E wipo/grtkf/IC/17/inf/12 Original: English date : October 18, 2010 Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore Seventeenth Session Geneva, December 6 to 10, 2010 genetic



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E

WIPO/GRTKF/IC/17/INF/12

OriGINAL: English

DATE : October 18, 2010



Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore

Seventeenth Session

Geneva, December 6 to 10, 2010
GENETIC RESOURCES: DRAFT INTELLECTUAL PROPERTY GUIDELINES FOR ACCESS AND EQUITABLE BENEFIT-SHARING: UPDATED VERSION

Document prepared by the Secretariat

I. introduction


1 At its sixteenth session, held from May 3 to 7, 2010, the Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (“the Committee”) “invited the Secretariat to prepare and make available for the next session of the Committee […] as an information document, an updated version of document WIPO/GRTKF/IC/7/9 (“Genetic Resources: Draft Intellectual Property Guidelines for Access and Equitable Benefit-Sharing”)”.1

2 The present information document is the updated version of document WIPO/GRTKF/IC/7/9. In preparing this updated version, the document has also been streamlined where possible to enhance its accessibility. In the interests of keeping the present document as concise and current as possible:




  • the cover document of the present document summarizes relevant background information, essentially reproducing the contents of the cover document of document WIPO/GRTKF/IC/7/9, with minimal editorial changes to reflect more recent developments and to update and streamline its content; and

  • the Annex comprises the updated draft Guidelines, which incorporate various examples of actual and model contractual clauses contained in the WIPO database of sample contracts and received from Member States in response to questionnaires WIPO/GRTKF/IC/Q.2 and WIPO/GRTKF/IC/Q.62; the sampling of intellectual property-related clauses is for illustration only and exemplifies how intellectual property aspects of access to genetic resources and benefit-sharing have been addressed in existing agreements; they are provided without any claim to be exhaustive, representative or complete; and

  • the Appendixes to the Annex contain, in Appendix I, a list of monetary and non-monetary benefits as contained in the Bonn Guidelines and, in Appendix II, a list of actual and model contractual agreements for access to genetic resources and benefit-sharing referred to in the present document.

3 The remainder of this cover document describes the Substantive Context within which the draft Guidelines have been prepared (Part II), introduces the International Policy Context in which the Draft Guidelines should be framed including, in particular, the policy processes of the Convention on Biological Diversity (CBD) and the Food and Agriculture Organization of the United Nations (FAO) (Part III), briefly reviews the Previous Work of the Committee on this matter (Part IV), and outlines how this document was prepared and is structured (Part IV).
II. SUBSTANTIVE CONTEXT

4 Since its inception, the Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore has worked towards guidelines on the intellectual property (IP) aspects of mutually acceptable terms in agreements that concern access to genetic resources and the equitable sharing of benefits from the use of accessed resources. This work has been aimed at producing a resource, to alert custodians of genetic resources to the practical issues that arise when they elect to enter into agreements on access and benefit sharing. The Committee’s work has been based on an empirical survey of experience in this field, and a database collecting actual terms of agreements. As a first step, the Committee agreed on a set of guiding principles to frame this work, then oversaw the collection and analysis of practical experience in this area, and considered a draft set of guidelines (WIPO/GRTKF/IC/7/9, submitted to the seventh session in November 2004).

5 Genetic resources can provide an important input for research and the development of new products, in an increasingly broad range of technological and industrial sectors. The terms and conditions of access to those genetic resources, the exercise of prior informed consent by the providers of genetic resources, and the resulting arrangements made for the sharing of benefits from their use and development are critical issues. Existing international law and a number of regional, national and sub-national laws and regulations set the framework for exercising prior informed consent and determining the terms and conditions of access, as well as benefit-sharing. Key elements of international law include the Convention on Biological Diversity (CBD) and the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGR) of the Food and Agricultural Organization (FAO). The CBD, adopted in 1992, provides an international framework for access and benefit sharing for genetic resources. The ITPGR, adopted in 2001, covers plant genetic resources for food and agriculture (PGRFA) and established a multilateral system of access and benefit-sharing for certain PGRFA. In conformity with the access and benefit sharing provisions of these international instruments, national regimes have been developed to regulate access to genetic resources. Within access and benefit-sharing agreements, the specific arrangements made for IP management can be crucial in ensuring that they operate to create benefits from access to genetic resources, and in particular to ensure that those benefits are shared equitably and the interests and concerns of the resource providers are fully respected.

6 The important role of IP practices and clauses within contractual arrangements for access to genetic resources and benefit-sharing has been widely recognized in most genetic resource policy processes. It is a specific requirement in a number of regional instruments and of several national laws which have already been considered by the Committee3, as well as the Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of the Benefits Arising out of their Utilization (“Bonn Guidelines”) adopted by the Conference of Parties of the CBD. The sixth CBD COP encouraged WIPO to “make rapid progress in the development of model intellectual property clauses which may be considered for inclusion in contractual agreements when mutually agreed terms are under negotiation”.4 This Draft Intellectual Property Guidelines in the Annex aim to heed and complement the international policy context of genetic resources policy making processes.

7 Within access and benefit-sharing agreements, the specific arrangements made for IP management can be crucial in ensuring that they operate to create benefits from access to genetic resources, and in particular to ensure that those benefits are shared equitably and the interests and concerns of the resource providers are fully respected. IP issues that can be determined in agreements include the entitlement to seek IP rights in inventions and other results of research using the resources, ownership and licensing of such derivative IP, responsibility for maintaining and exercising IP rights. Some commentators have pointed to the limitations of contracts as a means of defining and governing relationships in relation to the access and use of genetic resources. However, since this approach is already widely used in the field, and is required under many national genetic resource regulations, stakeholders have called for guidelines on the IP aspects of contracts concerning access and benefit-sharing.

III. INTERNATIONAL POLICY CONTEXT


8 The main intergovernmental processes and fora in which policy frameworks on access and benefit-sharing have been developed include the CBD and the FAO5.

Convention on Biological Diversity (CBD)

Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of the Benefits Arising out of their Utilization

9 In April 2002, the sixth meeting of the Conference of the Parties of the CBD adopted, as part of its Decision VI/24, the Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of the Benefits Arising out of their Utilization.6 The Guidelines are meant to assist Parties to the CBD when developing and drafting legislative, administrative and policy measures on access and benefit sharing, and also when developing contracts and other arrangements under mutually agreed terms for access and benefit sharing7.


International Regime on Access and Benefit-sharing

10 The World Summit on Sustainable Development (WSSD)8 adopted a Plan of Implementation which called for action to “negotiate within the framework of the Convention on Biological Diversity, bearing in mind the Bonn Guidelines, an international regime to promote and safeguard the fair and equitable sharing of benefits arising out of the utilization of genetic resources”.9 The ninth meeting of the Conference of the Parties (COP 9) of the CBD in May 2008 set a comprehensive work program for the next two years, with the goals of adopting an international regime on access and benefit sharing (ABS) referring to genetic resources, and carrying out further work on traditional knowledge associated to genetic resources questions concerning Article 8(j) and related articles of the CBD. The international regime on ABS is currently being negotiated on the basis of a draft protocol for possible adoption at COP 10.



Food and Agriculture Organization of the United Nations (FAO)
International Treaty on Plant Genetic Resources for Food and Agriculture

11 In order to address the characteristics of plant genetic resources for food and agriculture (PGRFA), governments negotiated within the FAO Commission on Genetic Resources for Food and Agriculture (CGRFA) the International Treaty on Plant Genetic Resources for Food and Agriculture. This Treaty has established a Multilateral System of Access and Benefit-Sharing (MLS) for PGRFA and entered into force on June 29, 2004. Article 12.4 on facilitated access to PGRFA within the MLS provides that facilitated access shall be provided pursuant to a standard material transfer agreement. In its Resolution 1/2006 of 16 June 2006, the Governing Body of the ITPGRFA adopted the Standard Material Transfer Agreement (SMTA). Several Research Centers are operating under the MLS.10



International Code of Conduct for Plant Germplasm Collecting and Transfer

12 A component of the Global System on PGRFA11 which refers to access and


benefit-sharing contracts is the FAO International Code of Conduct for Plant Germplasm Collecting and Transfer (1993).12 The Code was adopted by the 1993 FAO Conference as a voluntary instrument providing a framework which governments may use in developing national regulations or formulating agreements for the collection of germplasm. In 2009 the Commission on Plant Genetic Resources for Food and Agriculture asked the FAO Conference to revise the Code13.

IV. PREVIOUS WORK OF THE COMMITTEE

13 At its first session in April 2001, the Committee supported a Task which would lead to “the development of ‘guide contractual practices’ … for contractual agreements on access to genetic resources and benefit-sharing, taking into account the specific nature and needs of different stakeholders, different genetic resources, and different transfers within different sectors of genetic resource policy”.14 When considering this Task, the Committee decided to take a two-step approach to the development of the Guide Contractual Practices.15

14 The first stage of this approach was “a systemic survey of actual contractual agreements” in the form of an online database16. Document WIPO/GRTKF/IC/2/3 identified possible operational principles for IP clauses of contractual agreements concerning access to genetic resources and benefit-sharing. Further, a study of IP and genetic resources licensing was based on a widely circulated survey (questionnaire WIPO/GRTKF/IC/Q.2) to secure information about relevant contracts and licenses. The responses received to the questionnaire were incorporated into a pilot, on-line database of contractual agreements relating to IP, access to genetic resources and benefit-sharing17 and subsequent amendments were made to the electronic database available in three languages.18 The WIPO Contracts Database demonstrated a broad divergence in the approaches taken to the identification and management of IP issues in this area19. In the fourth session, the Secretariat reported on this activity in document WIPO/GRTKF/IC/4/10 to illustrate current practices relating to contracts or licenses concerning IP and genetic resources.

15 At its fifth session, document WIPO/GRTKF/IC/5/9 reported on further updating of the contracts database to a fully operational and comprehensive version and analyzed the empirical data contained in the contracts database for further development of guidelines, best practice and other guidance on IP aspects of contracts.20
16 At its sixth session, the Committee considered draft guidelines provided in the Annex to document WIPO/GRTKF/IC/6/5 (“Draft Intellectual Property Guidelines for Access and Benefit-Sharing Contracts”) and a number of delegations provided comments on them. The document built on information gathered and principles agreed or identified in the first five sessions of the Committee, in order to advance the task of developing guide contractual practices. It applied those principles in the form of draft Guide Contractual Practices.

17 At its seventh session, document WIPO/GRTKF/IC/7/9 progressed to the second stage by furthering the “principles identified [by Committee members] applied for the development of guide practices”, based on the four principles considered at its second session. The Committee was invited to note and comment upon the content of the document, the identified operational principles for the development of the Guide Contractual Practices, the possible distillation of model contractual provisions, and the annexed update to the draft Guide Contractual Practices, and to consider the options for future work including those identified in paragraphs 40 to 42, above.21 A number of comments were made on the contents of document WIPO/GRTKF/IC/7/9 expressing support for the future work as proposed in paragraph 43 of the document. A number of delegations expressed strong opposition to the future work proposed in paragraph 43 of the document and to the contractual approach detailed in the document, and stated that this activity would inevitably detract from other work of the Committee, particularly considering the difficult financial situation of the organization. The Chair concluded at this session that there was no consensus on the future work of the Committee in this area and suggested that no decision should be taken at this session but that it should be kept on the agenda for the eighth session of the Committee.22


18 At the eighth session of the Committee, which took place in June 2005, work on the Draft Guidelines was reported on in document WIPO/GRTKF/IC/8/9. The Committee noted this and other documents on the genetic resources agenda item, and “further took note of the diverse views expressed on this issue.” At the ninth session (April 2006) and the tenth session (November 2006) of the Committee, the Committee similarly considered reports on the Draft Guidelines but no substantive decisions were taken by the Committee.

19 At its eleventh session, document WIPO/GRTKF/IC/11/8(a), commissioned at the tenth session, proposed further options for continuing work on IP and genetic resources. In option IX of the cover document it proposed “considering options for stakeholder consultations on and further elaboration of the draft guidelines for contractual practices contained the Annex of document WIPO/GRTKF/IC/7/9” and in its Annex under “options for possible activities on IP and mutually agreed terms for fair and equitable benefit-sharing” in option C.2 that “based on the additional information available and included in the Database, the Committee might wish to consider to further develop the guide contractual practices contained the Annex of document WIPO/GRTKF/IC/7/923”.

20 The list of options on genetic resources including the option of further elaborating the Draft Intellectual Property Guidelines for Access and Equitable Benefit-sharing was reiterated in documents WIPO/GRTKF/IC/12/8(a) and WIPO/GRTKF/IC/13/8(a) in the twelfth (February 2008) and thirteenth (October 2008) sessions of the Committee, as well as in the revised version of document WIPO/GRTKF/IC/11/8(a) prepared and published in document WIPO/GRTKF/IC/16/6 Prov. The revised list of options prepared for the sixteenth session in document WIPO/GRTKF/IC/16/6 proposed in its Annex option C.2 [Draft guidelines for contractual practices] “considering options for stakeholder consultations on and further elaboration of the draft guidelines for contractual practices contained in the Annex of document WIPO/GRTKF/IC/7/9, based on the additional information available and included in the online database”.

21 At its sixteenth session, in May 2010, the Committee requested the Secretariat to prepare this current update of the Draft Guidelines and update the WIPO Database of Biodiversity-related Access and Benefit-sharing Agreements currently online. Following this decision, the Secretariat circulated a questionnaire to Member States and observers (WIPO/GRTKF/IC/Q.6). Following this request, the Secretariat received several questionnaires, actual and model agreements, and seven model as well as further guidelines and other information resources on activities in this field. The material was received with the understanding that it could also contribute to the updated version of document WIPO/GRTKF/IC/7/9. Information on updating of the database and material received is contained in document WIPO/GRTKF/IC/17/INF/11 (“Note on Updating of WIPO’s Online Database of Biodiversity-related Access and Benefit-sharing Agreements”).

V. PRINCIPLES ESTABLISHED BY THE COMMITTEE FOR GUIDE CONTRACTUAL PRACTICES

22 At its second session, the Committee had identified and considered a set of draft principles for the development of Guide Contractual Practices which found broad support24. In addition to commenting on the four principles identified in document WIPO/GRTKF/IC/2/3, the Committee members also identified certain additional possible principles. The operational principles were identified in document WIPO/GRTKF/IC/2/3 as follows:


Principle 1: The IP-related rights and obligations set out in the Model IP clauses should recognize, promote and protect all forms of formal and informal human creativity and innovation, based on, or related to, the transferred genetic resources.
Principle 2: The IP-related rights and obligations set out in the Guide Contractual Practices should take into account sectorial characteristics of genetic resources and genetic resource policy objectives and frameworks.
Principle 3: The IP-related rights and obligations set out in the Guide Contractual Practices should ensure the full and effective participation of all relevant stakeholders and address process issues related to contract negotiation and the development of IP clauses for access and benefit-sharing agreements, including in particular traditional knowledge holders where traditional knowledge is covered by the agreement.
Principle 4: The IP-related rights and obligations set out in the Guide Contractual Practices should distinguish between different kinds of use of genetic resources, including commercial, non-commercial and customary uses.
23 These principles and comments received upon are reflected in the draft Intellectual Property Guidelines for Access and Equitable Benefit-sharing, contained in the Annex to this document. The following paragraphs summarize the comments provided on the four proposed principles by Committee members and reproduced additional principles identified by the Committee:

Principle 1: The IP-related rights and obligations set out in the Model IP clauses should recognize, promote and protect all forms of formal and informal human creativity and innovation, based on, or related to, the transferred genetic resources.

24 This principle reflects three parameters of the draft Guide Contractual Practices:



    1. the draft Guide Contractual Practices are limited to IP-specific elements of contractual agreements for access and benefit-sharing.25 All other aspects lie outside WIPO’s mandate and are left to the relevant fora and processes, while fully taking into account the legal frameworks and policy guidance which those fora and processes have produced;



    1. the draft Guide Contractual Practices reflect one of the basic objectives of IP, namely to promote human innovation and creativity, and the dissemination and application of its results, in particular the equitable sharing of benefits from access to and use of genetic resources;



    1. the forms of innovation and creativity based on genetic resources which are recognized by the draft Guide Contractual Practices include both formal and informal innovations, 26 and this accordingly entails respect for traditional knowledge (TK) associated with genetic resources.

25 A broad range of Committee members expressed support for this principle.27 In deliberating on this principle, Committee members made the following comments on its appropriate application:

  • the application of the principle should be without prejudice to the legal protection that had to be given to the providers of the genetic resource, the State and its communities;28

  • if applied indiscriminately, the principle might be too wide;29

  • the application should take into account that genetic resources in the form in which they existed in nature, and mere discoveries, did not qualify for the recognition of IP rights;30

  • existing IP agreements should be used as guidance for defining the limits of IP systems;31

  • the application should involve a clearer use of the terms “creativity” and “innovation”, in particular the terms ‘formal’ and ‘informal’ innovation;32 and

  • the application should take into account possible sui generis protection of TK and genetic resources.33

All the comments which were provided by Committee members have been taken into account when applying Principle 1 in the development of the draft Guide Contractual Practices in the Annex.

Principle 2: The IP-related rights and obligations set out in the Guide Contractual Practices should take into account sectorial characteristics of genetic resources and genetic resource policy objectives and frameworks.

26 This principle foresees that the Guide Contractual Practices would take into consideration the sectorial genetic resource policy objectives and frameworks which have been, or are being, developed in the relevant international fora. These objectives and frameworks are taken into account while ensuring that patent rights shall be available without discrimination as to the place of invention or the field of technology and whether products are imported or locally produced. The principle rests, inter alia, on the fact that Committee members have decided that the work of the Committee should be consistent with the work of the CBD and the FAO.34 It takes account of general principles, guidelines and concepts which have been developed by the relevant fora for access and benefit-sharing. For example, in the case of contracts concluded in the context of the Multilateral System of Access and Benefit-sharing, which will be established under the International Treaty for Plant Genetic Resources for Food and Agriculture (ITPGR), the parties would be acting not only in their private interests, but in that of the international community. Furthermore, the Member States suggested since the first session of the Committee that “it would … be important to include prior informed consent in contractual arrangements”.35 Moreover, the guide contractual practices would be consistent with and reflective of current contractual and commercial practices within those genetic resource sectors.

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