WORLD TRADE  
ORGANIZATION  IP/C/W/447 
8 June 2005 
 
 (05-2339) 
Council for Trade-Related Aspects 
of Intellectual Property Rights Original:   Spanish 
 
 
 
ARTICLE 27.3(B), RELATIONSHIP BETWEEN THE TRIPS AGREEMENT 
AND THE CBD AND PROTECTION OF TRADITIONAL KNOWLEDGE 
AND FOLKLORE 
 
Communication from Peru  
   The following communication, dated 2 June 2005, is being circulated at the request of the 
delegation of Peru. 
 
_______________ 
 
 
Biodiversity, Traditional Knowledge and Intellectual Property:  Peru's Position 
in Relation to Disclosure of Origin and Legal Provenance 
 
 
I. EXECUTIVE SUMMARY 
 The most controversial issue in internati onal discussions on the relationship between 
biodiversity, traditional knowledge and intellectua l property at the present time is the political and 
legal viability of requirements concerning disclos ure of origin and legal provenance of genetic 
resources or traditional knowledge.
1 
  Countries are divided between those that oppose th e inclusion of this type of requirement in 
the patent system (at international or national le vel) represented by the Agreement on Trade-Related 
Aspects of Intellectual Property Rights (TRIPS) of  the World Trade Organization (WTO), those that 
are considering the possibility of such inclusion, al beit on a voluntary basis and one that is limited (to 
disclosure of origin) and those others, including Peru, which advocate mandatory inclusion so as to guarantee the more efficient and secure implementati on of TRIPS itself and generate a situation of 
positive synergy between TRIPS and the C onvention on Biological Diversity (CBD).
2 
                                                      
1 The world's foremost specialists on intellectual property have agreed that the requirements for 
disclosure of origin (also referred to  as "disclosure of origin or source") and legal provenance do not conflict 
with the TRIPS obligations.  See for example the report:  Memorandum prepared by Joshua Sarnoff del Glushko 
– Samuelson Intellectual Property Clinic, Washington University College of Law, American University.  
Compatibility with Existing International Intellectua l Property Agreements of Requirements for Patent 
Applicants to Disclose Origins of  Genetic Resources and Traditional Kn owledge and Evidence of Legal Access 
and Benefit Sharing (June 2004).  This document was commissioned by the Public Interest Intellectual Property 
Advisors, Inc.  It is important to point out that the concept of legal provenance presupposes the existence of prior informed consent (PIC) and of fair and equitable benefit-sharing. 
2 An important milestone in the WTO context is the Doha Declaration (adopted on 14 November 2001 
at the Fourth WTO Ministerial Conference), in paragraph 19 of which Ministers agree to instruct " the Council 
for TRIPS, in pursuing its work programme including under the review of Article 27.3(b), the review of the 
implementation of the TRIPS Agreement under Article 71.1 and the work foreseen pursuant to paragraph 12 of IP/C/W/447 
Page 2  
 
  
 One of the main concerns of Peru and vari ous other countries (including the Group of Like-
Minded Megadiverse Countries)
3 is the fact that the patent system, as currently operated, frequently 
gives rise to situations in which inventions base d directly or indirectly on genetic resources of 
Peruvian origin or the traditional knowledge of Peruvian communities pass the novelty or 
inventiveness tests when they should not do so or , alternatively, that these resources or knowledge 
could have been obtained in an unaut horized or patently illegal manner. 
  These circumstances do much to undermine the functioning of the patent system itself and have a direct effect on the interests of the countri es concerned with regard to both the fulfilment of 
international obligations under the CBD and the est ablishment of levels of complementarity between 
that international instrument and the TRIPS Agreement.   As part of a lengthy process initiated in the ear ly 1990s, Peru has consistently maintained its 
position on disclosure and legal provenance in the different intergovernmental negotiating forums 
where the subject has been addressed, i.e. the CBD itself, the WTO and the World Intellectual 
Property Organization (WIPO).  Accordingly, Peru deems it necessary:   (a) To establish an international obligat ion under the TRIPS Agreement (as well as 
another binding international instrument, possibly including the WIPO Patent Law 
Treaty or the Substantive Patent Law Treaty) so as to require the disclosure, under the 
mechanism for evaluating patent appli cations, of the geographical and legal 
provenance of genetic resources or traditi onal knowledge that could form part 
(directly or indirectly) of an invention; 
  (b) to establish penalties for non-compliance with  this requirement in those instruments; 
and 
  (c) to establish obligations, guidelines or r ecommendations to improve and substantially 
tighten up the search systems in respect of information that is relevant (to genetic resources and traditional knowledge) so as to evaluate novelty and inventiveness.
4 
                                                                                                                                                                     
this Declaration, to examine, inter alia, the relationship between the TRIPS Agreement and the Convention on 
Biological Diversity, the protection of traditional knowledge and folklore, and other relevant new developments 
raised by Members pursuant to Article 71.1.  In undertaking this work, the TRIPS Council shall be guided by the 
objectives and principles set out in Articles 7 and 8 of the TRIPS Agreement and shall take fully into account the 
development dimension ."  It is also important to emphasize the efforts and manifest interest of countries like 
Peru in making progress on implementation issues, as provided in paragraph 12 of the Declaration, which 
recognizes " implementation-related ... concerns ", "implementation problems faced by Members ", and hence the 
necessity that " outstanding implementation issues shall be an integral part of the Work Programme " established 
by Members . 
3 The Group of Like-Minded Megadiverse Countries was officially set up in February 2002 as a policy 
coordination area for the main megadiverse countries (Cancún Declaration, Mexico).  The Group has the 
following members:  Brazil, Bolivia, China, Colombia , Costa Rica, Ecuador, In dia, Indonesia, Kenya, 
Madagascar, Malaysia, Mexico, Peru, Philippines, Venezuela. 
4 Peru has also maintained a consistent position on the need to promote the development of an 
international regime on access to genetic resources and benefit-sharing (process under way in the CBD 
framework) and an international regime for protection of the traditional knowledge of indigenous and local 
communities.  Thus, Decision VII/19 of the Seventh Co nference of the Parties to the CBD, held in Kuala 
Lumpur, Malaysia (2004), established a negotiating mandate for this international regime.  At its third meeting, 
held in Bangkok, Thailand, in February 2005, the Ad Hoc Open-Ended Working Group on Access and 
Benefit-Sharing initiated a technical anal ysis of the elements that could be included in the regime.  This idea of 
an international regime emerged as a policy issue in 2002 in the context of proposals promoted by the Group of Like-Minded Megadiverse Countries (see footnote 3).  At the same time, at Andean Community level and under 
the mandate established in Decision 391, Andean Community Decision 524, approved in 2004, set up a  IP/C/W/447 
 Page 3 
 
 
  
 Specifically, Peru contends that the following action is essential:   Revision of TRIPS and examination of its rela tionship with the CBD, addressing the issue of 
incorporating the requirement of legal provenance a nd disclosure of origin under the exclusions from 
patentability and under the conditions required fo r patent applications (Articles 27 and 29, 
respectively).  It is hoped that the work leading up to the Sixth Ministerial Conference in Hong Kong 
in December 2005, and the text of the correspond ing Declaration, will reflect this concern and 
establish a specific mandate for achieving this objec tive during and by the end of the Development 
Round. 
 
II. INTRODUCTION 
 What common features are shared by resources such as hercampuri (Gentianella alborosea 
(Gilg) Fabris) , camu camu (Myrciaria dubia) , yacon (Smallanthus sonchifolius) , caigua (Cyclanthera 
pedata L) , sacha inchi (Plukenetia volubilis L) , maca (Lepidium meyenii)  and chanca piedra 
(Phyllantus niruri) ? 
 
 First of all, they are plants of Peruvian  origin that serve useful purposes in human 
medicine and nutrition.  Secondly, they are plants  which for centuries have been conserved and used 
directly by small indigenous communities in  the Andean and Amazon region, and whose 
characteristics, functions, properties, applications  etc., are the subject of traditional knowledge.  
Thirdly, at the present day, they are plants with wider social uses, which in some cases have been 
industrialized in the wake of the opening up of ma rkets (at national and international level) for 
products derived from them.  Finally – and this is  perhaps the most important element – they are 
plants which have given rise to inventions curren tly protected by patents granted principally in the 
United States, Europe and Japan.  There are dozens of  patents and large numbers of claims relating to 
these plants.
5 
 
 Despite the difficulty and the fact that no e xhaustive studies have as yet been carried out on 
the economic exploitation of genetic resources in  Peru and the traditional knowledge associated 
therewith, a worldwide study conducted in 1999 conc luded that the annual overall market value of 
genetic resources (used in biotechnology, the pharmaceutical industry, crop protection and 
bioremediation) is approxi mately US$500-800 billion.6  Beyond the question of the actual figures – 
which may or may not be accurate – it is clear that genetic resources are extremely valuable.  If we also take account of traditional knowledge that c ontributes to research and development processes - 
reducing research costs by 25 per cent - the (economi c) value of these intangibles is also clearly seen 
to be very high.
7   
 
                                                                                                                                                                     
Working Group on the Rights of Indigenous Peoples tasked inter alia  to promote development of a common 
regime (at regional level) for the protection of traditional knowledge. 
5 See:  document IP/C/W/441 (March 2005), Ar ticle 27.3(e), Relationship between the TRIPS 
Agreement and the CBD and Protection of Traditional Knowledge and Folklore, Communication from Peru 
dated 28 February 2005, Council for TRIPS, WTO.  See also:  document WIPO/GRTKF/IC/5/13, Patents Referring to Lepidium meyenii (maca) : Responses of Peru.  Document submitted by Peru at the fifth session of 
the WIPO Intergovernmental Co mmittee.  See also: Venero, Begoña.  Addressing the Disclosure Requirement at 
the International Level – the Role of the TRIPS Ag reement. ICTSD/CIEL/IDDRI/ IUCN/QUNO Dialogue on 
Disclosure Requirements. WTO Public Symposium, Geneva, 21 April 2005. 
6 Laird, Sarah, Ten Kate, Kerry.  The Commercial  Use of Biodiversity.  Access to Genetic Resources 
and Benefit-Sharing.  Earthscan Publications Ltd., London, 1999.  
7 Balick, M.J. 1990.  Ethnobotany and the identification of therapeutic agents from the rainforest.  
In:  Chadwick, D.J (eds) Bioactive Compounds from Plants.  Chichester, UK, Wiley & Sons,  p.22. IP/C/W/447 
Page 4  
 
  Given these circumstances, two questions arise that are fundamental to the discussions on the 
relationship between biodiversity, traditi onal knowledge and intellectual property: 
  - How and under what circumstances/conditi ons was access gained to these plants and 
the traditional knowledge associated therew ith, thus giving rise to patentable 
inventions? 
  - Are the patents granted "good" patents in the sense that the inventions are actually 
new and involve an inventive step? 
 
 The first question is relevant to the extent th at, since the entry into force of the CBD (1993), 
Peru has introduced specific standards regulati ng access to genetic resources (Andean Community 
Decision 391)
8 and the protection of traditional knowledge (Law No. 27811).9  As from 1993, and 
more specifically since 1991 and 2002, access to genetic resources and the use of traditional knowledge have been governed by a set of princi ples and a series of standards, respectively, 
non-compliance with which implies that unauthori zed or unlawful actions have been committed. 
  Concerning the second question, cases such as that of ayahuasca (US Plant Patent 5,751), quinoa (US Patent 5,304,718), the n eem tree (US Patent  5,124,349 or patent No. 436 257 B1) granted 
by the European Patent Office or the turmeric plan t (US Patent 5,401,504) have demonstrated that, in 
many instances, inventions relating to plants conserved and traditionally used by indigenous 
communities do not stand up to more rigorous assessment s regarding novelty and inventiveness.  This 
occurs because no account was taken, at the time of the assessment, of traditional uses that would 
have invalidated or impaired the claimed novelty and inventiveness. 
  Inasmuch as it is impossible for countries i ndividually to be able to guarantee compliance 
with the conditions of access to their resources and protection of traditional knowledge, all countries 
have a responsibility to help ensure that the ob ligations and responsibilities established in the CBD 
(and incorporated in nationa l legislation) are fulfilled.
10  It is here that the intellectual property, and 
patent regime in particular can directly contribute to the fulfilment of the objectives of the CBD (in respect of access and benefit-sharing).  
 Accordingly, certain additional requirements c ould be established for the processing of patent 
applications so as to ensure that the patents gran ted are "good" ones, not based on unauthorized or 
even unlawful acts.
11  TRIPS establishes no specific limitations on the type of requirements applicable 
to operations under the system.12  Specifically, the proposed requirements relate to disclosure of origin 
                                                      
8 Andean Community Decision 391 on a Common Regime on Access to Genetic Resources 
(July 1996). 
9 Law establishing the regime for protection of the collective knowledge of indigenous peoples relating 
to biological resources, 10 August 2002. 
10 Although the United States has not ratified  the CBD, the fact of having signed  it places it under an 
obligation, pursuant to the principles set forth in the Vienna Convention on the Law of Treaties, not to interfere 
with efforts to achieve its effec tive and efficient implementation. 
11 For example, the consequences of not disclosing th e origin of genetic materi al incorporated in an 
invention and non-complian ce with legislation on access to genetic resources or protection of traditional 
knowledge, could invalidate the patent granted if the owner cannot prove that he is the actual inventor.  Lack of 
candour in the provision of information could be sanctioned by non-application of the right granted (as occurs in 
the United States) (290 US 240, citing Deweese v. Reinhard 165 US 386). 
12 Additional requirements are not new to the patent system.  In the case of biotechnological inventions, 
particularly as regards micro-organisms, the deposit of the micro-organism in question is deemed necessary to 
contribute to the full disclosure of the invention.  The Budapest Treaty on the International Recognition of the 
Deposit of Micro-organisms for the Purposes of Patent Procedures  (28 April 1977) establishes a deposit 
procedure and international authorities for the maintenance of inventions referring to micro-organisms.  This  IP/C/W/447 
 Page 5 
 
 
 and legal provenance (of the resources or traditional knowledge that directly or indirectly could form 
part of the invention).   At the same time, patent offices could be required to observe much stricter procedures when conducting searches for the assessment  of novelty and inventiveness.
13 14 
 
III. GENERAL CONTEXT AND DEFINITION OF THE PROBLEM 
 The reasons for the importance of the question of disclosure of origin  and legal provenance 
are economic (genetic resources and traditional k nowledge have economic significance and it is 
necessary to ensure the possibilities of their commercial exploitation a nd industrialization), legal (the 
need to grant "good" patent righ ts and the need for complementarities between legal regimes at the 
international level), cultural (the need to respect  the beliefs and rights of indigenous peoples) and 
political (the need to safeguard countries' inter ests with regard to sovereign rights over their 
resources).  
 Compared with the situation some years a go, it has to be acknowledged that much progress 
has been made not only in the c onceptual discussion on the disclosure of origin and legal provenance 
but also, and much more importantly, inasmuch as this topic is already the subject of policy 
negotiations in different fields and forums.   A group of countries particularly rich in biodiversity, which have historically been suppliers 
of genetic resources (and traditional knowledge), ta kes the view that the only way to enforce 
disclosure requirements is to ensure that they are recognized by the authorities of the countries in 
which most patents are granted.   Accordingly, these requirements should be inco rporated in the legislation of the United 
States, Japan and the European countries and should form part of the administrative patent granting 
procedures of the US Patent and Trademark Office, the Japan Patent Office and the European Patent 
Office, respectively.  A first step would be the inclusion of these requirements in the text of the 
TRIPS Agreement.   It has to be acknowledged that even in the b est of cases, i.e. when disclosure of origin and 
legal provenance is recognized in the United States, Europe and Japan, not all the problems associated 
with the unauthorized or unlawful use of r esources and associated traditional knowledge will be 
resolved.
15 
 
                                                                                                                                                                     
requirement is universally considered necessary to prom ote the efficient operation of the system and is never 
criticized for hampering or undermining the way the system works. 
13 This idea has been raised in some  judicial decisions in the United St ates, on the basis of Corona Cord 
Tire Co. v. Dovan Chem. Corp. (US Supreme Court, 1928).  In that case, a prior invention that was not publicly 
known served to invalidate the novelty of a second invention. 
14 See:  Center for International Environmental Law (CIEL).  Comments on Improving Identification of 
Prior Art. Recommendations on Traditional Knowledge Re lating to Biological Diversity Submitted to the United 
States Patent and Trademark Office , 2 August 1999.  See also:  Ruiz, Manuel.  The International  Debate on 
Traditional Knowledge as Prior Art in the Patent System: Issues an d Options for Developing Countries . Trade 
Related Agenda, Development and Equity.  Occasiona l Papers 9, South Centre, October, 2002.    
15 Situations may arise where:  it is impossible to determine the origin of a resource (or of components 
of an invention);  the invention relates to derived or synthesized products that differ substantially from the 
original resources;  the information on traditional knowledge may not have been available at the time of the 
assessments;  etc.  Nevertheless, the proposed changes to the system would in fact have practical effects in some 
circumstances (without entailing an excessively high co st/benefit ratio) and would in particular reflect an 
element of political will and good faith tending to generate consensus and the search for appropriate solutions. IP/C/W/447 
Page 6  
 
  However, such recognition has a number of immediate positive implications which deserve 
mention:  
• Re-establishment of trust-based relations between ("Southern") countries traditionally 
considered to be suppliers of resour ces and ("Northern") countries traditionally 
considered to be users; 
 
• improved conditions for the establishment of  regimes of access to genetic resources 
and protection of traditional knowledge that are less authoritarian and restrictive; 
 
• elaboration of common but differentiated co mmitments and obligations in accordance 
with a basic CBD principle; 
 
• contribution to ensuring that "good" rights (legal certainty) are granted under the 
intellectual property system and the patent system in particular;  and 
 
• establishment of positive synergies and co mplementarity between the CBD and the 
intellectual property system, TRIPS in particular. 
 
IV. BACKGROUND ON PERU'S POSITION IN RECENT YEARS 
 The earliest instance of Peruvian representativ es putting forward an explicit proposal on the 
need to link the patent system with the regime of access to genetic resources (and with protection of traditional knowledge) was at a re gional workshop on access to genetic  resources held in August 1994 
at Villa de Leyva, Colombia, in the context of th e elaboration of Andean Community Decision 391 on 
access to genetic resources.
16  Subsequently, when negotiations on the Andean access regime were 
initiated in 1995, at the Third Meeting of Governmental  Experts, greater attention began to be paid to 
this type of proposal.  During the Second Conferen ce of the Parties to the CBD (Jakarta, 1995), Peru 
also raised this idea in the course of the negotiati ng sessions.  Later on, at the various conferences of 
the parties held to date (and at the meetings of  the Subsidiary Body on Scientific, Technical and 
Technological Advice), contributions we re also made in this regard. 
 
 Initially viewed with some suspicion, this idea has gradually evolved, has received various 
inputs and has been considerably refined, so much  so that it has become a negotiating position uniting 
the interests of many countries, especially devel oping countries with substantial biodiversity in their 
territories.  
 Peru, together with other countries, has since 1994 been fostering and promoting the idea of 
disclosure of origin and legal provenance in differe nt forums.  In this connection, as was already 
stated, it has maintained a steadfast position on the subject, both within the CBD and in WIPO, the WTO and various other forums (including regional processes). 
 
 Peru's official position is that it advocates am endment of the TRIPS Agreement to include the 
requirement that an applicant for a patent on biol ogical materials or traditional knowledge disclose the 
source and country of origin of the resource used in the invention, as well as evidence of prior informed consent and fair and equitable benefit-sh aring.  These three elements are necessary for the 
prevention of biopiracy and bad patents, and this  position has been upheld in numerous statements 
                                                     
 
16 Subsequently, at the Second Conference of the Par ties to the CBD (Jakarta, Indonesia, 1995), in the 
context of the Global Biodiversity Forum, there was a discussion on the document by Tobin, Brendan. 
Certificates of Origin.  A Role for IPR Regimes in Securing Prior Informed Consent  (Peruvian Environmental 
Law Society, Lima, 1995), which contained the first ever detailed analysis of the possibility and viability of 
linking the regime on access (and protection of traditiona l knowledge) with the inte llectual property system.  IP/C/W/447 
 Page 7 
 
 
 and contributions (presented individually or in conj unction with countries with similar interests), in 
different forums, especially the WTO.  It is reflected in numerous documents: 
 
• Document WT/GC/W/362 (October 1999) – Proposal on Protection of the Intellectual 
Property Rights Relating to the Traditiona l Knowledge of Lo cal and Indigenous 
Communities.  Communication from Bolivia, Colombia, Ecuador, Nicaragua and 
Peru, 4 October 1999.  General Council, WTO. 
 
• Document WT/CTE/W/176 (October 2000)/IP/C/W/246 (March 2001) – Peru's 
Experience of the Protection of Tradi tional Knowledge and Access to Genetic 
Resources.  Communication from Peru to the Committee on Trade and Environment and to the TRIPS Council, respectively, WTO. 
 
• Document IP/C/W/403 (June 2003) – Th e Relationship between the TRIPS 
Agreement and the Convention on Biological Diversity and the Protection of Traditional Knowledge.  Submission by Boliv ia, Brazil, Cuba, Dominican Republic, 
Ecuador, India, Peru, Thailand and Venezuela.  TRIPS Council, WTO. 
 
• Document IP/C/W/420 (March 2000) – The Relationship between the TRIPS 
Agreement and the Convention on Biological Di versity (CBD).  Checklist of issues.  
Submission from Brazil, Cuba, Ecuador, I ndia, Peru, Thailand and Venezuela, 
26 February 2004.  TRIPS Council, WTO. 
 
• Document IP/C/W/429 (September 2004) – El ements of the Obligation to Disclose 
the Source and Country of Origin of th e Biological Resources and/or Traditional 
Knowledge Used in an Invention.  Subm ission from Brazil, India, Pakistan, Peru, 
Thailand and Venezuela, 20 September 2004.  TRIPS Council, WTO. 
 
• Document IP/C/W/438 (December 2004) – 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.  Submission from Bolivia, 
Brazil, Cuba, Ecuador, India, Pakistan, Pe ru, Thailand and Venezuela, 30 November 
2004.  TRIPS Council, WTO. 
 
• Document IP/C/W/441 (March 2005) – Article 27.3(b), Relationship between the 
TRIPS Agreement and the CBD and Prot ection of Traditional Knowledge and 
Folklore.  Communication from Peru, 28 February 2005.  TRIPS Council, WTO. 
 
• Declaration of the Andean Countries on Prom oting Disclosure of Origin in the WTO 
Negotiations Relating to Intellectual Pr operty and Protection of Biodiversity.  
90
th Ordinary Session of the Commission of the Andean Community, Lima, 
28 March 2005. 
 
• Statements by the Permanent Representative of Peru to the WTO Trade Negotiations 
Committee on 21 March and 19 May 200 5, and to the General Council on 
26 May 2005. 
  In other regional and bilatera l negotiating forums, Peru has ex pressed the same interest and 
presented relevant proposals.  For example, in the context of the FTAA (Free Trade Area of the 
Americas) negotiations, Peru and the other An dean countries submitted proposals for specific 
provisions on access to genetic resources and traditi onal knowledge to be in cluded in the chapter on IP/C/W/447 
Page 8  
 
 intellectual property.  Similarly, in the free trad e agreement negotiations be tween Colombia, Ecuador 
and Peru, on the one hand, and the United States, on the other, proposals on this subject were also put forward.
17 
 
V. DEVELOPMENTS IN RESPECT OF PUBLIC POLICY AND LEGISLATION (IN 
PERU AND THE ANDEAN REGION) 
 Regulation on protection of plant varieties .  The first legal precedent anywhere in the world 
that establishes a direct and explicit link between intellectual property and access to genetic resources 
and protection of traditional knowledge can be f ound in Peru's regulation on protection of plant 
varieties.18  This regime determines the rules and th e institutional framework applicable to the 
protection of the rights of plant breeders. 
  Article 15 of the Regulation provides that the application " for the granting of a breeder's 
certificate shall be submitted to the Of fice 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 in formation, under Article 16 of the Supreme 
Decree, is that the application shall be declared to have lapsed.   Andean Community Decision 391 .  Decision 391 is the first regional enactment regulating 
the terms and conditions of access to genetic resourc es in the countries of the region.  As a result of 
formal proposals made by Peru and Colombia at th e negotiating meetings on the Andean regime on 
access to genetic resources, Andean Community Decision 391
19 provided for the adoption of legal 
requirements at regional level (valid only among the five countries of the Andean Community), which 
directly link the access regime to intellect ual property and pate nts in particular. 
  The Second Supplementary Provision of Decision 391 provides that: 
 
 " The Member Countries shall not acknowledge ri ghts, including intellectual property rights, 
over genetic resources, by-products or syn thesized products and associated intangible 
components [including traditional knowledge], that were obtained or developed through an 
access activity that does not comply with the provisions of this Decision . 
 
                                                     
 
17 Negotiations on the US-Colombia, Ecuador, Peru  Free Trade Agreement were  started in May 2004. 
18 Supreme Decree No. 008-96-ITINCI, Regulation on protection of the rights of breeders of new plant 
varieties, 6 May 1996, which regulates the implementation of Decision 345 on Common Provisions on the 
Protection of the Rights of Br eeders of New Plant Varieties. 
19 Andean Community Decision 391 on a Common Re gime on Access to Genetic Resources, approved 
on 2 July 1996.  IP/C/W/447 
 Page 9 
 
 
  Furthermore, the Member Country affected may request nullificat ion 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 s upply a copy thereof as a prerequisite for 
granting the respective right, wh en they are certain or there are reasonable indications that 
the products or processes w hose protection is being requested have been obtained or 
developed from genetic resources or their by-pr oducts originating 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 information about the authorized access contracts and 
intellectual property rights granted ". 
  This regulation marks a milestone in comparative legislation by establishing as a condition for granting an intellectual property right (and more par ticularly a patent for invention) that there be 
compliance with requirements under a different lega l regime, in this case one relating to access to 
genetic resources. 
 
 Andean Community Decision 486 .  Decision 486 establishes the legal industrial property 
framework (patents, designs, utility models, marks, etc.) applicable in the countries of the Andean 
region.  Consolidating the idea of disclosure of  origin and legal provenance, Andean Community 
Decision 486
20 incorporated rules on this subject for th e first time in a standard-setting intellectual 
property enactment of regional scope  per se . 
  Article 26(h) and (i) of the Decision provides that applications for patents shall contain:   " (h) if applicable, a copy of the access contract , where the products or processes for which a 
patent application is being filed were obtai ned or developed from genetic resources or 
by-products originating in any one of the Member Countries;   
  (i) if applicable, a copy of the document certify ing the licence or authorization to use the 
traditional knowledge of indigenous, African Am erican or local commun ities in the Member 
Countries, where the products or processes w hose 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 D ecision 391 and the amendments and regulations 
thereto currently in force; " 
  Article 75(g) and (h) of Decision 486 goes a little further by providing that a patent shall be 
declared absolutely void if the applicant has faile d to submit a copy of the access contract or the 
document certifying the licence or author ization for use of traditional knowledge. 
  The Law on Collective Knowledge .  Law No 27811 is the first law enacted for the protection 
of traditional knowledge associated with biological di versity in particular.  Through a system of 
registers, licences and compensatory mechanisms, it is hoped to achieved a degree of legal protection 
for the traditional knowledge of Peru's indigenous peoples. 
 
                                                     
 
20 Andean Community Decision 486 on a Common Industrial Property Regime, 14 September 2000. IP/C/W/447 
Page 10  
 
  In the matter of disclosure of origin a nd legal provenance, the Second Supplementary 
Provision of Law 27811 provides that:
21 
 
 "Where a patent application relates to prod ucts 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 co llective knowledge concerned is in the public 
domain.  Failure to comply with this obligation shall be grounds for refusi ng to grant the patent or, 
where appropriate, declaring it void." 
 
 This provision supplements at national level the provisions of Decision 486, specifically with 
regard to the disclosure of the origin and legal provenance of traditional knowledge that could form 
part of an invention.   Law No. 28216 and the National Commi ssion on Prevention of Biopiracy.  Lastly, Law 
No. 28216, under which a National Commission for the Protection of Access to Peruvian Biological 
Diversity and Collective Knowledge (commonly know n as the Commission for Prevention of Acts of 
Biopiracy)
22 was formally established, provides for a seri es of measures to deal with the phenomenon 
of biopiracy (see final paragraph for the definition of "biopiracy").   The Commission's functions, as defined in Article 4, include the following:    "(c)  To identify and follow up patent applications made or patents granted abroad that relate 
to Peruvian biological resources or collective k nowledge of the indigenous peoples of Peru; 
  (d)  to make technical evaluations of the paten t applications or patent grants referred to in 
the preceding paragraph; 
 
 (e)  to issue reports on the cases studied, and to transmit recommendati ons to the competent 
State authorities; 
  (f)  to lodge objections or institute acti ons for annulment concerning patent applications 
made or patents granted abroad that relate to P eruvian biological or genetic material or the 
collective knowledge of the indigenous and native peoples of Peru". 
 
 The third and final supplementary provision of the Law defines "biopiracy" as "access to and 
unauthorized use without compensation of biologi cal 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 Biologica l Diversity and the existing rules on the subject.  
This appropriation may come to light through physical inspection,  through ownership rights in 
products incorporating such illegally  obtained elements or, in some  cases, through the invocation of 
such rights".  
 Peru is making strenuous efforts to achieve the effective and efficient implementation of this 
regulatory framework.  INDECOPI, with the support of a number of institutions (including the 
Peruvian Institute for Natural Products, the Peruvi an Environmental Law Society, the Confederation 
of Amazonian Communities of Peru, the Ministry of  Foreign Trade and Tourism, among others), is 
engaged in a major campaign to raise the indigeno us communities' awareness of these issues and of 
their outstanding importance.  At the same ti me, INDECOPI, as coordinator of the National 
                                                     
 
21 Law Establishing the Regime for Protection of the Collective Knowledge of Indigenous Peoples 
Relating to Biological Resources, 10 August 2002. 
22 Law on Protection of Access to Peruvian Biological Diversity and to the Collectiv e Knowledge of 
the Indigenous Peoples, 1 May 2004.  IP/C/W/447 
 Page 11 
 
 
 Commission on Prevention of Biopiracy, is worki ng among other things on implementation of the 
National Public Register of Collective Knowle dge, establishment of an institutional portal on 
collective knowledge, and a regular search facility  for patents relating to genetic resources and 
traditional knowledge of Peruvian origin.  VI. POLICY AND REGULATORY ADVANCES IN OTHER COUNTRIES
23 
 Following the example of Peru and the A ndean region, various countries have adopted 
policies and regulations that incorporate requireme nts relating to disclosure of origin and legal 
provenance.  
 Costa Rica .  In 1998, Costa Rica approved the La w on Biodiversity (Law No. 7788) which 
included provisions on disclosure of  origin and legal provenance. 
  Article 80 of the Law provides that both "The National Seeds Office and the Intellectual 
and Industrial Property Registries must compulsorily  consult the Technical Office of the Commission 
[National Biodiversity Management Commission] before granting intellectual or industrial property 
protection to innovations that involve elemen ts of biodiversity.  They shall in all cases submit the 
certificate of origin issued by the Technical Office of the Commission and the prior consent.  
Reasoned opposition by the Technical Office shall prevent registration of the patent or protection of 
the innovation".  
 Central America  .  Also in 1998, a draft Central American Protocol on Access to Genetic 
and Biochemical Resources and Associated Traditi onal Knowledge was approve d.  Article 26 of the 
Draft provides that " upon registration of products and processes t hat may involve the use of resources 
and knowledge, the intellectual property registr ies and competent authorities, as appropriate, shall 
require submission of the certificate of or igin demonstrating lawfulness of access.  Any failure to 
comply with this provision or any violation of the laws on access or of the conditions of contracts for 
access shall cause approval or registration to be withheld from the applicant". 
 
 Venezuela .  The Law on Biological Diversity is an omnibus enactment which deals mainly 
with the conservation of diversity and its components.   It also contains specific chapters on access to 
genetic resources and intellectual property rules.
24 
 
 Article 82 of the Law provides that " intellectual property rights over collected samples 
or parts thereof shall not be recognized  where they have been acquired illegally  or where they 
involve the collective knowledge of local indigenous peoples and communities ". 
 
 Brazil .  In 2001, Brazil adopted Provisional Measure 2186-16.25  This measure governs, 
among other things, access to the genetic heritage of Brazil and matters relating to technology transfer 
and the protection of traditional knowledge.   Article 31 of the Provisional Measure provides that "the granting by the competent bodies of industrial property rights over the process or produc ts obtained from the sample of the component of 
the genetic heritage shall be conditional on compliance with this Provisional Measure and, where 
                                                     
 
23 Highlights in the texts are designed to identify the precise location of references to disclosure of 
origin and legal provenance.  
24 Law No. 4,780, Law on Biological Diversity (2000). 
25 Provisional Measure 2186-16 regu lating sections II.1 and II.4 of  Article 225 of the Constitution, 
Articles 1, 8(j), 10(c), 15 and 16 of the CBD, provisions on access to the genetic heritage, protection and access 
to associated traditional k nowledge, benefit-sharing and access to t echnology for conservation and transfer, 
among other things (August 2001). IP/C/W/447 
Page 12  
 
 appropriate, the applicant shall provide information on the origin of the genetic material and 
associated traditional knowledge ". 
  India .  Section 6(1) of India's Biodiversity Act,  approved in 2002, provides that "no person 
shall apply for any intellectual property right, by whatever name called, in or outside India, for any 
invention based on any research or informati on on a biological resource obtained from India without 
obtaining the previous approval of the Nation al Biodiversity Authority before making such 
application .  Provided that if a person applies for a patent, permission of the National Biodiversity 
Authority may be obtained after the acceptance of th e patent but before confirmation of the patent by 
the patent authority concerned". 
 
 Some developed countries have also adopted  changes to their regulatory frameworks and 
public policies so as to make explicit provision for the requirement of disclosure of origin. 
  Switzerland .  In May 2003, the Government of Sw itzerland submitted to the WIPO Working 
Group on Reform of the Patent Cooperation Treaty a proposal on disclosure of the origin of genetic 
resources and traditional knowledge in patent ap plications.  Specifically, Switzerland proposes 
amending the PCT regulations to include a new ru le 51 bis 1(g), which would enable PCT member 
States to require disclosure of the origin of genetic resources and trad itional knowledge used for 
inventions that could include those elements.  
 Norway .  Norway recently approved an amendment to its patent legislation, providing for the 
inclusion of a disclosure requirement in respect of th e origin of genetic resources.  Failure to provide 
the required information would entail refusal to pr ocess the application or annulment of the patent 
granted, as applicable.  
 The Norwegian Patents Act and the most recent amendments thereto (in force since 
May 2004) provide as follows in section 8(b):   "If an invention concerns or uses biological material, the patent application shall include 
information on the country from which the inventor collected or received the material (the providing country).  If it follows from the national law in the providing country that access to 
biological material shall be subject to prior c onsent, the application shall state whether such 
consent has been obtained. 
  If the providing country is not the same as the country of origin of the biological material, the 
application shall also state the country of orig in.  The country of origin means the country 
from which the material was collected from its na tural environment.  If the national law in the 
country of origin requires that access to biological  material shall be subject to prior consent, 
the application shall state whether such consent has been obtained.  If the information set out 
in this subsection is not known, the applicant shall so indicate. 
  The duty to disclose information under the first and second paragraphs applies even where the 
inventor has altered the structure of the materi al received.  The duty to disclose information 
does not apply to biological material derive d from the human body.  Breach of the duty to 
disclose information is subject to penalty in accordance with the General Civil Penal 
Code §166.  The duty to disclose information is  without prejudice to the processing of patent 
applications or the validity of rights arising from granted patents". 
 
 European Directive .  There are other examples of approved regulations, where the 
negotiations and preliminary texts in cluded consideration of the requirement of disclosure of origin.  
This is the case in particular for the European Di rective on the legal protection of biotechnological  IP/C/W/447 
 Page 13 
 
 
 inventions, Directive No. 98/44/EC.  Preambular para graph 27 of the Directive contains a reference to 
disclosure in the following terms:   "Whereas if an invention is based on biological mate rial of plant or animal origin or if it uses 
such material, the patent application should,  where appropriate, include information on the 
geographical origin of such material, if known;  whereas this is without prejudice to the 
processing of patent applications or the valid ity of rights arising from granted patents". 
  These cases serve to demonstrat e that advances are already being made in respect of public 
policy and specific regulations which, with diffe rent degrees of detail and binding force, recognize 
requirements concerning disclosure of origin and le gal provenance of genetic resources and traditional 
knowledge.  
VII. PROPOSALS FOR THE INTERNATIONAL AND REGIONAL NEGOTIATING 
AGENDA 
 The CBD process and the WIPO Intergovernme ntal Committee have, of course, shown 
flexibility in the discussion of issues relating to disclosure.
26  In short, in conceptual terms, 
considerable progress has been made since 1995 in the analysis and discussion of the legality of these 
requirements, their economic impli cations for the intellectual property system (and the patent system 
in particular), their practical effects and their political repercussions. 
 
 In terms of effectiveness, however, the TRIPS review process under way in the WTO 
(pursuant to instructions originally set out in pa ragraph 19 of the Doha Declaration - see footnote 2) 
and the binding nature of the WTO mandates ma ke this the ideal forum for incorporating 
requirements concerning disclosure of origin an d legal provenance in the text of the TRIPS 
Agreement.  The mandate contained in paragra ph 12 of the Doha Declaration in respect of 
implementation also makes this forum particularly relevant.   
  Specifically, Peru proposes an amendment to Ar ticle 27 of the TRIPS Agreement in the form 
of a further exception to patentability, with the fo llowing wording [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 
legislation on the subject, including failure to obt ain the prior informed consent of the country 
of origin or the community concerned and fa ilure to reach agreement on conditions for the 
fair and equitable sharing of be nefits arising from their use. 
 
 Nothing in TRIPS shall prevent Members fr om adopting enforcement measures in their 
domestic legislation, in accordance with th e principles and obligations enshrined in the 
Convention on Biological Diversity". 
 
 This exception establishes that patents should not be granted in cases of infringement or breach of binding rules under other legal regimes dire ctly related to possible inventions, especially in 
the biotechnological field.  The regimes concer ned are those governing access to genetic resources 
and the protection of traditional knowledge.   
                                                     
 
26 The most recent and comprehensive study prepar ed on this topic by the WIPO Secretariat is 
document WIPO/IP/GR/05/3, Examination of Issues Relating to the Interrelation of Access to Genetic 
Resources and Disclosure Requirements in Intellectual Property Rights Applications (May 2005), a document which will be submitted at the Ad Hoc Meeting on genetic resources and disclosure requirements, Geneva, 
3 June 2003. IP/C/W/447 
Page 14  
 
  
 Peru also proposes an amendment to Article 29(1), consisting in the addition of a paragraph 
which expressly provides as follows:  
 "Where appropriate, Members shall require the disc losure of origin and legal provenance in 
the patent applications to be submitted ". 
 
 It will left to countries to define in their dom estic legislation the pena lties applicable in cases 
of failure to comply with this rule.  The op tions in this connection include not processing an 
application, pending compliance with the proposed re quirements, declaring the application to have 
lapsed if these requirements are not met during the re view procedure, declaring nullity (incurable or 
relative, i.e. remediable), if the patent is grante d and non-compliance is subsequently ascertained, etc. 
  The Sixth WTO Ministerial Conference in H ong Kong, to be held in December 2005, should 
include in its agenda and subse quent Declaration an explicit re ference to the question of the 
relationship between intellectual pr operty, biodiversity and traditi onal knowledge and the need to 
establish positive synergies between TRIPS and the CB D.  These synergies include recognition, in the 
context of the disclosure of origin and legal prove nance, of suitable means for establishing a direct 
connection between the intellectual property regime and the regime for access to genetic resources 
(and protection of traditional knowledge) and for guaranteeing, in the final analysis, that the 
objectives of both regimes are satisfactorily fulfilled. 
 
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