WORLD TRADE  
ORGANIZATION  IP/C/W/484 
2 November 2006 
 
 (06-5266) 
Council for Trade-Related Aspects 
of Intellectual Property Rights Original:   Spanish 
 
 
 
RESPONSE TO COMMENTS CONTAI NED IN DOCUMENT IP/C/W/469 
RELATING TO THE PERUVIA N COMMUNICATION IP/C/W/458 
 
Communication from Peru  
 
  The following communication, dated 23 October 2006, is being circulated at the request of the delegation of Peru.  It was circulated ah ead of the Council meeting held in October 2006. 
 
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I. BACKGROUND 
1. On 7 November 2005, Peru submitted to the Wo rld Trade Organization (hereinafter WTO) 
document IP/C/W/458, "Analysis of Potential Cases of Biopiracy". 
2. The purpose of the document submitted by Pe ru was to highlight the progress made in 
identifying and analysing patent applications and patent grants concerning inventions obtained or 
developed through the use of camu camu ( Myrciaria dubia ). 
3. The document describes some of the problems that a country like Peru has to face upon 
identification of a pending patent application or  patent grant whose subject-matter concerns an 
invention obtained or developed from the use of  a biological resource or traditional knowledge 
without securing the prior informed consent of the c ountry of origin of the resource or the indigenous 
people owning rights in the knowledge, and without providing for any type of compensation to that 
country or indigenous people. 
4. The document also contains comments on the lim itations and problems faced by countries 
such as Peru, or that may be faced by them, in identifying, monitoring and studying patent 
applications or granted patents that involve imprope rly granted rights or weaken regimes for access to 
and/or protection of traditional knowledge. 
5. The document notes that a large number of pendi ng patent applications and granted patents do 
not meet the novelty and inventive step criteria or, wh en they do meet patentability requirements, they 
(directly or indirectly) incorporate genetic re sources and traditional knowledge that have been 
obtained illegally, irregularly or questionably, to say the least. 
6. The United States, for its part, submitte d to the WTO on 13 March 2006 document 
IP/C/W/469 entitled "Article 27.3( B), Relationship Between the TR IPS Agreement and the CBD, and 
the Protection of Traditional Knowledge and Folklore". IP/C/W/484 
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  7. Peru welcomes the comments presented by the United States delegation and hopes that this 
commitment to deepen the debate, especially the fact-based technical debate, will make it possible to 
achieve a satisfactory solution to the problems  currently confronting countries like Peru. 
8. In that document, the United States made the following comments on document IP/C/W/458 
submitted by Peru. 
 (a) "The most recent submissions by Peru and the Annex attached to document 
IP/C/W/459 help to identify the actual experiences that these delegations consider to illustrate their concerns.  We believe further analysis of these documents is 
warranted."  (Paragraph 11). 
 
 (b) "It is not clear how the mere fact that  a pending patent application, or a granted 
patent, that refers to genetic resources or  claims an invention that may have some 
relation to these resources can lead to a conclusion that the genetic resources or 
intellectual knowledge at issue has been obtained 'illegally, irregularly, or questionably'."  (Paragraph 12). 
 
 (c) "It has been noted that many of the reso urces cited by Peru and other Members in the 
course of the discussions are grown in many countries throughout the world, including many of those countries in which patents are filed.  Further, it is noted that many resources of Peruvian origin have b een exported and sold as raw material for 
direct consumption or industrial processing, with a view to immediate economic 
benefits.  Peru itself acknowledges this issu e as a "major problem" … .  The threshold 
question that must arise is whether these e xports or the transactions concerning those 
exports were subject to the access and benef it-sharing regime of Peru.  If not, this 
leads to the conclusion that it is likely that many, if not all, of the inventions cited 
have used starting materials that were obt ained by legitimate means, e.g., through 
commercial channels, and not by illegal,  irregular or questionable means."  
(Paragraph 13). 
  (d) "Additionally, a cursory review of seve ral of the patents listed in the Peruvian 
submission … reveal that the inventors of sev eral of these patents did in fact disclose 
the source and/or origin of the genetic res ource related to the invention.  Given that 
many of the issued patents involving genetic resources cited by Peru and others do, in 
fact, disclose source and/or origin of the biological material, it is clear that the proposed new disclosure requirements in and of themselves will not attain the purported goals."  (Paragraph 14). 
 
 (e) "Peru's concept of "bio-piracy" appears to  be limited solely to the context of pending 
patent applications and granted patents.  As  discussed previously, patenting in and of 
itself does not amount to misappropriation.  The analyses presented by Peru may provide useful information concerning prio r art to help understand whether or not a 
patent should be (or should have been) granted in these cases.  However, there is nothing in those experiences that suggests that the proposed new disclosure 
requirement for source and/or origin would have been relevant to these 
determinations."  (Paragraph 16). 
  (f) "The experience of Peru is instructive in identifying the perceived 'problems' faced in 
collecting information, but here again, it is the US proposals, not the new proposed 
disclosure requirements, that can address these problems."  (Paragraph 24). 
  IP/C/W/484 
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   (g) "However, disclosure of source, origin, PI C or benefit-sharing agreements have little, 
if any, bearing on how to alter the situations  cited by Peru.  In fact, the applications 
for several of the patents listed in the Pe ruvian submission … did indeed disclose the 
source and/or origin of their starting material."  (Paragraph 25). 
 
9. The context of the debate originates in the pr oposal to include disclosure of source and/or 
origin in patent applications.  This proposal is not considered valid by the US delegation, which is of 
the view that a contractual system accompanied by the use of organized databases to improve prior art 
searches concerning patent applications would, among other means, constitute a better way of 
addressing the problems referred to by Peru and other delegations. 
10. This document seeks to clarify some of the comments made by the United States on the 
document submitted by Peru. 
11. The United States indicates1 that it is not clear how a patent  application or a granted patent 
that refers to genetic resources or claims an inven tion that may have some relation to those resources 
can lead to the conclusion that the genetic r esources or traditional knowledge at issue have been 
obtained "illegally, irregularly or questionably". 
12. As a preliminary point, it is important to indicat e that the document prepared by Peru states 
that it concerns an analysis of potential  cases of biopiracy.  This means that it deals with "possible" 
cases of biopiracy.  There is no implication that all the cases described in the document are as at this 
date cases of biopiracy.  Nor is there any attempt to insinuate that all patent applications or granted 
patents that involve genetic resources or trad itional knowledge have been  obtained illegally or 
irregularly. 
13. However, Peru reiterates what is stated in pa ragraph 7 of its communication, since we are not 
here faced with isolated cases that have arisen r ecently.  There are a considerable number of cases 
which are arousing the concern of many countri es – especially developing countries rich in 
biodiversity – and which are related to the effectiv e protection of the patent system.  In the Council 
for TRIPS, Peru and many other countries have prese nted various cases in order to demonstrate with 
concrete evidence the extent of their concerns. 
14. Since the entry into force of the Convention on Biological Diversity (CBD), it has been 
recognized – in accordance with the United Nations Charter and international law – that countries 
have sovereign rights over their natural resources and have the power to regulate access to genetic 
resources.  This legal obligation is enforceable erga omnes  and the legal right protected is the resource 
itself. 
15. In this connection, the disclosure of source and/ or origin would make it possible – first of all 
– to identify those cases in which a resource native to Peru is being used outsi de its jurisdiction and 
thereby to verify the legality or illegality of access to the biological resource and/or traditional 
knowledge which was used as the source for developm ent of the process or product to be patented.  
As there is at present no obligation to disclose the or igin of resources used in patents, each State must 
use the means at its disposal if it is  to be able to meet its legal oblig ations under the CBD;  this entails 
enormous expenditure and has made it necessary to set up institutions responsible for monitoring 
these obligations.  In the case of Peru, as was reporte d previously, some of this responsibility falls on 
the National Anti-Biopiracy Commission. 
                                                      
1 See page 3, paragraph 12 of document IP/C/W/469. IP/C/W/484 
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  16. A second element relates to compliance with pate ntability criteria (novelty, inventive step and 
industrial application), when inventions are b ased on traditional knowledge or genetic resources – 
over and above the question as to whether they have been obtained by lawful or unlawful means. 
17. There is thus here a second level of analysis, relating to the possibility for a State like Peru – 
once the origin of the resource has been verified – to review compliance with the patentability criteria, 
in this case those relating to novelty and inventive step in particular.  The purpose of this analysis is to 
determine whether or not an invention satisfies tho se criteria, or to ascertain whether – as has occurred 
in various cases, including cases concerning "maca" – the patented product or process is already 
covered by prior art.  And it is at this point that it is particularly relevant to verify the existence of 
traditional knowledge associated with the genetic resource. 
18. Thus, the disclosure requirement would make it possible not only to ascertain the physical 
origin – the first level of compliance with the Per uvian State's obligations under the CBD – but also to 
comply with the second-level obligation to take into account and, consequently, to respect the 
associated traditional knowledge, which is understood to constitute the prior art and which in many 
cases may not be known by the examiner. 
19. Although Peru shares the United States' views about the usefulness of databases and public 
information systems
2, such systems would be of no value if the provenance or origin of the resource 
used in the invention could not be established. 
20. Moreover, a third level of analysis should enable  a State to check – if an application or a 
patent involves a resource of Peruvian origin that  satisfies the patentability criteria – that compliance 
has also been secured with another of the obliga tions laid down by the CBD:  obtaining the prior 
informed consent of the patent holder and fair and equitable benefit-sharing, in accordance with 
existing national rules on the subject.  Once again, in  order to be able to carry out this analysis, 
knowledge of the origin of the resource is necessar y, for which purpose a binding rule of universal 
scope is required, one which, in the opinion of Peru  and several delegations, must take the form of a 
requirement, under the patent system, for disclosure of  the source and/or origin of genetic resources. 
21. Contrary to what is stated by the United Stat es in its communication, the great majority of 
patent applications or patents3 do not disclose the origin of the resource from which the process or 
                                                      
2 In fact, Peru recognized this possibility in the Memorandum of Understanding with the United States 
negotiated under the Free Trade Agreement between the two countries.  In addition, the National Institute for the 
Defence of Competition and Intellectual Property is introducing a portal on traditional knowledge of indigenous 
peoples, which can be accessed free of charge (www.indecopi.gob.pe/portalctpi ). 
3 Set out below are some examples taken from the US database: 
1. Imidazole alkaloids from Lepidium  meyenii and methods of usage.  
 US 6,878,731 Cui , et al. April 12, 2005 
 Lepidium  meyenii (commonly referred to as Maca ) is indigenous to the Andean Mountains at 
an altitude of higher than 10,000 feet.  To the Andean Indians, Maca is a valuable commodity.  
Because so little else grows in the region, Maca  is often traded with communities at lower 
elevations for other staples like rice, corn, and beans. 
2. Compositions and methods for their preparation from lepidium : 
 US 6,552,206 Zheng , et al. April 22, 2003  
 Lepidium  meyenii, commonly called maca  or Peruvian ginseng, is a perennial plant having a 
fleshy, edible, tuberous root.  Another species is Lepidium  peruvianum. 
3. Herbal composition for enhancing sexual response 
 6,444,237 Heleen September 3, 2002  In a preferred embodiment of the present inve ntion the composition further includes effective 
amounts of BEC and Lepidium  meyenii (" Maca "), a traditional Peruvian aphrodisiac.  IP/C/W/484 
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  product to be patented has been de veloped.  Hence the necessity for the patent system to include a 
universal obligation to disclose origin. 
22. Frequently, even when it is indicated that the resource used is known in Peru or comes from 
the Peruvian Andes, its precise origin is not clea rly established.  Accordingly, it would be of 
secondary importance to establish whether or not the resource is marketable.4  Furthermore, the 
existence of a disclosure requirement would in fact serve to dispel any doubts concerning the legal 
provenance of the resource and, where appropriate, to determine that the resource was obtained legally and through commercial channels, rulin g out any presumption of illegal acquisition. 
23. These initiatives are supplemented by detailed nati onal regulations in various areas relating to 
the promotion and protection of genetic resour ces, access to genetic resources and protection of 
traditional knowledge, which are aimed at establishi ng a satisfactory balance between the sustainable 
use of such resources and the positive utilization and implementation of the patent system, to which 
Peru also attaches great importance. 
24. Recently, this initiative was supplemented by th e introduction of a new database system for 
the registration of traditional knowledge of i ndigenous peoples (www.indecopi.gob.pe/portalctpi
), 
which Peru hopes will be consulted extensively, pr incipally for the purpose of determining species 
originating in Peru, and associated traditional knowledge  in particular. 
II. CONCLUSIONS 
25. Peru's position is clear:  despite the existence of useful tools for improving the patent system 
– and verifying compliance with existing patentab ility obligations, especially as regards the novelty 
and inventive step criteria – the inclusion of the re quirement to disclose the source and/or origin of 
biological resources, as proposed in document IP/C/W/473, is essential if the patent system is to 
reflect adequately the obligations arising from the CBD, obligations which Peru and all Member 
States are required to fulfil. 
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4 In any event, it is curious to st ate that there are curren tly also problems regarding the entry of natural 
products of biodiversity into the territory of the European Union, given the existence of a Community regulation which blocks the entry of a group of biological resources regarded as "novel foods" (Novel Foods Regulation 
(EC) No. 258/97).