WORLD TRADE  
ORGANIZATION  IP/C/W/475 
26 July 2006 
 
 (06-3596) 
Council for Trade-Related Aspects 
of Intellectual Property Rights Original:  English 
 
 
RESPONSE TO QUESTIONS RAISED ON THE DRAFT AMENDMENT  
TO TRIPS – ARTICLE 29 BIS 
 
Communication from Brazil  
 
 
 The following communication, dated 24 July 2006, is being circulated at the request of the 
Delegation of Brazil.  
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1. Whether there is any need to disclose more than source. 
 
1. There is a clear need to disclose the country providing the resources as well as the source.  
The country of origin would be subject to the reasonable inquiry criteria.  There are a number of reasons for this. 
2. Firstly, disclosing only the source, say person  A or laboratory A, without indicating the 
country providing the resources would not achieve the objectives of the proposed amendment.  
Laboratory A, for example, could be a multinational company laboratory in various countries and the 
simple indication of a name will give no clue as to which laboratory of the many provided the 
resources. 
3. Secondly, there are definitions in the CBD fo r both "country of origin" and "providing 
country", and disclosing information on them is an es sential requisite for the patent system to become 
supportive of the CBD in regard to its recogniti on of countries' sovereignty over their natural 
resources. 
4. Finally, disclosure of country providing and country of origin is needed to address the 
international dimension of the misappropriation issu e, because through patenting in one country rights 
may be conferred to indi viduals or companies or other entities over resources that may have been 
misappropriated in other countries. 
5. Source is equally relevant information, and its disclosure has been included in the draft 
amendment.  But it is not enough, per se , to address the international dimension of the 
misappropriation issue. 
2. Why is the term biological resource instead of genetic resources used?   
6. The CBD recognizes that "States have, in accordan ce with the Charter of the United Nations 
and the principles of international law, the soverei gn right to exploit their own resources...".  Thus, the 
power enjoyed by the States is not limited to regula tion of genetic resources.  Accordingly, the fact 
that Article 15 of the CBD addresses "access to genetic resources" should not be interpreted as 
preventing States from regulating access and benef it-sharing relating to biological resources. IP/C/W/475 
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  7. Furthermore, the term biological resources, which is broader, is intended to ensure that all 
possible cases of biopiracy are covered and to keep  pace with technological developments especially 
with respect to biotechnology.  This terminology is  similar to the term "biological material" which 
had been used in earlier submissions and which is, for example, used in the EU Biotechnology 
Directive (Directive 98/44 of 6 July 1998) at recita l paragraph 27 and defined in Article 2 of the said 
Directive. 
3. How would the three triggers "concerns", "d erived from" and "developed with" work 
or rather what do they mean in practice?   
8. These three triggers seek to encompass the releva nt situations in which biological resources 
and/or associated traditional knowledge contributed to reaching an invention, while providing a 
margin of flexibility for the national competent author ities of the country where the patent is sought to 
define whether the applicant has effectively complied with the rule or not.  Two of the triggers – 
"concerns" and "derived from" – have meanings th at are already known to Members who have used 
them in their legislation. 
9. The term "concerns" refers to cases where a predom inant or substantial pa rt of the invention 
incorporates the genetic resources.  This usage w ould be similar to that of the EU Biotechnology 
Directive at Article 3.1. 
10. The term "developed with", in contrast, may not necessarily incorporate any of the genetic 
resources but the resources and/or associated traditiona l knowledge is critical in the development of 
the claimed invention.  This will be particular ly the case with respect to traditional knowledge 
associated with the genetic resources where the trad itional knowledge may be rarely incorporated in 
the claimed invention but the knowledge was indi spensable in the develo pment of the claimed 
invention. 
11. The term "derived from" is intended to cover de rivatives.  It appears in Article 8.1 of the 
EU Directive, referring to propagation or multiplication from the original biological material. 
4. Who will decide whether there has been rea sonable inquiry as contemplated under 
paragraph 2 of the proposed Article 29 bis and what does reasonable inquiry mean?   
12. "Reasonable inquiry" is similar in nature to th e expressions of the type "reasonable ground to 
know" commonly used in many legislations of  Members and in the TRIPS Agreement itself 
("reasonable efforts", Article 34;  "reasonable grou nd to know";  Article 37;  "reasonable steps under 
the circumstances", Article 39). 
13. The applicant would initially determine what enqui ry is reasonable to satisfy the requirement, 
which is generally understo od to mean due diligence. 
14. The role of the patent office would be limited,  in principle, to confirming that the patent 
application discloses information in the prescribed form. 
5. Does the word "including" in the second sen tence of paragraph 2 and paragraph 3 
mean there are additional requirements ot her than evidence of PIC and ABS?   
15. The word "including" in paragraph 2 does not require the applicant to disclose additional 
information other than evidence of PIC and ABS.  If the applicant furnishes evidence of PIC and ABS 
he would have met the requirement.  IP/C/W/475 
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6. What is to be understood by the term associated traditional knowledge?   
16. The proponents intend to give its ordinary mean ing to the term traditional knowledge (TK).  
The word "associated" is prefixed to TK in order to restrict the disclosure to TK that has some 
relevance to the biological resources used in de veloping or concerning the subject matter of the 
invention.  Therefore, not all forms of traditional knowledge are covered. 
17. The term is not new or unheard of.  Many patent offices use the concept of traditional 
knowledge in determining prior art.   
7. Will the requirement to publish require publicatio n with the patent or separately from 
the patent application? 
18. Publication will be at the discretion of each Member.  The requirement is that the disclosure 
information be published at the same time as or si multaneously with the patent application or patent 
grant, whichever is first.  A Member can choose to publish the disclosure information in the same 
document of the application or grant or in a separat e document accompanying the application or grant.  
In the case of supplementary or correctional inform ation under paragraph 3, this will in most cases be 
published separately. 
8. How would the concept of unenforceable wo rk under paragraph 5 of the draft article 
including in those countries where there are only provisions for revocation?   
19. Paragraph 5 presents unenforceability as an alternat ive to revocation.  It means that patent 
holders failing to comply with disclosure are not entitle d to go to court to enforce their rights.  Under 
common law, this is similar to the principle that you cannot go to a court of equity with unclean hands. 
20. The situation is not unheard of.  For example, in countries where renewal fees are payable, a 
patent holder who has not paid a renewal fee on the due date cannot go to court to enforce the rights 
under a patent for which maintenance fees are not paid. 
9. Why is the substance of the text broader than the title says?   
21. In the TRIPS Agreement titles usually give a general sense of the issue and not all the 
elements of an article.  Article 30, for example, is titled "Exceptions to rights Conferred", but does not 
mention any exception;  instead, it establishes the th ree-step test.  Article 27, "patentable subject 
matter", also refers to exclusions to patentab ility.  Notwithstanding this fact;  it is not titled 
"Patentable Subject Matter and Exclusions from Patentability". 
10. Will there be a transitional period for implemen tation in addition to the period to be 
given for ratification of the amendment?   
22. Because it is predominantly in the interest of developing countries to  contain biopiracy, and 
the problem has not been tackled adequately for te n years since the entry into force of TRIPS, the 
proposed amendment does not foresee additional trans itional periods.  Save for LDCs, whose general 
transition period has been extended to 2013 under th e TRIPS Agreement as a whole, with possible 
additional extensions for all treaty obligations, the proposed amendment would enter into force within 
the period given for ratifications.  It is consid ered that the period between the adoption of the 
amendment and ratification will be sufficient to allo w countries to make the necessary changes in law. IP/C/W/475 
Page 4  
 
  11. If there are no PIC or ABS requirements in the providing country, would a declaration 
of providing country and source together with a declaration that there are no PIC and ABS requirements suffice?   
23. The applicant is required by the proposed amendment to present information including 
evidence of compliance with the applicable legal requirements
 in the providing country for PIC and 
ABS.  If the providing country does not have any applicable legal requirements for PIC and ABS a 
declaration to this effect by the applicant shall su ffice with regard to the obligation contained in the 
second part of paragraph 2 of the amendment.  The patent office would not have to assess the validity 
of such information.  The m echanism would work based on prima facie  assumptions that the 
information was provided correctly and in good faith. 
24. However, the applicant would still be required to disclose the country providing, from whom 
in that country the biological resource and/or  associated TK was obtained and, as known after 
reasonable inquiry, the country of origin. 
12. To which applications will the requirement a pply?  Only those made after the entry into 
force of the amendment?   
25. The obligations under the amendment will appl y only to applications made after the 
assumption of the obligation under the proposed article by WTO Members. 
13. What does "with reasonable ground to know in paragraph 5 mean?   
26. The phrase "know or having reasonable grounds to know" adds no novelty to the patent 
system.  It is a widely used legal concept, found in many legislative provisions.  Indeed, this terminology is used in the TRIPS Agreement itself, for example in Articles 44 and 45.  In paragraph 1 
of Article 44 on injunctions the TRIPS Agreement provides inter alia that "Members are not obliged 
to accord such authority in respect of protected subj ect matter acquired or ordered by a person prior to 
knowing or having reasonable grounds to know that dealing in such subject matter would entail the 
infringement of intellectual property right".  Simila r language is used in paragraph 1 of Article 45 
regarding damages.  The words in paragraph 5 of the proposed article 29 bis will have a similar 
meaning to that in Articles 44 and 45 of TRIPS. 
27. This is a legal concept which essentially mean s that:  considering the knowledge of the 
applicant, the resources available to them and normal business and scientific practices, they are 
expected to know. 
28. So for example, if there is an ABS law in th e country providing the resources, the applicant 
would be reasonably expected to know of this law and its requirement.  It also implies that the 
applicant is expected to exercise ordinary due  diligence and not be reckless and careless. 
14. Does paragraph 1 of the proposed article mean that non-CBD members will have to 
comply with CBD requirements?   
29. Paragraph 1 indicates the broader objectives th at will be served by the proposed TRIPS 
amendment.  Once introduced, the disclosure provision will be a TRIPS requirement and not a CBD 
obligation, notwithstanding the objective sought of  mutual supportiveness between the two treaties, 
which is in accordance with the relevant Doha Ministerial Mandates. 
30. The amendment does not bind non-CBD Parties to the provisions of the Convention, as the 
disclosure obligations are acquired exclusively unde r and in accordance with the TRIPS Agreement.  IP/C/W/475 
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31. This is normal practice, particularly in th e case of TRIPS which has transposed several 
provisions contained in international treaties negotia ted outside of the Organization into the realm of 
the WTO.  Reference in TRIPS to provisions take n from of the Paris Convention or several other 
WIPO treaties on intellectual property rights does not mean that non-WIPO members are complying with any other WIPO obligations. 
15. Does the requirement for correction of inform ation only apply to the pre-grant period 
or also to post-grant period?  In other wo rds, will there be a continuing obligation under 
paragraph 3 once the patent has been issued? 
32. The requirement applies to the pre-grant and post -grant periods.  This is  made clear by the use 
of the words "applicant" and "patentee".  Since failure to comply with the obligation under the 
proposed article can prevent the further processing of  an application or result in revocation of the 
patent, the flexibility for submitting additional info rmation which might prevent this from happening 
clearly benefits the applicant or the patentee as the ca se may be.  In other words, in both the pre-grant 
and post-grant periods there will be a continuing oppo rtunity for providing supplemental or corrective 
information that is relevant to the fulfilment of the obligation. 
16. With whom would benefits be shared and wi th whom would benefit sharing contracts be 
negotiated?   
33. The legal requirements of each WTO Member w ill determine with whom the benefit sharing 
contracts are negotiated with.  The amendment do es not intend to impose a uniform approach on 
WTO Members. 
17. Can Members impose fees on applicants to cover any costs associated with this 
obligation?   
34. It is anticipated that the obligations unde r the proposed amendment will not impose undue 
burden and costs on the patent applicants or holders  or on patent offices in Member countries.  For 
this reason, unless demonstrated otherwise, it is not foreseen that additional fees will need to be 
charged to cover the costs.  However, where a Me mber considers it relevant, they could take this 
obligations into account in setting fees together with any other considerations they make in 
determining fees.  In essence, the intention of the pr oponents is to leave this issue to the discretion of 
Members subject to any other rules in the TRIPS Agreement or other treaties such as the Patent 
Cooperation Treaty (PCT) that those Members may be party to. 
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