Grpc 25 Minutes Final April09

Minutes of the 25th Session of the GRPC.

MINUTES OF THE GENETIC RESOURCES POLICY COMMITTEE (GRPC)

25th Session, WorldFish Center, Penang, 17-19 March 2009 Members present: Carlos Correa (Chair)

Emile Frison (Committee Secretary) Carl-Gustaf Thornström (CGIAR member)

Tony Gregson (Alliance Board) Shadrack Moephuli (CGIAR member) Orlando de Ponti (Private sector) Dan Leskien (FAO Observer) Benito Odala Eliasi (Farmers’ Organizations) Chee Yoke Ling (NGOs)

Excused absences: Mike Gale (Science Council), Teresita Borromeo (NARS) Mahmoud Solh (Alliance Executive) Members of Secretariat: Michael Halewood (Bioversity) Resource Persons: Victoria Henson-Apollonio (CAS-IP), Guat Hong Teh

(CAS-IP), Lim Eng Siang (Bioversity International) Observers: Nguyen Hong Nguyen; Curtis Lind (WorldFish Center)

Tuesday 17 March A. Welcome, introductions, logistics, and adoption of the agenda Dr Stephen Hall, the Director General of the WorldFish Center, welcomed participants to the meeting. The agenda was adopted; it is included as Appendix 1 to these minutes. B. Overview of activities from GRPC 24 work plan Michael Halewood summarized progress to date on the work plan developed by GRPC 24. He also introduced the issues raised by the Executive Committee of the Inter Centre Working Group on Genetic Resources (ICWG-GR) in a teleconference held on 9 March 2009, concerning issues they wanted to bring to the committee’s attention. C. Report concerning preparations for the Third Session of the Governing Body of the International Treaty The committee reviewed the agenda of the Third Session of the Governing Body to be held 1-5 June, 2009. Michael described the reports that are being prepared, through the SGRP, on behalf of the Centres, for submission to the Governing Body meeting. D. Report of the intersessional activities of the Secretariat of the Commission on Genetic Resources for Food and Agriculture Dan Leskien provided an update on the relevant intersessional activities of the Secretariat of the Commission on Genetic Resources for Food and Agriculture (the Commission).


The Commission’s Intergovernmental Technical Working Group on Animal Genetic Resources for Food and Agriculture held its fifth session in January 2009. The Working Group requested FAO, inter alia, to prepare a draft Funding Strategy for the implementation of the Global Plan of Action for Animal Genetic Resources. The Intergovernmental Technical Working Group on Plant Genetic Resources will hold its fourth session in July 2009; it will focus on the review of the second State of the World’s Plant Genetic Resources for Food and Agriculture. The Working Group will also consider the process for the review of the Global Plan of Action for the Conservation and Sustainable Utilization of Plant Genetic Resources for Food and Agriculture (GPA PGRFA). The Commission will hold its Twelfth Regular Session on 19-23 October 2009. The Session will be preceded by one-day regional consultations and a one-day special event on access and benefit-sharing for genetic resources for food and agriculture. The Commission will focus on (1) Access and benefit-sharing for GRFA; (2) the Strategic Plan for the implementation of the Multi-year Programme of Work; and (3) the up-dated State of the World’s PGRFA and the process for up-dating the GPA PGRFA. The draft Strategic Plan will be circulated to the regions, intergovernmental organizations, the CGIAR and non-governmental organizations, in March/April 2009. The Commission Secretariat has commissioned studies on the use and exchange of genetic resources in the various sectors of GRFA. The CGIAR is directly involved in the preparation of the studies on microbial genetic resources and forest genetic resources and is coordinating a study on climate change and GRFA. It was noted in subsequent discussion that a number of products of the Global Public Goods II (GPG 2) project should be reported to the next meeting of the Commission, including for example, the crop-specific guidelines to address the risk of adventitious introgression of transgenes into ex situ collections. E. FAO/Bioversity/Treaty Secretariat Joint Programme on Treaty Implementation Michael described the activities of the Joint Programme. The committee noted the importance of countries and regions making significant progress with Treaty implementation. In the absence of such progress, the committee expressed concern that the Treaty could become a ‘dead letter’. It was noted that involving plant breeders in Treaty implementation activities is critically important. Victoria Henson-Apollonio provided details about the CAS-IP national partners programme, highlighting the possibility of involving national partners in Treaty implementation. F. Revising/developing a system-wide policy on intellectual assets Emile Frison informed the committee that, following GRPC 24, the draft policy was circulated to the Alliance Executive, and was the subject of a side-meeting held during the CGIAR Annual General Meeting in Maputo, December 2008, attended by a number of Director Generals and other Centres’ representatives. During the Maputo meeting, participants were requested to provide examples of how the draft policy would impact


negatively on their Centres’ activities. Participants agreed to send additional comments to Emile, on behalf of the committee, following the Maputo meeting. The committee considered the comments that were sent to Emile. The committee welcomed the approval of the policy, by ICRISAT’s Board of Trustees. The committee took into consideration two papers recently developed by the Science Council as part of a strategic study concerning product stewardship and liability in the context of IPR: Michael Blakeney’s “Liability of CGIAR Centres and NARS partners under intellectual property and biosafety laws arising from the supply of biological resources”; and Rebecca Bratspies’ and Vibha Dhawan’s “A Recommended Stewardship Framework of the Consultative Group on International Agricultural Research”. The committee noted that it has a mandate, as set out in its terms of reference, to “keep development in intellectual property protection under review and advise the CGIAR on the further modification and implementation of the Centres’ IPR guiding principles and related policies”. The committee then reviewed and revised the draft policy to clarify outstanding ambiguities, in the light of comments received. The revisions consisted essentially of clarifications to some paragraphs. The revised draft policy, with changes in ‘track changes’ mode is included as Appendix 3 to these minutes. The same draft, with the changes accepted is included in Appendix 4. It was agreed that the Secretariat will develop, by 9 April 2009, a short explanatory document which will include an introductory paragraph that mentions the evolving international legal framework; the increasing need to be able to address IPR-related issues in the day-to-day work of the Centres; the committee’s mandate; and the collective expertise of its members. The main part of the document will consist of a paragraph-by-paragraph explanation of the draft policy, including examples. The final GRPC-approved explanatory document and policy will be sent to the Chair of the CGIAR and the Chair of the Alliance Executive. G. Patents and Plant Breeding Victoria provided an update concerning the enola bean case. She informed the committee about the amicus brief, filed by CIAT, with support from CAS-IP. Oral arguments will be heard in the Court of Appeals for the (US) Federal Circuit (CAFC) for patent appeals, on 3 April, 2009. The presentation also covered recent developments in patent law, agreements and other intellectual property areas dealing with agriculture and plant breeding particularly noting a letter sent by scientists at public institutions to the US Environmental Protection Agency (EPA). This letter expressed the concerns of scientists about restrictive conditions under which they receive material from the private sector. Victoria’s presentation is included as Appendix 5 to these minutes. Orlando de Ponti described the evolution of policy positions within the International Seed Federation (ISF) concerning the coexistence of plant variety protection and patent protection.


In subsequent discussion, it was noted that the new trend in making patent applications for ‘native traits’ (endogenous traits) could have significant impacts on the availability of a broad range of materials for research and breeding. It was also noted that there is a trend, in the US, towards patenting traits and functions, and not genes/gene sequences per se.

Wednesday 18 March

I. Using the SMTA, including addressing the outcomes of the Meeting of Experts on the SMTA and MLS, with consideration of distribution for non-food/feed purposes, direct use by farmers, reporting, etc Eng Siang Lim joined the committee by telephone for the discussion of the policy concerning distributions of materials for non-food/non-feed purposes. The committee expressed its appreciation for Lim’s important insights. Following the telephone call, the committee reviewed the draft MTA for non-food/non-feed purposes that had been developed by the Secretariat, and made recommendations for further revisions. The Secretariat will make those revisions and circulate it for the approval of the committee members. Once approved by the GRPC, Emile will forward the GRPC-approved draft policy (GRPC 23) and associated draft MTA to the Alliance Executive for approval. The committee reconsidered its previous recommendation as follows:

“The committee noted the importance of the principle that the CGIAR Centres should make PGRFA as widely and openly available as possible. The committee further noted that the Centres’ practices and policies in this regard may represent precedents for countries to follow. The vast majority of materials distributed by the Centres as PGRFA under Development since January 1, 2007 has not been subject to additional conditions, and therefore could have been distributed as PGRFA. The committee recommended that the Centres adopt a ‘best practice’ of distributing improved germplasm as PGRFA, and only distribute it as PGRFA under Development when it is necessary to have additional conditions to those included in the SMTA.* Those conditions must be consistent with the Treaty, the SMTA, and the Policy of the Alliance of CGIAR Centres on Intellectual Assets, when it has been adopted. The committee noted that while the Centres’ designation of their improved germplasm as PGRFA under Development should be limited to special circumstances, it should still be open for Centres to do so, where appropriate, including where that germplasm is derived from materials accessed from the in

* Article 6.6 of the SMTA states: “Entering into a material transfer agreement under paragraph 6.5 [i.e., as PGRFA under Development] shall be without prejudice to the right of the parties to attach additional conditions, relating to further product development, including, as appropriate, the payment of monetary consideration.”


trust collections before the entry into force of the Agreements between the Centres and the Governing Body of the Treaty.”

In light of comments received from IRRI, the committee reconsidered the issue, and recommended that:

• All material in the in trust collections should be distributed as normal PGRFA. • Materials from the Centres’ breeding programmes can be distributed as PGRFA

under Development. The committee discouraged Centres from exercising the option to include additional terms that restrict availability.

• Reports to the Governing Body should differentiate between PGRFA, PGRFA under Development with additional conditions, and PGRFA without additional conditions.

J. Question and answer session regarding update papers The committee noted that the World Intellectual Property Organization (WIPO) is coordinating technical assistance at regional and national levels for the development of traditional knowledge protection laws. The draft Guidelines for the Acquisition and Use of Traditional Knowledge by CGIAR Scientists will be forwarded, by Emile to the Chair of the Alliance, for subsequent distribution to the Alliance Executive. K. Roundtable on additional genetic resources policy issues of relevance to the CGIAR The committee reconsidered the two papers developed by the Science Council, “Liability of CGIAR Centres and NARS partners under intellectual property and biosafety laws arising from the supply of biological resources” and “A Recommended Stewardship Framework of the Consultative Group on International Agricultural Research”. Committee members expressed their appreciation of the papers, particularly the case studies in the paper by Bratspies and Dhawan. It was noted that the both papers rely disproportionately on US and European laws and contexts. In addition, it was noted that both papers appear to assume that once a patent is granted in a single jurisdiction, the CG Centres and actors in other countries are bound by those patents; it must be recalled that IPRs are territorially bound in application to the jurisdictions granting them. It was noted that uncertainties about liability and stewardship are making it difficult for public sector organizations, including the Centres, to finalize agreements with private companies. It was also noted that while it is important to implement appropriate policies, the increasing costs of complying with liability and other forms of regulation ends-up working to the advantage of big companies that can afford the high costs of compliance. Committee members then identified the following issues, of particular relevance to the CGIAR, which will need to be addressed on a system-wide basis:

• Implementing agreements with the Governing Body.


• Acquiring and distributing PGRFA outside the scope of the Treaty. • Evolving international frameworks that address animal, fish, tree, and microbial

genetic resources • Partnerships with the private sector. • Centres’ generation and use of intellectual assets. • Liability and stewardship. • Science and quality control risk management awareness. • Building-up capacity within the system to be able to address complex legal issues. • Developing a framework to promote connections to farmers, creating

opportunities for farmers to inform Centres’ policy priority-setting, and ‘translating’ the relevance of the Centres’ work to farmers.

• Evolving policy frameworks concerning farmers’ rights, and the contributions made by the Centres to their realization, both at the level of programmatic activities, and contributions, based on those activities, to meetings of the Governing Body of the Treaty.

• Evolving policy frameworks in support of sustainable use of PGRFA and contributions Centres can make to them.

• Multi-stakeholder perspectives to give ‘heads-up’ to the Centres on nascent policy issues, and to help the Centres ‘think-through’ policy options. Given the kinds of issues that may arise in the future, it may be necessary to increase representation on the GRPC (or similar body) of people with expertise in microbial, animal, and other kinds of agricultural genetic resources beyond plants.

• Day-to-day technical assistance dealing with the complexities of access and benefit-sharing rules (both those that exist, and the complexities that arise when they don’t exist).

• Genetic resources impact assessments, particularly with respect to the introduction of exotic species, varieties and breeds.

L. Future of the GRPC in the framework of the new CGIAR – suggestions to put to the Transition Management Team Emile Frison provided an update of the CGIAR Change Management process. A new Consortium Board will be created within the next year. It will be up to the Consortium Board to decide what kinds of committees it needs to provide advice. The committee reiterated its earlier observation (GRPC 24) that the CGIAR system will continue to need expert advice on genetic resources and other legal and regulatory issues in the future. The committee reiterated its earlier recommendation that a committee like the GRPC should be established to provide advice to the Consortium Board. The Chair of the committee sent a message to Kathy Sierra on 18 December 2008, regarding the future roles and activities of the GRPC and CAS-IP. On 8 January 2009, Ren Wang replied, saying that the issue will be addressed by the Transition Management Team. The committee agreed that the Chair will send a follow-up message to Kathy Sierra, as the Chair of ExCo, confirming its opinion concerning outstanding genetic resources policy issues that will need to be addressed in the years to come, the importance of maintaining a mechanism for obtaining advice on these issues from a


multiplicity of perspectives both inside and outside the CGIAR, and indicating the committee’s willingness to continue to serve if called upon to do so. M. ICWG-GR request to consider coordinating a system-wide process to develop a policy on the implementation of the risk assessment management guidelines The request by the ICWG-GR to the GRPC was introduced by Michael. The committee members noted with appreciation the work that has been done in the development of the risk management guidelines in the context of the Global Public Goods II project. The committee noted that the current drafts are too elaborate to be implementable. The committee noted the importance of having a coordinated system-wide approach to risk management and recommended that the SGRP develop a more manageable, user-friendly framework, which could be considered by GRPC 26 for recommendation to the Alliance. Furthermore the committee noted the need for consideration of science risk management including quality control management. N. Update on the development of CAS-IP’s License Central Guat Hong Teh presented the ongoing work of CAS-IP in the development of a web-based contract tool, to be used by the CGIAR Centres. The first type of document, which will be available on line later this year, will be memoranda of understanding. The committee welcomed the development of license central and recommended that additional funds be made available to CAS-IP for further work on this tool. The Chair of the committee will also send a letter emphasizing such a recommendation to the Director of the CGIAR. The committee commented on the importance of such a tool for the Centres with regards to developing a better capacity and understanding of the language and use of agreements. Such capacity will be needed in particular by the Centres to implement the international assets policy.

Thursday 19 March

O and P. Review/update of the GRPC work plan, and adoption of main conclusions. The committee amended the GRPC work plan, which is attached as Appendix 2 to these minutes. Q. AOB and next meeting GRPC 26 will be held Sept 22-24, in Rome.


Appendix 1: GRPC 25/A.1

GENETIC RESOURCES POLICY COMMITTEE 25th Session

WorldFish Center Penang, Malaysia 17-19 March 2009 DRAFT AGENDA

Tuesday 17 March 9:00 – 9:30 A. Welcome, introductions, logistics, adoption of agenda. (Introduced by Carlos Correa, Emile Frison, Stephen J. Hall) Documents A.1. Agenda

A.2. ICWG-GR teleconference concerning GRPC 24 report and GRPC 25 agenda

9:30 – 10.00 B. Overview of activities from GRPC 24 work plan (Introduced by Michael Halewood) Documents B.1. GRPC 24 work plan (annotated) 10:00 – 10:30 Coffee/Tea break 10.30 – 11.15 C. Report on the intersessional activities of the Governing Body of the

International Treaty, including the Meeting of Experts on the SMTA and MLS

(Introduced by Michael Halewood) Documents

C.1. Second Technical Consultation on Information Technology Support for the Implementation of the Multilateral System of Access and Benefit Sharing

11.15 – 12.00 D. Report on intersessional activities of the Commission on Genetic

Resources for Food and Agriculture (Introduced by Dan Leskien)

Documents D.1 SGRP/Bioversity coordinated papers concerning sectoral approaches to ABS

12.00 – 12.30 E. FAO/Bioversity/International Treaty Secretariat Joint Programme on

Treaty Implementation (Introduced by Michael Halewood)

Documents


E.1 Capacity Building Project for Developing Countries on Implementation of the Treaty and its Multilateral System of Access and Benefit-sharing

12:30 – 13:30 Lunch 13.30 – 15.00 F. Revising/developing system-wide policy on intellectual assets (Introduced by Emile Frison)

Documents F.1 Collected responses from Director Generals of the CG Centres

regarding the proposed Intellectual Assets Policy Statement F.2 Liability of CGIAR Centers and NARS partners under IP and

biosafety laws arising from the supply of biological resources (Michael Blakeney)

F.3 A Recommended Stewardship Framework for the CGIAR (Rebecca Bratspies and Vibha Dhawan)

F.4 Draft Summary of Discussion on the GRPC, “Draft Intellectual Assets Policy Statement”, held at Maputo, 30 Nov. 2008

15:00 – 15:30 Coffee/Tea break 15:30 – 17:00 F. Revising/developing system-wide policy on intellectual assets (cont’d) Group dinner Wednesday 18 March 8:30 – 9:00 G. Patents and plant breeding. A discussion led by Orlando de Ponti with

presentation by Victoria Henson-Apollonio, including an update on enola, patent case law, etc.

Documents 9.00 – 10.00 H. Assessment of Centres' impact concerning technology transfers as

benefit-sharing, and contributions to the implementation of farmers' rights. (Introduced by Victoria Henson-Apollonio) Documents

10:00 - 10:30 Coffee/Tea break 10:30 – 12:00 I. Using the SMTA, with consideration of distribution for non-food/feed

purposes, direct use by farmers, reporting, etc (Introduced by Michael Halewood)

Documents I.1 Draft MTA for non-food/feed purposes with changes I.2 Draft MTA with changes approved I.3 Notes on MTA (including Policy)


I.4 Revised Guide for the CGIAR Centres Use of the SMTA I. 5 The SMTA, commercialization and distribution to farmers I.6 Reporting template for Centres

12.00 – 12.30 J. Question and Answer session regarding update papers

Documents J.1 Report of the CBD meeting on Group of Legal and Technical

Experts on Concepts, Terms, Working Definitions and Sectoral Approaches. 2 – 5 December 2008. Windhoek, Namibia

J.2 Update on WIPO J.3 Update on Guidelines for Traditional Knowledge practices in

the CGIAR Centres 12:30 – 13:30 Lunch 13.30 – 14.30 K. Roundtable on additional genetic resources policy issues of relevance

to the CGIAR (Introduced by Carlos Correa)

14:30 – 15:30 L. Future of the GRPC in the framework of the new CGIAR – suggestions

to put to the Transition Management Team (TMT) 15:30 – 16:00 Coffee/Tea break 16.00 – 17.00 M. Request from ICWG-GR regarding risk management guidelines 17:00 – 17:30 N. Update on CAS-IP’s License Central Group dinner Thursday 19 March 08:30 - 10:00 O. Review/update of the GRPC work plan

(Introduced by Emile Frison) Documents M.1 minutes GRPC 24

10:00 - 10:30 P. Adoption of main conclusions, action list and report 10:30 - 11:00 Coffee/Tea break and Group photo 11:00 - 11:30 P. Adoption of main conclusions, action list and report (continued) 11:30 - 12:00 Q. AOB, next meeting, closing


12:00- 13:30 Lunch 13:30 – 16:00 Workshop: Policy issues affecting the conservation and use of aquatic genetic resources


Appendix 2: GRPC Work Plan (as amended at GRPC 25) Issue Activity/Input Outputs Timetable Consultations with the legal experts convened by the GB secretariat

The GRPC Secretariat will work closely with the Secretariat of the Governing Body to develop submissions to the Second International Expert Group Meeting.

Documents prepared for Expert Group Meeting

Whenever the meeting is held in 2009

Reporting on uses of the SMTA

Secretariat will revise the recommendations in the Centres’ Guide to Using the SMTA. Centres will submit reports on acquisitions and transfers using the SMTA, to the third Session of the Governing Body.

Revisions of the Centres’ Guide Submissions to the Governing Body

June 2009

Template with optional conditions for PGRFA under Development

Secretariat will develop next draft of the template after the intellectual assets policy has been finalized and adopted.

Revised draft template

Guidelines for Centres acquisition of germplasm

Secretariat will forward the draft guidelines and draft GAA to the AE for approval via E-mail.

End of March End of March 2009

Guidelines for the Centres’ use of the SMTA

The Guide for the Centres’ use of the SMTA will be further revised to include work on the template with optional conditions for PGRFA under Development, best practices for associated information, and system-wide policies on distributing materials for non-food/feed, acquiring new materials and intellectual assets if/when they are adopted. The revisions in the guide should be highlighted.

Revised guide sent to the committee members Comments from members to Secretariat by 19 April, 2009 Final revision of the Centres Guide (version 2)

19 March 2009 19 April, 2009


Issue Activity/Input Outputs Timetable Including materials in the MLS

Secretariat to prepare communication to the Director of the CGIAR concerning the message from the GB Secretariat to Treaty Parties requesting them to provide a list of the collections they are including in the MLS.

Draft message July 2009, following GB3

Distributing materials for non-food/feed purposes

Secretariat will revise the MTA and send it to committee for comments/approval. The draft policy document and draft MTA will be forwarded to the AE Chair for distribution to AE for comments/approval.

Revised draft MTA Comments from members Message to AE Chair

End of April 2009 End of May 2009 GRPC 26??

Guidance for Centres’ research involving traditional knowledge

Emile will forward the draft guidelines to the AE for approval via e-mail. CAS-IP will prepare information document to be sent to WIPO and UN Permanent Forum for Indigenous Peoples.

E-mail message to AE, copied to ICWG-GR. Considered/approved guidelines Report to GRPC 25

Policy on intellectual assets

Secretariat will write explanatory document. CAS-IP will contribute as well. Explanatory document will be sent to committee members. Committee members to comment/approve. Draft policy and explanatory document sent to the Chair of the AE and Chair of the CGIAR.

Draft overview document Comments Revised overview document

9 April 2009 24 April 2009


Issue Activity/Input Outputs Timetable Implementation of the IA policy

CAS-IP to conduct a survey of current and future capacity in legal and IP across the Centres.

Survey GRPC 26

Assessment of Centres’ impact concerning: 1. technology transfers as benefit-sharing, and 2. contributions to the implementation of Farmers’ Rights

CAS-IP will draft paper for presentation to the GRPC.

Draft paper

Before GRPC 26

Demand driven GRPC agenda setting process

Secretariat will continue to consult systematically with the ICWG-GR, AE. The Chair will send a message to the ICWG-GR executive.

Update papers GRPC by Secretariat Message from the Chair

GRPC 26 March 2009

Developments at CBD, WIPO, WTO, other bodies

Secretariat will prepare short update paper(s) summarizing relevant developments. CGIAR Centres will be represented in relevant meetings.

Update papers

GRPC 26

Cartagena Protocol on Biosafety

Monitoring progress of the international meetings.

Update paper GRPC 26

(Cross)-sectoral approaches to ABS

Secretariat will continue work with University of Louvain to develop paper on AMiGR to submit to the 12th session of the Commission. Bioversity will make contributions to Plant, AnGR sectoral papers for the Commission. Lead development of paper, through SGRP, on impact of climate change on interdependence.

Draft papers and or progress report

GRPC 26


Issue Activity/Input Outputs Timetable Patenting strategies

CAS-IP to write 3 page document on patenting trends, including focus on developing countries.

Short paper GRPC 26

License Central Message to CGIAR Director recommending additional funds for License Central.

Message

GRPC at ExCo/Business meeting

Chair to report to business meeting/ExCo.

Chair’s report November 2009

GRPC in the Change Process

Follow-up letter to Kathy Sierra from the Chair of the committee.

Letter to Kathy Sierra

Appendix 3:

GRPC proposal:

Policy of the Alliance of CGIAR Centres on Intellectual Assets*

Preamble The mission of the CGIAR is: To achieve sustainable food security and reduce poverty in developing countries through scientific research and research-related activities in the fields of agriculture, forestry, fisheries, policy, and environment. The policy on intellectual assets of the Alliance of International Agricultural Research Centres supported by the Consultative Group on International Agricultural Research (CGIAR) is driven by the mission of the CGIAR and the imperative that the products of the Centres' research should be available without restriction. [the order of these two sentence has been reversed]

The Centres work with a wide range of partners, including national agricultural research systems (NARS), advanced research institutes (ARIs), civil society organizations, regional and international intergovernmental organizations and increasingly, private sector. The Centres are supported by funding from countries, international and regional organizations, and private entities. The Centres produce, manage and provide access to the products of their research and development for use by, and for the benefit of, the poor, especially farmers in developing countries. Centres hold their in-trust collections of germplasm for the benefit of the world community, in accordance with agreements signed by Centres and the Governing Body of the International Treaty on Plant Genetic Resources for Food and Agriculture (International Treaty).†

Objective

The objective of this policy is to establish common standards and procedures for the CGIAR Centres regarding the acquisition, management and release of intellectual assets.

All policies of CGIAR Centres that affect the acquisition, management and release of intellectual assets shall conform with this policy. Definitions

* Upon approval by the Alliance, this policy will replace the ‘Guiding Principles for the Consultative Group on International Agricultural Research Centres on Intellectual Property and Genetic Resources,’ 1996. It does not include issues relating to stewardship and liability. It is anticipated that separate policies will be developed to address those issues in the future. † The text of these agreements is available at: http://www.sgrp.cgiar.org/sites/default/files/AgreementwithCentresfinal.doc

Halewood, Michael � 18.3.09 8:04



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‘Intellectual assets’ refers to all products of research and development activities, including, but not limited to: improved germplasm, technologies, software, information, publications, vaccines, databases, methodologies and know-how. ‘Market segment’ refers to restrictions including territorial and/or field of use. General conditions of access to Centers’ intellectual assets

1. The Centres will make their intellectual assets globally available without restriction, subject to the following exception:

When it is indispensable for the effective utilization or further improvement of Centres’ intellectual assets, the Centres may grant limited exclusivity for commercialization in a defined market segment, for a limited period of time, provided they continue to make the intellectual asset available, for research and development in developing countries as well as for ARIs in support of the CGIAR mission.

2. The Centres will not seek or assert intellectual property rights‡ over their intellectual assets, subject to the following exception:

When it is indispensable for the effective utilization or further improvement of Centres’ intellectual assets, the Centres may seek or assert or allow third parties to seek or assert intellectual property rights over the Centres’ intellectual assets, provided they continue to make the intellectual asset available for research and development in developing countries as well as for ARIs in support of the CGIAR mission.

3. The Centres will not use their intellectual assets with the sole intention to raise income.

The Centres may charge financial compensation in return for providing access to their intellectual assets, on the condition that this does not divert the Centres from their research agendas. However, the Centres will continue to make the intellectual asset available for research and development in developing countries as well as for ARIs in support of the CGIAR mission.

Incorporation of third party intellectual assets 4. Centres may only enter into agreements concerning the use of intellectual assets of third parties subject to IPRs or contractual rights that restrict the availability of the resulting products for commercialization, research or development in developing countries , when: a) the intellectual asset the Centre is producing will result in significant improvements to food security and or poverty alleviation in the countries where it can be

‡ Concerning copyright, which normally vest automatically upon the creation of a ‘work’, see paragraph 6 below.



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made available, and, b) no equivalent intellectual asset is available from other sources under no or less restrictive conditions. Transparency

5. The Centres will promptly make public the justification for, and describe the conditions of, their granting limited exclusivity, or seeking or asserting (or allowing third parties to seek or assert) intellectual property rights (other than copyright) over their intellectual assets, particularly when availability in developing countries is affected. Centres will also make public the justification for entering into agreements described in paragraph 4.

Dissemination of research results 6. The Centres will publish their research and development results in a timely manner and in a way that allows open access. This includes results of research and development that is carried out by the Centre itself, or in partnership with another organization. The Centres will allow the reproduction and distribution of their copyrighted works by third parties without the need to obtain permission from the Centres, provided that proper citation is made and the work is not altered. Preventing misappropriation 7. The Centres should take action, as appropriate, to pre-empt intellectual property claims over their intellectual assets by others without the Centres’ authorization.

8. The Centres shall abide by the ‘CGIAR's Ethical Principles Relating to Genetic Resources,’§ and shall respect the rights of traditional knowledge holders by seeking their prior informed consent for the documentation, use and publication of information associated with their traditional knowledge, consistent with national and international law.

§ These guidelines can be found at [URL]





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Appendix 4:

GRPC proposal:

Policy of the Alliance of CGIAR Centres on Intellectual Assets*

Preamble The mission of the CGIAR is: To achieve sustainable food security and reduce poverty in developing countries through scientific research and research-related activities in the fields of agriculture, forestry, fisheries, policy, and environment. The policy on intellectual assets of the Alliance of International Agricultural Research Centres supported by the Consultative Group on International Agricultural Research (CGIAR) is driven by the mission of the CGIAR and the imperative that the products of the Centres' research should be available without restriction.

The Centres work with a wide range of partners, including national agricultural research systems (NARS), advanced research institutes (ARIs), civil society organizations, regional and international intergovernmental organizations and increasingly, private sector. The Centres are supported by funding from countries, international and regional organizations, and private entities. The Centres produce, manage and provide access to the products of their research and development for use by, and for the benefit of, the poor, especially farmers in developing countries. Centres hold their in-trust collections of germplasm for the benefit of the world community, in accordance with agreements signed by Centres and the Governing Body of the International Treaty on Plant Genetic Resources for Food and Agriculture (International Treaty).†

Objective

The objective of this policy is to establish common standards and procedures for the CGIAR Centres regarding the acquisition, management and release of intellectual assets.

All policies of CGIAR Centres that affect the acquisition, management and release of intellectual assets shall conform with this policy. Definitions

* Upon approval by the Alliance, this policy will replace the ‘Guiding Principles for the Consultative Group on International Agricultural Research Centres on Intellectual Property and Genetic Resources,’ 1996. It does not include issues relating to stewardship and liability. It is anticipated that separate policies will be developed to address those issues in the future. † The text of these agreements is available at: http://www.sgrp.cgiar.org/sites/default/files/AgreementwithCentresfinal.doc

‘Intellectual assets’ refers to all products of research and development activities, including, but not limited to: improved germplasm, technologies, software, information, publications, vaccines, databases, methodologies and know-how. ‘Market segment’ refers to restrictions including territorial and/or field of use. General conditions of access to Centers’ intellectual assets

1. The Centres will make their intellectual assets globally available without restriction, subject to the following exception:

When it is indispensable for the effective utilization or further improvement of Centres’ intellectual assets, the Centres may grant limited exclusivity for commercialization in a defined market segment, for a limited period of time, provided they continue to make the intellectual asset available, for research and development in developing countries as well as for ARIs in support of the CGIAR mission.

2. The Centres will not seek or assert intellectual property rights‡ over their intellectual assets, subject to the following exception:

When it is indispensable for the effective utilization or further improvement of Centres’ intellectual assets, the Centres may seek or assert or allow third parties to seek or assert intellectual property rights over the Centres’ intellectual assets, provided they continue to make the intellectual asset available for research and development in developing countries as well as for ARIs in support of the CGIAR mission.

3. The Centres will not use their intellectual assets with the sole intention to raise income.

The Centres may charge financial compensation in return for providing access to their intellectual assets, on the condition that this does not divert the Centres from their research agendas. However, the Centres will continue to make the intellectual asset available for research and development in developing countries as well as for ARIs in support of the CGIAR mission.

Incorporation of third party intellectual assets 4. Centres may only enter into agreements concerning the use of intellectual assets of third parties subject to IPRs or contractual rights that restrict the availability of the resulting products for commercialization, research or development in developing countries , when: a) the intellectual asset the Centre is producing will result in significant improvements to food security and or poverty alleviation in the countries where it can be

‡ Concerning copyright, which normally vest automatically upon the creation of a ‘work’, see paragraph 6 below.

made available, and, b) no equivalent intellectual asset is available from other sources under no or less restrictive conditions. Transparency

5. The Centres will promptly make public the justification for, and describe the conditions of, their granting limited exclusivity, or seeking or asserting (or allowing third parties to seek or assert) intellectual property rights (other than copyright) over their intellectual assets, particularly when availability in developing countries is affected. Centres will also make public the justification for entering into agreements described in paragraph 4.

Dissemination of research results 6. The Centres will publish their research and development results in a timely manner and in a way that allows open access. This includes results of research and development that is carried out by the Centre itself, or in partnership with another organization. The Centres will allow the reproduction and distribution of their copyrighted works by third parties without the need to obtain permission from the Centres, provided that proper citation is made and the work is not altered. Preventing misappropriation 7. The Centres should take action, as appropriate, to pre-empt intellectual property claims over their intellectual assets by others without the Centres’ authorization.

8. The Centres shall abide by the ‘CGIAR's Ethical Principles Relating to Genetic Resources,’§ and shall respect the rights of traditional knowledge holders by seeking their prior informed consent for the documentation, use and publication of information associated with their traditional knowledge, consistent with national and international law.

§ These guidelines can be found at [URL]

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Patents and PlantBreeding

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Enola Patent

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Enola patent

Larry Proctor, D.B.A. Pod-Ners, filed a patentapplication on November 15, 1996U.S. Patent # 5,894,079 issued April 13,1999, with 15 claims

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Enola patent reexamination

CIAT requested a reexamination in theUSPTO (Action had to be an ex partesprocedure, based on the filing date of theoriginal patent application.)The reexamination was filed December 20,2000An application for reissue of the Patent wasfiled by Proctor on January 31, 2001Reexam and reissue merged June13, 2001

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Enola patent reexamination

On April 19, 2008 the Board of PatentAppeals and Interferences (BPAI, ultimateappeals board in the USPTO) rejected all ofthe claims in the reissue application.On June 17, 2008, Proctor filed an appealwith the Federal court, the CAFC.This appeal is case#2008-1492, Pod-Ners vs.the USPTO

Where were we in this story at the lastGRPC meeting?

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Recent events

On January 2009, CIAT filed an Amicus Brief tosupport the USPTOThis brief was prepared, pro bono, by the law firmMorrison & Foerster (MoFo), as a result of a requestby CAS-IP team member, Peter BlochAn additional brief was filed by the Government ofMexico; the CIAT brief was coordinated with theMexican brief and the brief filed by the USPTO.

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Enola Patent Reexam

The CIAT Amicus brief points out:• That if this patent were to stand that it would

interfere with CIAT’s ability to provide yellowbeans to everyone, particularly people andinstitutions in the U.S., especially thoseinstitutions that work to help poor farmers

• Yellow beans are not new, even in the U.S.• That the written description, not withstanding the

deposit of “Enola” seeds in a BudapestDepository, is indefinite. (What is the role of suchdeposits, especially as there will be some naturalvariation in deposits of biological material?)

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The CIAT Amicus brief argues

Yellow beans are not new and are obviousAllowing such broad claims, based on a color,would undermine the patent system –manyfrivolous utility patent applications would befiled

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The CIAT Amicus brief argues

Patent deposits are not a substitute for clearwritten descriptionsCIAT would no longer be able to distributeyellow beans without threatIf the CAFC does not uphold the USPTO, thequestion of validity should be remanded (sentback) to the USPTO to take into account all ofthe types of yellow beans that have beendistributed by CIAT over the years

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The Enola matter is scheduled to be held on Friday, April 3, 2009, with Pod-Ners and the PTO solicitor having 15 minutes each for oral argument.

Oral transcripts will be availableas podcasts from the CAFC site,24 hrs. later

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Patent update

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Recent Activity in U.S. case law

Supreme Court Decides Quanta v. LG Electronics,__ U.S. __ (2008),

• 19–page unanimous decision that provides some new lifeto the doctrine of patent exhaustion

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“Quanta”

Does the buying of the seed, mean that therights on this seed are exhausted?“When a self-replicating living invention issold, does the purchaser have a right toreproduce that invention to make one – orthousands or more – copies?”

---Hal Wegner

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One of the grounds to deny patent exhaustion is stated inMonsanto Co. v. Scruggswhere the court concludes that acontrary conclusion would have“eviscerate[d] the rights of thepatent holder.”105 There is nocitation of any authority for oragainst this position nor is thereany public policy position taken for an alternative ground todeny the application of patent exhaustion

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Many other areas where Patent law issuesare in the news and could affect the CGCenters

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In re Kubin (Kubin v USPTO)• Obviousness --Rejection of claims to gene

sequences, arguments heard January 9 in CAFCJacobsen vs. Katzer et al• Validity of OS Licenses, decided by the CAFC,

July 13, 2008

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