintendent of the national park  will consider the application.  For example, research proposals 
involving threatened or endangered species must be accompanied by a permit from the US Fish and 
Wildlife Service and the National Marine Fisheries Service.  Application materials, including Guidelines to Researchers for Study Proposals , can be obtained from the Internet (www.nps.gov
) or 
by contacting the park in which the proposed rese arch is to take place.  Specimen collection for 
scientific research would be authorized only if the collection is necessary for the stated scientific goals 
included in the written research proposal.  The resear ch proposal must detail the activities that will 
occur in the park together with the analyses th at will occur elsewhere, such as in the scientists' 
laboratory or office. 
53. Each proposal is reviewed to ensure complia nce with the National Environmental Policy Act 
and other relevant laws, regulations and policies.  Depending on the complexity and sensitivity of the 
proposal, the superintendent may also require a revi ew by relevant scientific experts, internal or 
external.  Permits may be issued only if the prop osed research will not have an adverse impact on 
public health and safety, environmental or scenic va lues, natural or cultural resources, other scientific 
research, management responsibilities, allocation and use of facilities, and visitor activities. 
54. Researchers granted permits to work in National Park System areas must complete an 
Investigator's Annual Report on the required form for each year of the permit, including the final year.  
This may be done on paper or over the In ternet.  The reports themselves document the 
accomplishments of research conducted in the parks.   The principal researchers are accountable for 
the accuracy and content of their reports.  In additio n to the reports, park research coordinators can 
request copies of field notes, data, reports, publica tions and other documents and materials related to 
studies conducted in the National Park System Areas. 
55. As noted above, specimens and components of specimens  collected under permit are to be 
used for scientific or educational purposes only;  sp ecimens collected in parks may be loaned by the 
NPS for scientific purposes but may not be sold fo r any purpose;  research results derived from NPS 
specimens may not be used for commercial or other revenue-generating purposes without further 
permission. 
56. According to National Park Service policy, an y party that submits an application for a 
Scientific Research and Collecting Permit proposing to use the results of research for commercial or 
revenue-generating purposes must enter into a CRA DA or other approved benefit-sharing agreement 
with the NPS.  Under a CRADA, the National Park Service makes a clear distinction between sale or 
other transfer to third parties of collected rese arch specimens or materials and the sale or other 
transfer of the results of research based upon the co llected research specimens or materials.  The sale 
or other transfer to third parties of collected specime ns or components thereof is strictly prohibited.  
The party to the CRADA, however, may make comme rcial or other revenue-g enerating use of the 
results of its research, with benefit sharing to the National Park Service as provided for in the 
CRADA. 
57. The scientific research and collecting permit issu ed by the National Park Service to the other 
party spells out the terms and conditions under whic h that party is permitted  to collect research 
specimens or other materials from the park and the purposes to which such specimens or other 
materials may be put.  The CRADA or other benefit-sharing agreement identifies the allocation of ownership in any inventions made, and the other rights and obligations of the parties, including 
reporting requirements and the manner in which any di sputes should be handled.  Some contracts may 
provide for express damages in the event of a breach of any of the provisions of the agreement by the 
party seeking to collect research specimens or othe r materials.  Reporting requirements may include 
notification of the development of any inven tion based upon research using research specimens 
collected in the parks and identification of the contra ct in any patent application claiming an invention 
developed as a result of the research on collected specimens or other materials.  IP/C/W/368/Rev.1 
 Page 23 
 
 
  58. Only one CRADA has been negotiated by the NPS up to the date of the submission of 
document IP/C/W/393.  The litigation in 1998 imposed  a requirement to comply with the National 
Environmental Policy Act and the NPS is developing an environmental impact statement to consider 
the effects of benefit sharing within the National Park System. 
59. The proponents of this approach have said that a similar system, adapted to the legal systems 
and government structures of other countries, woul d work well in promoting the sustainable use of 
genetic resources  and in ensuring that benefits resulting from any research using those resources are 
shared with the source of the resources.  Such be nefits could include training for scientists, direct 
application of the research results (as in the example of the genetic pedigree of the endangered Yellowstone wolves), or monetary remuneration.   
2. Discussion of the national-based approach 
(a) Transboundary use of genetic r esources and traditional knowledge 
60. The issue of whether the national-based appro ach can adequately address transboundary use 
of genetic resources and traditional knowledge  has been raised.  One view is that: 
- the national-based approach, including contracts, while helpful and even required 
under the CBD, as paragraphs 4 and 7 of Ar ticle 15 of the CBD require access and 
benefit sharing to be on mutually agreed te rms, cannot be the only solution in cases of 
erroneously granted patents and trans boundary use of genetic resources and/or 
traditional knowledge.
100  Given the transboundary nature of the problem, often 
involving the acquisition of material in one country and the seeking of a patent in 
another, reliance on national or regional measures alone may not be sufficient to 
increase transparency, and multila teral approaches are needed.101  While such actions 
may be illegal under the law of the country providing the genetic resources, there may 
be little that can be done under that law wh en the genetic material and traditional 
knowledge is used outside that jurisdicti on.  Thus, contractual arrangements or 
similar mechanisms in national laws woul d only suffice if they are obligatory and 
enforceable across borders102; 
                                                      
100 African Group, IP/C/W/404;  Bolivia, IP/C/M/37/Ad d.1, para. 241;  Brazil, IP/C/M/48, para. 40, 
IP/C/M/47, para. 27, IP/C/M/46, paras. 79-81, IP/C/M/4 0, para. 90, IP/C/M/39, para. 126, IP/C/M/37/Add.1, 
para. 238, IP/C/M/36/Add.1, para. 220;  Brazil and India, IP/C/W/443;  Colombia, IP/C/M/36/Add.1, para. 209;  
China, IP/C/M/40, para. 120;  India, IP/C/M/48, para. 53, IP/C/M/47, para. 34, IP/C/M/45, para. 25, 
IP/C/M/37/Add.1, para. 223;  Indonesia, IP/C/M/36/Add.1, para. 217;  Kenya, IP/C/M/42, para. 114;  Pakistan, IP/C/M/36/Add.1, para. 211;  Peru, IP/C/W/447, IP/C/W/441/Rev.1, IP/C/M/48, para. 18, IP/C/M/40, paras. 84-
85, IP/C/M/36/Add.1, para. 203;  Switzerland, IP/C/M/46, para. 75;  Zimbabwe, IP/C/M/36/Add.1, para. 201. 
101 African Group, IP/C/W/404;  Bolivia, IP/C/M/ 37, para. 241;  Brazil, IP/C/M/48, para. 26, 
IP/C/M/47, para. 27, IP/C/M/46, paras. 79-81, IP/C/M/4 0, para. 90, IP/C/M/39, para. 126, IP/C/M/37/Add.1, 
para. 238, IP/C/M/36/Add.1, para. 220;  Brazil et al, IP/C/W/403;  Brazil and India, IP/C/W/443;  Chile, 
IP/C/M/40, para. 126;  China, IP/C/M/40, para. 120;  IP/C/M/47, para. 57;  Colombia, IP/C/M/36/Add.1, para. 209;  India, IP/C/M/48, para. 49, IP/C/M/47, para. 34, IP/C/M/45, para. 25, IP/C/M/37/Add.1, para. 223;  
Indonesia, IP/C/M/36/Add.1, para. 217;  Kenya, IP/C/M/4 2, para. 114;  Pakistan, IP/C/M/36/Add.1, para. 211;  
Peru, IP/C/M/48, para. 18, IP/C/M/46, para. 50, IP/C/M/40, para. 84, IP/C/M/36/Add.1, para. 203;  Switzerland, IP/C/M/47, para. 78, IP/C/M/46, para. 75. 
102 Brazil and India, IP/C/W/443. IP/C/W/368/Rev.1 
Page 24  
 
  - contracts alone cannot deter those with the intent of acting in bad faith as contracts 
may not be concluded in accordance with national access and benefit-sharing regimes
103; 
- there is no obligation in international law on all Members to legislate on the issue of 
prior informed consent and benefit sharing, particularly for Members not party to the 
CBD.104  It is not clear how the national-based  approach could be reconciled with a 
commitment to negotiations for an access and benefit-sharing regime that were 
launched at the World Summit on Sustainabl e Development (WSSD) at Johannesburg 
in 2003105; 
- if voluntary contracts are a sufficient mean s of ensuring respect of the rights of the 
country or community of or igin of genetic material/tr aditional knowledge, why would 
a similar logic not also apply in respect of the protection of intellectual property and why is specific IP legislation that applies even in the absence of contracts considered 
necessary?  Such an approach would be akin  to arguing that, in order to ensure the 
effective operation of the patent system, fo r example, only national patent laws are 
needed and that no international agreemen t, such as the TRIPS Agreement, is 
necessary.
106 
61. In response, the following views have been expressed: 
- the reference to "national laws" does not  imply that international norms have no 
relevance nor that the solutions proposed ar e not international in character.  Indeed, 
appropriate international guidelines, such  as the Bonn Guidelines and guidance from 
the IGC at WIPO, which address issues of appropriate access and benefit sharing 
outside the patent system, may be relevant  and helpful to Members in achieving the 
shared objectives107; 
- a national contract-based system can be inte rnational in its outlook and may contain, 
inter alia , choice of forum, choice of law, or international arbitration provisions 
relevant to cross-boundary dispute or enforcement issues governing cases where 
commercialization that might lead to benefit sharing has taken place in a different country
108; 
- the case has not been made for why a contractual system that would apply to the vast 
majority of those seeking access within the framework of national laws would not serve effectively.
109  It is possible that a few individuals could ignore the legal 
requirements and simply put an herb in their pocket, in the same way that some 
individuals counterfeit trademarks or pira te copyrighted works, but this does not 
negate the value of a contractual system that  would apply to the vast majority of those 
seeking access, just as trademark and copyright laws apply in their spheres.  Just as is done in the case of trademark counterfeiting and pirated copyrighted works, criminal 
provisions and/or civil liability for failure to  comply can be included in the country's 
                                                     
 
103 Peru, IP/C/M/46, para. 50;  Switzerland, IP/C/M/46, para. 75. 
104 Brazil, IP/C/M/37/Add.1, para. 238, IP/C/M/36/Add.1, para. 220;  Brazil et al, IP/C/W/403;  India, 
IP/C/M/37/Add.1, para. 223. 
105 EC, IP/C/M/48, para. 65. 
106 Brazil, IP/C/M/32, para. 128;  Brazil and India, IP/C/W/443;  India, IP/C/M/47, para. 34;  Peru, 
IP/C/M/36/Add.1, para. 203. 
107 United States, IP/C/W/449. 
108 United States, IP/C/W/449, IP/C/M/49, para. 99. 
109 United States, IP/C/W/449.  IP/C/W/368/Rev.1 
 Page 25 
 
 
  laws for those few who might take genetic resources without entering into an access 
agreement with the appropriate party110; 
- cases where no contract has been concluded in violation of the domestic access and 
benefit-sharing regime woul d be governed by the requirements and penalties, whether 
criminal and/or civil, of national regimes111; 
- in regard to the point relating to the W SSD declaration, a country could promote and 
encourage prior informed consent and equ itable sharing of benefits on mutually 
agreed terms at the national level without being a party to the CBD.112  Countries not 
parties to the CBD have ensured that bioprospectors and researchers from their countries are made aware of the national access and benefit-sharing systems in other 
countries.
113 
62. In response to the point made about the eff ectiveness of a "national contract-based system 
with an international outlook", the question has b een raised as to why bad patents and instances of 
misappropriation are increasing when such a system is already in place.114  It has also been said that 
the suggestion for the use of private forums to enforce provisions dealing with matters of state 
responsibility is unnecessary when the WTO with its dispute settlement mechanism is itself an 
appropriate forum.  Further, there is no merit in relegating an issue of state responsibility to private 
international law through arbitration procedures th at bind Members only when they agree to them, 
particularly when there are equity issues that need to be addressed.115  In response to the comparison 
with trademark and copyright laws, it has been said that, while there are penalties to redress trademark 
and copyright infringement, such as the revocation of the right itself, such remedies cannot be found 
in the contract system.116  With respect to countries not party to the CBD, while it is acknowledged 
that they may be taking certain measures to pr omote the objectives of the CBD, these are insufficient 
since there is no legislation to ensure that acts of  non-compliance of their citizens with respect to the 
CBD legislation in other countries can be remedied.117 
(b) Bargaining power of parties to the contract 
63. The issue of the bargaining power of the two par ties to the contract has also been raised.  One 
view is that: 
- while contractual arrangements may have a role to play, the unequal bargaining 
strength of the parties to the contract and th e lack of an obligation to enter into or 
enforce a contract renders them insufficient both in terms of entering into contracts in 
the first instance as well as enforcing them outside the country of origin of the 
biological resource and/or associated traditional knowledge118; 
                                                      
110 United States, IP/C/W/257. 
111 United States, IP/C/M/49, para. 100 
112 United States, IP/C/M/48, para. 25. 
113 United States, IP/C/M/49, para. 94.  
114 Brazil et al, IP/C/W/459. 
115 Brazil et al, IP/C/W/459;  India, IP/C/M/48, para. 52. 
116 China, IP/C/M/39, para. 135. 
117 Brazil et al, IP/C/W/459. 
118 Brazil, IP/C/W/228, IP/C/M/36/Add.1, para. 220;  Brazil et al, IP/C/W/438, IP/C/W/403;  India, 
IP/C/M/46, para. 38;  Pakistan, IP/C/M/28, para. 158;   Peru, IP/C/M/46, para. 50, IP/C/M/40, para. 85, 
IP/C/M/36/Add.1, para. 203, IP/C/M/35, para. 236, IP/C/M/32, para. 133. IP/C/W/368/Rev.1 
Page 26  
 
  - indigenous and local communities lack legal training in the negotiation of contractual 
terms and it would be difficult for them to  negotiate equitable and beneficial terms.
119  
The majority of owners of genetic resour ces are not aware of the benefits to be 
obtained from their resources.120  Such unequal bargaining power may lead to unfair 
results since developed countries might take advantage of their strong position on 
technology to force developing countries to accept unfair contracts.121 
64. In response it has been said that: 
- one flexibility of the proposed system is that Members may, if appropriate, regulate 
the terms of agreement through national laws or rules.  In such cases, the country of 
origin would determine, for any cases it deems appropriate, certain terms of 
collection without the need for arms-length bargaining in the typical sense122; 
- the seeking of information by outsiders  on knowledge, innova tions and practices 
would create an opportunity to educate communities that are unfamiliar with the 
basics of negotiations, contracts and various forms of intellectual property, that might be relevant to them in marketing thei r knowledge, innovations, and practices for use 
by those outside their communities, and for obtaining an equitable share of the 
benefits arising from the utilization of their knowledge, innovati ons and practices.  
Likewise, it would also provide an opportunity for indigenous and local communities to indicate that they do not want their knowledge, innovations an d practices disclosed 
or shared with the larger community.  This  would be an appropriate time to provide 
information on the use of trade secret law as a tool for maintaining limitations on the 
circulation of the knowledge,  innovations and practices.
123 
(c) Transaction costs 
65. With respect to transaction costs under the na tional-based approach, it has been said that: 
- transparency and predictability in acces s and benefit sharing, including prior 
informed consent, cannot be established th rough a fragmented and costly nation-by-
nation system, but only through an intern ationally established and enforced system124; 
- myriad separate and different national systems with no common denominator cannot 
effectively regulate the relationships be tween entities, persons and activities taking 
place in different countries125; 
- it is not clear how the national-based approach takes into account the generally 
long-term nature of research and de velopment activities involving genetic 
resources.126 
66. In response it has been said that: 
                                                      
119 Peru, IP/C/M/40, para. 85, IP/C/M/36/Add.1, para. 203. 
120 Kenya, IP/C/M/46, para. 67. 
121 China, IP/C/M/47, para. 57. 
122 United States, IP/C/W/449. 
123 United States, IP/C/W/257. 
124 Brazil and India, IP/C/W/443. 
125 Brazil and India, IP/C/W/443. 
126 Switzerland, IP/C/W/446.  IP/C/W/368/Rev.1 
 Page 27 
 
 
  - a contract-based system need not entail high transaction costs if implemented in an 
effective and systematic manner, e.g., by providing clear points of contact and setting 
forth clear statements of agreement to minimize disputes127; 
- contract-based access and benefit sharing, with appropriate monitoring and 
enforcement, including regular reporting to  the points of contact, would help to 
centralize monitoring and would not be a "fragmented" system128; 
- there is adequate flexibility under a contract -based system to address issues related to 
the long-term nature of R&D activities invol ving genetic resources, such as regular 
reporting requirements and the sharing of benefits in cases of patent expiry or 
assignment of patent.129 
(d) Effectiveness of remedies proposed 
67. With respect to the effectiveness of the remedi es proposed, it has been said that civil and 
criminal remedies provided for under national laws in the country providing the genetic resources 
would not provide a sufficient deterrent to check illegal use in third countries130 in cases where no 
contracts on access and benefit sharing are concluded131 and bio-prospecting and use of genetic 
resources and traditional knowledge takes place wit hout the authorization of the competent national 
authority.132 
68. In response it has been said that, in the vast majority of cases, compliance will be facilitated 
through cooperation between the hol ders, or other appropriate authorities, and users of the genetic 
resources and/or traditional knowledge.  The rare cases where a party violates the national regime 
would be subject to criminal and civil provisions, si milar to those in other areas of misconduct, such 
as breaches of environmental law, health and safet y laws and other fields in which governments have 
an important regulatory interest.133 
69. Questions have been asked as to whether it woul d be the national or international authorities 
who would be involved in monitoring an interna tional contracts-based access and benefit-sharing 
regime and, if international, under which jurisdiction they would operate.134 
B. DISCLOSURE APPROACH  
70. Three proposals put forward in the Council's work for disclosure requirements in patent 
applications are briefly set out below, followed by a sub-section on their advantages as claimed by their proponents.  Following this description of the three proposals, the discussion on these proposals 
is summarized. 
                                                     
 
127 United States, IP/C/W/449. 
128 United States, IP/C/W/449. 
129 United States, IP/C/M/49, para. 101. 
130 India, IP/C/M/36/Add.1, para. 212. 
131 Switzerland, IP/C/M/46, para. 75. 
132 Indonesia, IP/C/M/36, para. 217;  Pakistan, IP/C/M/36/Add.1, para. 211;  Peru, IP/C/M/35, 
para. 236, IP/C/M/32, para. 133;  Switzerland, IP/C/M/47, paras. 77-78. 
133 United States, IP/C/W/434, IP/C/W/257. 
134 Canada, IP/C/M/49, para. 106.  IP/C/W/368/Rev.1 
Page 28  
 
  1. Proponents' description of the disclosure approach 
(a) Main features of the proposed disclosure requirements  
 The TRIPS disclosure proposal 
 
71. A proposal has been made that  the TRIPS Agreement should be  amended in order to oblige 
Members to require that an applicant for a patent  relating to biological materials or to traditional 
knowledge provide the following information,  as a condition of acquiring patent rights: 
 (i) the source and country of origin of the biological resource and of the traditional 
knowledge used in the invention; 
 
 (ii) evidence of prior informed consent from the authorities under the relevant national 
regime;  and 
  (iii) evidence of fair and equitable benef it sharing under the relevant national regime. 
 
This proposal is hereinafter referred to as "the TRIPS disclosure proposal".
135 
 72. With such an amendment, it would be manda tory for Members to have the proposed 
disclosure requirements in their national laws and regulations and these requirements would be 
obligatory for patent appli cants applying for patents in these juri sdictions whenever they use genetic 
resources and/or associated traditional knowledge in their inventions.  There should be a reporting 
obligation on issues relating to the paten ting or commercialization of inventions.
136 
73. The obligation to provide evidence of prior informed consent would be discharged by a 
declaration in the patent application, accompanied, where relevant, by a certificate issued by a relevant national authority or a duly certified co ntract between the applicant and the national 
authorities of the country of origin.
137  The obligation to provide evidence of fair and equitable sharing 
of benefits with the source and country of orig in and/or local/indigenous communities, would be 
fulfilled by providing evidence, at th e time of the patent application, of an existing or future benefit-
sharing arrangement that is premised upon mutually agreed terms and is fair and equitable in the 
circumstances.138  The terms of benefit sharing would c over elements relating to the conditions, 
obligations, procedures, types, timing, distribution an d mechanisms of the benefits to be shared.  The 
                                                      
135 African Group, IP/C/W/404, IP/C/M/40, para . 76;  Andean Community, IP/C/M/37/Add.1, 
para. 231;  Brazil, IP/C/W/228, IP/C/M/46, para. 81, IP /C/M/42, para.101, IP/C/M/39, para. 126, IP/C/M/38, 
para. 230, IP/C/M/37/Add.1, para. 237, IP/C/M/36/Add. 1, para. 219, IP/C/M/33, para. 121, IP/C/M/32, 
para. 128, IP/C/M/29, paras. 146 and 148; IP/C/M/28, para. 135, IP/C/M/27, para. 122;  Brazil et al, IP/C/W/403, IP/C/W/429/Rev.1, IP/C/W/356;  China, IP/C/M/47, para. 57, IP/C/M/37/Add.1, para. 229, 
IP/C/M/36/Add.1, paras. 227-228;  Colombia, IP/C/M/46, para. 57, IP/C/M/42, para. 119, IP/C/M/40, para. 121, 
IP/C/M/38, para. 239, IP/C/M/37/Add.1, para. 231, IP/C/M/36/Add.1, para. 209;  Ecuador, IP/C/M/47, para. 49, IP/C/M/25, para. 87;  India, IP/C/W/198, IP/C/W/195, IP /C/M/45, para. 25, IP/C/M/42, para. 113, IP/C/M/40, 
paras. 81-82, IP/C/M/36/Add.1, paras. 212 and 214, IP/C/M/30, para. 169, IP/C/M/24, para. 81;  Indonesia, 
IP/C/M49, para. 159, IP/C/M/47, para. 51, IP/C/M/36/ Add.1, para. 217;  Kenya, IP/C/M/47, para. 68, 
IP/C/M/46, para. 67, IP/C/M/42, para. 114, IP/C/M/40, para. 107, IP/C/M/37/Add.1, para. 239, 
IP/C/M/36/Add.1, para. 233, IP/C/M/28, para. 144;  Pakistan, IP/C/M/36/Add.1, para. 211;  Peru, 
IP/C/M/36/Add.1, para. 203, IP/C/M/40, para. 84;  Thailand, IP/C/M/42, para. 105, IP/C/M/25, para. 78;  Venezuela, IP/C/M/40, para. 102, IP/C/M/36/Add.1, para . 208; IP/C/M/32, para. 136; IP/C/M/28, para. 165;  
Zimbabwe, IP/C/M/36/Add.1, para. 201. 
136 Brazil, IP/C/M/47, para. 25. 
137 Brazil, IP/C/M/47, para. 29;  Brazil et al , IP/C/W/438;  India, IP/C/M/46, para. 39. 
138 Brazil and India, IP/C/W/443;  Brazil et al, IP/C/W/442.  IP/C/W/368/Rev.1 
 Page 29 
 
 
  patent applicant would also have to indicate how the national authority (and community, where 
applicable) would enforce such an arrangement.139  The onus on the patent applicant would be limited 
to providing information and evidence that is know n to him, or should have been known to him.140  It 
has been said that, since traditional communities ar e often weak in the negotiation process, a benefit 
sharing agreement primarily entered into with th em be subsequently suppl emented and confirmed by 
the national regulatory authority.141 
74. Prior informed consent and benefit sharing,  as embodied in the CBD, would have to be 
respected even in cases where specific access and bene fit-sharing regimes may not have been set up in 
the countries of origin.142  Where there is no national regime, th e applicant would be required to state 
that fact and that there has been consent at leas t from the authority or community in charge of the 
location where the genetic resources and/or traditional knowledge has been accessed or that there is a 
benefit-sharing arrangement, or a fu ture one is envisaged, with the authority or community in charge 
of the location from which the resources or the kno wledge is accessed, in full compliance with other 
applicable laws, regulations and pr actices of the country of origin.143 
75. As regards the legal effects of non-disclosure or  inadequate or wrongful disclosure of any of 
the three components required under this proposal, it has been said that144: 
- at the stage of processing of the patent a pplication, the processing of the application 
would be delayed until the necessary declar ation and evidence of prior informed 
consent reaches the authorities.  This would be accompanied by penalties and time-limits within which the proper declaration and evidence must be provided;  otherwise the application would be deemed withdrawn; 
- at the post-grant stage, the patent woul d be revoked, particularly where fraudulent 
intent is established; 
- criminal and/or administrative sanctions would follow outside the patent system to 
ensure punitive damages or adequate compensation; 
- full or partial transfer of the rights to the invention would also follow where full 
disclosure would have shown that anothe r person or community or governmental 
agency is the inventor or part inventor;  
- there would be a narrowing of the scope of the claims where part of the claims is 
affected due to lack of novelty or fraudul ent intention or where full disclosure would 
have led to refusal to admit those parts of the claims; 
- the above remedies would be subject to  the possibility of a judicial review. 
                                                     
 
139 Brazil and India, IP/C/W/443;  Brazil et al, IP/C/W/442. 
140 Brazil, IP/C/M/48, para. 36. 
141 India, IP/C/M/49, para. 144. 
142 Brazil, IP/C/M/47, para. 85. 
143 Brazil,  IP/C/M/47, para. 29;  Brazil and India,  IP/C/W/443;  Brazil et al, IP/C/W/438;  India, 
IP/C/M/46, para.39. 
144 Brazil et al, IP/C/W/438, IP/C/W/429/Rev.1, IP/C/W /403;  India, IP/C/M/46, para. 40, IP/C/M/45, 
paras. 22-23. IP/C/W/368/Rev.1 
Page 30  
 
  76. It has also been said that, while a certain degr ee of leeway may be given to the exact legal 
effect for each infraction, Members should neverthel ess have an obligation to ensure that the effect of 
insufficient, wrongful or no disclosure is effective in terms of its deterrent, compensatory and equity 
value.
145  It would be left to countries to define in th eir domestic legislation the penalties applicable in 
cases of failure to comply with the requirements and the above-mentioned requirements are offered as 
options.146  Remedies available would be retrospective so as to cover past use.147 
77. It has been said that any use, including incide ntal use, of genetic resources and or associated 
traditional knowledge, the disclosure of which is ne cessary to determine the existence of prior art, 
inventorship or entitlement to the claimed invention and the scope of the claim, and/or is necessary for 
understanding or carrying it out, should be sufficient to trigger the disclosure requirement i.e. to 
require the applicant to disclose the requisite info rmation.  Such uses of genetic resources and/or 
associated traditional knowledge could include tho se that result in forming part of the claimed 
invention;  use during the process of developing th e claimed invention;  use that is a necessary 
prerequisite for the development of the invention;   or use to facilitate the development of the 
invention where it forms part of the necessary ba ckground material for the development of the 
invention.148 
78. As regards the burden of proof in case of non-co mpliance with disclosure requirements, it has 
been said that applicants should be required to pos itively discharge a burden of proof that the genetic 
resources and/or traditional knowledge have been le gally and legitimately accessed and that benefit 
sharing had taken place or would take place if a patent  is granted with respect to the invention that 
used the biological resources and/or traditional knowledge.149   Applicants are expected to employ all 
reasonable measures to determine the country of orig in and source of material used but the onus on 
them would be limited to disclosure of evidence th at is known or should have been known to them.150 
79. As regards the legal form that such an amen dment to the TRIPS Agreement might take, the 
following suggestions have been made: 
- an amendment to Article 27 of the TRIPS Agreement151 in the form of a further 
exception to patentability, with the following wording152: 
  "[Members may also exclude from patentability]:  (c) products or processes which directly or indirectly include genetic 
resources or traditional knowledge obtained in the absence of compliance with international and national legisla tion on the subject, including failure to 
obtain the prior informed consent of the country of origin or the community 
concerned and failure to reach agr eement on conditions for the fair and 
equitable sharing of benefits arising from their use. 
 Nothing in TRIPS shall prevent Members from adopting enforcement 
measures in their domestic legislation, in accordance with the principles and 
obligations enshrined in the Convention on Biological Diversity." 
                                                     
 
145 Brazil et al, IP/C/W/429/Rev.1;  India,  IP/C/M/45, para. 22. 
146 Peru, IP/C/W/447, IP/C/M/48, para. 22. 
147 China, IP/C/M/36/Add.1, para. 228. 
148 Brazil et al, IP/C/W/429/Rev.1;  India, IP/C/M/45, paras. 22 and 53. 
149 Brazil et al,  IP/C/W/438, IP/C/W/429/Rev.1;  India, IP/C/M/45, para. 24. 
150 Brazil et al, IP/C/W/429/Rev.1;  Colombia, IP/C/M/46, para. 57. 
151 Brazil, IP/C/W/228, IP/C/M/33, para. 121, IP/C /M/32, para. 128; Peru, IP/C/W/447, IP/C/M/48, 
para. 20. 
152 Peru, IP/C/W/447, IP/C/M/48, para. 20.  IP/C/W/368/Rev.1 
 Page 31 
 
 
  - an amendment to Article 29153 consisting of the addition of a paragraph as set out in 
the following alternative texts proposed: 
 "Members shall require an applicant for a patent to disclose the 
country and area of origin of any biological resources and traditional knowledge used or involved in the invention, and to provide 
confirmation of compliance with all access regulations in the country 
of origin."
154 or 
 
 "Where appropriate, Members shall requi re the disclosure of origin and legal 
provenance in the patent app lications to be submitted." 155 
- the introduction of a new article in the TRIPS Agreement.156   
80. An option suggested has been an authoritativ e interpretation of Article 29 of the TRIPS 
Agreement.157 
 The PCT disclosure proposal 
 
81. Another proposal that has been discussed is that the Regulations under the Patent 
Co-operation Treaty (PCT) of WIPO be amended so  as to explicitly enable the national patent 
legislation of contracting parties to the PCT, to  require the declaration of the source of genetic 
resources and traditional knowledge in patent applications, if an invention is directly based on such 
resource or knowledge (hereinafter referred to as "the PCT disclosure proposal").  The proposal would 
also grant applicants the possibility of satisfying this  requirement at the time of filing an international 
patent application, or later during the interna tional phase. This declaration of source would be 
included in the international publi cation of the patent application.158 
82. The proposed disclosure requirement would be  permissive, explicitly enabling Members to 
incorporate it into their national laws and regulat ions.  But, once so incorporated, it would be 
obligatory for patent applicants who apply for patent s in those Members' jurisdictions whenever they 
directly base their inventions on the genetic res ources or traditional knowledge.  The point has been 
made that the optional nature of the requireme nt would allow the national governments and the 
international community to gain experience with the disclosure requirement without prejudice to further international efforts.
159   
83. It is proposed that patent applicants be requi red to declare the "source" of genetic resources 
and traditional knowledge.  The term "source" should be understood in its broadest sense possible. 
This is because, according to the CBD, the Bonn Guid elines and the International Treaty of the FAO, 
a multitude of entities may be involved in access a nd benefit sharing.  The entity competent (to be 
declared as the source) should first be the one to  grant access to genetic resources and/or traditional 
knowledge or the one  to participate in the shari ng of the benefits arising out of their utilization.160 
                                                      
153 African Group, IP/C/W/404, IP/C/M/40, para. 76;  China, IP/C/M/40, para. 121;  Colombia, 
IP/C/M/40, para. 127;  Cuba, IP/C/M/40, para. 117;  India, IP/C/W/195, IP/C/M/24, para. 81;  Peru, IP/C/W/447, IP/C/M/48, para. 20;  Zimbabwe, IP/C/M/40, para. 76. 
154 African Group, IP/C/W/404. 
155 Peru, IP/C/W/447, IP/C/M/48, para. 21. 
156 Brazil et al, IP/C/W/403. 
157 Cuba, IP/C/M/40, para. 117. 
158 Switzerland, IP/C/W/433, IP/C/W/423, IP /C/W/400/Rev.1, IP/C/M/49, para. 115. 
159 Switzerland, IP/C/W/433, IP/C/M/46, para. 74. 
160 Switzerland, IP/C/W/433. IP/C/W/368/Rev.1 
Page 32  
 
  84. As regards the legal effects, it has been sai d that the disclosure requirement should be a 
formal and not a substantive requirement.
161  In general, the legal effects of wrongful disclosure or 
non-disclosure, currently allowed for under the PCT and the PLT, should apply to failure to disclose 
or wrongful disclosure of the source of genetic resources and traditional knowledge.162  If the patent 
applicant does not comply with the requirement to di sclose within the set time-limit, not less than two 
months, national law may foresee that in the nati onal phase the PCT application is not processed any 
further until the patent applicant has furnished the required declaration or consider it withdrawn on 
grounds of non-compliance.  If, however, the appli cant submits, with the international application or 
later during the international phase, the proposed d eclaration containing standardized wording relating 
to the declaration of the source, the designated offi ce must accept this declaration and may not require 
any further document or evidence relating to the source declared, unless it reasonably doubts the 
veracity of the declaration concerned.  Based on Article 10 of the Patent Law Treaty (PLT) of WIPO to which, through reference, such an amendment would also apply, if it is discovered after the 
granting of a patent that the applicant failed to disclose the source or subm itted false information, 
national law may envisage the validity of granted patent s being affected by a lack of or an incorrect 
declaration of the source, only if this is due to fra udulent intention.  The possibility for judicial review 
has also been suggested.  Other sanctions provided for in national law, including criminal sanctions 
such as fines, may be imposed.
163 
85. In order to apply the disclosure requirement or to trigger it for genetic resources, the proposal 
requires that the invention must be "directly based " on "a specific genetic resource to which the 
inventor has had access."  This wording makes clear that the invention must make immediate use of 
the genetic resource, that is, depend on the specific pr operties of this resource, and that the inventor 
must have had physical access to this resource, th at is, its possession or at least contact which is 
sufficient enough to identify the properties of the gene tic resource that are relevant for the invention.  
With regard to traditional knowledge the inventor mu st know that the invention is "directly based" on 
such knowledge;  that is, the inventor must con sciously derive the invention from this knowledge.164  
Based on the terminology used in the relevant intern ational instruments and their scope of application, 
the traditional knowledge in question must be relate d to or associated with the genetic resources in 
question.165 
86. It has also been suggested that a list of gove rnment agencies that are competent to obtain 
information about patent applica tions containing a declaration of the source of genetic resources 
and/or traditional knowledge be established.166  Patent offices receiving such  patent applications could 
inform the competent government agency in another country, through a standardized letter, that it had 
been declared as the source.  The competent govern ment agency could either be the national focal 
point foreseen under paragraph 13 of the Bonn Guid elines and/or national competent authorities for 
access and benefit sharing to be established under paragraphs 14 and 15 of these Guidelines.  By 
making the list available on the internet, patent o ffices would have easy access to it and could, without 
much administrative burden or cost, provide the comp etent national authority with the information so 
that a country would not need to monitor patent a pplications worldwide to verify whether it had been 
declared as a source and if so, whether all access and benefit-sharing requirements had been fulfilled.
167  The two measures - the obligatory disclosure requirement at the national level and this 
information system - would allow a party to a cont ract on access and benefit sharing to verify whether 
                                                      
161 Switzerland, IP/C/W/433, IP/C/M/46, para.22. 
162 Switzerland, IP/C/W/423 . 
163 Switzerland, IP/C/W/423. 
164 Switzerland, IP/C/W/423, IP/C/W/400/Rev.1. 
165 Switzerland, IP/C/W/423. 
166 Switzerland, IP/C/W/400/Rev.1, IP/C/M/46, para.76, IP/C/M/42, para. 97. 
167 Switzerland, IP/C/M/49, para 115, IP/C/M/46, para. 76.   IP/C/W/368/Rev.1 
 Page 33 
 
 
  the other party is complying with its obligations arising under that contract and would simplify the 
enforcement of these contractual obligations.168 
 The mandatory disclosure proposal 
 
87. A further approach outlined in the Council, also submitted as a proposal in the WIPO IGC169, 
is that each country would accept an obligation to re quire all patent applicants to disclose information 
on the country of origin or source of genetic resour ces used in the invention which patent applicants 
know or have reason to know (her einafter referred to as "the mandatory disclosure proposal").170  
There could also be a requirement on the appli cant to declare the specific source of traditional 
knowledge associated with genetic resources, if the a pplicant is aware that the invention is directly 
based on such traditional knowledge;  in this context,  a further in-depth discussion of the definition of 
"traditional knowledge" has been suggested as being necessary.171  The disclosure requirement would 
be legally binding and universal and would apply to all national, regional and international patent 
applications at the earliest stage possible.172 
88. Such a disclosure requirement would not act, de facto or de jure , as an additional formal or 
substantial patentability criterion.173  The requirement would only be a formal one.  If the applicant 
fails or refuses to declare the required informati on or, despite being given the opportunity to do so, 
fails to remedy that omission, the patent appli cation would then not be further processed and the 
applicant would be duly informed of this consequence.   Once the patent is granted the legal effects of 
the non-respect of the requirement i.e. if the in formation provided were in correct or incomplete, 
would lie outside the ambit of patent law, for ex ample by providing effective, proportionate and 
dissuasive sanctions in civil law (e.g. claims for comp ensation) or in administrative law (e.g. fines for 
refusal to submit information to the authorities or for submitting wrong information).  With this framework, each country would decide for itself how it would provide for sanctions in cases of violation of the disclosure requirement.
174 
89. Under this approach, the disclosure obligation would be triggered when the genetic resource 
or traditional knowledge forms part of the claimed invention or has been necessary for the 
development resulting in the invention.  In other words, the invention must be directly based on the specific genetic resource. 
90. The burden of proof in regard to compliance with the disclosure requirements would rest on 
the alleger that there has been non-compliance.
175  According to usual rules, it would be up to those 
who might wish to contest such disclosure in an ad ministrative procedure or before a court to provide 
proof to the contrary.176 
                                                      
168 Switzerland, IP/C/M/47, para. 77. 
169 EC, IP/C/M/48, para. 62, IP/C/M/47, para. 58. 
170 EC, IP/C/W/383, IP/C/M/49, para. 124, IP/C/M/44, para. 29, IP/C/M/42, para. 107, IP/C/M/40, 
para. 95, IP/C/M/37/Add.1, para. 228, IP/C/M/35, para. 234, IP/C/M/30, paras. 144-146;  Norway, IP/C/M/40, 
para. 86, IP/C/M/39, para. 120. 
171 EC, IP/C/M/47, para. 58. 
172 EC, IP/C/W/383, IP/C/M/42, para. 108, IP/C/M/39, para. 127, IP/C/M/38, para. 247, 
IP/C/M/37/Add.1, para. 228;  Norway, IP/C/M/36/Add.1, para. 210. 
173 EC, IP/C/W/383, IP/C/M/42, para. 108, IP/C/M/39, para. 127, IP/C/M/38, para. 247, 
IP/C/M/37/Add.1, para. 228.  
174 EC, IP/C/W/383, IP/C/M/49, para. 124, IP/C/M/ 47, para. 58, IP/C/M/44, para. 32, IP/C/M/38, 
para. 247, IP/C/M/37/Add.1, para. 228. 
175 EC, IP/C/M/46, para. 47, IP/C/M/44, para. 33. 
176 EC, IP/C/M/44, para. 32. IP/C/W/368/Rev.1 
Page 34  
 
  91. With respect to prior informed consent and bene fit sharing, it has been said that a simple 
notification procedure to a centralized body could be followed by the patent office every time it 
receives a declaration.
177  A list of government agencies competent to obtain information about patent 
applications containing a declaration of the sour ce of genetic resources and/or traditional knowledge 
could be established.178  Such a list could be maintained by WIPO in close cooperation with the CBD.  
Alternatively, the clearing house mechanism of th e CBD could be recognized as the central body to 
which the patent offices would send the available information.179  The information would then be 
available to all CBD parties as well as to the public.180 
92. As regards legal form, the view  has been expressed that discu ssion of this aspect would be 
premature as it would depend on what substance could be agreed upon.  There are many options that 
could be considered if there were to be an agreem ent on substance, such as inserting a new article in 
the TRIPS Agreement or a new obligation in an existing Article provided it is properly calibrated.181  
Another view is that there should be a mandatory provision in the TRIPS Agreement182;  one 
possibility would be to add such a provis ion to Article 29 of the TRIPS Agreement.183 
(b) Claimed advantages of the disclosure approach 
93. The view has been expressed that a requirement  to disclose source or origin of genetic 
resources and traditional knowledge w ould have the following advantages: 
- increase in transparency regarding acce ss to genetic resources and traditional 
knowledge and benefit sharing and help source countries to monitor and keep track of 
compliance with access and benefit-sharing rules in a cost-effective way184, since, in 
the view of some of the proponents, one of the major uses of genetic resources and of 
traditional knowledge associated with them, takes place through the patent system185; 
- facilitation and simplification of the en forcement of obligations under the CBD 
through the provision of incentives on patent applicants for the conclusion of contracts
186, such as material transfer agreemen ts for the transfer of biological 
materials and information transfer agreements for the transfer of traditional 
knowledge.187  In the view of some of the proponents, this applies particularly where 
the legal effects include revocation of the patent.188  It would thus help improve the 
operation of access and benefit-sharing systems and make it difficult for those involved in acts of misappropriation wh ile benefiting victims of such acts
189; 
                                                      
177 EC, IP/C/M/47, para. 58. 
178 EC, IP/C/W/383, IP/C/M/47, para. 59, IP/C/M/46, para. 47, IP/C/M/42, paras. 107-108, IP/C/M/39, 
para. 127, IP/C/M/37/Add.1, para. 228. 
179 EC, IP/C/M/47, para. 58, IP/C/M/49, para. 124 
180 EC, IP/C/M/44, paras. 31 and 35, IP/C/M/42, para. 106. 
181 EC, IP/C/M/46, para. 49, IP/C/M/44, para. 33. 
182 Norway, IP/C/M/49, para. 120 
183 Norway, IP/C/M/39, para. 120, IP/C/M/38, para. 244. 
184 Brazil, IP/C/M/48, para. 38;  Brazil and India, IP /C/W/443;  Brazil et al, IP/C/W/403, IP/C/W/356;  
EC, IP/C/M/46, para. 46, IP/C/M/44, para. 30, IP/C/M/37/Add.1, para. 228, IP/C/M/33, para. 121, IP/C/M/32, 
para. 128;  India, IP/C/W/195, IP/C/M/48, para. 52, IP/C/M/40, para. 82;  Peru, IP/C/W/447, IP/C/M/48, 
para. 18;  Switzerland, IP/C/W/423, IP/C/M/42, para. 98. 
185 Brazil et al, IP/C/W/459. 
186 Switzerland, IP/C/W/423, IP/C/M/42, para. 98. 
187 Egypt, IP/C/M/37/Add.1, para. 204; India, IP/C/W/195, IP/C/M/37/Add.1, para. 223 . 
188 Brazil, IP/C/M/48, para. 41;  Brazil et al , IP/C/W/403;  India, IP/C/M/40, para. 82. 
189 Peru, IP/C/M/46, para. 51.  IP/C/W/368/Rev.1 
 Page 35 
 
 
  - grant of better patents through more focused  searches in patent offices and lessening 
of the need for burdensome challenges re garding patent validity which would 
contribute to a more effective implementa tion of the CBD and improve the operation 
of the patent system.190  There would be an addition of information available to patent 
examiners on prior art regarding traditional knowledge191, including that which only 
exists in oral form or is documented only in local languages.192  Disclosing the source 
of origin would therefore enable searches that might be outside the scope of established databases
193; 
- introduction of an important confidence-building measure that would help restore the 
trust of all stakeholders194 in the patent system so that it works for all in an equitable 
manner and, more particularly, increase confidence among bio-collectors and 
biodiversity-rich countries and indigenous communities.  Beneficiary countries or 
communities would have the incentive to ge nerate less complex or burdensome but 
more effective national access and benefit-sharing regimes195; 
- development of a predictable environmen t for governments, investors, traditional 
communities and researchers that could lead to more biotechnological R&D in 
developing countries, thus creating a win- win situation for both providers and 
accessors196; 
- it would particularly help inculcate resp ect for the beliefs and rights of indigenous 
peoples and safeguard countries' inte rests in their genetic resources.197 
94. In regard to the PCT disclosure proposal, the fo llowing more particular advantages have been 
claimed.  It would:198 
- explicitly enable the Contracting Parties of the PCT to introduce a disclosure 
requirement in their national laws.  It w ould thus provide a sound legal basis at the 
international level for Members to introdu ce measures regarding the declaration of 
the source of genetic resources and traditi onal knowledge in their national patent 
laws; 
- leave Members with adequate flexibility to  develop an efficient national legislation 
according to their needs; 
- not be so burdensome for patent applicants so as to deter them from filing for patents 
and encourage them to maintain secrecy over their inventions; 
- enable the patent applicant to declare the source/s most appropriate with regard to the 
invention in question.  In most cases patent  applicants would be able to declare the 
                                                      
190 EC, IP/C/M/46, para. 46, IP/C/M/44 para. 30;  India, IP/C/M/48, paras. 57 and 60. 
191 EC, IP/C/M/37/Add.1, para. 228. 
192 Brazil et al, IP/C/W/403;  India, IP/C/M/40, pa ra. 82, IP/C/M/39, para. 123, IP/C/M/37/Add. 1, 
para. 253;  Switzerland, IP/C/M/42, para. 98. 
193 Brazil, IP/C/M/48, para. 39. 
194 Switzerland, IP/C/M/46, para. 73. 
195 Brazil, IP/C/M/46, paras. 82 and 85;  EC, IP/C/M/46, para. 46, IP/C/M/44, para. 30;  India, 
IP/C/M/40, para. 82;  Norway, IP/C/M/39, para. 121;  Peru, IP/C/W/447, IP/C/M/48, para. 94 . 
196 Brazil, IP/C/W/228, IP/C/M/37/Add.1, para. 236;  Brazil et al, IP/C/W/356;  Indonesia, 
IP/C/M/36/Add.1, para. 217. 
197 Peru, IP/C/M/48, para. 18. 
198 Switzerland, IP/C/W/423, IP/C/M/42, para. 98. IP/C/W/368/Rev.1 
Page 36  
 
  source and, in exceptional cases, to declare th at the source is unknown to them or the 
inventor.  There would thus be little risk that the grant of patents for resulting inventions would be jeopardized by the l ack of knowledge about the sources of the 
used genetic resource or traditional knowledge; 
- enable measures to be in conformity w ith all international obligations under the 
relevant international agreements, includ ing the TRIPS Agreement, the CBD and the 
FAO International Treaty on Plant Gene tic Resources for Food and Agriculture 
(ITPGRFA) and contribute towards their implementation by Members in a mutually supportive way; 
- represent a specific measure to implemen t the Bonn Guidelines as it would enable 
those who have been identified as having contributed to the resource management 
and to scientific and/or commercial processes to participate in the sharing of benefits as mentioned in paragraph 48 of these Guidelines. 
95. In regard to the mandatory disclosure propo sal, it has been said that the proposal, while 
facilitating the implementation of the objectives of the CBD, would not affect the balance of rights 
and obligations set out in the TRIPS Agreement,  nor the rights of WTO Members to create a 
favourable environment for research and developmen t activities in the field of biotechnology.  The 
patent system would continue to be a highly eff ective tool for stimulating innovation, technological 
progress and economic development and, provided it was appropriately calibrate d, the introduction of 
such a disclosure requirement would not necessa rily be burdensome to patent offices or to 
applicants.
199 
(c) Examples given of experience with use of the disclosure approach 
96. The main information provided in the TRIPS Council by delegations with respect to their 
countries' experience with use of the disclosure appro ach is set out below.  Further detail can be found 
in the documents referenced in the footnotes. 
97. The Council was informed that Norway has amende d some of the provisions of its Patent Act,  
taking account of certain provisions of the CBD re lating to benefit sharing and prior informed 
consent.  Under the new provisions, patent applica tions concerning biological material should include 
information on the country of origin of the materi al.  Should the national legislation of the providing 
countries so require, information on prior info rmed consent should also be submitted.  These 
provisions do not, however, apply to  international patent applicati ons and the processing of national 
patent applications would not be prejudiced by them.  Failure to provide correct information is subject 
to penalty in accordance with Section 166 of the Gene ral Civil Penal Code with respect to giving false 
testimony in writing to a public authority.  The No rwegian policy on this issue is being reviewed and 
more definitive views and further information on national experiences will be submitted when the 
internal review is completed.200 
98. The Council was also informed of the legisla tion of Peru and of the Andean Community.201  
Peru's regulation on protection of plant varieties is  said to establish a direct and explicit link between 
intellectual property and access to genetic resource s and protection of traditional knowledge.  This 
regime determines the rules and the institutional frame work applicable to the protection of the rights 
of plant breeders.  Article 15 of the Regulation provides that the application "for the granting of a 
                                                      
199 EC, IP/C/M/49, para. 123. 
200 Norway, IP/C/M/48, para. 81, IP/C/M/47, para. 65 , IP/C/M/43, para. 54, IP/C/M/40, paras. 87-88, 
IP/C/M/39, para. 121. 
201 Peru, IP/C/W/447, IP/C/M/48, para. 93.  IP/C/W/368/Rev.1 
 Page 37 
 
 
  breeder's certificate shall be submitted to the Office of Inventions and New Technologies [of 
INDECOPI] and shall contain or have attached, as appropriate: 
 (e) the geographical origin of the raw plant ma terial of the new variety to be protected, 
including, where appropriate, the document certifying the legal provenance of the 
genetic resources, issued by the competent au thority, with respect to access to genetic 
resources, 
  (f) the origin and genetic content of the vari ety, including any know n details with regard 
to the source of the genetic resources used in the variety or the breeding thereof, as 
well as any information on knowledge relati ng to the variety [including traditional 
knowledge], where appropriate". 
 The penalty for not submitting the required information, under Article 16 of the Supreme Decree, is that the application shall be declared to have lapsed. 
99. The Andean Community Decision 391 on a Common Regime on Access to Genetic 
Resources, approved on 2 July 1996, provides for th e adoption of legal requirements at the regional 
level (valid only among the five countries of the And ean Community), which is said to directly link 
the access regime to that of intellectual propert y and of patents in particular. The Second 
Supplementary Provision of Decision 391 provides that: 
 "The Member Countries shall not acknowledge rights, including intellectual property rights, 
over genetic resources, by-products or synt hesized products and associated intangible 
components [including traditional knowledge], th at were obtained or developed through an 
access activity that does not comply with  the provisions of this Decision. 
  Furthermore, the Member Country affected ma y request nullification and bring such actions 
as are appropriate in countries that have c onferred rights or granted protective title 
documents". 
 In much more specific terms, the Third Supplementary Provision provides that:   "The competent national offices on intellectual pr operty shall require the applicant to give the 
registration number of the access contract and supply a copy thereof as a prerequisite for 
granting the respective right, when they are cert ain or there are reasonable indications that the 
products or processes whose protection is being requested have been obtained or developed 
from genetic resources or their by-products orig inating in any one of the Member Countries.  
The competent national authority and the comp etent national offices on intellectual property 
shall establish systems for exchanging informati on about the authorized access contracts and 
intellectual property rights granted". 
 100. Decision 486 on a Common Industrial Property Regime (14 September 2000) of the Andean 
Community which establishes the legal industrial  property framework (patents, designs, utility 
models, marks, etc.) applicable in the countries of the Andean region is said to consolidate the idea of 
disclosure of origin and legal provenance.  Arti cle 26(h) and (i) of the Decision provides that 
applications for patents shall contain: 
 "(h) if applicable, a copy of the access cont ract, where the products or processes for which 
a patent application is bein g filed were obtained or deve loped from genetic resources 
or by-products originating in any one of the Member Countries; 
 IP/C/W/368/Rev.1 
Page 38  
 
   (i) if applicable, a copy of the document ce rtifying the licence or authorization to use the 
traditional knowledge of indigenous, African American or local communities in the Member Countries, where the products or processes whose protection is being requested were obtained or developed from such knowledge originating in any one of 
the Member Countries, in accordance with the provisions of Decision 391 and the 
amendments and regulations thereto currently in force". 
 Article 75(g) and (h) of Decision 486 provides that a pa tent shall be declared absolutely void if the 
applicant has failed to submit a copy of the access contract or the document certifying the licence or 
authorization for use of traditional knowledge.
202 
101. Peru's Law No 27811 (Law Establishing the Regime for Protection of the Collective 
Knowledge of Indigenous Peoples Re lating to Biological Resources, 10 August 2002) is said to aim, 
through a system of registers, licences and compen satory mechanisms, to achieve a degree of legal 
protection for the traditional knowledge of Peru's indi genous peoples.  In the matter of disclosure of 
origin and legal provenance, the Second Supplementary Provision of Law 27811 provides that: 
 "Where a patent application relates to pr oducts or processes obtained from collective 
knowledge, the applicant shall be required to submit a copy of the licence contract, as a 
prerequisite for the granting of the relevant  right, unless the collective knowledge concerned 
is in the public domain.  Failure to comply w ith this obligation shall be grounds for refusing 
to grant the patent or, where appropriate, declaring it void." 
 
This provision supplements at national level the pr ovisions of Decision 486, specifically with regard 
to the disclosure of the origin and legal provenan ce of traditional knowledge that could form part of 
an invention.203 
102. Peru's Law No. 28216 (Law on Protection of A ccess to Peruvian Biological Diversity and to 
the Collective Knowledge of the Indigenous Peoples, 1 May 2004), under which a National 
Commission for the Protection of Access to Peruvian Biological Diversity and Collective Knowledge 
(commonly known as the Commission for Prevention of Acts of Bio-piracy) was formally established, provides for a series of measures to deal with biop iracy.  The third and fina l supplementary provision 
of the Law defines "biopiracy" as "access to and unauthorized use without compensation of biological 
resources or traditional knowledge of the indigenous people by third parties, without the necessary 
authorization and in contravention of the principles established in the Convention on Biological 
Diversity and the existing rules on the subject.  This  appropriation may come to light through physical 
inspection, through ownership rights in products incorporating such ille gally obtained elements or, in 
some cases, through the invocation of such rights". 
103. The Commission's functions, as defined in Article 4, include the following: 
 "(c) to identify and follow up patent appli cations made or patents granted abroad that 
relate to Peruvian biological resources  or collective knowledge of the indigenous 
peoples of Peru; 
  (d) to make technical evaluations of the patent applications or patent grants referred to in 
the preceding paragraph; 
 
 (e) to issue reports on the cases studied, and to transmit recommendations to the 
competent State authorities; 
                                                     
 
202 Peru, IP/C/W/447, IP/C/M/48, para. 93. 
203 Peru, IP/C/W/447, IP/C/M/48, para. 93.  IP/C/W/368/Rev.1 
 Page 39 
 
 
   
 (f) to lodge objections or institute actions for annulment concerning patent applications 
made or patents granted abroad that relate to Peruvian biological or genetic material 
or the collective knowledge of the indigenous and native peoples of Peru".204 
 
104. Some of the work of the Commission on anal yzing potential cases of biopiracy has been 
described in IP/C/W/441/Rev.1 (with respect to he rcampuri, camu-camu, yacón, caigua, sacha inchi 
and chancapiedra) and IP/C/W/458 (with respect to camu-camu). 
105. Other disclosure requirements established at the national or regional level have been 
mentioned in the Council.  These include, at the re gional level, the Organization of African Unity's 
Model Law for the Protection of the Rights of Local Communities, Farmers and Breeders and the 
Regulation of Access to Biological Resources and Pr eambular paragraph 27 of the European Directive 
on the Legal Protection of Biotechnological Inventio ns (Directive No. 98/44/EC), and, at the national 
level, the laws of Belgium, Brazil, Cost a Rica, India, the Philippines and Venezuela.205 
106. In response to the Peruvian submission, IP/C/W /441/Rev.1, it was noted that the patentability 
of the claimed inventions in the cited, publishe d but pending patent applications had not been 
determined, and, in relation to that point, it was not  clear how the mere filing of a patent application 
could amount to an act of misappropriation.  With resp ect to the patent applications relating to maca, a 
review of the US data base has revealed that all the applications disclosed the country of origin as 
Peru.  Apparently, the inventor s have created new, useful a nd non-obvious inventions from the 
genetic material that fully meet  the patenting criteria under US pa tent law, for example patents 
pertaining to chemically active isolates, chemical  compounds and compositions and not to the plant 
itself.  This is also the case with respect to the patent applications relati ng to chancapiedra as they 
cover novel compositions useful in cosmetics that met the statutory requirements for patentability.  
Thus, while Peru has listed more than thirty speci es of plants from which the active ingredients might 
be derived and that were available from sources throughout the world, it has not identified any 
examples of misappropriation or biopiracy.206   It was also said that after a preliminary check of the 
Japanese patent applications cited, there does not ap pear to be any biopiracy as the genetic resources 
referred to in the document were cultivated worl dwide, including in Japan, and that the negative 
connotation in the words "potential cases of biopiracy" is unwarranted.207 
107. In response, it was said that no case was sought to be made that the mere presentation of a 
patent application constitutes pr oof of misappropriation or biopiracy.  The Peruvian National Anti-
Biopiracy Commission has, in the initial phase of its work, identified approximate ly fifty products for 
which patent applications have been filed.  In a second phase, the Commission would identify the 
applications where the Peruvian National Auth orities consider that there could have been 
misappropriation in order to begin proceedings to refuse the grant of such patent applications.  This is  
a very difficult task since the Peruvian patent syst em grants only five or ten patents annually, thus 
necessitating searches, not within the Peruvian patent system, where there is an obligation to disclose 
origin, but in countries where the majority of pate nt applications are presented and where the large 
corporations carry out research and development usi ng foreign genetic resources.  This demonstrates 
the need for a universal, legally binding patent di sclosure requirement as it would be much easier for 
countries like Peru to search for specific cases, without having to go through expensive legal 
procedures.  With respect to patents involving th e use of maca the Peruvian government would have 
                                                      
204 Peru, IP/C/W/447, IP/C/M/48, para. 93. 
205 India, IP/C/M/48, para. 97;  Peru, IP/C/W/447. 
206 United States, IP/C/M/47, para. 45. 
207 Japan, IP/C/M/49, para. 111, IP/C/M/48, para. 77. IP/C/W/368/Rev.1 
Page 40  
 
  found it impossible to present the cases on revocation of patents in foreign countries were it not for 
international support from non-g overnmental organizations.
208 
108. With regard to the EC Directive (98/44/EC ) on the legal protection of biotechnological 
inventions, it has been said that it was adopted on 6 July 1998 and subsequently transposed into the 
national law of the EU member States.  The preamble of the Directive, in particular recital 27, lays 
down that if an invention is based on biological material of plant or animal origin or if it uses such 
material, the patent application should, where a ppropriate, include information on the geographical 
origin of such material, if known.  This provision is without prejudice to the processing of patent applications or to the validity of rights arising from granted patents.  This provision amounts to an 
encouragement to disclose the geographical origin of  biological material in the patent application, 
along the lines indicated by Article 16(5) of the CBD, as this could be helpful for the process of 
equitable benefit-sharing.
209 
109. It has been said that certain patents granted for claimed inventions involving the use of 
turmeric and neem are examples of problems th at could have been obviated, had a disclosure 
requirement been in place.  Some examples, along w ith other views expressed in relation to them, can 
be found in Section B.2(k) below. 
2. Discussion of the disclosure approach  
110. The discussion of the disclosure approach is grouped under eleven sub-sections.  The first 
records discussion on the issue of how a requirement to disclose origin or source might work and its 
merits and demerits.  The second focuses on similar i ssues in relation to disclosure of prior informed 
consent and benefit sharing.  The third is focused  on the issue of remedies for non-compliance with a 
disclosure requirement, including patent revocation.  The fourth discusses what would trigger a 
disclosure requirement, in particular, the degree of closeness of the relationship between genetic 
resources and traditional knowledge in question and th e invention itself that would be necessary.  The 
fifth is about definitions of terms used such as biopiracy, genetic resources and traditional knowledge.  
The next three treat the subject of the relationshi p of a disclosure requirement with the PCT/PLT, the 
TRIPS Agreement and the CBD.  The last three disc uss the implications of a disclosure requirement 
for achieving prior informed consent and benefit sh aring, for preventing erroneously granted patents 
and for the patent system.  
(a) Disclosure of origin and/or source of genetic resources a nd traditional knowledge 
111. The implementation of a suggested disclosure requi rement with respect to geographical origin 
and/or source of the genetic resources and traditio nal knowledge under the proposals made has been 
discussed.  The proponents of the national-based appr oach have said that proposals for new patent 
disclosure requirements regarding origin and/or s ource would not achieve their purported objectives 
of ensuring appropriate access and equitable benefit sharing, nor the goal of preventing erroneously 
granted patents.  Further, proposals for such new patent disclosure requirements would introduce 
many negative consequences, incl uding the addition of new uncertainties, into the patent system, 
imposing significant administrative burdens on Member s, undermining the role of the patent system 
in promoting innovation, and underm ining potential benefit-sharing.210 
112. In response, it has been said that new patent  disclosure requirements would not only help 
source countries to monitor and keep track of comp liance with access and benefit-sharing rules in a 
                                                      
208 Peru, IP/C/M/47, paras. 71 and 73. 
209 EC, IP/C/M/49, para. 127.  
210 United States, IP/C/W/434, IP/C/W/449.  IP/C/W/368/Rev.1 
 Page 41 
 
 
  cost-effective way211, but would facilitate and simplify the en forcement of obligations under the CBD 
through the provision of incentives on patent applicants for the conclusion of contracts.212  In the view 
of some of the proponents, this applies particular ly where the legal effects include revocation of the 
patent.213  (See also Section B.1.(b) above). 
113. Clarifications have been sought from the proponents of the disclosure approach as to: 
- what the definitions are of "source" and "country of origin" in their proposals and 
how these concepts relate to traditiona l knowledge;  whether it would be necessary 
for patent applicants to disclose both or would disclosure of either one of them be sufficient
214; 
- what would happen if patent applican ts access genetic resources from a source 
different to the country of origin - since there would be situations where the genetic 
resource is indigenous to one country but freely available in several countries - and in such a situation which is the country to be disclosed
215; 
- why the proponents refer only to the country of origin even though Article 15 of the 
CBD refers to the contracting party providing genetic resources216; 
- whether, due to the reference to the "count ry of origin", plant genetic resources for 
food and agriculture under the Internationa l Treaty of FAO would be excluded from 
the proposed disclosure requirement217; 
- who would decide that the country of origin is not known to the patent applicant218; 
- if the patent application were to disclose source, but not origin, or vice versa, how 
would a possible conflict be resolved if the other country came forward to claim a 
share in a benefit-sharing arrangement219; 
- whether there would be a need to disclo se the origin or source when the genetic 
resources are obtained from an ex situ  country or available for legal purchase from 
the market in many countries220; 
- how would a dispute involving plants found transnationally221 and also cultivated in 
the country of patent grant be resolved.222 
                                                      
211 Brazil, IP/C/M/48, para. 38;  Brazil and India, IP /C/W/443;  Brazil et al, IP/C/W/403, IP/C/W/356;  
EC, IP/C/W/228, IP/C/M/46, para. 46, IP/C/M/44, para. 30;  Egypt, IP/C/M/37/Add.1, para. 204;  India, 
IP/C/W/195, IP/C/M/48, para. 52, IP/C/M/40, para. 82;  Peru, IP/C/W/447, IP/C/M/48, para. 18;  Switzerland, 
IP/C/W/423, IP/C/M/42, para. 98. 
212 Switzerland, IP/C/W/423, IP/C/M/42, para. 98. 
213 Brazil, IP/C/M/48, para. 41;  Brazil et al , IP/C/W/403;  India, IP/C/M/40, para. 82. 
214 Switzerland, IP/C/W/446. 
215 Chinese Taipei, IP/C/M/48, para. 89. 
216 Switzerland, IP/C/M/47, para. 76. 
217 Switzerland, IP/C/M/47, para. 76. 
218 Switzerland, IP/C/W/446. 
219 Malaysia, IP/C/M/48, para. 82. 
220 Chinese Taipei, IP/C/M/48, para. 89. 
221 Canada, IP/C/M/48, para. 74. 
222 Japan, IP/C/M/48, para. 77. IP/C/W/368/Rev.1 
Page 42  
 
  114. In response, it has been said that under the TRIPS disclosure proposal, the following would 
apply: 
- although the CBD refers to both "country of origin" and the "country providing 
genetic resources", it is the country of origin that is relevant in the context of prior 
informed consent and access and benefit sharing under the CBD, since genetic 
resources are the property of the country of origin through the recognition of 
sovereign rights under the CBD.
223  Country of origin is defined in the CBD as the 
country, which possesses genetic resources in in situ  conditions.  In situ conditions 
mean conditions where genetic resources exist within ecosystems and natural 
habitats, and, in the case of domesticated or cultivated species, in the surroundings 
where they have developed their distinctive properties224; 
- in accordance with Article 15.5 of the CBD, however, prior informed consent would 
have to be obtained from the country providing the resources, unless otherwise determined by that country.  Black’s Law Dictionary defines source as “a place where 
something is found or whence it is taken or derived;  or a person or a thing that 
originates or sets in motion or is a primary agency in producing any course of action 
or result”.
225  It is for these reasons that di sclosure of both source and country of 
origin are recommended primarily in order to prevent the grant of bad patents that do not fulfil the patentability criteria of novelt y and/or inventive step and to avoid 
misappropriation
226; 
- in cases where the genetic material is available from multiple sources, the source 
would be the country from where the applicant has received the material and the 
country of origin is the country in which the genetic resource is indigenous227; 
- it is within the spirit of the CBD to incl ude the origin of knowledge associated with 
the resources i.e. the country which possesses the genetic resources in in situ  
conditions and/or the associated knowledge with them228; 
- plant genetic resources for food and agricultu re would be included and the disclosure 
requirements applicable would be those w ithin the scope and context of the FAO 
Treaty, although there may be other ways to reflect the concerns expressed in this regard.
229 
115. Also responding to the questions put, it has been said that, under the PCT disclosure proposal, 
the following would apply: 
- if the patent applicant (or inventor) has information at hand about the primary source, 
this must be disclosed; if he has info rmation on the primary and one or several 
secondary sources, the primary source must be disclosed whereas disclosure of the 
secondary ones would be optional;  if he has information about a secondary source 
but not about a primary source, this seconda ry source must be disclosed;  if he has 
information about several secondary sources but not about the primary source, the 
                                                      
223 India, IP/C/M/49, paras. 137-138, IP/C/M/45, para. 53. 
224 India, IP/C/M/49, para. 137. 
225 India, IP/C/M/49, para. 138.  
226 Brazil et al, IP/C/W/459;  India, IP/C/M/49, para. 138. 
227 Brazil et al, IP/C/W/459. 
228 India,, IP/C/M/49, para.138.  
229 Brazil, IP/C/M/48, para. 44;  India, IP/C/M/49, para. 139.   IP/C/W/368/Rev.1 
 Page 43 
 
 
  secondary source with the closest relationship to the primary source must be 
disclosed, but the rest would be optional230; 
- the term "source" should be understood broa dly to cover the terms "Contracting Party 
providing genetic resources", "origin", "geogr aphical origin", "country of origin of 
genetic resources", the Multilateral System es tablished by the International Treaty of 
the FAO, and any other sources that may be relevant231; 
- definitions of "primary" and "secondary" sources are given in the CBD (Articles 15, 
16, 19 and 8(j)) and the International Treaty of the FAO.  Primary sources are the contracting parties providing genetic r esources, indigenous and local communities 
and the multilateral system established by the International Treaty of the FAO.  
Secondary sources are ex situ  collections such as gene banks, botanical gardens, 
scientific literature, and databases on ge netic resources and traditional knowledge
232; 
- the source/s to be declared should be the most appropriate one/s where an entity is 
competent to grant access to genetic res ources and/or traditional knowledge or to 
participate in the sharing of the benefits arising out of their utilization.  If such a 
source is not known, a declaration would be made to this effect.  This is because a 
multitude of entities may be involved in access and benefit sharing and the objective 
of disclosure should be to increase transparency.233  Limiting the number of sources 
permitted to be declared could hinder research activities and could prevent the development of innovations
234; 
- the term "country of origin" is not used because the CBD, in the context of access and 
benefit sharing, refers to "Contracti ng Party providing genetic resources".  
Furthermore, it excludes the International Tr eaty of the FAO, since it is not based on 
a bilateral, country-by-country approach but establishes a multilateral system of 
access and benefit sharing.235 
116. It has been said that, under the mandatory disclosure proposal, the following would apply: 
- the country of origin that would be re quired to be disclosed should, whenever 
possible, be the country which possesses the genetic resources in situ .  However, 
when this country is not known, the patent  applicant's obligation would be to indicate 
the source of the specific genetic resource to which the inventor has had physical 
access and which is known to him.236  This could be the research centre, gene bank or 
entity from which the inventor acquired the resource237; 
- the definition of the "country of origin " is based on Article 2 of the CBD which 
defines this as "the country which possesses those genetic resources in in situ  
conditions".  Admittedly, "country of orig in" does not reflect the wider concept of 
"country providing the genetic resources" reflected in Article 15 of the CBD.  However, the proposal takes this into account  because when the country of origin is 
                                                     
 
230 Switzerland, IP/C/W/433, IP/C/M/45, para. 49. 
231 Switzerland, IP/C/W/423, IP/C/M/44, para. 25, IP/C/M/43, para. 59, IP/C/M/42, paras. 97-99, 
IP/C/M/40, para. 71. 
232 Switzerland, IP/C/W/433, IP/C/M/45, para. 49. 
233 Switzerland, IP/C/W/433, IP/C/M/45, para. 49. 
234 Switzerland, IP/C/W/423, IP/C/M/42, para. 98. 
235 Switzerland, IP/C/M/47, para. 76. 
236 EC, IP/C/M/47, para. 58. 
237 EC, IP/C/M/46, para. 45. IP/C/W/368/Rev.1 
Page 44  
 
  not known to the applicant, it is possible to provide the "source" which can include 
the "country providing the genetic resources"
238; 
- the term "disclosure of source of genetic  resources" is preferred to "geographic 
origin" as, in principle, all applicants s hould know the source of genetic resources or 
traditional knowledge and, in certain circumstances, it might be impossible or 
unreasonably burdensome for the applicant to  investigate the entire chain backwards 
to the origin.  Under the proposal, no a dditional research would be required on the 
applicant's part239 and it is the patent applicant himself who should judge if the 
country of origin is known to him240; 
- problems relating to the fact that genetic  material originates from more than one 
country should be resolved through arrange ments with the source countries concerned 
and in the context of the CBD.241  One way to make the disclosure requirement work 
would be to have national authorities deliver an internationally recognized certificate which would provide evidence of the origin, prior informed consent and 
benefit sharing in one document, as is being discussed in the Access and Benefit 
Sharing Working Group of the CBD.  However, many countries do not yet have 
national legislation on access and benefit sharing and are not in a position to deliver certificates of origin, and the negotiation in  the Working Group is at a very early 
stage.
242 
117. A question was raised as to how benefits would be shared in case of access and use of genetic 
resources  obtained from  ex situ sources.243 
(b) Disclosure of evidence of prior info rmed consent and benefit sharing 
118. The issue of how the suggested requirement to disclose evidence of pr ior informed consent 
and benefit sharing might be implemented has been discussed.  One view has been that: 
- it is not feasible to require, in addition to the declaration of the source of genetic 
resources, evidence of prior inform ed consent and benefit sharing.244  This is because 
patent offices are not capable of verifying this information.  Among other reasons, the 
terms and conditions of a contract woul d remain confidential and are thus not 
accessible to the patent granting authority.245  Such terms may vary with regard to the 
form of benefits shared, the timing and othe r conditions and what is fair and equitable 
may differ on a case-by-case basis246 and patent offices w ould have no way of 
judging fairness or equity.247  (See further discussion on this point in (k) below); 
- determinations by the patent granting or  other national authorities on prior informed 
consent and benefit sharing cannot be easily  reconciled with contractual autonomy, 
                                                      
238 EC, IP/C/M/46, para. 45. 
239 EC, IP/C/M/46, para. 45. 
240 EC, IP/C/M/48, para. 66. 
241 EC, IP/C/W/383. 
242 EC, IP/C/W/383, IP/C/M/48, para. 64, IP/C/M/47, para. 61, IP/C/M/46, para. 45, IP/C/M/44, 
paras. 35-36. 
243 Canada, IP/C/M/49, para. 107. 
244 EC, IP/C/M/44, para. 34;  Norway, IP/C/M/38, para. 244;  Switzerland, IP/C/W/400/Rev.1. 
245 Malaysia, IP/C/M/48, para. 82;  Switzerland, IP/C/W/446, IP/C/W/400/Rev.1. 
246 Malaysia, IP/C/M/48, para. 82;  Switzerland, IP/C/W/446, IP/C/W/400/Rev.1. 
247 Malaysia, IP/C/M/48, para. 82;  Switzerland, IP/C/W/446, IP/C/W/400/Rev.1.  IP/C/W/368/Rev.1 
 Page 45 
 
 
  particularly under the CBD where benefit sharing is to be on mutually agreed terms 
between the provider and user of the genetic resource248; 
- if the country of origin of the relevant traditional knowledge or genetic resources has 
no benefit-sharing infrastructure in place for the use of the traditional knowledge and/or genetic resources, there would not be any compensation to the custodians of 
the relevant knowledge or resource even if  a patent relating to these materials is 
identified
249; 
- it is premature to consider introducing a requirement on prior informed consent and 
benefit sharing since, for the time being, many countries do not possess national regimes to implement access and benefit sharing, nor have those that do made these 
fully operational or effective, they are not in a position to deliver certificates of 
evidence
250; 
- the requirement to provide evidence of prio r informed consent in patent applications 
is particularly problematic with regard  to plant genetic resources for food and 
agriculture covered by the ITPGRFA becau se this treaty does not foresee that prior 
informed consent must be obtained.  If this requirement is to be introduced, it would 
have to apply only to gene tic resources covered by the CBD and not covered by the 
ITPGRFA.  In such a case, patent-granting authorities would not only have to verify 
whether the provided evidence is correct but  also whether the genetic resources in 
question were obtained according to the provisions of the CBD or ITPGRFA251; 
- the PCT disclosure proposal appears to recognize the shortcomings of a disclosure 
requirement in ensuring that the objectives of the CBD are met by suggesting that the 
proposal be implemented in conjunction with an apparen tly multilateral system of 
notification, in which national patent o ffices would identify and notify points of 
contact designated to receive such information in other governments.252  I n  t h e  
context of this proposal, a clarification was sought as to who would determine which 
would be the designated government agencies and what would be their role253; 
- there is some incoherence in the TRIPS disclosure proposal between "requiring, as a 
condition for acquiring patent rights, that  applicants furnish evidence of prior 
informed consent" and "requiring applicants  to provide information known to them or 
which they should reasonably know".254 
119. The following questions ha ve also been raised: 
- Who determines whether the requirements of  benefit sharing have been met by the 
applicant:  the patent authority or the na tional authority where the genetic resource 
originated?255  If it is the patent authority, or even the courts of the country where the 
                                                      
248 Switzerland, IP/C/W/446. 
249 United States, IP/C/W/434, IP/C/M/46, para. 31. 
250 Australia, IP/C/M/36/Add.1, para. 222;  EC, IP/C/M/47, para. 62, IP/C/M/44, paras. 33 and 37;  
New Zealand, IP/C/M/47, para. 53. 
251 Switzerland, IP/C/W/400/Rev.1. 
252 United States, IP/C/W/434. 
253 Canada, IP/C/M/49, para. 109. 
254 EC, IP/C/M/47, para. 60.  
255 Switzerland, IP/C/W/446. IP/C/W/368/Rev.1 
Page 46  
 
  patent authorities are located, how would su ch authorities be able to judge adherence 
to laws that are outside their own jurisdiction?
256 
- Would the national legislation of the country of origin also be applicable to traditional 
knowledge, or would it be up to the indige nous and local community to determine 
whether the sharing of benefits is "e quitable and fair in the circumstances"?257  Who 
would decide whether the prior inform ed consent of local and indigenous 
communities is necessary and how would such procedures be carried out in practice by patent applicants?
258 
- With respect to certification systems of compliance at the national or international 
levels, how would this address cases where the beneficiaries are not clearly 
identifiable or if the source of origin is unknown?259 
- If benefit sharing cannot take place, coul d the patent application still continue?260 
- Would the three requirements mean that th ree separate documents should be given to 
the patent office?261 
- Would evidence of benefit sharing have to be disclosed in regard to the provider of 
genetic resources or to the provenance of genetic resources?262 
- How could patent applicants fulfil, in pr actice, the requirement of indicating how the 
national authorities would enforce arrangeme nts to ensure future benefit-sharing 
arrangements without having to resort to expensive litigation?263 
120. In response it has been said that: 
- it is the laws and practices of the country of origin that would provide the framework 
for determining whether appr opriate benefit-sharing arra ngements have been entered 
into.  It is national authorities implementi ng such laws who would determine what is 
equitable and fair, in accordance with the CBD264; 
- the burden on patent offices would be r easonable since in order to invoke liabilities 
and sanctions, it would have to be proven by the country providing access that the 
evidence produced is false or that benefit shar ing has not been fair and equitable.  If it 
is false, the opponent must produce evidence before the patent office to prove this. 
The patent office would take a final decision in this matter, just as in the case of any 
other false document produced before it, following the provisions of the patent law. If it is alleged that the benefit sharing has not  been fair and equitable, the opponent must 
take appropriate action under the domestic access and benefit-sharing regime in the 
relevant domestic jurisdiction and produce th e result of this to the patent office, 
                                                     
 
256 Canada, IP/C/M/49, para. 108;  Malaysia, IP/C/M/47, para. 81. 
257 Switzerland, IP/C/W/446. 
258 EC, IP/C/M/48, para. 65;  Switzerland, IP/C/W/446. 
259 Malaysia, IP/C/M/47, para. 81. 
260 Malaysia, IP/C/M/47, para. 81. 
261 EC, IP/C/M/48, para. 63. 
262 Malaysia, IP/C/M/44, para. 40. 
263 Switzerland, IP/C/W/446. 
264 India, IP/C/M/48, para. 97.  IP/C/W/368/Rev.1 
 Page 47 
 
 
  which would have to accept this.  Thus the patent office would not need to interpret 
foreign laws on access265; 
- a reporting obligation would bind the person seeking access to inform the 
communities and/or the national authorities of all instances of commercialization and 
patenting. If this information is not given and if the benefits arising out of such 
utilization are not shared, it is clear that ther e is no fair and equitable benefit sharing. 
Any dispute in this regard would be addr essed to the appropriate national authority 
under the access and benefit sharing laws and not to the patent office266; 
- contractual autonomy envisaged under the CBD  is subject to prior informed consent 
and fair and equitable benefit sharing a nd cannot be used as an argument not to 
implement CBD provisions267; 
- whether traditional knowledge is included in the access and benefit-sharing regime is 
a matter for national policy.  Similarly, wh ether prior informed consent of the local 
and indigenous communities is necessary depends upon the national policy of the 
country of origin/ the country providi ng genetic resources and also upon whether 
there is traditional knowledge associated with  the concerned resource and whether the 
communities indicated are the source of the resources.  If the knowledge and/or the resources rest with the communities and the domestic law mandates prior informed consent from them, the person seeking access to the resources or traditional 
knowledge would have to ensure that pr ior informed consent is obtained from 
them
268; 
- while it is true that the quality of implem entation of the disclosure approach could be 
enhanced through the building of better netw orks between designated focal points in 
various countries and clearing-house mechan isms established at the international 
level, this does not negate the need for the disclosure requirements nor dilute the contribution it could make to improving the access and benefit-sharing system and to 
the patent system.
269 
(c) Remedies for non-compliance with disclosure requirements, including patent revocation 
121. The issue of remedies for non-compliance with  disclosure requirements, including revocation 
or invalidation of the patent, has been discussed.  The need for such a re medy has been questioned 
and concerns have been raised about its implica tions for the effective functioning of the patent 
system.270  One view that has been expressed is that: 
- instead of attempting to single out patent a pplications and trying to deal with them 
with new patent disclosure requirements that may negatively affect technological 
development, a more appropriate solution would be strengthening national regimes 
outside the patent systems in order to ta ke a comprehensive, holistic approach and 
address all instances of commercialization of misappropriated resources and/or 
                                                      
265 Brazil and India, IP/C/W/443;  India, IP/C/M/49, paras. 141-142  
266 India, IP/C/M/49, paras. 141-142. 
267 India, IP/C/M/49, para. 144.  
268 India, IP/C/M/49, para. 144. 
269 Brazil, IP/C/M/48, para. 39. 
270 EC, IP/C/W/383, IP/C/M/44, para. 32, IP/C/M/38, para. 247;  Korea, IP/C/M/49, para. 121;  Japan, 
IP/C/M/49, para. 110;  Switzerland, IP/C/W/423;  United States, IP/C/W/449. IP/C/W/368/Rev.1 
Page 48  
 
  traditional knowledge that need to be a ddressed outside the patent system in any 
event
271; 
- it has not been shown that legal conseque nces other than those based in the patent 
system would not have a sufficient deterrent  effect on patent applicants who may not 
respect disclosure requirements272; 
- it is not clear what circumstances woul d justify the proposed sanctions of the 
revocation of the patent or the full or par tial transfer of the rights to the invention 
under the TRIPS disclosure proposal273 nor which rights could be foreseen to be 
partially transferred and who would be th e appropriate recipient of such rights.274 
122. In response it has been said that: 
- the consequence of failure to disclose/wr ongful disclosure should be addressed within 
the patent system as leaving it outside the patent system would nullify the disclosure requirement and reduce it to a mere formality.
275  This is because there would be no 
effective remedy to deliberate non-complian ce by a patent applicant with the access 
and benefit-sharing regime and no other means of effectively ensuring that the 
providers are given back a share of the profits for the contribution they have made to 
the market value of the claimed invention276; 
- while invoking fines or other penalties outside the patent system in cases of non-
compliance with the disclosure requirement w ould not affect the material outcome of 
patent applications, the intended objectives of requiring disclosure would not be met 
as they would not have the necessary de terrent effect against misappropriation.277  
However, in cases where it is found that pr ior informed consent and benefit sharing 
have taken place even when the required disclosure was not made, other kinds of 
penalties, outside the patent system, could be foreseen278; 
- revocation or invalidation would only be a pplicable in cases wh ere, for fraudulent 
reasons, there is failure to disclose eviden ce of prior informed consent and benefit 
sharing.  This would be similar to existing procedures in the patent system with 
regard to cases of revocation where fraudulen t intention is found for insufficient, 
wrongful or lack of disclosure and where it is determined that proper disclosure of 
information would have led to the refusal to  grant the patent either on the grounds of 
lack of novelty due to the existence of prior art or on grounds of ordre public  or 
morality279; 
- forms of commercialization, other than th rough patents, would be dealt with under 
national access and benefit-sharing regimes.  It does not follow that, since a patent 
                                                      
271 United States, IP/C/W/449. 
272 EC, IP/C/W/383, IP/C/M/44, pa ra. 32, IP/C/M/38, para. 247. 
273 Chinese Taipei, IP/C/M/46, para. 71;  Switzerland, IP/C/W/446. 
274 Canada, IP/C/M/49, para. 108. 
275 Brazil et al, IP/C/W/403;  China, IP/C/M/39, para. 135;  India, IP/C/M/40, para. 82, IP/C/M/39, 
para. 138, IP/C/M/38, para. 232. 
276 India, IP/C/M/49, para. 145. 
277 Brazil, IP/C/M/48, para. 41. 
278 Brazil, IP/C/M/48, para. 41. 
279 Brazil, IP/C/M/48, para. 41;  Brazil et al, IP/C/W/459.  IP/C/W/368/Rev.1 
 Page 49 
 
 
  disclosure requirement would not cover all instances of commercialization, such a 
requirement is not necessary280; 
- it would not be reasonable for Members to gr ant or maintain patents if an invention 
has infringed the rights of local people a nd has obtained genetic resources through 
biopiracy.281  Yet, there may be no national level regulation in some countries that 
places restrictions on the use of patent rights acquired without respecting CBD-
related obligations, other than costly re vocation proceedings within the patent 
system.282 
123. The consequences for benefit sharing of sanc tioning patent revocation for non-compliance 
with disclosure requirements have been discussed.  One view has been that this would reduce the 
benefits available to be shared for the following reasons: 
- if a patent were issued, but later invalidat ed, or if an application were published but 
never issued, the invention would have been  disclosed to the public and third parties 
would be free to use and commercialize the knowledge or resources disclosed without any obligation to share benefits
283; 
- such a requirement could deter an inventor  from seeking a patent and if a patent is 
never issued and the information never publis hed, the inventor may still be able to 
commercialize the invention without disclosing the invention to the public and without any obligation to share benefits
284; 
- if a patent applicant has entered into a valid benefit-sharing agreement with the 
custodians of the traditional knowledge or genetic resources but, due to uncertainties 
in the law, such disclosure is found to be i nvalid or if there is improper disclosure that 
results in revocation of a patent due to litig ation by a third party not affiliated with a 
traditional knowledge or genetic resources hol der, this could upset the pre-existing 
benefit-sharing agreement. 
Thus, the remedy proposed could itself destroy, or have significant negative consequences on, the 
benefit being sought.285  The rejection of the patent applicati on or the invalidation of the patent would 
neither be in the interest of innovation nor of  those who expect to share in the benefits.286  On the 
other hand, patents, in combination with an e ffective national access and benefit-sharing regime, 
could be a valuable tool to generate benefits that could later be shared.287 
124. In response it has been said that, while it is true that benefits from an invention would be 
diminished if patents are not issued, or are revoke d, and inventions are commercialized, this is no 
different from situations involving any invention or  patent and is not limited to patents involving 
disclosure of the country and source of origin.  Su ch situations could be dealt outside the patent 
                                                      
280 Brazil et al, IP/C/W/459. 
281 China, IP/C/M/39, para. 135. 
282 India, IP/C/M/48, para. 53. 
283 United States, IP/C/M/40, para. 122, IP/C/M/39, para. 131. 
284 Canada, IP/C/M/37/Add.1, para. 232;  EC, IP/C/M/48, para. 63;  Japan, IP/C/M/48, para. 75, 
IP/C/M/40, para. 97, IP/C/M/32, para. 142;  Korea, IP/C /M/46, para. 53, IP/C/M/32, para. 140;  United States, 
IP/C/W/434, IP/C/W/209, IP/C/M/46, para. 28, IP/C/M/45, para. 44, IP/C/M/39, paras. 128-129 and 131, IP/C/M/37/Add.1, para. 235. 
285 United States, IP/C/W/449. 
286 United States, IP/C/W/434. 
287 Australia, IP/C/M/47, para. 55;  United States, IP/C/W/434, IP/C/M/47, para. 47, IP/C/M/46, 
paras. 24-25, IP/C/M/40, para. 122. IP/C/W/368/Rev.1 
Page 50  
 
  system, using other legal means to rectify the damage.
288  For example, the product could be 
commercialized by the communities themselves (in case of invalidation) or competition could be 
introduced in the market place with those w ho commercialize it (in cases of commercialization 
without patent rights).289   Such situations would have to be  addressed within the national regimes in 
conjunction with other international rules outside th e patent system including, where applicable, by 
addressing issues relating to trade secret laws or competition laws.290 
(d) Trigger for disclosure 
125. The issue of the degree of closeness of the relationship between genetic resources and 
traditional knowledge in question and the inventio n itself that would be necessary for the disclosure 
requirement to be applicable has been raised (referre d to as "trigger for disclosure").  In this respect 
one view is that: 
- it would be difficult to determine the degree of closeness of the relationship between 
the claimed invention and the relevant genetic resources or traditional knowledge 
where it would be necessary to disclose origin or source291; 
- the proposal in the TRIPS disclosure proposal that the trigger for disclosure be "any 
use", even "incidental use", goes too far292; 
- the resources and knowledge related to an invention may be multifarious and the 
process of inventing sometimes involves different raw materials, including the compounds extracted from plants.  Therefore, certain terms used in the patent application, such as "derived from", "use d in" and "based on" c ould have unintended 
specific and legal implications related to the trigger for disclosure.
293 
126. Clarification has been sought as to whether: 
- the term "immediate" used in the PCT disclosure proposal, where it is proposed that 
disclosure be required in cases where the invention has made "immediate use" of the genetic resource, denotes a time dimension rather than the making use of a specific property of the genetic resource
294; 
- if the proposed declaration of source could be made to any one of the entities 
involved in granting access to genetic res ources and traditional knowledge or as many 
as could be identified, it is not clear what  the consequence of inadvertently leaving 
some out in patent applications would be.295 
127. In response, it has been said that296: 
- the invention would have had to have ma de immediate use of the genetic resource 
and that the inventor must have had physical access to this resource, i.e., the inventor 
must have possessed, or at least have had contact which is sufficient to identify the 
                                                      
288 Brazil and India, IP/C/W/443;  India, IP/C/M/47, para. 36. 
289 Brazil and India, IP/C/W/443. 
290 Brazil and India, IP/C/W/443. 
291 United States, IP/C/M/46, paras. 27-28. 
292 EC, IP/C/M/46, para. 47. 
293 Chinese Taipei, IP/C/M/48, para. 89. 
294 Malaysia, IP/C/M/44, para. 41. 
295 Malaysia, IP/C/M/44, para. 41. 
296 Switzerland, IP/C/W/423, IP/C/M/45, para 48.  IP/C/W/368/Rev.1 
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  properties of the genetic resources that were  relevant for the invention.  Thus, for 
example, the source of a plant would have to be declared in the patent application if the corresponding invention related to a ch emical compound which the inventor had 
extracted from this plant; 
- with regard to traditional knowledge, the proposed new rule would require that the 
inventor know that the invention is "dir ectly based" on this knowledge, i.e., had 
consciously derived the invention from th is knowledge.  Since traditional knowledge 
is of an intangible nature, physical access is not possible and therefore would not be a 
prerequisite.  This is intended to avoid case s where, for example, the inventor uses a 
chemical compound derived from a plant to  develop a new pharmaceutical, without 
knowing that an indigenous community had knowledge concerning the 
pharmaceutical use of the plant; 
- the term "directly" should have no time dimension; - according to the CBD, the Bonn Guidelines a nd the International Treaty of the FAO, 
a multitude of entities may be involved in acces s and benefit sharing.  To take into 
account this multitude of entities, it is proposed to require patent applicants to declare 
the source of genetic resources and traditiona l knowledge in patent applications, the 
term "source" being underst ood in its broadest sense possible to include both primary 
and secondary sources.  Only if the patent applicant (or the inventor) has no information at hand about the primary or secondary source, may he disclose that such source is unknown.  Consider ing the broad unde rstanding of the term "source," cases 
where neither a primary nor a secondary source is known are likely to be rare.
297 (See 
also Section IV. B. 2(a) above.). 
(e) Use of terms:  biopiracy and misappropriation, genetic materi al or genetic resources and 
traditional knowledge or know ledge, innovations and practices 
128. There has been some discussion on the use of term s.  The issue of the definition of the terms 
"biopiracy" and "misappropriation" has been raised.298  In response, it has been said that these terms 
have been used variously to refer to illegal and/or  illegitimate acts with respect to the acquisition and 
use of genetic resources and traditional knowledge from developing countries.  The term "piracy" is 
defined in Black's Law Dictionary as the "unaut horized and illegal reproduction or distribution of 
materials protected by copyright, patent, or trademark law".  In A Treatise on the Law of Property in 
Intellectual Productions , Eaton S. Drone states that "The test of  piracy [is] not whether the identical 
language, the same words, are used, but whethe r the substance of the production is unlawfully 
appropriated".  It has been said that the term biopira cy is, in many ways, similar to the term "piracy" 
and involves misappropriation.  The definition of these terms is not a precondition for the 
establishment of a disclosure obligation just as the lack of an agreed WTO definition of the term 
"piracy" did not stop WTO Members from including in the TRIPS Agreement extensive enforcement 
provisions.299  When asked why the definition of the terms "biopiracy" and "misappropriation" was 
limited only to acts taking place in developing countries300, it was clarified that this was stated as a 
fact and not as a part of the definition.301 
                                                      
297 Switzerland, IP/C/W/433. 
298 Switzerland, IP/C/W/446, IP/C/M/47, para. 76. 
299 Brazil, IP/C/M/48, para. 42. 
300 Canada, IP/C/M/48, para. 74. 
301 Brazil, IP/C/M/48, para. 42. IP/C/W/368/Rev.1 
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  129. It has also been said that Peru's Law on Protec tion of Access to Peruvian Biological Diversity 
and to the Collective Knowledge of the Indigenous Peoples (Law No. 28216) contained a definition of 
biopiracy (see Section IV.B.1.(c) of this note).  In addition, at website:  www.biopirateria.org, there is another definition that biopiracy is "illegal or unauthorized access to and use of biodiversity 
components (mainly genetic and biological resources)  and associated traditional knowledge, as part of 
development and research processes and application of  biotechnology".  It is also associated with 
innovations protected by intellectual property rights (especially patents) and that incorporate these 
components or indigenous knowledge obtained directly  or indirectly without prior consent of or 
authorization from their owners".
302 
130. It has also been said that the Action Group on Erosion, Technology and Concentration (ETC 
Group) defined biopiracy as "the appropriation of the knowledge and genetic resources of farming and 
indigenous communities by individuals or institu tions seeking exclusive monopoly control (usually 
patents or plant breeders' rights) over th ese resources and knowledge".  WIPO defined 
misappropriation as "any acquisition, appropriation or utilization of traditional knowledge by unfair or 
illicit means.  Misappropriation may also include deriving commercial benefit from the acquisition, 
appropriation or utilization of traditional knowledge when the person using that knowledge knows or 
is negligent in failing to know, that it was acqui red or appropriated by unfair means; and other 
commercial activities contrary to honest practices that gain inequitable benefit from traditional 
knowledge".  In the light of this, these two terms were used interchangeably.303 
131. Clarifications have been sought as to why proposals made had referred to "biological 
resources" and "biological material" instead of "gen etic resources", which is the terminology used in 
the CBD, the Bonn Guidelines and the Internatio nal Treaty of FAO in the context of access and 
benefit sharing.304 
132. With respect to whether the terms used should be "genetic resources" or "genetic material" or 
"biological materials", it has been said that the te rms "biological resources" and "genetic resources" 
have been used interchangeably in national legi slation, international fo rums and some regional 
arrangements.305 
133. It has also been said that under the CBD, genetic  resources are defined to be genetic material 
of actual or potential value, where genetic material means any material of plant, animal, microbial or 
other origin containing functional units of heredity .  On the other hand, biological resources are wider 
in scope and are defined to include  genetic resources, organisms or parts thereof, populations, or any 
other biotic component of ecosystem with actual or potential use or value for humanity.  Therefore, 
biological resources may refer to those that exist in  natural or crude form and to whole organisms, 
including human beings, while genetic resources are obtained only after some value addition such as 
through isolation from a particular biological r esource. Most of the developing, mega-diverse 
countries do not have the capacity to isolate the va luable components and therefore provide access to 
biological resources in their crude or natural stat e and to the knowledge associated with their use. 
Since the definition of biological resources includ es genetic resources, these terms should not create 
any confusion in the context of the new disclosure requirements.306 
134. With regard to the terms "knowledge, innovatio ns and practices" and "traditional knowledge", 
it has been said that these should be treated as synon ymous to ensure consistency with the CBD, the 
Bonn Guidelines and the International Treaty of FAO.  Based on international instruments the 
                                                      
302 Peru, IP/C/M/48, para. 93. 
303 India, IP/C/M/49, para. 136. 
304 Switzerland, IP/C/W/446, IP/C/M/49, para. 139. 
305 Switzerland, IP/C/W/423. 
306 India, IP/C/M/49, para. 139.  IP/C/W/368/Rev.1 
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  relevant knowledge, innova tions and practices must be related to or be associated with the genetic 
resources.  It has been suggested that, since th e proposed measure is under patent law, the focus 
should be the knowledge, innovations a nd practices that can give rise to a technical invention.  Other 
forms of knowledge should be beyond the scope of application of this measure.307 
(f) Relationship with the Patent Co-ope ration Treaty, Patent Law Treaty 
135. The question has been raised about the impli cations of the TRIPS and mandatory disclosure 
proposals for the PCT and PLT of WIPO.308 
136. In response it has been said that: 
- there could be many options with respect to the PCT and PLT, including that taken by 
the proponents of the PCT approach in thei r proposal and these could be discussed in 
the appropriate WIPO  bodies309; 
- in the TRIPS Council the issue is the discharge of a mandate under the WTO work 
programme, not developments elsewhere.  It is foreseen that the implementation of the disclosure obligation, once agreed and defined under the TRIPS Agreement, could 
also facilitate action elsewhere.  However,  changes elsewhere without the proposed 
changes to the TRIPS Agreement would no t be sufficient to address either the 
mandate given or the problem that is to be addressed , as a disclosure obligation for 
WTO Members cannot be established through non-WTO instruments.
310  Thus, the 
proposed amendment to PCT regulations s hould be seen not as a substitute for the 
amendment to the TRIPS Agreement, but as an addition to it311; 
- a solution through establishment of transparency measures alone would not meet the 
objectives of establishing rights and obligations requiring prior informed consent, 
benefit sharing and disclosure of source or origin of genetic resources and/or 
traditional knowledge used in inventions.312 
137. The view has been expressed that the proposal to amend the regulations under the PCT of 
WIPO would not be very useful in respect of those Members that are not WIPO contracting parties.313 
(g) Relationship with the TRIPS Agreement 
138. As regards the consistency of a disclosure requi rement with the TRIPS Agreement, one view 
is that: 
- substantive patentability criteria are set out  in Article 27.1 and Article 29 lays down 
obligations that must or can be imposed on patent holders in order to check whether patentability criteria have been met.  The existing disclosure rules in Article 29 are 
directly related to determining whethe r an invention meets the standards of 
patentability and to disclosing the technolog y for which patent protection is being 
                                                     
 
307 Switzerland, IP/C/W/423. 
308 Canada, IP/C/M/49, para. 107;  Switzerland, IP/C/W/446, IP/C/M/48, para.16, IP/C/M/47, para. 76. 
309 EC, IP/C/M/49, para. 128, IP/C/M/48, para. 66. 
310 Brazil, IP/C/M/48, para. 45. 
311 Brazil, IP/C/M/47, para. 83;  Colombia, IP/C/M/45, para. 39.  
312 Dominican Republic, IP/C/M/40, para. 110. 
313 Chinese Taipei, IP/C/M/46, para. 71. IP/C/W/368/Rev.1 
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  sought to enable others to reproduce it and learn from it.
314  The new disclosure 
requirements proposed under the mandatory disclosure approach should not act as an additional substantive patentability criterion
315, as none of them, including 
information indicating country of origin, ai m to ensure compliance with patentability 
requirements such as proper inventorship, novelty or inventive step316; 
- a disclosure requirement applicable to only some fields of technology might also 
conflict with Article 27.1 which provides fo r non-discrimination in patent availability 
between fields of technology317; 
- such disclosure requirements would also be contrary to Article 62.1 of the Agreement 
which only provides for "reasonable procedures and formalities"318 and would modify 
the balance of rights and obligations found in the TRIPS Agreement319; 
- it is not clear if the proposed amendmen t to the TRIPS Agreement with respect to 
disclosure that allows revocation of a patent would impact on Members' other 
exisiting obligations under this Agreement.320 
139. In response, it has been said that: 
- the TRIPS Agreement provides Members with  adequate flexibility and allows for the 
disclosure of source as proposed in the context of the PCT321 or a disclosure of origin 
requirement322, as long as failure to disclose does not result in invalidation of the 
patent; 
- Article 29 does not preclude imposition of additional requirements for disclosure as 
long as the provisions are "reasonable" as provided for in Article 62.1323; 
- several countries have already establish ed such requirements in their national 
legislation as a means of implementing the CBD and there would be legal certainty if the TRIPS Agreement were amended accordingly.
324  The WTO has recognized the 
need to reconcile health, sa fety and other regulatory standards with trade rules as seen 
from the Agreements on SPS and TBT.  There is no reason why a similar 
reconciliation should not take place between TRIPS and the CBD325; 
- the proposed modification to the TRIPS Agre ement would not violate the principle of 
non-discrimination as to the field of technol ogy in Article 27.1 because the inherent 
difference in patent applications covering inventions using biological resources and 
                                                      
 314 EC, IP/C/W/383, IP/C/M/44, para. 29, IP/C/M/43, para. 37, IP/C/M/42, paras. 107-108, IP/C/M/39, 
para. 127, IP/C/M/37/Add.1, para. 228;  Japan, IP/C/M/ 46, para. 77, IP/C/M/40, para. 97, IP/C/M/39, para. 137, 
IP/C/M/37/Add.1, para. 216, IP/C/M/36/Add.1, para. 225, IP/C/M/29, para. 155;  Norway, IP/C/M/39, 
para. 120;  United States, IP/C/M/30, para. 177.  
315 EC, IP/C/M/42, para. 108, IP/C/M/37/Add.1, para. 228. 
316 United States, IP/C/W/434, IP/C/M/46, para.26. 
317 Japan, IP/C/M/29, para. 155. 
318 Japan, IP/C/M/29, para. 155. 
319 United States, IP/C/W/434, IP/C/M/48, para. 25. 
320 Canada, IP/C/M/49, para. 108. 
321Switzerland, IP/C/M/42, para. 99. 
322 Norway, IP/C/M/40, para. 86. 
323 India, IP/C/M/37/Add.1, para. 224, IP/C/M/36/Add.1, para. 214. 
324 India, IP/C/W/198, IP/C/W/195, IP/C/M/29, para. 165. 
325 India, IP/C/M/48, para. 53.  IP/C/W/368/Rev.1 
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  associated traditional knowledge makes add itional conditions on patent applicants 
necessary to enable better assessment of such applications326; 
- the objectives in Articles 7 and 8 and principles of the TRIPS Agreement would 
justify the need for evidence of  prior informed consent to be available in the patent 
system thus establishing a mutually s upportive and harmonious relationship between 
the TRIPS Agreement and the CBD.327  It would encourage the development of the 
biotechnology industry, while taking into account the objectives of the TRIPS Agreement to promote biotechnological innova tion and the transfer and dissemination 
of technology to the mutual advantage of producers and users of technological knowledge.
328  Further there is a mandate under the Doha Declaration to fully take 
into account the development dimension.329  With regard to benefit sharing, the 
disclosure proposal is a means to avoid monopolies being created where none is envisaged in the patent system, allowi ng market forces to play their role
330; 
- it is not sufficient to have the option to require the requisite disclosure at the national 
or regional level.331  It is necessary to link these elements to existing disclosure 
requirements in the TRIPS Agreement.332  Incorporation of such an obligation in the 
TRIPS Agreement and its enforcement thr ough the WTO dispute settlement system 
would provide a mechanism to help ensu re compliance with the prior informed 
consent/benefit-sharing rules of the CBD.333 
(h) Relationship with the CBD 
140. With regard to the issue of the relationship of the disclosure requirement with the CBD, it has 
been said that: 
- the disclosure proposal goes beyond the requirements of the CBD.  The CBD leaves it 
to each country to establish its own system for controlling access to genetic resources and benefit sharing, without being pr escriptive about how this should be done.
334  It 
does not even mention patent disclosure requirements.  It only calls upon parties to 
condition access to genetic resources on prior informed consent and to encourage the 
equitable sharing of benefits arising from the utilization of genetic resources upon 
mutually agreed terms335; 
- the CBD has a mandate to elaborate and negotiate an international regime on access 
to genetic resources and benefit sharing.  One outcome of the CBD process has been the Bonn Guidelines.  After CBD parties gain experience from implementation of 
these Guidelines, they will have a better understanding on how to promote prior 
                                                     
 
326 Brazil et al, IP/C/W/403;  India,  IP/C/M/40, para. 82, IP/C/M/37/Add.1, para. 224. 
327 Brazil et al, IP/C/W/438;  Peru, IP/C/M/46, para. 50. 
328 Brazil, IP/C/M/37/Add.1, para. 236. 
329 Brazil, IP/C/M/43, para. 61;  India, IP/C/M/47, para 40;  Peru,  IP/C/M/47, para. 72, IP/C/M/43, 
para. 45. 
330 India, IP/C/M/46, para. 42. 
331 Peru, IP/C/M/48, para. 92. 
332 Brazil et al, IP/C/W/438;  India, IP/C/M/46, para. 42. 
333 African Group, IP/C/W/404, IP/C/W/206, IP/C/M /40, para 78;  Brazil, IP/C/W/228;  India, 
IP/C/M/29, para. 160;  Norway, IP/C/W/293, IP/C/M/35, para. 237;  Pakistan, IP/C/M/42, para. 112;  Peru, 
IP/C/M/48, para. 92. 
334 EC, IP/C/W/254;  Japan, IP/C/W/236;  Singapore, JOB(00)/7853, IP/C/M/29, para. 168. 
335 United States, IP/C/W/449, IP/C/M/48, para. 25, IP/C/M/47, para 42. IP/C/W/368/Rev.1 
Page 56  
 
  informed consent, access to genetic res ources and related trad itional knowledge, and 
equitable benefit sharing
336; 
- the disclosure approach does not address the fact that an access and benefit-sharing 
infrastructure in a country and a mechan ism for the resolution of disputes are 
necessary to enable the sharing of such bene fits.  Members appear to share the view 
that national, contract-based access and benefit-sharing systems are essential 
elements of any solution337; 
- effective implementation of the CBD objectives requires a combination of legislative 
and/or regulatory approaches setting the general rules, including the disclosure and contractual approaches.
338 
141. In response it has been said that: 
- the CBD does not create obligations on patent disclosure requirements because it is 
not an intellectual property agreement339; 
- mandatory furnishing of evidence of prior informed consent by patent applicants 
would facilitate the monitoring of access and be nefit sharing, and, with other laws on 
the enforcement of the provisions of the CBD, would ensure transparency in the 
administrative procedures for the grant of a patent340; 
- there is a significant international dimension to the question of the mutual 
supportiveness of the CBD and the TRIPS Agreement.  Article 5 of the CBD 
envisages international cooperation with comp etent international organizations.  The 
WTO sets minimum standards for patents based on biological resources and/or 
traditional knowledge and is therefore the competent international organization with 
respect to cross-border biopiracy and misappropriation.341 
142. See also the views reflected in paragraph 18 of this note. 
(i) Implications for prior informed consent and benefit sharing 
143. The issue of whether a disclosure requirement to submit evidence of prior informed consent 
or benefit sharing is necessary or desirable to secure the implementation of prior informed consent 
and benefit sharing has been discussed.  In support of  the view that such a disclosure requirement is 
neither necessary nor desirable342, the following reasons have been given: 
- patent disclosure requirements per se  cannot ensure prior informed consent or transfer 
benefits as such requirements would mere ly convey the information requested and 
would have no mechanism to tran sfer benefits between parties343; 
                                                      
336 Switzerland, IP/C/M/45, para. 47;  United States, IP/C/W/449, IP/C/M/49, para. 94. 
337 Australia, IP/C/M/46, para. 65; United States, IP/C/W/434, IP/C/M/46, para. 25, IP/C/M/39, 
para. 131, IP/C/M/37/Add.1, para. 235. 
338 EC, IP/C/M/47, para 60; Switzerland, IP/C/M/46, para. 75. 
339 India, IP/C/W/459, IP/C/M/49, para. 87, IP/C/M/48, para. 49. 
340 India, IP/C/M/47, para. 35. 
341 India, IP/C/M/47, para. 35. 
342 Australia, IP/C/M/47, para. 55;  United St ates, IP/C/W/434, IP/C/M/40, para. 124. 
343 United States, IP/C/M/40, para. 122.  IP/C/W/368/Rev.1 
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  - patent disclosure requirements would be ineffective in enforcing a country's access 
and benefit-sharing regime where those w ho utilize genetic resources or traditional 
knowledge in their commercial products do not apply for a patent in the first place.  
This may occur because there are many ways of protecting ideas other than through patents, that lead to commercialization of products, including through trade secrets 
and unfair competition laws.
344  It may also occur because the product is not 
protectable in the source country.  For inst ance, neither herbal remedies nor plant 
varieties may be patentable in a particular country345; 
- only contractual obligations that establis h the rights and obligations of the entities 
involved prior to any access to genetic resources could ensure that prior informed 
consent is achieved.346  Countries could establish systems of prior informed consent, 
such as permit systems that impose civil and/or criminal penalties for extracting 
genetic resources without a permit, so th at the permit would serve as evidence of 
prior informed consent.347 (see further discussion under Section A above); 
- patent applicants with the intent of ac ting in bad faith would not be deterred by 
disclosure requirements348; 
- such disclosure requirements would lead to  undue burdens on applicants seeking to 
comply with them, and may discourage applicants from seeking protection and 
encourage them to keep their inventions secret.  This, in turn, could also undermine any potential benefit sharing and therefore be ineffective in achieving its objective
349; 
- such disclosure requirements, particularly  where the sanction proposed is revocation 
of the patent right, would provide an additional avenue to litigation and cause 
uncertainties that would undermine the role of the patent system, which again would 
have a negative effect on any benefit sh aring that could be derived therefrom350; 
- work at the international level might be  better focused on a limited number of issues 
that are likely to attract consensus such as disclosure of source or origin and not on 
evidence of prior informed consent and benefit sharing.351   International efforts 
should focus on efforts to encourage the establishment of appropriate access and 
benefit-sharing systems that (1) improve compliance by providing users with clear rules for collection of genetic materials, and (2) help ensure that where uses of 
genetic resources or traditional knowledge ar e made, benefits are equitably shared 
with the appropriate parties.
352 
144. In response it has been said that: 
                                                      
344 United States, IP/C/W/434. 
345 United States, IP/C/W/449. 
346 United States, IP/C/W/434, IP/C/M/39, para. 130. 
347 United States, IP/C/W/434. 
348 United States, IP/C/W/434. 
349Canada, IP/C/M/37/Add.1, para. 232;  EC, IP/C/M/48, para. 63;  Japan, IP/C/M/48, para. 75, 
IP/C/M/40, para. 97, IP/C/M/32, para. 142;  Korea, IP/C /M/46, para. 53, IP/C/M/32, para. 140;  United States, 
IP/C/W/434, IP/C/W/293, IP/C/W/209, IP/C/M/46, para. 28, IP/C/M/45, para. 44, IP/C/M/39, paras. 128-129 
and 131, IP/C/M/37/Add.1, para. 235. 
350 United States, IP/C/W/449. 
351 EC, IP/C/M/43, paras. 37 and 64;  New Zealand, IP/C/M/46, para. 58, IP/C/M/45, para. 52. 
352 United States, IP/C/W/449. IP/C/W/368/Rev.1 
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  - all the three elements of the TRIPS disclos ure proposal are important in ensuring the 
mutual supportiveness between the TRIPS Agreement and the CBD and cannot be 
delinked from each other.
353  The requirements to furnis h evidence of prior informed 
consent and benefit sharing are essential in ensuring that domestic access and benefit-sharing regimes are respected and implemen ted effectively by providing remedial 
action at the global level through the TRIPS Agreement against violation of domestic 
law by bioprospectors.
354  This is because there may be  no national level regulation in 
some countries that places restrictions on the use of patent rights acquired without 
respecting CBD-related obligations, other th an costly revocation proceedings within 
the patent system355; 
- the disclosure system is not intended to be  a stand-alone system and could not on its 
own be a satisfactory guarantee of the shar ing of benefits arising from the use of 
genetic resources.  Rather, it would compleme nt the main legal instrument in this 
respect, i.e. the enforcement of a sound a nd effective national legislation for access, 
benefit sharing and the protection of traditional knowledge356 through a system of 
contracts and civil and criminal law.357  National laws could lay down the minimum 
standards for prior informed consent and benefit sharing, and their use could be further facilitated by model forms of materi al transfer agreements, which should not 
conflict with the basic CBD framework.
358  Thus the proposed disclosure 
requirements are intended to offer an eff ective incentive for patent applicants to 
comply with national access and benefit-sharing requirements359; 
- while it is true that the disclosure requirement by itself would not deter those intent 
on acting in bad faith, the legal consequen ces of the failure to comply with the 
disclosure requirements of the proposed international regime can, if properly calibrated as proposed, deter them.
360  It would thus act as a self-monitoring and auto-
check mechanism leading to lesser instances of unauthorized use.361  Applicants with 
good intentions committed to lawfully accessi ng genetic resources of mega-diverse 
countries would have nothing to fear from the proposed disclosure requirement362; 
- these requirements are useful even without national access and benefit-sharing 
systems being in place.  In new and emerging policy areas, such as intellectual property, there have been examples when it has not been considered necessary to put 
in place national systems before international norms were set
363;  
                                                      
353 Brazil, IP/C/M/37/Add.1, para. 237;  India, IP/C/M/38, para. 233. 
354 Brazil et al, IP/C/W/459;  India, IP/C/M/38, para. 233. 
355 India, IP/C/M/48, para. 53. 
356 Brazil, IP/C/M/47, para. 26, IP/C/M/46, para. 81 , IP/C/M/36/Add.1, para. 219;  EC, IP/C/M/44, 
para. 30, IP/C/M/37/Add.1, para. 227, IP/C/M/30, para. 144;  Brazil and India, IP/C/W/443;  China, IP/C/M/39, para. 133;  India, IP/C/M/40, para. 82, IP/C/M/36/Add.1, para. 212. 
357African Group, IP/C/W/404;  Brazil, IP/C/M/36/ Add.1, para. 219;  EC, IP/C/W/383, IP/C/W/254, 
IP/C/M/46, para 45, IP/C/M/44, para. 30;  India, IP/C/M/36/Add.1, para. 212;  New Zealand, IP/C/M/46, para. 60. 
358 India, IP/C/M/37/Add.1, para. 223. 
 359 Brazil, IP/C/M/48, para. 36, IP/C/M/46, para. 81;  Peru, IP/C/M/48, para. 19. 
360 Brazil and India, IP/C/W/443. 
361 EC, IP/C/W/383, IP/C/M/44, para. 30, IP/C/M/37/Add.1, para. 228;  India, IP/C/M/40, para. 82, 
IP/C/M/37/Add.1, para. 223. 
362 Brazil, IP/C/M/46, para. 81. 
363 Brazil et al, IP/C/W/459.  IP/C/W/368/Rev.1 
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  - the fact that benefit sharing may only take place after the grant of a patent and the 
commercialization of the relevant technology  does not raise a problem with respect to 
furnishing evidence of benefit-sharing arrangements364; 
- admittedly if there is no patent, benefits de rived from a patent cannot be claimed;  but 
the possibility of getting benefits from comme rcialization or from the grant of access 
itself still exists.365 
145. In response, it has been said that: 
- since it has been consider ed that the disclosure requirement would supplement and 
not substitute for national systems, the na rrower question is whether the requirement 
could be justified by its ability to ensure  effective operation of national access and 
benefit-sharing regimes, notwithstanding its negative effects on the patent system, 
technological development and benefit sharing366; 
- examples of misappropriation given in the context of the discussi ons in the Council 
appear to relate to improper collection a nd/or use of genetic resources or traditional 
knowledge rather than the act of patenting per se , which does not amount to 
misappropriation.  Such examples show that the patents were granted for new, useful 
and non-obvious in ventions based on genetic materials and not on the materials 
themselves.367  Since it has been clarified that "misappropriation" is not the act of 
patenting or applying for a patent, but rath er the fact that traditional knowledge or 
genetic resources are accessed in violation of a national access regime and being exploited without obtaining prior inform ed consent and without providing for 
equitable benefit sharing, it is not a patent disclosure requirement that can help ensure 
prior informed consent and benefit sh aring, but rather having in place a 
comprehensive and effective access and benefit-sharing regime that directly regulates inappropriate behaviour
368; 
- it is not clear how disclosure requirement s could be designed to supplement national 
legislation that is not in place as is the case of the majority of Members.  Establishing 
national access and benefit-sharing systems, and evaluating experience with their operation in order to strengthen further su ch systems is essential before discussing 
supplemental disclosure requirements th at would single out only commercial 
applications involving patents, whic h may negatively affect technological 
development
369; 
- a country could promote and encourage prior informed consent and equitable sharing 
of benefits on mutually agreed terms at th e national level without being a party to the 
CBD.370  Even those not parties to the CBD have ensured that bioprospectors and 
researchers from their countries are made  aware of the national access and benefit-
sharing systems in other countries.371 
                                                      
364 Brazil, IP/C/M/47, para. 28. 
365 Brazil et al, IP/C/W/459. 
 366 United States, IP/C/W/434. 
367 United States, IP/C/W/434, IP/C/M/47, para. 44, IP/C/M/46, para. 24. 
368 United States, IP/C/W/449. 
369 United States, IP/C/M/48, para. 30. 
370 United States, IP/C/M/48, para. 25. 
371 United States, IP/C/M/49, para. 94. IP/C/W/368/Rev.1 
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  (j) Implications for preventing erroneously granted patents 
146. The issue of whether a disclosure requirement  is necessary or desirable for preventing 
erroneously granted patents has been discussed.  One view is that the new patent disclosure 
requirements proposed would be ineffective in ach ieving the objective of preventing erroneously 
granted patents for the following reasons: 
- information regarding source and/or country of origin is generally not material to 
patentability.  Even without such disclos ure, examiners in the patent office can 
understand the invention in the application properly, and can examine the application 
so as to judge patentability.
372  A more effective approach in achieving the objectives 
of preventing erroneously granted patents would be one that focuses on information 
material to patentability.  One significant a dvantage of this approach is that the 
information required is solely related to issues of patentability and thereby would not 
introduce new uncertainties of laws unrelated  or tenuously related to the invention 
into the patent system373; 
- determination of inventorship is generally  based in a country's patent law and on acts 
of invention.  Information regarding the c ountry of origin or the source (i.e. country 
locations or ex situ  collection sites) is not generally relevant to these considerations 
and would therefore be of little value in this process374; 
- lowering the standard for disclosure to info rmation that is known or should have been 
known to the applicant would not help as su ch disclosure would still be irrelevant.375  
147. In response it has been said that: 
- a reason for bad or questionable patents is insufficient disclosure of existing 
knowledge and the inadequacy of the existi ng patent system to check the relevant 
details.376  The disclosure requirement would give the patent office useful hints to 
enquire into the novelty and inventiveness cl aimed in the invention as information on 
source and country of origin in relation to  the holders of the resources and/or the 
knowledge associated with them could be u seful in the case of challenges to patents 
granted, whether in patent offices or in courts377, as for example in the case of the 
turmeric patent.378  Moreover, if the disclosure requirement is made mandatory, the 
patent examiner can require the applicant during the processing of the application to furnish more information to ensure that  patents are not issued for ineligible 
inventions
379; 
- while it is true that the mere disclosure of  source and country of origin may not in and 
of itself help ascertain inventorship or pate ntability, it would be helpful to the extent 
that the disclosed information would help determine whether the biological resource 
and/or traditional knowledge is used:  to fo rm part of the claimed invention;  during 
the process of developing the claimed invention;  as a necessary prerequisite for the 
development of the invention;  to facilitate the development of the invention;  and/or 
                                                      
372 Japan, IP/C/M/48, para. 75;  United States, IP/C/W/449. 
373 Japan, IP/C/M/49, paras. 110-111;  United States, IP/C/W/449. 
374 United States, IP/C/W/449. 
375 Japan, IP/C/M/48, para. 75. 
376 Brazil and India, IP/C/W/443. 
377 Brazil and India, IP/C/W/443;  New Zealand, IP/C/M/47, para. 52. 
378 India, IP/C/M/48, para. 55. 
379 Brazil et al,  IP/C/W/459.  IP/C/W/368/Rev.1 
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  as necessary background material and/or information for the development of the 
invention.  Such information would be releva nt in determining:  the existence of prior 
art and the non-obviousness of the claimed inve ntion;  inventorship or entitlement to 
the patent;  the scope of the claim;  and/or for understanding or carrying out the invention
380; 
- in cases of inventions based on biological resources and/or associated traditional 
knowledge, the source and origin of the biological resources and associated traditional knowledge would be critical fo r ascertaining whether the applicant has 
invented what is claimed or just found the "invention" in nature or obtained it from traditional cultures, especially if such know ledge is undocumented and exists in oral 
form or is documented in a local language
381; 
- the disclosure of source proposed in the context of the PCT would support the 
determination of prior art regarding trad itional knowledge through the simplification 
of the search of traditional knowledge databases and transparency measures.  Traditional knowledge databases are increasi ngly being established at local, national, 
and regional levels.  The international Internet portal for traditional knowledge 
proposed in the WTO and WIPO would present an additional and complementary measure.  These transparency measures would also aid the determination of prior art with regard to traditional knowledge that only existed in oral form, because the 
declared source could provide an important starting-point for the further examination.
382 
148. See further discussion on the implications for the patent system in (k) below. 
(k) Implications for the patent system 
149. Three issues have been discussed, namely whether the proposed mandatory disclosure 
requirements would be burdensome on patent o ffices, whether it would be burdensome on patent 
applicants and how it would affect the operation of the patent system.  With respect to whether a 
disclosure requirement would be burdensome on patent o ffices, one view is that: 
- patent offices would have both legal and administrative difficulties in determining the 
geographical origin of genetic resources and traditional knowledge383; 
- patent examiners would be unable to carry out the task of verification of compliance 
with prior informed consent and benefit sharing not only because they may not have 
the necessary legal and technical compet ence to determine the correctness of 
evidence provided384, but because the terms and conditions of a contract would 
remain confidential and would thus not be accessible to the patent-granting authority
385.  Even if these terms were made available, this verification task would 
overburden patent offices and create problems of legal interpretation, especially with 
respect to requirements to comply with foreign laws.386  Patent offices would have no 
                                                      
380 Brazil et al,  IP/C/W/459. 
381 Brazil, IP/C/M/48, para. 37. 
382 Switzerland, IP/C/M/42, para. 98. 
383United States, IP/C/W/209. 
384 Australia, IP/C/M/47, para. 55;  Chinese Taipei, IP/C/M/46, para. 71;  EC, IP/C/W/383, IP/C/M/44, 
para. 35;  Switzerland, IP/C/W/400/Rev.1. 
385 Malaysia, IP/C/M/48, para. 82;  Switzerland, IP/C/W/446, IP/C/W/400/Rev.1. 
386 EC, IP/C/M/47, para. 59;  Switzerland, IP/C/W/400/R ev.1;  United States, IP/C/M/46, paras. 27-28.   IP/C/W/368/Rev.1 
Page 62  
 
  way of judging their fairness or equity.
387  These tasks could best be carried out by the 
parties to the contracts on access and benefit sharing388; 
- such requirements may lead to significant additional administrative costs, including 
for training and systems de velopment in patent offices.389  The case has not been 
made as to how disclosure requirements would not add to costs390, nor why a 
contractual system would not serve effectively to regulate this area391; 
- it seems important to determine approximately  how many patent a pplications per year 
could involve patent disclosure regard ing genetic resources and/or associated 
traditional knowledge, if such an obligation we re to be introduced.  This would allow 
the impact of any disclosure regime to be  appropriately assessed given each country's 
national situation.392 
150. In response it has been said that: 
- the role of patent offices would be essentially that of ensuring that the applications 
are complete.  The proposal would not requi re patent examiners to determine the 
validity of the information given about these arrangements in order to grant a 
patent.393  Patent examiners would confirm that  the patent application contains a 
declaration in the prescribed form indicati ng that prior informed consent has been 
obtained and that benefits have been shared and/or that there exists an arrangement for future benefit sharing in accord ance with the relevant national law
394; 
- assessment of the necessary evidence provided, in cases where there is fraud alleged,  
would be routine for patent offices as the proposed requirements would not be more 
burdensome than any other under the existing patent application procedures.395  
Patent offices would need to take decisions based on the documents providing evidence of prior informed consent and be nefit sharing only when the validity of a 
patent is challenged in the pre- or post- grant opposition or revocation proceedings.  In 
such cases the patent office would have evidence from both the parties to the 
proceedings and could take a decision ju st as it does on any other ground on which 
the grant of a patent is opposed or revocation of a patent is requested.
396 
- disclosure requirements could even be a pplied selectively, say only in cases where a 
Member has reasonable grounds to suspect th at national biodiversity legislation has 
been violated by a patent applicant397; 
                                                      
387 Malaysia, IP/C/M/48, para. 82;  Switzerland, IP/C/W/446, IP/C/W/400/Rev.1. 
388United States, IP/C/W/434.. 
389 Australia, IP/C/M/47, para. 55, IP/C/M/46, para. 65 ;  EC, IP/C/M/47, para. 59, IP/C/46, para. 65;  
Japan, IP/C/M/32, para. 142;  Korea, IP/C/M/46, para. 53, IP/C/M/32, para. 140;  United States, IP/C/W/434, IP/C/M/46, para. 28, IP/C/M/37/Add.1, para. 235. 
390 Australia, IP/C/M/46, para. 65. 
391 United States, IP/C/W/434, IP/C/M/46, para. 32. 
392 Canada, IP/C/M/48, para. 72. 
393EC, IP/C/M/47, para. 59;  India, IP/C/M/47, para. 38. 
394 India, IP/C/W/198, IP/C/M/29, para. 166,. 
395 Brazil et al, IP/C/W/459;  Brazil, IP/C/W/356, IP/C/W/228;  India, IP/C/M/40, para. 82, 
IP/C/M/36/Add.1, para. 214, IP/C/M/29, paras. 165-166;  Indonesia, IP/C/M/36/Add.1, para. 217;  Thailand, 
IP/C/M/29, para. 173;  Pakistan, IP/C/M/36/Add.1, para. 211;  Peru, IP/C/M/36, para. 203. 
396 Brazil and India, IP/C/W/443. 
397 Brazil, IP/C/W/228;  Thailand, IP/C/M/29, para. 173.  IP/C/W/368/Rev.1 
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  - the proposed disclosure requirements would increase the capacity of patent offices to 
examine patent applications that deal with biological resources and associated traditional knowledge
398; 
- the perceived administrative burdens and costs of the disclosure proposal should be 
considered in light of the high costs of collecting evidence in revocation proceedings 
in the absence of disclosure requirements.399  Moreover, in terms of implementation 
for the United States system, the proposed disclosure requirement would not be burdensome at all, as it could be cove red under the existing requirement for 
information material to patentability.  What  would need to be included is evidence of 
prior informed consent and benefit-sharing arrangements
 400; 
- it is ironic that some countries are arguing that the disclosure mechanism should not 
be included because it would be  burdensome when, in effect, TRIPS itself has already 
proven to be quite burdensome for deve loping countries and for consumers of 
technology in general.401  The current patent system has not provided certainty for all 
stakeholders particularly those from mega-diverse countries who have been 
victimized by misappropriation of thei r traditional knowledge and/or genetic 
resources.402 
151. The issue of the possible burden on patent app licants of the disclosure approach has been 
discussed.  One view is that: 
- such disclosure requirements would lead to  undue burdens on applicants seeking to 
comply with them, and may discourage applicants from seeking protection and 
encourage them to keep their inventions secret403; 
- patent applicants would be required to submit double or even triple information 
which would bring little advantage to Members.404 
152. In response it has been said with respect  to the TRIPS disclosure proposal that: 
- the onus on the patent applicant would be limited to providing information and 
evidence that is known to him or should have been known to him so that the 
administrative and cost burden on him would be minimal405; 
                                                      
398 Brazil, IP/C/M/48, para. 36. 
399 Brazil and India, IP/C/W/443;  Hong Kong, China, IP/C/M/46, para. 88. 
400 India, IP/C/M/47, para. 38. 
401 Brazil, IP/C/M/47, para. 26. 
402 Brazil, IP/C/M/46, para. 82. 
403Canada, IP/C/M/37/Add.1, para. 232;  Japan, IP/C/M/32, para. 142, IP/C/M/40, para. 97;  Korea, 
IP/C/M/46, para. 53, IP/C/M/32, para. 140;  United States, IP/C/W/434, IP/C/W/209, IP/C/M/46, para. 28, 
IP/C/M/45, para. 44, IP/C/M/39, paras. 128-129 and 131, IP/C/M/37/Add.1, para. 235. 
404 Switzerland, IP/C/W/400/Rev.1, IP/C/M/46, para.73. 
405 Brazil, IP/C/M/48, para. 36. IP/C/W/368/Rev.1 
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  - the recording and collection of the inform ation necessary to meet the obligation with 
respect to disclosure requirements should not require applicants to undertake significant effort outside what would need to be done in the process of developing a patent application for an invention i.e. su ch burdens would exist even where there is 
no disclosure obligation
406; 
- in the case of evidence regard ing prior informed consent, it is only if the knowledge 
and/or the resources rest with the commun ities, and the domestic law mandates prior 
informed consent from them, that th e person seeking access to the resources or 
traditional knowledge would have to ensure that prior informed consent is obtained 
from them.  This does not create any additio nal burden on the applicant because, in 
most of the countries, evidence of prior in formed consent is a pre-requisite to the 
grant of access to biological resources and traditional knowledge407; 
- the burden imposed on patent applicants w ould be reasonable considering the serious 
nature of the problem to which a solutio n is being sought.  Such a disclosure 
requirement would pave the way for interna tional solutions that would result in cost 
saving for countries that are victims of biopiracy who would not need to divert 
resources in order to seek the revocation of patents based on illegally obtained resources or traditional knowledge.
408 
153. In regard to the PCT and mandatory disclosure proposals, it has been said that disclosure of 
source has been preferred as all applicants woul d know the source from which they obtained genetic 
resources or traditional knowledge. Such a requireme nt would not be burdens ome nor would it deter 
the filing of patent applications.409  Under the mandatory disclosure proposal, information on the 
country of origin would also be requested but only if it could be provided with no additional research 
on the applicant's part410, and it would be the patent applicant himself who should judge if the country 
of origin is known to him.411 
154. The issue of the possible consequences of the disclosure approach on the operation of the 
patent system and its ability to fulfil its underlying public polic y purposes has been discussed.  One 
view is that: 
                                                      
406Brazil et al, IP/C/W/459, IP/C/W/429/Rev.1;  I ndia, IP/C/M/45, para. 21;  EC, IP/C/M/46, 
paras. 45-47. 
407 India, IP/C/M/49, para. 143.  
408Brazil, IP/C/M/46, para. 83;  Brazil et al, IP/C/W/4 03;  India, IP/C/M/45, para. 21, IP/C/M/36/Add.1, 
para. 214;  Indonesia, IP/C/M/36/Add.1, para. 217. 
409 EC, IP/C/M/46, para. 45;  Switzerland, IP/C/W/423, IP/C/M/42, para. 98. 
410 EC, IP/C/M/46, para. 45. 
411 EC, IP/C/M/48, para. 66.  IP/C/W/368/Rev.1 
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  - information from new disclosure requireme nts regarding source or country of origin 
is not generally relevant to considerations of inventorship  or prior art and therefore 
would be of little value to patent ex aminers in making such determinations412;  
- new disclosure requirements, particularly where the sanction proposed is revocation 
of the patent right, would provide an additional avenue to litigation and cause 
uncertainties that would undermine the role of the patent system in promoting 
innovation and technological development as  they may discourage applicants from 
seeking protection and encourage them to keep their inventions secret.  This, in turn, 
would undermine any potential benefit sh aring and therefore be ineffective in 
achieving its objective;413 
- patent law is not designed to regulate or enforce misconduct issues, such as 
misappropriation of traditional knowledge or genetic resources, but to promote 
progress of useful arts.  As such it do es not condone or legitimize violations of 
misappropriation of genetic resources or traditional knowledge just as it does not do 
so for violations of environment, health or safety laws.414  Patents do not give right 
holders a right to use their inventions and restrictions are placed on the use of certain 
patented inventions.  For example, there ar e laws and regulations regulating the use of 
pharmaceuticals or firearms and of emissions from automotive engines which are implemented and enforced outside the patent system.  Similarly, a contract-based access and benefit-sharing system could effe ctively and adequately achieve domestic 
policy goals related to the conservation and sustainable use of genetic resources
415; 
- recent studies indicate that patent-based access and benefit-sharing systems would 
have significant negative effects on the development of particular sectors, such as biotechnology, while there would be broad ramifications impacting more sectors
416; 
- it is questionable whether the disclosure requirements could be justified by their 
ability to ensure effective operation of national access and benefit-sharing regimes, 
notwithstanding their negative effects on the patent system, technological 
development and benefit sharing.  There may be an over-estimation of the "green 
gold" that may be available from the potentia l benefits from patenting of inventions 
based on genetic resources.417 
155. A question has been raised as to what would be the impact on the international patent system 
in the case where possible sanctions for wrongful or  no disclosure are placed outside the patent 
system.418 
156. In response it has been said that new disclosure requirements proposed would help improve 
the operation of the patent system in that: 
                                                      
412 United States, IP/C/W/449, IP/C/W/434. 
413Canada, IP/C/M/37/Add.1, para. 232;  Japan, IP/C/M/32, para. 142;  Korea, IP/C/M/46, para. 53, 
IP/C/M/32, para. 140;  United States, IP/C/W/449, IP/C /W/434, IP/C/W/209, IP/C/M/46, para. 28, IP/C/M/45, 
para. 44, IP/C/M/39, paras. 128-129 and 131, IP/C/M/37/Add.1, para. 235. 
414 United States, IP/C/M/48, para. 28, IP/C/M/46, para. 32. 
415 United States, IP/C/M/47, para. 48, IP/C/M/46, para s. 28 and 32, IP/C/M/42, para. 109, IP/C/M/40, 
para. 124. 
416 United States, IP/C/W/49, para. 95. 
417 New Zealand, IP/C/M/47, para. 54. 
418 Canada, IP/C/M/49, para. 107. IP/C/W/368/Rev.1 
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  - they would aid in the determination of wh ether the claimed invention is patentable.  
The process of examination would be f acilitated through the introduction of the 
disclosure requirements
419 since these requirements woul d add to the information 
available to patent examiners on prior ar t regarding traditional knowledge, including 
that which only exists in oral form or is documented only in local languages.420  
Disclosing the source of origin would theref ore enable searches that might be outside 
the scope of established databases.421  Through more focused searches, patent offices 
could grant better patents and lessen the n eed for burdensome challenges regarding 
patent validity422; 
- with respect to the PCT disclosure pr oposal, the requirements would not be so 
burdensome as to deter patent applicants from fulfilling them423 (see further details in 
paragraph 94 of this note); 
- with respect to the mandatory disclosure proposal, they would not be burdensome to 
patent offices or applicants and would ensure  that the patent system continues to be 
an effective tool to stimulate innovation, technological progress and economic 
development (see also paragraph 95  of this note); 
- they do not create unacceptable risks, but add to the legitimacy and certainty of the 
patent system that only the eligible inven tions are protected.  Since the sanctions only 
affect fraudulent claims, without creati ng any additional uncertainty as alleged424,  
they would improve the operation of the pa tent system to ensure its robustness, 
sustainability and relevance to the pursuit of the actual objectives of the intellectual 
property system 425; 
- they would be useful in cases relating to challenges to patents granted, whether in 
patent offices or in courts.426  For example, in the case of the turmeric patent, the 
applicant for the patent 5401504, on the da te of application, i.e. 28 October 1996, 
acknowledged, but did not disclose the teaching about healing properties of turmeric.  
The USPTO did not take the next steps to check these teachings, and granted a patent.  
The same, and more, teachings had to be  provided in the opposition proceedings, 
which became the basis of revocation on 21 April 1998 on the grounds of lack of 
novelty and non-obviousness.  The information hidden by the applicant was material to patentability, and would have been pr ovided by him had there been a disclosure 
requirement.  This is evidence of the cert ainty that the disclosure requirement would 
introduce into the patent system
427; 
                                                      
419 Brazil and India, IP/C/W/443; EC, IP/C/M/37/Add.1, para. 228;  India, IP/C/M/48, para. 60. 
420 Brazil et al, IP/C/W/403;  India, IP/C/M/40, pa ra. 82, IP/C/M/39, para. 123, IP/C/M/37/Add.1, 
para. 253. 
421 Brazil, IP/C/M/48, para. 39. 
422 EC, IP/C/M/44, para. 30, IP/C/M/37/Add.1, para. 228. 
423 Switzerland, IP/C/M/42, para. 98. 
424 Brazil et al, IP/C/W/459;  India, IP/C/M/48,  para. 57;  Switzerland, IP/C/M/42, para. 98. 
425 Brazil, IP/C/M/46, para. 83;  EC, IP/C/M/46, pa ra. 46, IP/C/M/44 para. 30;  India, IP/C/M/45, 
para. 20, IP/C/M/40, para. 82. 
426 Brazil and India, IP/C/W/443;  New Zealand, IP/C/M/47, para. 52. 
427 India, IP/C/M/48, para. 55.  IP/C/W/368/Rev.1 
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  - they would introduce an important conf idence-building measure that would help 
restore the trust of all stakeholders428 in the patent system so that it works for all in an 
equitable manner429; 
- they would also be of significant adva ntage to researchers and bio-prospectors who 
use the patent system by facilitating fu ture access to genetic resources and by 
reducing the probability and cost of litigati on on patent validity or entitlement to the 
patent.430  Beneficiary countries or communities would have the incentive to generate 
less complex or burdensome but more effective national access and benefit-sharing regimes.
431  This would help provide a pred ictable environment for governments, 
investors, traditional communities and researchers and could lead to more 
biotechnological R&D in developing countries,  thus creating a win-win situation for 
both providers and accessors432; 
- various types of disclosure requirements are already an accepted norm in international 
patent law practice.433 
157. In response to the specific example given of th e turmeric patent in the United States, it was 
said that, while there is no way of completely elimin ating the grant of erroneous patents, in this case 
the patent applicants were two Indian nationals who did reveal that India was the country of origin of 
turmeric.  This information was, however, irreleva nt to the patentability issues and did not help in 
preventing the grant of this patent.  On the other ha nd, if it were true that the applicants withheld 
information material to patentability regarding th e wound healing properties of turmeric that was 
known to them, then the patent would have been une nforceable under US law.  In this case the patent 
was cancelled on the basis of the relevant prior art brought forward and taken into account in the re-
examination proceedings and not on the basis of any alleged inequitable conduct for hiding known 
information. In this view, this leads to the conclusion that proposed disclosure requirements 
regarding, among other things, source and/or orig in of genetic resources or traditional knowledge, 
would not be effective in addressing concerns over mi stakenly granted patents and that other options 
should be pursued that more directly address this goal and do not have negativ e consequences on the 
patent system.434 
_______________ 
  
                                                     
 
428 Switzerland, IP/C/M/46, para. 73. 
429 Brazil, IP/C/M/46, paras. 82 and 85;  EC, IP/C/M/46, para. 46, IP/C/M/44, para. 30;  India, 
IP/C/M/40, para. 82;  Norway, IP/C/M/39, para. 121;  Peru, IP/C/W/447, IP/C/M/48, para. 94. 
430 Brazil and India, IP/C/W/443;  Brazil et al,  IP/C/W/438;  India, IP/C/M/46, para. 39. 
431 Brazil, IP/C/M/46, paras. 82 and 85;  EC, IP/C/M/46, para. 46, IP/C/M/44, para. 30;  India, 
IP/C/M/40, para. 82;  Norway, IP/C/M/39, para. 121;  Peru, IP/C/W/447, IP/C/M/48, para. 94;  Switzerland, 
IP/C/M/46, para. 73. 
432 Andean Community, IP/C/M/37/Add.1, para. 231;  Brazil et al, IP/C/W/356;  Brazil, IP/C/W/228, 
IP/C/M/37/Add.1, para. 236;  Indonesia, IP/C/M/36/Add.1, para. 217. 
433 Brazil et al, IP/C/W/429/Rev.1;  India, IP/C/M/45, para. 20. 
434 United States, IP/C/M/49, para. 160.  IP/C/W/368/Rev.1 
Page 68  
 
  ANNEX 
 
DOCUMENTS OF THE TRIPS COUNCIL WITH  RESPECT TO THE REVIEW OF THE 
PROVISIONS OF ARTICLE 27.3(B);  TH E RELATIONSHIP BETWEEN TRIPS AND  
THE CONVENTION ON BIOLOGICAL DIVERSITY;  AND THE PROTECTION  
OF TRADITIONAL KNOWLEDGE AND FOLKLORE 
 
  The reports on the meetings of the TRIPS Council held during the period January 1999 to 
October 2005 (IP/C/M/21-35, 36/Add.1, 37/Add.1, 38- 40 and 42-49) reflect the work done so far in 
the TRIPS Council with respect to three agenda items, namely, the review of the provisions of 
Article 27.3(b);  the relationship between the TR IPS Agreement and the Convention on Biological 
Diversity (CBD);  and the protection of traditional knowledge and folklore (List A).  The substantive 
discussions in the TRIPS Council on these issues have b een recorded in the reports of the meetings 
held from August 1999 to October 2005 (IP/C/M/ 24-35, 36/Add.1, 37/Add.1, 38-40 and 42-49). 
 
 Other documents that have been made available include: 
  - Members' submissions relating to the three afore-mentioned agenda items.  Over the 
period December 1998 to June 2005, 52 pape rs have been submitted by Members or 
groups of Members (List B). 
 - Information on national legislation, practices and experi ences submitted by eight 
Members (List C). 
 - Responses to the questionnaire on Artic le 27.3(b) from 25 Members (List D). 
 - Information provided on work in six in tergovernmental organizations (List E). 
 - Notes by the Secretariat on relevant issues under discussion in the TRIPS Council 
(List F).  IP/C/W/368/Rev.1 
 Page 69 
 
 
   
LIST A – Records of the work of the TRIPS Council 
 IP/C/M/21-35, 36/Add.1,
37/Add.1, 38-40 and  42-49 Minutes of the TRIPS Council Meetings 22 January 1999 –  
25-26, 28 October 2005 
 
LIST B - Members' submissions relating to the three agenda items 
2005 
Bolivia, Brazil, 
Colombia, Cuba, 
India, and Pakistan IP/C/W/459 The Relationship between the TRIPS 
Agreement and the CBD, the Protection of 
Traditional Knowledge and Folklore – Technical Observation on US Submission IP/C/W/449 18 November 2005 
Peru IP/C/W/458 Analysis of Potentia l Cases of Biopiracy 7 November 2005 
United States IP/C/W/449 Article 27.3(b) - Relationship between the    
TRIPS Agreement and the CBD and Protection  of Traditional Knowledge and Folklore 10 June 2005 
Peru IP/C/W/447 Article 27.3(b) - Relationship between the 
TRIPS Agreement and the CBD and Protection 
of Traditional Knowledge and Folklore 8 June 2005 
Switzerland IP/C/W/446 The Relationship between the TRIPS 
Agreement and the CBD, the Protection of 
Traditional Knowledge and the Review of Implementation of the TRIPS Agreement under Article 71.1 30 May 2005 
Peru IP/C/W/441/Rev.1 Revised ve rsion of document IP/C/W/441 - 
Article 27.3(b) - Relationship between the TRIPS Agreement and the CBD and Protection 
of Traditional Knowledge and Folklore 19 May 2005 
Brazil, India IP/C/W/443 The Relationship between the TRIPS 
Agreement and the Convention on Biological 
Diversity (CBD) and the Protection of Traditional Knowledge:  Technical Observations on Issues Raised in a Communication by the United States (IP/C/W/434) 18 March 2005 
Bolivia, Brazil, 
Colombia, Cuba, 
Dominican Republic, Ecuador, India, Peru, Thailand IP/C/W/442 The Relationship between the TRIPS 
Agreement and the Convention on Biological 
Diversity (CBD) and the Protection of Traditional Knowledge – Elements of the Obligation to Disclose Evidence of Benefit-Sharing under the Relevant National Regime 18 March 2005 
Peru IP/C/W/441 Article 27.3(b) - Relationship between the 
TRIPS Agreement and the CBD and Protection of Traditional Knowledge and Folklore 8 March 2005 
Dominican 
Republic IP/C/W/429/Rev.1/ 
Add.3 Request of the Dominican Republic to be added 
to the list of sponsors of document 
IP/C/W/429/Rev.1 10 February 2005 IP/C/W/368/Rev.1 
Page 70  
 
  LIST B - Members' submissions relating to the three agenda items 
Colombia IP/C/W/429/Rev.1/ 
Add.2 Request of Colombia to be added to the list of 
sponsors of document IP/C/W/429/Rev.1 20 January 2005 
2004 
Bolivia, Brazil, 
Cuba, Ecuador, India, Pakistan, Peru, Thailand, Venezuela IP/C/W/438 The Relationship between the TRIPS 
Agreement and the Convention on Biological Diversity (CBD) and the Protection of Traditional Knowledge – Elements of the Obligation to Disclose Evidence of Prior 
Informed Consent under the Relevant National 
Regime 10 December 2004 
United States IP/C/W/434 Article 27.3(b) - Relationship between the 
TRIPS Agreement and the CBD and the Protection of Traditional Knowledge and Folklore 26 November 2004 
Switzerland IP/C/W/433 Further Observations by Switzerland on its 
Proposals regarding the Declaration of the Source of Genetic Resources and Traditional 
Knowledge in Patent Applications 25 November 2004 
Bolivia IP/C/W/429/Rev.1/ 
Add.1 Request of Bolivia to be added to the list of 
sponsors of document IP/C/W/429/Rev.1 14 October 2004 
Cuba, Ecuador IP/C/W/429/Rev.1 Revised version of document IP/C/W/429 and 
request from Cuba and Ec uador to be added to 
the list of sponsors 27 September 2004 
Brazil, India, 
Pakistan, Peru, Thailand and Venezuela IP/C/W/429 Elements of the Obligation to Disclose the 
Source and Country of Origin of Biological Resources and/or Traditional Knowledge used in an Invention 21 September 2004 
Switzerland IP/C/W/423 Additional Comments by Switzerland on its 
Proposal Submitted to WIPO Regarding the Declaration of Source of Genetic Resources 
and Traditional Knowledge in Patent 
Applications 14 June 2004 
Bolivia IP/C/W/420/Add.1 Request of Bolivia to be added to the list of 
sponsors of Document IP/C/W/420 5 March 2004 
Brazil, Cuba, 
Ecuador, India, Peru, Thailand and Venezuela IP/C/W/420 The Relationship between the TRIPS 
Agreement and the Convention on Biological Diversity (CBD) – Checklist of Issues 2 March 2004 
2003 
Morocco on 
behalf of the African Group IP/C/W/404 Taking Forward the Review of Article 27.3(b) 
of the TRIPS Agreement  26 June 2003 
Bolivia, Brazil, 
Cuba, 
Dominican 
Republic, Ecuador, India, Peru, Thailand, Venezuela IP/C/W/403 The Relationship between the TRIPS 
Agreement, the Convention on Biological 
Diversity and Traditional Knowledge 24 June 2003  IP/C/W/368/Rev.1 
 Page 71 
 
 
  LIST B - Members' submissions relating to the three agenda items 
2003 (cont'd) 
Switzerland IP/C/W/400/Rev.1 Revised version of document IP/C/W/400 - 
Article 27.3(b) - The Relationship between the 
TRIPS Agreement, the Convention on 
Biological Diversity and Traditional Knowledge – Revision 18 June 2003 
Switzerland IP/C/W/400 Article 27.3(b)  - The Relationship between the 
TRIPS Agreement, the Convention on Biological Diversity and Traditional Knowledge 28 May 2003 
2002 
Peru IP/C/W/356/Add.1 Request of Peru to be added to the List of 
Sponsors of Document IP/C/W/356 1 November 2002 
European 
Communities 
and Member 
States IP/C/W/383 Review of Article 27.3(b) of the TRIPS 
Agreement, and the Relationship between the 
TRIPS Agreement and the Convention on 
Biological Diversity (CBD) and the Protection of Traditional Knowledge and Folklore 17 October 2002 
Brazil on behalf 
of the delegations of Brazil, China, 
Cuba, 
Dominican Republic, Ecuador, India, Pakistan, 
Thailand, 
Venezuela, Zambia and Zimbabwe IP/C/W/356 
 The Relationship between the TRIPS 
Agreement and the Convention on Biological Diversity 24 June 2002 
2001 
Australia IP/C/W/310 Communication from Australia:  Review of 
Article 27.3(b) 2 October 2001 
Norway IP/C/W/293 Communication from Norway:  Review of 
Article 27.3(b) of the TRIPS Agreement:  The Relationship 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 Communicati on 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 
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 IP/C/W/368/Rev.1 
Page 72  
 
  LIST B - Members' submissions relating to the three agenda items 
2001 (cont'd) 
Peru IP/C/W/246 Communication from Peru:  Peru's Experience 
of the Protection of Traditional Knowledge and 
Access to Genetic Resources 04 March 2001 
2000 
Japan IP/C/W/236 Review of the provisions of Article 27.3(b) -  
Japan's view 11 December 2000 
Singapore JOB(00)/7853 Non-paper by Singa pore - Article 27.3(b) 11 December 2000 
Brazil IP/C/W/228 Review of Article 27.3(b) – Communication 
from Brazil 24 November 2000 
India JOB(00)/6091 Non-paper by India 5 October 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 
Mauritius IP/C/W/206 Communication from Mauritius on behalf of the 
African Group 20 September 2000 
India IP/C/W/196 Communication from India 12 July 2000 
India IP/C/W/195 Communication from India 12 July 2000 
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 
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 
Norway IP/C/W/167 Review of the Provisions of Article 27.3(b) - 
Communication from Norway 3 November 1999 
Andean Group IP/C/W/165 Review of the Provisions of Article 27.3(b) - 
Proposal on the Intellectual Property Rights 
Relating to the Traditional Knowledge of Local and Indigenous Communities – Communication from Bolivia, Colombia, Ecuador, Nicaragua and Peru 3 November 1999 
India IP/C/W/161 Review of the Provisions of Article 27.3(b) - 
Communication from India 3 November 1999 
Brazil IP/C/W/164 Review of the Provisions of Article 27.3(b) -  
Communication from Brazil 29 October 1999 
United States IP/C/W/162 Review of the Provisions of Article 27.3(b) – 
Communication from the United States 29 October 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 1999  IP/C/W/368/Rev.1 
 Page 73 
 
 
  LIST B - Members' submissions relating to the three agenda items 
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 
2005 
Norway IP/C/M/49, paras. 81-84 Minutes of Meeting of the Council for 
TRIPS 26 and 28 October 2005 
Peru IP/C/M/49, paras. 81-84 Minutes of Meeting of the Council for 
TRIPS 26 and 28 October 2005 
Peru IP/C/W/458 Analysis of Potentia l Cases of Biopiracy 7 November 2005 
India IP/C/M/48, paras. 43-45 Minutes of Meeting of the Council for 
TRIPS 14-16 June 2005 
Norway IP/C/M/48, para. 67 Minutes of Meeting of the Council for 
TRIPS 14-16 June 2005 
Peru IP/C/W/447 Article 27.3(b), Relationship between the 
TRIPS Agreement and the CBD and Protection of Traditional Knowledge and Folklore 8 June 2005 
Peru  IP/C/W/441/Rev.1 Article 27.3(b), Relationship between the 
TRIPS Agreement and the CBD and Protection of Traditional Knowledge and 
Folklore 19 May 2005 
Peru IP/C/M/47, paras. 16-23 Minutes of Meeting of the Council for 
TRIPS 8-9 and 31 March 2005 
Peru IP/C/W/441 Article 27.3(b), Relationship Between the 
TRIPS Agreement and the CBD and protection of Traditional Knowledge and Folklore 8 March 2005 
2004 
Australia IP/C/M/46, para. 63 Minutes of Meeting of the Council for 
TRIPS  1-2 December 2004 
Peru IP/C/M/45, para. 31 Minutes of Meeting of the Council for 
TRIPS 21 September 2004 
EC IP/C/M/43, para. 39 Minutes of Meeting of the Council for 
TRIPS 8 March 2004 
Norway IP/C/M/43, para. 54 Minutes of Meeting of the Council for 
TRIPS 8 March 2004 
2003 
United 
States IP/C/M/42, para. 110 Minutes of Meeting of the Council for 
TRIPS 18 November 2003 
EC IP/C/M/42, para. 108 Minutes of Meeting of the Council for 
TRIPS  18 November 2003 
Norway IP/C/M/40, paras. 87-88 Minutes of Meeting of the Council for 
TRIPS 4-5 June 2003 
Norway IP/C/M/39, para. 121 Minutes of Meeting of the Council for 
TRIPS 18-19 February 2003 IP/C/W/368/Rev.1 
Page 74  
 
  LIST C - Information on national legislation, practices and experiences 
United 
States IP/C/W/393 Access to Genetic Resources Regime of 
the United States National Parks 28 January 2003 
2002 
Peru IP/C/M/38, para. 245 Minutes of Meeting of the Council for 
TRIPS 25-27 and 29 November 
and 20 December 2002 
India  IP/C/M/37/Add.1,  
para. 253 Minutes of Meeting of the Council for 
TRIPS 17-19 September 2002 
New 
Zealand IP/C/M/37/Add.1,  
para. 248 Minutes of Meeting of the Council for 
TRIPS 17-19 September 2002 
Peru IP/C/M/36/Add.1,  
para. 204 Minutes of Meeting of the Council for 
TRIPS 25-27 June 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 o f 
Article 27.3(b) 2 October 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 
India IP/C/W/198 Protection of Biodiversity and Traditional 
Knowledge – The Indian Experience 14 July 2000 
 
LIST D - Information on Review of the Provisions of Article 27.3(b) 
2004 
Moldova IP/C/W/125/Add.24 Review of the Provisions of 
Article 27.3(b) -  Information from Members – Addendum 26 January 2004 
2002 
Lithuania IP/C/W/125/Add.23 Review of the Provisions of 
Article 27.3(b) -  Information from Members – Addendum 22 July 2002 
2001 
Czech 
Republic IP/C/W/125/Add.8/Suppl.1 Review of the Provisions of 
Article 27.3(b) -  Information from Members - Supplement 18 September 2001 
Hong Kong,  
China IP/C/W/125/Add.21 Review of the Provisions of 
Article 27.3(b) - Information from Members – Addendum 10 August 2001 
Thailand IP/C/W/125/Add.22 Review of the Provisions of 
Article 27.3(b) - Information from 
Members - Addendum 10 July 2001 
Estonia IP/C/W/125/Add.20 Review of the Provisions of 
Article 27.3(b) - Information from 
Members – Addendum 2 July 2001  IP/C/W/368/Rev.1 
 Page 75 
 
 
  LIST D - Information on Review of the Provisions of Article 27.3(b) 
2000 
Iceland  IP/C/W/125/Add.19 Review of the Provisions of 
Article 27.3(b) -  Information from Members - Addendum 17 July 2000 
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 
South Africa IP/C/W/125/ 
Add.16/Corr.1 Review of the Provisions of 
Article 27.3(b) – Information from 
Members – Addendum - Corrigendum 25 May 1999 
Norway IP/C/W/125/Add.17 Review of the Provisions of Article 
27.3(b) – Information from Members – 
Addendum 19 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 
Morocco IP/C/W/125/Add.14 Review of the Provisions of 
Article 27.3(b) – Information from Members - Addendum 20 April 1999 
US IP/C/W/125/Add.5 Review of the Provisions of 
Article 27.3(b) – Information from Members – Addendum 20 April 1999 
Switzerland IP/C/W/125/Add.15 Review of the Provisions of 
Article 27.3(b) – Information from 
Members - Addendum 13 April 1999 
Australia IP/C/W/125/Add.13 Review of the Provisions of 
Article 27.3(b) – Information from Members - Addendum 16 March 1999 
Canada IP/C/W/125/Add.12 Revi ew of the Provisions of 
Article 27.3(b) – Information from Members - Addendum 12 March 1999 
Poland IP/C/W/125/Add.11 Review of the Provisions of 
Article 27.3(b) – Information from Members - Addendum 12 March 1999 
Japan IP/C/W/125/Add.7 Review of the Provisions of 
Article 27.3(b) – Information from 
Members - Addendum 12 March 1999 
Slovenia IP/C/W/125/Add.10 Review of the Provisions of 
Article 27.3(b) – Information from 
Members - Addendum 16 February 1999 
Korea IP/C/W/125/Add.9 Review of the Provisions of 
Article 27.3(b) – Information from Members - Addendum 16 February 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 IP/C/W/368/Rev.1 
Page 76  
 
  LIST D - Information on Review of the Provisions of Article 27.3(b) 
Romania IP/C/W/125/Add.6 Review of the Provisions of 
Article 27.3(b) – Information from Members – Addendum 16 February 1999 
1999 (cont'd) 
Hungary IP/C/W/125/Add.1 Review of the Provisions of 
Article 27.3(b) – Information from Members - Addendum 16 February 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 
EC IP/C/W/125/Add.4 Review of the Provisions of 
Article 27.3(b) – Information from Members - Addendum 10 February 1999 
Zambia IP/C/W/125/Add.3 Review of the Provisions of 
Article 27.3(b) – Information from 
Members - Addendum 10 February 1999 
Bulgaria IP/C/W/125 Review of the Provisions of 
Article 27.3(b) – Information from Members 3 February 1999 
 
LIST E  - Information on the work of intergovernmental organizations 
2002 
World Bank IP/C/W/347/Add.4 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 21 October 2002 
UPOV IP/C/W/347/Add.3 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 
UNCTAD IP/C/W/347/Add.2 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 
CBD IP/C/W/347/Add.1 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 
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  IP/C/W/368/Rev.1 
 Page 77 
 
 
  LIST E  - Information on the work of intergovernmental organizations 
WIPO JOB(02)/15 WIPO Activities of Relevance to the Work of the 
Council for TRIPS 4 March 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 from 30 October to 1 November 2000 in Geneva: Outcome of the expert meeting 14 December 2000 
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 
WIPO IP/C/W/217 Document prepared by the International Bureau 
of WIPO for the round table on intellectual property and 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 
FAO IP/C/W/130/Add.2 Review of th e Provisions of Article 27.3(b) – 
Information from Intergovernmental Organizations  - Addendum 12 April 1999 
CBD IP/C/W/130/Add.1 Review of th e Provisions of Article 27.3(b) – 
Information from Intergovernmental Organizations  - Addendum 16 March 1999 
UPOV IP/C/W/130 Review of the Provisions of Article 27.3(b) – 
Information from Intergovernmental Organizations 17 February 1999 
 IP/C/W/368/Rev.1 
Page 78  
 
   
LIST F – Notes by the Secretariat 
2003 
IP/C/W/273/Rev.1 Review of the Provisi ons of Article 27.3(b): Illustrative 
List of Questions Prepared by the Secretariat – Revision 18 February 2003 
2002 
IP/C/W/370 The Protection of Trad itional Knowledge and Folklore – 
Summary of Issues Raised and Points Made 8 August 2002 
IP/C/W/369 Review of the Provisions of Article 27.3(b) of the TRIPS 
Agreement – Summary of Issues Raised and Points 
Made 8 August 2002 
IP/C/W/368 The Relationship between  the TRIPS Agreement and the 
Convention on Biodiversity – Summary of Issues Raised 
and Points Made 8 August 2002 
JOB(02)/60 The Protection of Trad itional Knowledge and Folklore – 
Summary of Issues Raised and Points Made 18 June 2002 
2002 (cont'd) 
JOB(02)/59 Review of the Provisions of Article 27.3(b) – Summary 
of Issues Raised and Points Made 18 June 2002 
JOB(02)/58 The Relationship between  the TRIPS Agreement and the 
CBD – Summary of Issues Raised and Points Made 18 June 2002 
2001 
IP/C/W/273 Review 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 
1999  
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 
Job No. 6955 Review of the Provisi ons of Article 27.3(b): Lifting of 
Reserve 16 December 1998 
 
__________