WORLD TRADE  
ORGANIZATION  IP/C/W/433 
25 November 2004  
 
(04-5134) 
Council for Trade-Related Aspects 
of Intellectual Property Rights Original:   English 
 
 
 
FURTHER OBSERVATIONS BY SWITZERLAND ON ITS PROPOSALS 
REGARDING THE DECLARATION OF THE SOURCE 
OF GENETIC RESOURCES AND TRADITIONAL 
KNOWLEDGE IN PATENT APPLICATIONS 
 
Communication from Switzerland  
 
  The following communication, dated 18 November 2004, is being circulated at the request of 
the Delegation of Switzerland. 
 
_______________ 
 
 
This present communication from Switzerland cont ains in its annex further observations on 
the Swiss proposals to amend the Regulations unde r the Patent Cooperation Treaty (PCT).  These 
proposals were presented to the Working Group on Reform of the PCT of the World Intellectual 
Property Organization (WIPO) in May 2003,
1 and would explicitly enable the Contracting Parties of 
the PCT to require patent applicants to decl are the source of genetic resources and traditional 
knowledge in patent applications .  The further observations on these proposals were posted on the 
PCT Reform Electronic Forum on 18 October 2004,2 and submitted to the Working Group on PCT 
Reform for its seventh session to be held from 30 May to 3 June 2005.3  They concern the formal vs. 
the substantive nature of the disclosure requirement , the optional vs. the mandatory introduction of the 
disclosure requirement at the national level, and the concept of the "source."  An appendix to the 
further observations contains the propo sed amendments to the PCT Regulations. 
 
By also submitting these further observations to the TRIPS Council, Switzerland aims at 
informing the discussions of the TRIPS Council on pa ragraph 19 of the Doha Ministerial Declaration 
about its efforts in the WIPO Working Group on the PCT Reform.  This present communication complements the two previous communications Sw itzerland submitted to the TRIPS Council in June 
2003 and June 2004 respectively:  The first communication
4 contains in its annex the proposals by 
Switzerland to amend the PCT;  the second communication5 contains in its annex additional 
comments on these proposals, which Switzerland submitted to the Working Group on PCT Reform in 
May 2004,6 and which concern the use of terms, the concept of "source," and the scope of the 
obligation to declare this s ource in patent applications. 
                                                      
1 See WIPO-documents PCT/R/ WG/4/13 and PCT/R/WG/5/11. 
2 Available at < http://www.wipo.int/wilma/pct-re form-eforum/200410/msg00001.html >. 
3 See WIPO-document PCT/R/WG/7, Paper No. 7, 26 October 2004. 
4 See WTO-document IP/C/W/400/Rev.1. 
5 See WTO-document IP/C/W/423. 
6 See WIPO-document PCT/R/WG/6/11. IP/C/W/433 
Page 2  
 
THE TEXT OF A SUBMISSION BY SWITZERLAND TO THE WIPO WORKING GROUP 
ON REFORM OF THE PATENT CO-OPERATION TREATY (PCT), CIRCULATED 
AS PCT/R/WG/7 TO THE SEVENTH SESSION TO BE HELD 
30 MAY TO 3 JUNE 2005 
  
FURTHER OBSERVATIONS BY SWITZERLAND ON ITS PROPOSALS REGARDING 
THE DECLARATION OF THE SOURCE OF GENETIC RESOURCES AND 
TRADITIONAL KNOWLEDGE IN PATENT APPLICATIONS 
  
TABLE OF CONTENTS 
 
I.
 OVERVIEW....................................................................................................................... .......2  
II. FORMAL VS. SUBSTANTIVE DISCLOSURE REQUIREMENT....................................3  
III. OPTIONAL VS. MANDATORY INTRODUCTION OF DISCLOSURE 
REQUIREMENT.................................................................................................................... ..4 
IV. THE CONCEPT OF THE SOURCE......................................................................................4  
V. CONCLUSIONS .................................................................................................................... ...5 
 
 
 
I. OVERVIEW 
1. At the fourth session of the Working Group on Reform of the Patent Cooperation Treaty 
(PCT) of the World Intellectual Property Organi zation (WIPO) held in May 2003, Switzerland 
submitted proposals regarding transparency measures unde r patent law in the area of genetic resources 
and traditional knowledge.1  More specifically, Switzerland propo sed to explicitly enable the national 
patent legislation to require the declaration of the source of genetic resources and traditional 
knowledge in patent appli cations, if an invention is directly based on such resources or knowledge. 
2. In order to further advance the discu ssions of the Working Group on PCT Reform, 
Switzerland submitted additional comments on its pr oposals to the sixth session of this Working 
Group held in May 2004.2  These comments concern the use of te rms, the concept of the "source" of 
genetic resources and traditional knowledge, the scope  of the obligation to declare this source in 
patent applications, and the possible legal sanctions  for failure to disclose or the wrongful disclosure 
of the source. 
3. In the discussions on the Swiss proposals held  at the sixth session of the Working Group on 
PCT Reform,3 a number of issues were raised requiring further clarification. The present submission, 
which complements the two previous submissions by Switzerland to this Working Group, addresses 
(1) the formal vs. substantive nature of the discl osure requirement, (2) the optional vs. the mandatory 
introduction of the disclosure requirement, and (3) the concept of "source". 
                                                      
1 These proposals are contained in PCT/R/WG/5/11. 
2 These additional comments are contained in PCT/R/WG/6/11. 
3 See PCT/R/WG/6/12, paras. 82-107, in particular paras. 105-107.  IP/C/W/433 
 Page 3 
 
 
II. FORMAL VS. SUBSTANTIVE DISCLOSURE REQUIREMENT 
4. When considering the introduction of the disclosure requirement in patent law, its legal nature 
(formal vs. substantive) needs to be determined.  Th is is decisive not only for the identification of the 
competent international forum to address and implem ent the requirement, but also with regard to the 
sanctions imposed for failure to disclose or wrongful disclosure of the source. 
5. Generally, the requirements with regard to pate nt applications can be categorized as follows:4 
• formal requirements  which are examined for the purposes of determining if a complete 
application has been filed; 
 
• formal requirements strongly linked to substance  concerning the various parts of the 
patent application for the purposes of search, examination and grant, that is, requirements which could affect the scope of a search or result in the rejection of the 
claims during the substantive examinati on of the patent application;  and 
 
• substantive requirements , under which the claims are evaluated for patentability, 
namely, definition of prior art, disclosure of the claimed invention, patentable subject matter, novelty, inventive step and industrial utility. 
 
6. The policy objective of the disclosure requireme nt proposed by Switzerland is to increase 
transparency in the context of access to genetic resources and traditi onal knowledge and the sharing of 
the benefits arising out of their utilization, in partic ular with regard to the obligations of the users of 
genetic resources and traditional knowledge.
5  Increased transparency will allow the providers of 
genetic resources and traditional knowledge to verify  whether the inventor an d/or patent applicant 
complied with the applicable rules and procedur es on access to these resources or this knowledge, and 
whether provision for benefit-sharing has been made .  This transparency measure will enhance the 
mutual supportiveness of the relevant international agreements, namely the treaties administered by 
WIPO, the Agreement on Trade-Related Aspects of  Intellectual Property Rights (TRIPS Agreement), 
the Convention on Biological Diversity (CBD) and the Bonn Guidelines on Access to Genetic 
Resources and Fair and Equitable Sharing of the Benefits Arising Out of Their Utilization (Bonn 
Guidelines), and the International Treaty on Plant Genetic Resources for Food and Agriculture 
(International Treaty) of the Food and Agriculture Organization (FAO). 
7. Due to its policy objective outlined above, the disclosure requirement is examined for the 
purposes of determining if a complete patent application has been filed.  The disclosure requirement is, in the view of Switzerland, linked neither to the search, examination or grant of patents, nor to the 
evaluation of the claims for patentability.  A ccordingly, it has to be considered as a formal 
requirement, not a formal requirement strongly linked to substance or even a substantive requirement. 
8. To clarify the legal situation and to provide for legal certain ty, Switzerland proposes to amend 
the Regulations Under the PCT to explicitly enable th e national legislator to require patent applicants 
to disclose the source of genetic resources and tradit ional knowledge in patent applications.  At the 
sixth session of the Working Group on the Reform of the PCT, the question was raised whether this 
Working Group is the competent forum to discu ss these proposals.  The Working Group can discuss 
only matters related to the PCT, that is matters rela ted to form or contents of patent applications.  
Accordingly, since the disclosure requirement is in  the nature of a formal requirement, the Working 
Group on the Reform of the PCT is the competent forum to address the proposals by Switzerland. 
                                                     
 
4 See generally SCP/5/6, para 51. 
5 See PCT/R/WG/5/11, para. 7. IP/C/W/433 
Page 4  
 
III. OPTIONAL VS. MANDATORY INTRODUCTION OF DISCLOSURE 
REQUIREMENT 
9. Switzerland proposes to amend the PCT Regulations  to explicitly enable the national patent 
legislation to require the declaration of the sour ce of genetic resources and traditional knowledge in 
patent applications.  The proposals thus leave it up to  the national legislator to decide whether such a 
requirement is to be introduced in the national pa tent legislation.  This optional nature of the 
disclosure requirement was chosen because of the great divergence in the views on transparency 
measures, and because at the international level the discussions on disclosure requirements have not 
brought any final results.  An optional introduction of the disclosure requirement would enable those 
States interested in introducing such a requirement to  do so, but would not oblige States to take action.  
Additionally, it would allow the national governme nts and the international community to gain 
experience with the disclosure requirement, withou t prejudice to further international efforts. 
10. In this context, the amendment proposed by Switzerland with regard to the international 
publication is of relevance:  the proposed Rule 48.2(a)(xi) provides that the pamphlet of the 
international publication shall contain any declarati on as referred to in the proposed Rule 4.17(vi).  
Accordingly, if one or several Contracting Parti es of the PCT require in their national legislation 
patent applicants to declare the source of gene tic resources and traditional knowledge as provided for 
in the proposed Rule 51 bis.1(g), this declaration, if already included in the international patent 
application, would form part of the international publication of this application.  As a result, any 
declaration of the source of genetic resources or traditional knowledge contai ned in an international 
patent application would generally become accessibl e to the public after the expiration of 18 months 
from the priority date of these applications by bei ng included in the international publication.  Thus, 
even though it is optional for the Contracting Parties of the PCT to implement the proposals by Switzerland at the national level, the proposed Rule 48.2(a)(xi) would in practice bring effects which 
are very similar to those of a mandatory approach:  by being included in the international publication, 
the declaration of the source would be publicly accessi ble, and would thus increase transparency in 
the context of access and benefit-sharing at the gl obal level, without it being necessary that it is 
mandatory for the Contracting Parties of the PCT to require patent applicants to declare the source.  
At the same time, the proposed Rule 48.2(a)(xi) co mbined with the optional approach as proposed by 
Switzerland would have the advantages described in the preceding paragraph. 
IV. THE CONCEPT OF THE SOURCE 
11. According to the CBD, the Bonn Guidelines and the International Treaty of FAO, a multitude 
of entities may be involved in access and benefit-shar ing.  To take into account this multitude of 
entities, Switzerland proposes to require patent appli cants to declare the source of genetic resources 
and traditional knowledge in patent applications, the term "source" be ing understood in its broadest 
sense possible. 
12. Based on the aforementioned international instru ments, the entity competent (1) to grant 
access to genetic resources and traditional knowledge, a nd/or (2) to participate in the sharing of the 
benefits arising out of their utilization, is in th e foreground to be declared as the source.  Depending 
on the genetic resource or traditional knowledge in  question, one can distinguish "primary" and 
"secondary" such sources:  primary sources are the Contracting Party providing genetic resources (see 
Arts. 15, 16 and 19 of the CBD), indigenous and local communities (see Art. 8(j) of the CBD), and the Multilateral System established by the Intern ational Treaty (see its Arts. 10-13), and secondary 
sources are ex situ  collections such as gene banks and botanical gardens as well as databases on 
genetic resources and traditional kn owledge, and scientific literature. 
  IP/C/W/433 
 Page 5 
 
 
13. As a result, according to the proposals by Sw itzerland, there is a "cascade" of primary and 
secondary sources that the patent applicant may be re quired to disclose in order to fulfil the disclosure 
requirement:  if the patent applicant (or th e inventor) has information at hand about: 
• the primary source, this primary source must be disclosed;  thus, for example, if the 
patent applicant knows that the source of a genetic resource is the Contracting Party 
providing this resource, this Contracting Party must be disclosed as the source; 
 
• the primary and one or several secondary sources, the primary source must be 
disclosed, whereas the disclosure of the secondary source is optional; thus, for 
example, if the patent applicant received the genetic resource from a botanical garden, 
but also knows the Contracting Party providi ng the genetic resource, this Contracting 
Party must be disclosed, whereas the disclosu re of the botanical garden is optional. 
 
• a secondary source, but not about a primary source, this secondary source must be 
disclosed;  thus, for example, if the patent applicant received the genetic resource from a botanical garden, but does not know the Contracting Party providing the genetic resource, the botanical garden must be disclosed as the source. 
 
• several secondary sources, but not about the primary source, the secondary source with 
the closest relationship to the primary source must be disclosed;  the disclosure of the 
other secondary sources is optio nal; thus, for example, if the genetic resource was 
provided from one botanical garden to several others, the first botanical garden in this chain must be disclosed, whereas the discl osure of the other botanical gardens is 
optional. 
 
14. Only if the patent applicant (or the inventor) has no information at hand about the primary or 
the secondary source, may he disclose that such  source is unknown.  Considering the broad 
understanding of the term "source," cases where ne ither a primary nor a secondary source is known 
are likely to be rare. 
V. CONCLUSIONS 
15. Formal vs. substantive disclosure requirement :  The policy objective of the disclosure 
requirement is to increase transp arency in the context of access to genetic resources and traditional 
knowledge and the sharing of the benefits arising out  of their utilization.  To achieve this policy 
objective, the disclosure requirement has to be examined for the purposes of determining if a 
complete patent application has been filed.  Ho wever, this policy objective neither requires nor 
justifies that the disclosure requirement is linked to the search, examination or grant of patents, or to 
the evaluation of the claims for patentability.  A ccordingly, it has to be considered as a formal 
requirement. In the context of amendments to  the Regulations Under the PCT only formal 
requirements can be taken into consideration. 
16. Optional vs. mandatory introduction of disclosure requirement in the PCT :  In view of the 
clear divergence of opinions among the Contracting Pa rties of the PCT with regard to the introduction 
of a formal disclosure requirement, Switzerland has proposed to make it optional for the national 
legislator to introduce such a requirement. 
17. The concept of "source" :  The relevant international instruments foresee a multitude of 
entities to be involved in access and benefit-sharing.  In the foreground to be declared as the source is 
the entity competent (1) to grant access to genetic  resources and traditional kn owledge, and/or (2) to 
participate in the sharing of the benefits arising out  of their utilization.  Depending on the genetic 
resource or traditional knowledge in question, one  can distinguish primary sources, including in 
particular Contracting Parties providing genetic  resources, the Multilateral System of FAO's IP/C/W/433 
Page 6  
 
International Treaty, indigenous and local communities, and secondary sources, including in particular ex situ  collections and scientific literature.  Acco rdingly, there is a "cascade" of possible 
primary and secondary sources:  patent applicants  must disclose the primary source to fulfil the 
disclosure requirement, if they have information about this primary source at hand.  A secondary 
source may only be disclosed if patent applicants  have no information at hand about the primary 
source. 
[Annex follows]  IP/C/W/433 
 Page 7 
 
 
ANNEX 
 
 
PROPOSED AMENDMENTS OF THE PCT REGULATIONS: 
 
DECLARATION OF THE SOURCE OF GENETIC RESOURCES AND TRADITIONAL 
KNOWLEDGE IN PATENT APPLICATIONS 
 
TABLE OF CONTENTS 
 
 
I. INTRODUCTION ................................................................................................................... .8 
Rule 4 The Request (Contents) .................................................................................................. ..........9  
4.1 to 4.16   [No change]...................................................................................................... ....................9  
4.17    Declarations Relating to National Requirements  Referred to in Rule 51bis.1(a)(i) to 
(v) and Rule 51bis.1(g) ............................................................................................................... 9 
4.11 to 4.18   [No change]..................................................................................................... ...................9  
Rule 26ter Correction or Addition of Declarations Under Rule 4.17..............................................10  
26ter.1   Correction or Ad dition of Declarations ............................................................................... ...10 
26ter.2   Processing of Declarations ........................................................................................... .......... 10 
Rule 48  International Publication ............................................................................................. .........11  
48.1   [No change]............................................................................................................. .....................11  
48.2   Contents .................................................................................................................... ................... 11 
48.3 to 48.6   [No change]..................................................................................................... .................11  
Rule 51 bis Certain National Requirements Allowed Under Article 27...........................................12  
51bis.1   Certain National Requirements Allowed................................................................................. 12 
51bis.2   Circumstances in Which Docume nts or Evidence May Not Be Required ............................... 12 
51bis.3  Opportunity to Comply with National Requirements ............................................................... 13 
 IP/C/W/433 
Page 8  
 
1. INTRODUCTION 
1. This Annex contains the wording of the amen dments of the PCT Regulations proposed by 
Switzerland regarding the declaration of the sour ce of genetic resources and traditional knowledge in 
patent applications.  Proposed a dditions and deletions are indicated, respectively, by underlining and 
striking through of the text concerned.  Amendmen ts are proposed to Rule 4.17 (addition to chapeau 
and new subpara. vi), Rule 48.2(a) (new subpara. xi), Rule 51 bis.1 (new subpara. g), Rule 51 bis.2 
(new subpara. d), and Rule 51 bis.3 (amendment of subpara. a).  Rule 26 ter is not proposed to be 
amended, but is included in this Annex for ease of reference. 
2. To take into account the discussions of the Working Group on the Reform of the PCT on the 
proposals by Switzerland, the wording of the amendm ents of the PCT Regulations originally proposed 
by Switzerland
6 has been slightly adapted, without, however, modifying the substance of the 
proposals.  This concerns, in particular, the use of  the term "traditional know ledge related to genetic 
resources" instead of the term "knowledge, inno vations and practices of indigenous and local 
communities relevant for the conservation and sustainable use of biological diversity." 
 
                                                      
6 See PCT/R/WG/5/11, paras. 24 and 29.  IP/C/W/433 
 Page 9 
 
 
Rule 4 
The Request (Contents) 
 
4.1 to 4.16   [No change] 
 
4.17    Declarations Relating to National Requiremen ts Referred to in Rule 51bis.1(a)(i) to (v) and 
Rule 51bis.1(g)  
 The request may, for the purposes of the nationa l law applicable in one or more designated 
States, contain one or more of the following decl arations, worded as prescribed by the Administrative 
Instructions: 
 
 (i)  to (iv)  [No change]   (v) a declaration as to non-prejudicial disclosures or exceptions to lack of novelty, as 
referred to in Rule 51 bis.1(a)(v); 
 
 (vi) a declaration as to the source of a specific genetic resource and/or traditional 
knowledge related to ge netic resources, as referred to in Rule 51 bis.1(g).  
  [COMMENT:  Rule 4.17 sets fort h those matters relating to which applicants may include a 
declaration in the request pursuant to Rule 4.1( c)(iii).  Such matters include those as to which 
designated Offices are entitled to require documents or evidence during the national phase of processing and which are expressly listed in Rule 51 bis.1(a).  The proposed new subparagraph (vi) 
would give patent applicants the possibility of satisfying the declaration requirement under national 
patent law in accordance with  the proposed new Rule 51 bis.1(g) at the time of filing an international 
patent application or later during the internationa l phase.  This would further simplify procedures 
related to the declaration of the source of genetic  resources and/or traditi onal knowledge related to 
genetic resources, with regard to international pate nt applications.  The Administrative Instructions 
will have to prescribe the standardized wording of such declarations which may be included in the 
request pursuant to the proposed Rule 4.17(vi).]  
4.11 to 4.18   [No change] IP/C/W/433 
Page 10  
 
Rule 26ter 
Correction or Addition of Declarations Under Rule 4.17 
 
26ter.1   Correction or Addition of Declarations 
 The applicant may correct or add to the request  any declaration referred to in Rule 4.17 by a 
notice submitted to the International Bureau within a time limit of 16 months from the priority date, 
provided that any notice which is received by the Inte rnational Bureau after the expiration of that time 
limit shall be considered to have been received on the last day of that time limit if it reaches it before 
the technical preparations for interna tional publication have been completed. 
 26ter.2   Processing of Declarations 
(a) Where the receiving Office or the International Bureau finds that any declaration referred to 
in Rule 4.17 is not worded as required or, in the case of the declaration of inve ntorship referred to in 
Rule 4.17(iv), is not signed as required, the receiving Office or the International Bureau, as the case may be, may invite the applicant to  correct the declaration within a time limit of 16 months from the 
priority date. 
(b) Where the International Bureau receives any correction or addition of a declaration under 
Rule 26ter.1 after the expiration of the time limit under Rule 26ter.1, the International Bureau shall 
notify the applicant accordingly and shall proceed as provided for in the Administrative Instructions. 
 
 [COMMENT:  Rule 26 ter is unchanged. It is included in this Annex for ease of reference only. Rule 
26ter provides procedures for the addition or correcti on of declarations in the request which are 
referred to in Rule 4.17.  It also applies in the context of the proposed new Rules 4.17(vi) and 
51bis.1(g). Rule 26 ter provides the applicant with a mechanism for providing or correcting a 
declaration of the source of genetic resources and/or traditional knowledge related to genetic 
resources pursuant to the proposed Rule 4.17(vi) during the international phase.] 
  IP/C/W/433 
 Page 11 
 
 
Rule 48 
International Publication 
 
48.1   [No change] 
 
48.2   Contents 
 
 (a)  The pamphlet shall contain:    (i) to (ix)  [No change] 
 
 (x) any declaration referred to in Rule  4.17(v), and any correction under Rule 26 ter.1, 
which was received by the International Bureau before the expiration of the time limit under 
Rule 26 ter.1, 
 
 (xi) any declaration referred to in Rule  4.17(vi), and any correction under Rule 26 ter.1, 
which was received by the International Bureau before the expiration of the time limit under 
Rule 26 ter.1. 
  [COMMENT:  The proposed Rule 48.2(a)(xi) provides that the pamphlet shall contain any declaration 
contained in the request that is referred to in the proposed Rule 4.17(vi), that is, a declaration 
regarding the source of a specific genetic resource  and/or traditional knowledge related to genetic 
resources, as referred to in the proposed Rule 51 bis.1(g).  With the proposed subpara. (xi), the 
declaration of the source of such a resource or such  knowledge in a patent a pplication would generally 
become accessible to the public after the expirati on of 18 months from the priority date of that 
application.  Accordingly, the proposed Rule 48.2( a)(xi) would further support the policy objective of 
the declaration of the source, that is, increasing tr ansparency in the context of access to genetic 
resources and traditional knowledge and the sharing of  the benefits arising out of their utilization.] 
  (b) to (i)  [No change]  
48.3 to 48.6   [No change] IP/C/W/433 
Page 12  
 
Rule 51 bis 
Certain National Requirements Allowed Under Article 27 
 
 
51bis.1   Certain National Requirements Allowed 
 (a) to (f)  [No change] 
 
(g)  Subject to Rule 51 bis.2, the national law applicable by the designated Office may, in
 
accordance with Article 27, require the applicant to furnish:  
 
(i)  a declaration as to the source of a specific genetic resource to which the 
inventor has had access, if the invention is directly based on such a resource;  
 
  (ii) a declaration as to the source of  traditional knowledge related to genetic 
resources, if the inventor knows that the invention is directly based on such 
knowledge;  
   (iii) a declaration that the source referred to in (i) or (ii) is unknown to the 
inventor or applicant, if this is the case.  
  
[COMMENT:  The proposed Rule 51 bis.1(g) provides that the nati onal law applicable by the 
designated Office may require patent applicants to furnish either a declaration as to the source of a 
specific genetic resource and/or traditional knowledge related to genetic resources, or a declaration 
that this source is unknown to the inventor or applicant.  The proposed Rule 51 bis.1(g) takes into 
account the discussions held in the Working Group on  PCT Reform on the proposals by Switzerland.  
Accordingly, the wording of the proposed Rule 51 bis.1(g) contains minor adaptations compared with 
the wording of the proposals originally submitted by  Switzerland to the Working Group on Reform of 
the PCT in May 2003.
7  These adaptations concern the structure and the use of terms, but do not alter 
the substance of the proposed Rule 51 bis.1(g).  These adaptations are:  First, the proposed Rule 
51bis.1(g) uses the term "traditional knowledge relate d to genetic resources" instead of the term 
"knowledge, innovations and practices of indige nous and local communities relevant for the 
conservation and sustainable use of biological diversit y."  In the view of Switzerland, both terms are 
fully synonymous,8 the term "traditional knowledge related to genetic resources" being used for 
reasons of simplicity and briefness.  Second, a s ubpara. (iii) is added to the proposed Rule 51 bis.1(g), 
containing the provisions of the last part of the orig inally proposed subparas. (i) and (ii), respectively, 
with regard to the case where the source is unknown to the inventor or applicant.  And third, the 
proposed subpara. (iii) clarifies th at the source must be unknown to the inventor or patent applicant.] 
 51bis.2   Circumstances in Which Docume nts or Evidence May Not Be Required 
 
 (a) to (c)  [No change] 
                                                     
 
7 See PCT/R/WG/5/11, paras. 24 and 29. 
8 See PCT/R/WG/6/11, para 11.  IP/C/W/433 
 Page 13 
 
 
 
(d)  Where the applicable national law requires the applicant to furnish a 
declaration as to the source (Rule 51 bis.1(g)), the designated Office shall not, 
unless it may reasonably doubt the veracity of the declaration concerned, require 
any document or evidence:  
 
 (i) relating to the source of a specific genetic resource (Rule 51 bis.1(g)(i) and 
(iii)) if, in accordance with Rule 4.17(vi) , such declaration is contained in the 
request or is submitted directly to the designated Office;  
 
 (ii) relating to the source of traditional knowledge re lated to genetic resources, 
(Rule 51 bis.1(g)(ii) and (iii)) if, in accordan ce with Rule 4.17(vi), such 
declaration is contained in the request or  is submitted directly to the designated 
Office.  
 
 
[COMMENT:  The proposed Rule 51 bis.2(d) is intended to limit the circumstances in which 
designated Offices are entitled to require documents or  evidence from applicants in the national phase 
in relation to certain matters refe rred to in the proposed Rule 51 bis.1(g).  The limitation is consistent 
with draft PLT Article 6(6).  Accordingly, if the request, in accordance with Rule 4.17(vi), contains a 
declaration as to the source of a genetic resource  or traditional knowledge, or a declaration that this 
source is unknown to the inventor or applicant (Rule 51 bis.1(g)), or if such a declaration is submitted 
directly to the designated Office, the Office woul d not be entitled to require documents or evidence 
relating to this declaration, unless the Office ha s reasonable doubts as to the veracity of the 
declaration.]  
51bis.3 Opportunity to Comply with National Requirements 
 (a)  Where any of the requirements referred to in Rule 51 bis.1(a)(i) to (iv),
 and (c) to (e), and 
(g), or any other requirement of the national law a pplicable by the designated Office which that Office 
may apply in accordance with Article 27(1) or (2),  is not already fulfilled during the same period 
within which the requirements under if Article 22 must be complied with, the designated Office 
circumstances, shall invite the applicant to comp ly with the requirement within a time limit which 
shall not be less than two months from the date of  the invitation. Each designated Office may require 
that the applicant pay a fee for complying with na tional requirements in response to the invitation. 
   [COMMENT: Rule 51 bis.3(a) provides that designated Offices shall invite the applicant to comply 
with those requirements of national law whic h designated Offices may apply under Rule 51 bis.1(a) 
and (c) to (e) and Article 27(1) and (2), respectivel y, which have not already been fulfilled by the time 
of entry of the application into the national phase.  It is proposed to apply this Rule also with regard to 
requirements of national law which desi gnated Offices may apply under Rule 51 bis.1(g).] 
    
 (b) to (c)  [No change] 
 
[End of document and of Annex] 
 
 
__________