AAFC Policy on Field Crop Germplasm

1 Effective date AAFC Policy on Field Crop Germplasm 1.1 This policy takes effect on ***** 2 Application 2.1 This policy applies to the Science and Technology Branch (STB) of Agriculture and Agri Food Canada. 3 Context AAFC Vision 3.1 The AAFC Policy on Field Crop Germplasm will help AAFC achieve its vision, to create a profitable and innovative agriculture, agri food and agri based products industry that seizes opportunities in responding to market demands and contributes to the health and well being of Canadians. 3.2 The policy is aligned to three fundamental, strategic outcomes: 3.2.1 a competitive and innovative sector, 3.2.2 a sector that contributes to society's priorities, and 3.2.3 a sector that is proactive in managing risk. Purpose 3.3 This policy outlines the approach of AAFC in providing access to Field Crop Germplasm developed in AAFC breeding programs. It is intended to remove uncertainty over AAFC s principles, practices and processes in relation to Germplasm release. Scope 3.4 Through its long history in Field Crop Germplasm development, AAFC develops the following types of Field Crop material: Early Generation Material, Elite Lines and Varieties. This policy addresses all three types of Field Crop Germplasm. 4 Definitions 4.1 Definitions to be used in the interpretation of this policy are in Appendix I. 5 Principles and Decision Framework 5.1 This policy is intended to provide clarification on the conditions under which AAFC will provide outside parties with access to AAFC Field Crop Germplasm. The provisions of this section 5 shall be considered in relation to all requests for access to AAFC Field Crop Germplasm, as applicable. 5.2 While this policy sets out principles and procedures, it is recognized that managing Field Crop Germplasm is a complex endeavour and access to it must be determined in the Page 1 of 8

specific circumstances of a given request. Best Interest of Canada 5.3 In managing access to its Field Crop Germplasm, AAFC will ensure that it is done in the Best Interest of Canada. In determining the Best Interest of Canada, AAFC considerations will include: 5.3.1 ensuring that the Canadian seed value chain has access to the best Field Crop Varieties in order to satisfy market needs in Canada and abroad; 5.3.2 making decisions to support variety needs of the Canadian farming industry with a range of Varieties offered at competitive prices; 5.3.3 ensuring a competitive advantage for Canadian growers and Canadian grain exporters which means that, where possible, AAFC will license Field Crop Varieties in Canada before other countries; 5.3.4 ensuring that, in providing access to AAFC Field Crop Germplasm, AAFC retains the ability to pursue Field Crop Germplasm research without restriction; 5.3.5 supporting AAFC access to Field Crop related intellectual property of third parties, such as germplasm, specific crop traits, crop development methods and technologies; and 5.3.6 developing material that promotes a healthy food supply, as well as industrial products, all the while ensuring stewardship of our environment. Additional Considerations 5.4 In making decisions regarding the provision of access to AAFC Field Crop Germplasm, AAFC will also take into account: 5.4.1 research program needs of AAFC 5.4.2 intellectual property considerations, including the application of this policy; and 5.4.3 applicable codes of ethics in relation to Field Crop breeding, such as the Wheat Workers Code of Ethics, the Code of Ethics for Plant Breeders and Co operators Conducting Cultivar Registration Trials in Canada. Advancement of Science and Innovation 5.5 AAFC, as a public research organization, recognizes the importance of advancing and supporting research efforts in relation to Field Crop Germplasm. Accordingly, in reviewing requests for access to AAFC Field Crop Germplasm, AAFC will consider if and how granting access will advance Field Crop Variety development research. Non Exclusive Access 5.6 In order to ensure the broadest possible access, where possible, AAFC prefers to grant non exclusive access to AAFC Field Crop Germplasm. Commercialization of Varieties 5.7 For the commercial marketing and propagation of Varieties, it is recognized that exclusive access is generally required in order to provide an incentive for industry to Page 2 of 8

invest, by enabling the generation of sufficient economies of scale necessary to realize an optimal return on investment. Accordingly, exclusive access will be the normal approach to commercialization of finished Varieties. Recognition of AAFC 5.8 Recipients of AAFC Field Crop Germplasm will be required to recognize AAFC as the source of the original Field Crop Germplasm in scientific publications and other public releases. Third Party Intellectual Property Rights 5.9 AAFC will respect the intellectual property rights of others in determinations regarding the granting of access to AAFC Field Crop Germplasm and Varieties. Where Germplasm or technologies of another party are incorporated into AAFC Field Crop Germplasm, rights of the owning party must be respected. Protection of AAFC s Intellectual Property Rights 5.10 AAFC will, at its discretion, protect its intellectual property rights in Field Crop Germplasm through the Plant Breeders Rights Act or other means. 6 Requests, Approvals and Material Transfer Agreements Request and Approval Process 6.1 All requests for access to AAFC Field Crop Germplasm must be made in writing. 6.2 Decisions regarding access to AAFC Field Crop Germplasm will be approved by both the STB Director General of the involved Ecozone(s) (or his or her delegate) and the Director, Office of Intellectual Property and Commercialization (OIPC) (or his or her delegate). Where appropriate, other Branches of AAFC will be consulted, such as Market and Industry Services Branch and Strategic Policy Branch. Consultations with other parties will also be conducted where required by an agreement under which AAFC Field Crop Germplasm was developed e.g. where an Encumbering Party has rights in the material. Material Transfer Agreement 6.3 To mitigate legal risks, preserve AAFC ownership rights, control usage of AAFC material and maintain AAFC s freedom to operate, AAFC Field Crop Germplasm (other than Varieties) will be made available to recipients under conditions set forth in a Material Transfer Agreement (MTA). The MTA will also allow AAFC to track and monitor the use of AAFC Field Crop Germplasm. 6.4 AAFC signs MTAs directly with organizations seeking access to AAFC Field Crop Germplasm. Page 3 of 8

7 Access to Unencumbered AAFC Germplasm for Non Commercial Research Purposes 7.1 AAFC provides access to its Unencumbered Field Crop Germplasm for non commercial research in plant breeding programs. 7.2 If the AAFC Field Crop Germplasm is a Variety that has protection under the Plant Breeders Rights (PBR) Act of Canada, any party may use such material in accordance with the PBR Act. 7.3 If Unencumbered AAFC Field Crop Germplasm does not have PBR protection, access to it can be requested by bona fide research organizations for non commercial research purposes. AAFC favours requests from organizations that are prepared to provide AAFC with access to some their material in exchange for access to some of AAFC s Field Crop Germplasm. 7.4 Access to Unencumbered AAFC Field Crop Germplasm for non commercial research purposes will be granted through non exclusive Material Transfer Agreements under which recipients must, among other conditions, agree: i. not to claim legal ownership or seek intellectual property protection over the AAFC Field Crop Germplasm or related information; ii. to use the AAFC Field Crop Germplasm only for non commercial research purposes; and iii. to not transfer the AAFC Field Crop Germplasm to another party. 8 Access to Deposited AAFC Germplasm 8.1 AAFC Field Crop Germplasm deposited with Plant Gene Resources Canada, Saskatoon, Saskatchewan is subject to the same rules as all other material at PGRC, namely the terms and conditions of the International Treaty on Plant Genetic Resources for Food and Agriculture which supports the free and unrestricted exchange of germplasm. Deposited AAFC Field Crop Germplasm is available in small quantities to all bona fide users for crop variety development and plant science studies. Requestors will be required to sign the Standard Material Transfer Agreement of the Treaty. 8.2 Requests for AAFC Field Crop Germplasm deposited at PGRC are to be directed to PGRC. More information is available at the following website: http://pgrc3.agr.gc.ca/orderordre_e.html 9 Access to Unencumbered AAFC Varieties for Commercial Purposes 9.1 For Unencumbered AAFC Varieties that AAFC proposes to license for commercial seed production, AAFC conducts an annual Request for Proposals (RFP). All interested parties can participate in the RFP. 9.2 The annual RFP is conducted with specific evaluation criteria, including financial offer, that are established in advance of the RFP. Evaluation criteria may be found at the following website: http://www4.agr.gc.ca/aafc AAC/displayafficher.do?id=1203473702150&lang=eng Page 4 of 8

9.3 Licenses to commercialize Unencumbered AAFC Varieties following an RFP are generally: a. exclusive, in order to create an incentive for licensees to invest in the protection and marketing of AAFC Varieties; and b. initially granted for the territory of Canada only, in order to provide a competitive advantage for Canadian seed growers and the Canadian grain export industry, prior to granting rights for production and sale of the Variety for any other country. 10 Access to AAFC Germplasm developed in Collaboration 10.1 AAFC conducts Field Crop Germplasm research in collaboration with outside parties. Collaborators provide funding, research expertise or intellectual property, or any combination of these three elements. 10.2 Where AAFC Field Crop Varieties are developed with a collaborator, any rights to access resulting AAFC Field Crop Germplasm shall be addressed in the agreement governing the collaboration. Most commonly, in exchange for its contribution to the AAFC Field Crop Germplasm research, the collaborator is granted an option to negotiate a license to AAFC Field Crop Varieties resulting from the project. 11 Access to Unencumbered AAFC Early Generation Material and Elite Lines for Outside Use 11.1 Organizations may wish to access Early Generation Material and Elite Lines, for use as advanced material in the requestor s own research program and for ultimate commercialization. The requesting party will usually select Lines from the accessed AAFC Field Crop Germplasm. 11.2 AAFC shall only grant access to Early Generation Material or Elite Lines where it satisfies the principles set out in section 5 of this policy and on such terms and conditions as set out in the governing agreement between AAFC and the requesting organization. 11.3 Depending on the Early Generation Material or Elite Lines involved and the nature of the request, AAFC may: i. utilize a Request for Proposals to ensure that all interested parties have the opportunity to access the involved material; ii. grant a non exclusive or exclusive license, as appropriate to the situation. 11.4 If AAFC were to withdraw completely from breeding of a particular Field Crop, it is expected that AAFC would have various types of Field Crop Germplasm available, namely Early Generation Material, Elite Lines and Varieties. In such a case, it is expected that AAFC would solicit outside interest in all or part of the Germplasm though a Request for Proposals. The Germplasm would be made available on a nonexclusive or exclusive basis, as defined in the Request for Proposals criteria. Page 5 of 8

11.5 It is recognized that determining appropriate access to Early Generation Material and Elite Lines is a complex process, with potentially negative results. For example, if several parties are given non exclusive access to the same Elite Lines, those parties could finish Varieties that are virtually identical. This is not necessarily desirable, as it is preferable to have Varieties with different traits and qualities available to the seed value chain. Research by multiple organizations to develop almost identical Varieties would be an unnecessary redundancy of scientific effort. Accordingly, AAFC may grant exclusive access to portions of its inventory of Early Generation Material and Elite Lines, in order to ensure the best possible investment of research resources 12 Access to Encumbered AAFC Field Crop Germplasm 12.1 There are a variety of ways in which AAFC Field Crop Germplasm can be Encumbered. It may: a. incorporate Germplasm or other proprietary material or tools owned an Encumbering Party; or b. have been developed with the investment of money or expertise of an Encumbering Party. 12.2 Access to Encumbered AAFC Field Crop Germplasm will only be granted where such access respects the rights of the Encumbering Party. The rights of the Encumbering Party may be set out in law, such as the Patent Act or the Plant Breeders Rights Act. Such rights may also be enunciated in an agreement between AAFC and the Encumbering Party, such as a material transfer agreement, a collaborative research and development agreement or a license agreement. In most cases, the conditions under which AAFC can grant access to Encumbered AAFC Field Crop Germplasm are set out in the applicable agreement between AAFC and the Encumbering Party. 13 AAFC s Reserved Discretion 13.1 In exercising its discretion in relation to access to Field Crop Germplasm, AAFC will consider the enumerated items of section 5 of this policy, as well as overall program considerations. 13.2 Should AAFC modify or discontinue its role in Field Crop Germplasm development, it is expected that this policy may be revised. 14 Related Acts and Policies AAFC Intellectual Property Policy AAFC Intellectual Property Procedures International Convention for the Protection of New Varieties of Plants International Treaty on Plant Genetic Resources for Food and Agriculture Patent Act (R.S.C., 1985, c. P 4) Plant Breeders Rights Act (S.C. 1990, c. 20) Plant Breeders Rights Regulations (SOR/91 594) Page 6 of 8

Seeds Act (R.S.C., 1985, c. S 8) Seeds Regulations (C.R.C., c. 1400) 15 Enquiries All enquiries regarding this policy should be directed to: Director, Office of Intellectual Property and Commercialization, Science and Technology Branch (613 773 1851 or anita.ploj@agr.gc.ca). Appendix I Definitions Early Generation Material is defined as F 1 to F 6 Germplasm that is not necessarily distinct, uniform or stable. It also includes base Germplasm that may provide wider genetic diversity in a crossing program. Elite Line is defined as a Line that is distinct, uniform and stable which could be double haploid lines or F 7 generation lines or higher or inbred lines. Elite Lines generally possess most of the characteristics sought for a specific purpose or environment. Encumbered is defined as being subject to the rights of another party. When AAFC Field Crop Germplasm is Encumbered, it means that AAFC does not have sole control over it. Encumbering Party means a party that has rights in relation to AAFC Field Crop Germplasm. An Encumbering Party may have obtained rights by contributing money or research expertise to the AAFC Field Crop Germplasm. An Encumbering Party may be the owner of Germplasm or other material or tools that have been incorporated into AAFC Field Crop Germplasm. Field Crop is defined as barley (feed and malting), buckwheat, canola and non canola type (Brassica juncea, Brassica napus, Brassica rapa), corn, field beans, field peas, flax (oilseed and fibre), forages (such as alfalfa, bromegrass, canarygrass, clover, fescue, mustard (condiment and industrial), orchardgrass, ryegrass, wild rye, wheatgrass, timothy), rye, safflower, sunflower, triticale and wheat. F x is a symbol used to designate the generation of Germplasm following the initial cross, with x being the generation of material. F 1 = first generation F 2 = second generation, etc. Germplasm is defined as the collective potential hereditary materials within a species of plant; within this policy it includes Early Generation Material, Elite Lines and Varieties. Line is defined as a group of genetically uniform individuals of a common ancestry. Request for Proposals (RFP) Request for Proposals (RFP) is defined as a solicitation by AAFC for business proposals to obtain a license. AAFC awards license rights based on a structured evaluation and selection procedure. Unencumbered is defined as not being subject to the rights of another party. When AAFC Field Crop Germplasm is Unencumbered, AAFC has all rights in and to the Germplasm and, thus, has sole control over it. Variety is defined as an assemblage of cultivated plants, including hybrids constituted by controlled cross pollination that are distinguished by common morphological, physiological, cytological, chemical or other characteristics; and retain their distinguishing characteristics when reproduced. Varieties can be registered under the Seeds Act and protected under the Plant Breeders Rights Act. Prior to registration or protection, a Variety is referred to as a Page 7 of 8

candidate variety. Page 8 of 8