WORLD TRADE  
ORGANIZATION  IP/C/W/470 
21 March 2006 
 
 (06-1273) 
Council for Trade-Related Aspects 
of Intellectual Property Rights Original:  English 
 
 
 
SUBMISSION IN RESPONSE TO THE COMMUNICATION FROM SWITZERLAND 
(IP/C/W/446)  
 
Communication from Bolivia, Cuba, Ecua dor, India, Sri Lanka and Thailand  
 
 
 The following communication, dated 13 March 2006, is being circulated at the request of the Delegations of Bolivia, Cuba, Ecua dor, India, Sri Lanka and Thailand.  It was circulated as an 
advance copy for the Council's March 2006 meeting. 
 
_______________ 
  1. In light of the proposed patent disclosure re quirements negotiations in the TRIPS Council, 
many technical questions were raised for consider ation.  These include the definitions of biopiracy 
and misappropriation, the interchangeable use of te rms such as biological and genetic resources, and 
the difference between country of origin and sour ce of biological/genetic resources.  Questions 
relating to the issue of compliance with the disclosure requirements are particularly important, as they are intended to ensure that the patentability criteri a are strictly met and that bad patents are not 
granted.  Document IP/C/W/446 by Switzerland lists a number of such issues that are relevant for 
implementation of the disclosure requirements.  The aim of this contribution is to answer all such 
concerns and thereby alleviate the so-called "amb iguities" surrounding the implementation issue.   
2. Often, the international community uses the terms "biopiracy" and "misappropriation of 
genetic resources" interchangeably.  Questions related to these definitions  are quite natural, given that 
there is no accepted definition of "biopiracy."  The Action Group on Erosion, Technology and 
Concentration (ETC Group) defines biopiracy as "t he appropriation of the knowledge and genetic 
resources of farming and indigenous communities by individuals or institutions seeking exclusive 
monopoly control (usually patents or plant breed ers' rights) over these resources and knowledge".
1  It 
gives an impression that biopiracy connotes misa ppropriation through intellectual property (IP) 
protection.  But in legal parlance, piracy means unlawfully appropriating the substance or production 
of another person.  The fundamental conflict be tween the TRIPS Agreement and the CBD is the 
failure of the former to recognize the privat e/IP involved in the traditional knowledge owned 
collectively.  Considering traditional knowledge an d genetic/biological resources as a form of IP, 
biopiracy assumes the same meaning as piracy of any ot her kind of IP.  Biopiracy can be the apt term 
since biological/genetic resources and the knowledge as sociated with them are subject to it.  WIPO 
defines misappropriation as "Any acquisition, appropria tion or utilization of traditional knowledge by 
unfair or illicit means.  Misappropriation may al so include deriving commercial benefit from the 
acquisition, appropriation or utilization of trad itional knowledge when the person using that 
knowledge knows, or is negligent in failing to k now, that it was acquired or appropriated by unfair 
means;  and other commercial activities contrary to h onest practices that gain inequitable benefit from 
                                                      
1 http://www.iprcommission.org/papers/word/ final_report/chapter4wordfinal.doc.   IP/C/W/470 
Page 2  
 
  traditional knowledge".
2  So it seems that there is nothing wrong with using the terms 
interchangeably.   
3. A similar situation arises when the proposed re quirements suggest that the patent applicant 
should disclose both source and country of origin of  the genetic/biological resources.  "Country of 
origin" is defined in the CBD as the co untry which possesses genetic resources in in situ  conditions.  
"In situ conditions " means conditions where genetic resources exist within ecosystems and natural 
habitats, and, in the case of domesticated or cultivat ed species, in the surroundings where they have 
developed their distinctive properties.3  It means that country of origin is the country from where the 
genetic resources originate.  Though not express, the CBD affords the flexibility to incorporate 
traditional knowledge into the access framewo rk conditioned by PIC and benefit sharing.4  T h e  
genetic resource has meaning and value only in cases where its traditional knowledge (TK) is known.  
It is the original knowledge associated with the ge netic resources from the country where it originated 
that belongs to that country.  This  could be made clear a nd mandatory by the incorporation of the term 
"traditional knowledge" in the definition of "country of origin".  So, in light of the proposed requirements, the definition can be a little wider to  also include the knowledge associated with the 
resources i.e. the country which possesses the genetic resources in in situ  conditions and/or the 
knowledge associated with them.  Thus recognition of traditional knowledge as part of the country of 
origin of the genetic resources is not an additiona l burden, as the spirit of the Convention reflects the 
need for its protection. 
4. The CBD refers to both "country of origin" and "country providing genetic resources", 
foreseeing the possibility that a genetic resource can be obtained from a source other than the country 
of origin.  In such cases, the country providing ge netic material will be the source of the resource 
while country of origin will be the actu al place where the resources are located in in situ  conditions 
and the law governing access shall be the law of the c ountry of origin.  This is included keeping in 
mind the fact that large quantities of genetic resources have moved out of the country of origin and are available from different sources.  That is why the disclosure of both source and country of origin 
is important to achieve the objective of the CBD.  Black's Law Dictionary defines source as "… a 
place where something is found or whence it is taken or derived;  or a person or a thing that originates 
or sets in motion or is a primary agency in produc ing any course of action or result."  Source of the 
biological resource indicates the actual place from where the resource is obtained.  It also connotes the individual, community or organization from which th e resources have been obtained.  "Country of 
origin" means the country where the genetic resources or iginate.  So the difference is that the source 
of genetic resource need not necessarily be from the country of origin.  If the resource is obtained 
from the country of origin having sovereignty over  the resource, then sour ce indicates the actual 
conservators of the resource and exactly where it is located in the country of origin.  But if it is 
obtained from a country other than the country of or igin, then the former will form the source.  The 
applicant will have to disclose both of them, as they together constitute the required tool in 
determining the novelty and inventive step of the cl aimed invention.  Disclosing both will also help 
when the source and country of origin are two diffe rent countries.  Article 15.5 of the CBD provides 
that access to genetic resources shall be subject to prior informed consent of the Contracting Party 
providing such resources, unless otherwise determined by that Party.  Moreover, Article 15.3 of the CBD provides that for the purpose of Article 15, 16 and 19, the country pr oviding genetic resources 
shall be the country of origin or the countries th at have acquired genetic resources in accordance with 
the CBD.  The genetic resources are the property of the country of origin through the recognition of 
sovereign rights by the CBD.  So the law governing acc ess must be that of the country of origin and 
there is no conflict with Artic le 15.5 in this regard.  
                                                     
 
2 WIPO/grtkf/IC_8_5[2] 
3 Article 2, CBD. 
4 Article 8(j), CBD.  IP/C/W/470 
 Page 3 
 
 
  5. In the proposals for the implementation of patent disclosure requirements, the terms 
"biological resources" or "biological material" are us ed instead of the term "genetic resources" used 
most often by the CBD, Bonn Guidelines and FAO Treaty.   It is to be noted that the CBD defines both 
the terms "biological resources" and "genetic resour ces".  Genetic resources are defined to be genetic 
material of actual or potential value where genetic material means any material of plant, animal, 
microbial or other origin containing functional units  of heredity.  On the other hand, biological 
resources are wider in scope and are defined to include genetic resources, organisms or parts thereof, populations, or any other biotic component of ecosystem with actual or potential use or value for humanity.  Taking the above definitions into account, we can see that biological resources may refer 
to something that exists in the natural or crude form and to the whole organism including human 
beings, while genetic resources can be obtained only after some kind of  value addition;  it refers to 
something that has been isolated from a particular biological resource with the help of new technology and screening equipment.  Most of the third wo rld nations, who are the biodiversity "hot spot" 
regions, do not have the capacity to isolate these valuable components and are providing access to the 
resources in their crude or natural state.  They ha ve only the biological resources and the knowledge 
associated with their use.  The traditional communities also possess knowledge only over the 
biological resources and their uses and not over the ge netic resources contained in them.  This may be 
the reason why most of the nations use the term "bio logical resources" instead of "genetic resources".  
It is also to be noted that the CBD does not take  away the freedom of a nation to shape its access 
regime based on its domestic policy.  Since the defi nition of biologi cal resources also includes genetic 
resources, these different terminologies do not create any confusion in the context of the new 
requirements.    
6. In addition to the disclosure of source and country  of origin, there is a two-fold obligation on 
the part of the applicant i.e., to give evidence in  respect of Prior Informed Consent (PIC) and also 
relating to fair and equitable sharing of benefits with the owners of the genetic/biological resources 
and the knowledge associated with them.  Regarding PIC, the proposed requirement mandates that the 
applicant should provide evidence to  show that the biological resources and/or TK used in the claimed 
invention is accessed through the pr ior informed consent of the national authority of the country of 
origin and/or the indigenous community wherever a pplicable.  In order to fulfil this requirement, the 
applicant has to annex, along with the patent appli cation, the PIC granted by the national authority or 
the community, as the case may be, that is obtained as a precondition to the access granted to him.  Furnishing of the said document is sufficient to satisfy this obligation.  The Patent Office shall 
consider this as a prima facie proof and based on this , proceed with the application.  The veracity of 
the document may be challenged during opposition or revocation proceeding.  There could be two 
types of challenges i.e., that (1) the document is fraudulent and (2) the document is obtained from a wrong person.  In both the cases the parties should se ek recourse to the domestic law.  The finding of 
the domestic authority should be binding on the patent  office.  The national patent offices are not 
required to test the veracity of the evidence produced  in this regard.  Ensuring PIC in the appropriate 
manner is the concern of the domestic law of th e country of origin and such a complex and 
burdensome task cannot be achieved by the patent o ffices.  But if the PIC granted is proved to be 
fraudulent or against the laws of the country of origin, it must be a ground for revocation, and other remedies proposed.  But in cases where it is obtai ned after taking reasonable care even from a wrong 
person, this need not result in revocation of the patent.  The applicant must be given a chance to 
correct the mistake and produce the new evidence obt ained from the correct person or authority.   
7. The question of whether PIC of the local and indigenous communities is necessary depends 
upon the national policy of the country of origin/ th e country providing genetic resources and also 
upon the fact of whether there exists TK over the concerned resource or whether the concerned 
communities are the source of the resources.  If the knowledge and/or the resource rest with the 
communities and the domestic law mandates a PI C from them, the person seeking access to the 
elements must ensure that PIC is obtained fro m the concerned communities.  The procedure for 
achieving this task is based on the law laid down by  the country of origin.  It does not create any IP/C/W/470 
Page 4  
 
  additional burden on the applicant as he knows wher e to go and get the resources and also because 
under CBD and the legislations made pursuant to it, evidence of PIC is a prerequisite to the granting 
of access to biological resources and TK. 
8. Considering the proposed obligation to furnis h evidence relating to benefit sharing as an 
international obligation, similar qu estions may arise as to how to fulfil this obligation and when such 
evidence would be considered sufficien t.  In this context, the patent applicant is required to annex the 
contract of benefit sharing or a certificate to this effect issued by a competent authority established as per the law of the country along with the patent app lication.  Since a contract of benefit sharing is 
actually a prerequisite under the CBD system for the granting of access, it does not impose any additional burden on him to procure the patent.  The national ABS regime has an active role to 
determine the question whether the sharing of benefits  is fair and equitable.  There are provisions in 
the national ABS framework to ensure fairness in be nefit sharing, prior to the granting of access to the 
resources, by the national authority in the country of origin.  As proposed by IP/C/W/442, paragraph 3, the two factors i.e. mutually agr eed terms and the reportin g obligation can form a 
concrete basis for the evidence of fair and equitabl e benefit sharing in the domestic level.  Mutually 
agreed terms depict the various bene fits to be shared, how and at what time they are to be shared, the 
mechanism of sharing and distribution etc.  It show s the nature of the benefits that must go to the 
providers.  The reporting obligation binds the person seeking access to inform the communities and/or 
the national authorities of all instances of commerc ialization and patenting.  If the commercialization 
or patenting of the bioprospecting activities is not made known to the appropriate agencies and the benefits arising out of such utiliza tion is not shared with them, it is clear that there is no fair and 
equitable benefit sharing, but any dispute in this regard shall be addressed to the appropriate national 
authority under the access laws and not to the patent office.   
9. Inclusion of TK within the access regime is absolutely a policy qu estion of the country 
providing access.  Determination of fa ir and equitable sharing of the benefits arising from utilization 
of TK is also up to the countries to decide.  Eith er the national authority or the concerned community 
or both together may carry it out as per the domestic law.  The contractual autonomy envisaged under 
the CBD is subject to PIC and fair and equitable bene fit sharing and is not affected by the freedom of 
implementation of the Parties to the Convention.   
10. Civil and criminal liability is imposed by most of the nations to effectively deal with the 
situation where benefits are not fairly and equita bly shared.  Along with the proposed sanctions such 
as revocation, the current anomalies in benefit sh aring can be cured to a great extent.  All the 
applicant has to do is attach the benefit-sharing agre ement or a certificate to this effect issued by a 
competent authority along with the patent appli cation.  As such, the evidence provided by the 
applicant in relation to benefit sharing acts as a prima facie proof, discharging his burden.  The assumption is that the agreement entered in the nationa l level manifests a fair and equitable sharing of 
benefits.  For invoking liabilities and sanctions, it must be proved by the country providing access 
and/or the resource/TK holder that the sharing is no t fair and equitable.  This country can challenge 
the validity of the agreement in the domestic jurisd iction based on the provisions in the national law 
and produce the result of the same to the patent o ffice.  This will make the job of the patent office 
simple and free from interpreting the foreign laws on access.  The patent office shall accept the same and act accordingly.   
11. The patent office is not required to test the ve racity of the evidence pr oduced by the applicant, 
but it becomes relevant, when the patent is challe nged on the ground that the benefit sharing was not 
made in a fair and equitable manne r.  The challenge could be that the evidence produced is false or it 
is not fair and equitable.  If it is a false doc ument the opponent shall produce the necessary evidence 
before the patent office to prove that the document is false.  The patent office shall take a final 
decision in this matter just like any other fal se document produced before them following the 
provisions of the patent law.  But in a case where th e challenge is that the agreement is not fair and  IP/C/W/470 
 Page 5 
 
 
  equitable the opponent shall take appropriate ac tion under the domestic ABS regime and produce the 
result of the same to the patent office.  The patent  office shall accept the same and act accordingly.   
12. The patent applicant can also indicate how the ABS contract is enforced.  The terms of the 
contract itself can contain the mode of enforcem ent coupled with the deterrence imposed through the 
proposed sanctions, such as revocation, transfer, etc.  Enforcement of the terms of the contract is not 
the concern of the patent office and not linked to the granting of the patent.  It is based on the 
provisions of the access law of the country of origin and the terms of the contract entered into by the parties.  Annexing the evidence of the contract with  the patent application will be sufficient to fulfil 
this obligation and based on this th e patent office can grant the patent. 
13. Revocation, full or partial transfer of rights over the invention, criminal or administrative 
liabilities etc., are the proposed sanctions for non-co mpliance with the disclosure requirements.  The 
first and foremost justification for imposing such sanctions is that the proposed requirements do not 
cast any additional burden on the applicant in relati on to the procurement of a patent.  What is 
proposed is only to furnish some material informati on and documents that he/s he has obtained prior to 
the granting of access to genetic resources or TK.  If the applicant is not ready to provide this minimal 
information that is very crucial in the determinati on of the issuance of a patent, such an application 
should not be processed.  If the applicant has made reasonable efforts and even after this there has 
been some genuine mistake, the applicant must be given another opportunity before imposing the 
sanctions.   
14. Revocation is proposed to be an effective m eans to deal with the fraudulent or deliberate non-
disclosure of the source and origin of the genetic r esources or the evidence of PIC and benefit sharing.  
Along with that, criminal and/or administrative sanctions are also suggested as alternative and 
additional measures.  The reason behind this is th at where the applicant deliberately wanted to 
misappropriate the genetic resources and associated traditional knowledge, these additional sanctions 
are justified.  The aim of the evidence of PIC and be nefit sharing is to ensure that the providers are 
given back a share of the profits gained from th e contribution they have made in providing high 
market value to the claimed invention.  If that goa l is not met, the remedy can be nothing other than 
revocation or criminal/civil/administrative liability.   
15. The disclosure of source and country of origin  are critical tools in the determination of 
novelty and inventiveness.  If there is a fraud in disclosing them, sanctions on the applicant are 
justified.  Full or partial transfer of the rights ove r the invention is another sanction proposed.  That 
will be an effective tool to deal with situations where the claimed invention is fully or partially the 
result of the contributions made by the resource providers to whom the knowledge over the resources 
is known and that the benefits are not equitably shared with them. 
16. Another question is the effect of the proposed obl igations on related inte rnational agreements.  
The proposals would have implications on the PCT and PLT especially in relation to the requirements 
of the application once the disclosure is made manda tory under the TRIPS.  As rightly submitted by 
Brazil, changes elsewhere without proposed chang es to the TRIPS Agreement will not be sufficient.
5  
Similarly, plant genetic resources under the F AO Treaty (ITPGRFA) cannot be excluded from the 
proposed obligations since the treaty falls within the larger framework of biological diversity.  But the 
disclosure of source and country of origin and th e production of evidence of PIC and benefit sharing 
in case of plant genetic resources that are included w ith in the scope of ITPGRFA could be integrated 
wherever applicable.   
                                                      
5 See IP/C/M/48, Paragraph 45. IP/C/W/470 
Page 6  
 
  17. The answers to the questions in IP/C/W/446 given above are preliminary, based on the 
currently available definitions.  Members could discu ss and work out definitions that may appear to 
be more appropriate in the TRIPS context.  Th e proponents of the disclosure proposal are ready to 
engage in such discussions. 
__________