By default, CIMMYT manages most of its research and development (R&D) outputs as international public goods. We make an exception to this rule only when necessary as per the guidance stated in the CGIAR Principles on the Management of Intellectual Assets as well as CIMMYT’s own guidelines on Intellectual Property Policy, Germplasm Policy and Research Data and Information Products Management Policy (collectively “IA Principles/Policies”).
The IA Principles recognize three ways, subject to meeting certain criteria, where the goods created by CGIAR centers may not be made immediately available to the public, i.e. through Limited Exclusivity Agreements (LEAs), Restricted Use Agreements (RUAs), and applying for Intellectual Property Rights (IPRs). This results from any of several needs, including (i) to create incentives where appropriate for downstream research partners and recipients to make additional investments of their own to further develop and/or commercially release improved materials received from CIMMYT; (ii) to obtain and incorporate technologies from the private sector whose use is restricted; (iii) to strategically pursue IPRs (such as patents, plant variety protection, utility models, design registration, trademarks, copyrights, and database protection) to prevent abuse or misappropriation of our Intellectual Assets by private sector companies.
In summary, CIMMYT enters into partnerships with the public and private sectors alike to create synergies to improve, test and/or validate an innovation, or maximize global accessibility by enhancing the quality, capacity, or speed with which its research results can be developed or disseminated, in furtherance of the CGIAR vision to improve livelihoods and promote food security, poverty reduction, and sustainable development.
When entering into a partnership that includes the elements of LEA, RUA and/or IPR, CIMMYT adheres to the following principles:
- The exclusivity granted to partners is always as limited as possible in duration, territory, and/or field of use;
- Such agreements will include clauses to ensure availability for research (“research exemption”) and availability in the event of a national or regional food security emergency (“emergency exemption”);
- Where the Intellectual Asset is derived from or includes plant genetic resources that are subject to the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA) whether because they are in trust materials, or they have previously been received under a Standard Material Transfer Agreement (SMTA) pursuant to the said Treaty, we will ensure in such agreements (i) the free and unlimited access to in trust materials and (ii) all relevant ITPGRFA obligations, including benefit-sharing obligations, are passed to the partner(s);
- Where applicable, partners are also required to commit to complying with national laws and regulations.
Restrictions arising from stewardship requirements and/or access to third-party technology
Legal and responsible use of certain Intellectual Assets (e.g. gene edited or transgenic products) requires compliance with specific conditions as prescribed under national biosafety laws and regulations. CIMMYT and/or its partners give access to such restricted third-party technology subject always to local legislations, consent from such technology providers, and compliance with stewardship requirements. In addition to these terms, the partner must also demonstrate compliance with CIMMYT’s relevant Policies. As part of this process, CIMMYT also helps to build or increase the capacity of partners so that they can satisfy the necessary regulatory and stewardship standards for use, testing and commercialization of such products.
To access third-party proprietary technology which is often vital for crop improvement, CIMMYT may sometimes have to enter into RUAs whereby restrictions are placed by such technology owners on the global accessibility of the resulting products/services for commercialization, research, and development. For instance, when patented transgenes or a certain new breeding system belongs to, or is otherwise developed or controlled by a private sector partner, CIMMYT agrees on the roles and responsibilities, as well as the dissemination strategies for those Intellectual Assets on a case-by-case basis. Those parameters are always set within the framework of existing laws and regulations, and stewardship requirements where applicable, considering the target geographies intended for each project, and the available financial resources to manage any biosafety risk adequately.
Partnerships that fall within this category include the following research projects:
- Seed Production Technology for Africa (SPTA)
- TELA Maize Project
- MLN Gene Editing Project
Sometimes CIMMYT needs to assess the suitability of a technology before investing substantial resources in or developing a plan for dissemination of potentially useful resulting Intellectual Assets.
In such cases, it becomes appropriate for CIMMYT to seek from the partner a license to access and use the technology royalty-free for purposes of evaluating its utility or field performance. In return, CIMMYT will usually provide the partner with the results of the evaluation. This collaboration approach allows CIMMYT to disseminate the lessons learned during testing, that could be useful to its target beneficiaries or the scientific community, at no cost, in exchange of providing data to the partner that could serve them for the improvement of their technology.
If the technology proves to have the potential for successful integration into CIMMYT R&D activities, CIMMYT negotiates with the partner a license that allows broader dissemination of any products that could be developed as part of R&D activities, through market segmentation if appropriate.
Germplasm product allocation
CIMMYT’s allocation principles and procedures, including the strategic use of limited exclusivity, are part of a dissemination strategy designed to maximize the impact of our germplasm. Geographically-limited exclusive commercialization license helps incentivize public or private seed organizations to invest in the national varietal registration and commercialization process in those countries where a particular hybrid may be a viable improvement over existing varieties. This is because with such exclusivity, partners may have assurance that the return made on their investments in the release, multiplication, commercialization, and quality control of improved hybrids may be recovered to ensure the sustainability of the commercialized varieties. By allocating a substantial number of genetically diverse hybrids to a variety of seed producers, every licensee is incentivized to invest in its portfolio. This approach particularly helps smaller- and medium-sized seed companies that cannot afford their own breeding programs and thereby enables a wider range of development partners, especially seed companies, to deploy genetically diverse, elite hybrid varieties to farmers who would otherwise not benefit from CIMMYT’s improved germplasm.
The permission to register and commercialize an improved line or hybrid that CIMMYT grants in such cases is always subject to a given country’s own laws and regulations for registration and commercialization.
CIMMYT regularly issues public announcements about new products that are available for licensing under such schemes, and invites any interested party to apply for licenses. CIMMYT then reviews allocation requests and, based on a number of factors, determines whether it will allocate the requested products to a particular partner for a particular geography. Those factors include but are not limited to:
- Whether the applicant is a public- or private-sector organization. Where possible, CIMMYT licenses its varieties to the national agricultural research system (NARS) in order to reach more smallholder farmers;
- Investment by the applicant in variety testing and seed production;
- The likelihood that seed will become widely available to smallholder farmers and/or as soon as possible;
- Diversity among suppliers;
- The diversity of regions where the variety will be marketed;
- Track record of the applicant as a CIMMYT collaborator; and
- The relative importance of a variety for the variety portfolio or success of an applicant.
CIMMYT selects or approves the allocation to a particular applicant/partner and grants commercialization rights using an LEA or a non-exclusive agreement. LEAs detail the terms and conditions under which the line or hybrid is licensed for registration and commercialization in a specified territory for a standard limited period, e.g. 5 years; non-exclusive agreements include provisions that allow CIMMYT to provide similar rights for commercialization of a line or hybrid to multiple partners in the same territory.
The decision to use an LEA or non-exclusive agreement is determined by several factors including the following:
- Whether or not the laws and regulations in a particular country allow for registration and/or commercialization of a product by multiple entities.
- Availability of funding under a specific project for CIMMYT or a partner organization to sponsor a product through the national release/registration process in specific target countries, so that commercialization licenses can be issued to multiple partners on a non-exclusive basis.
- Whether or not CIMMYT is able to identify and engage partners to sponsor and/or facilitate the release/registration process in specific target countries.
Importantly, consistent with CGIAR’s mission and vision, CIMMYT maintains a balance between the exclusivity granted under such LEA license agreements and the public interest in having continued access to CIMMYT’s varieties. Such balancing is achieved through the following:
- CIMMYT reserves the right to use and disseminate CIMMYT maize and wheat germplasm under the Standard Material Transfer Agreement (SMTA), to anyone worldwide for research, breeding and training, including all inbred lines and hybrids licensed for commercialization.
- All obligations under the ITPGRFA will be included in the licenses signed with the partner if the genetic resources used in the development of the hybrid or line originate from the Multilateral System (MLS).
- Terms necessary for CIMMYT to comply with the CGIAR Intellectual Assets Principles are expressly included in commercialization licenses with licensees.
- The term is limited in each license. For maize, it is granted for five years, renewable for another five years if the partner can demonstrate in the initial term the successful commercialization of the hybrid(s), or satisfactory potential to achieve it during the extended term. If a partner cannot demonstrate diligence, CIMMYT may terminate the license and, if commercialization potential for the subject hybrid(s) continues to exist, re-allocate and license the hybrid(s) to another partner in the original partner’s specified countries to ensure availability of the improved hybrid(s) to CIMMYT target beneficiaries. For wheat, it is assessed on a case-by-case basis.
- When possible, CIMMYT makes available, in the same region, multiple varieties or hybrids with similar functional characteristics as to performance and/or resistance to stresses.
CIMMYT deliberately promotes diversifying allocation of hybrids to public and private sector partners of all sizes and scale-up capacities. CIMMYT works closely with National Agricultural Research Systems (NARS) and seed companies to build capacity for registration and successful commercialization of new CIMMYT-derived varieties and hybrids in target geographies.
Additionally, through its Varietal Identification Number (VIN) system, CIMMYT prevents seed companies from wasting resources to pursue the registration of the same hybrid under a different name in a particular country, in contravention of most countries’ seed-related laws and regulations.
CIMMYT uses one of several standard license agreement templates to allocate elite CIMMYT-derived maize hybrids and open pollinated varieties (OPVs) for commercialization on either a non-exclusive or geographically- and time-limited exclusive basis.
The allocation process begins when CIMMYT posts a call for applications — open to both public and private sector institutions — to receive licenses to commercialize available CIMMYT-derived hybrids. Such calls are widely advertised through (i) CIMMYT’s website and online Maize Product Catalog, (ii) regional networks in sub-Saharan Africa, Asia, and Latin America, and (iii) email notifications to hundreds of public and private sector partner organizations. Once a call for applications is posted, the potential partners apply for (i.e., request) allocation of one or more products via the online Maize Licensing Portal. Applications are evaluated according to the Product Allocation Principles, as further explained within the call for applications and the document “Acquisition and Use of CIMMYT Maize Hybrids and OPVs for Commercialization”.
Following the allocation process, CIMMYT enters into commercialization licenses with various public and private sector partners for production, registration/release, and commercialization of one or more specified CIMMYT-derived hybrids, limited in time (5 years) and territory. CIMMYT typically does not charge any licensing fees or royalties in relation to these LEAs. CIMMYT even provides limited quantities of seed at either no cost or on a cost-recovery basis to the partner, depending on the quantities requested and whether donor funding is available to subsidize the cost recovery.
Exclusivity is furthermore subject to the partner’s ability to demonstrate that they are diligently pursuing commercialization of the hybrid, such that in case they are not, CIMMYT may terminate the agreement and re-allocate rights to another partner that will do so. Territory exclusivity is limited to a particular country, or set of countries, with particular hybrids. Further, exclusivity is limited to national registration and commercialization activities only; CIMMYT and other partners who receive the materials from CIMMYT under the SMTA maintain the freedom to use the same hybrid for research, breeding and training activities, and CIMMYT may further allocate the same licensed hybrid to different organizations for registration and commercialization in other countries.
CIMMYT distributes wheat lines under the Standard Material Transfer Agreement (“SMTA”) of the International Treaty on Plant Genetic Resources for Food and Agriculture (the “Treaty”) for research, breading and training. Those lines always remain available as International Public Goods through CIMMYT germplasm bank, with ability to distribute all around the world.
In some cases, an entity that tests different lines publicly released by CIMMYT, or as a result of a collaborative work in a project, a public or private institution can become interested in a particular line for commercialization in a given country. In those cases, partners express their interest to CIMMYT and, CIMMYT, using the criteria outlined for product allocation, makes a decision. Additional elements that CIMMYT considers in assessing the request for wheat lines include:
- Whether the request is to register for commercialization (according to country laws and regulations) or to request for permission to register plant breeder’s rights.
- The country for which the partner requests authorization to commercialize. For requests to obtain plant breeder’s rights, priority is given to requests for geographies that are not CIMMYT target or priority for dissemination, for example, high income countries;
- Ability to generate a benefit for CIMMYT target beneficiaries, as a way to increase scale and scope of impact. For example, the possibility for CIMMYT to access and release performance data of CIMMYT developed lines in certain environments where CIMMYT could not conduct the testing itself and when such data could be useful for different regions of the world, with similar environmental conditions.
Allocation of wheat varieties has taken place in the following cases:
As part of a collaboration relationship between Agrovegetal and CIMMYT (formalized through two Limited Exclusivity Agreements in 2013 and 2018), Agrovegetal has a non-exclusive access to advanced wheat lines that could be suitable for climate conditions in Spain. Agrovegetal will conduct further breeding efforts with those lines, through various growing and testing cycles and, as a result, it may select and stabilize some of those lines for later commercialization (limited to Spain). Agrovegetal may register some of those lines for commercialization or ask for plant breeders rights. Up to date, Agrovegetal has not requested authorization to apply for Plant Breeders Rights over any line developed by CIMMYT.
Rebel Seeds in Australia
In 2012, CIMMYT began the distribution of Borlaug 100, an improved wheat variety developed by CIMMYT. This variety was developed targeting particular “mega environment” conditions which include India’s Gangetic Valley, the Indus Valley in Pakistan, the Nile Valley in Egypt, and the Yaqui Valley in Mexico. Borlaug 100 is currently available as an international public good through at least 14 of its international nurseries with distribution in at least 80 countries including China, Egypt, Ethiopia, India, Iran, Kenya, Mexico, Pakistan, Tunisia and Zimbabwe.
Following an expression of interest by a company in Australia to commercialize Borlaug 100, CIMMYT tailored a dissemination strategy for the Australian market: the partner is permitted to apply for plant variety protection (“PVP”) to commercialize this variety in Australia, while CIMMYT continues to make the variety available worldwide – including in Australia – as an international public good for research, breeding and training in food and agriculture. CIMMYT may also make the variety available for commercial purposes in any country outside of Australia.
In developing this strategy CIMMYT undertook a thoughtful evaluation of the CGIAR and CIMMYT Policies as well as circumstantial factors including: lack of conflict with CIMMYT’s focus regions, increased distribution, continued performance improvement from data obtained, and a new funding stream from a high-income, developed country. Further, CIMMYT considered that plant varieties subject to PVP in most countries, including Australia, are nevertheless available for research and breeding pursuant to a so called ‘breeders exemption’ and so do not trigger the monetary benefit sharing obligations imposed under the Standard Material Transfer Agreement of the Treaty. Because Borlaug 100 was developed from genetic resources held in-trust for the benefit of the international community, under the current arrangement the partner will make annual contributions to the Treaty’s benefit-sharing fund and to CIMMYT for its programs. As consequence, this dissemination model supports both the benefit-sharing fund of the Treaty, and furthers the CGIAR Vision, with continued impact on resource-poor farmers in developing countries.
In 2020, CIMMYT granted permission to 2 partners in Tunisia to register 4 wheat lines as new plant varieties. The lines are currently going through testing for entry into the Tunisian national catalogue and will be automatically registered as new plant varieties if accepted by the regulators towards the end of December 2022, for commercialization purposes. Without CIMMYT granting the permission to these partners to register the lines for commercialization, farmers in Tunisia would not be able to obtain seeds of such wheat varieties for planting in their fields.
In these agreements, CIMMYT and partners who have receive the lines retain the right to use the lines for research, breeding and training for food and agriculture. CIMMYT also continues to retain the freedom to share the lines with third parties pursuant to the terms of the SMTA.