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How do Intellectual Property Rights (IPRs) help foster and protect innovation in the seed industry?
A strong intellectual property protection system fosters innovation because it rewards risk-taking and investment with a limited period of exclusive use, after which the product is in the public domain.
Plant breeding innovation plays a key role in driving long-term agricultural productivity, rural development, and environmental sustainability by encouraging the creation of new solutions. The seed sector (public and private) is one of the world’s most research and development-intensive industries. As is the case for other research-intensive sectors, companies, and public research institutes involved in innovation depend on a stable environment for the protection of intellectual property to ensure further R&D investments and maintain a strong innovative base.
Who owns the patents on tools for plant breeding innovation?
Worldwide, many of the patent holders on latest plant breeding methods (such as CRISPR technologies) are universities and research institutes. The patent landscape for gene editing is dynamic and rapidly evolving in key countries and globally. Since the early days of CRISPR use, the number of patents describing these tools has increased. These patents originate from Asia, Europe and the United States.
Since the patent landscape for latest plant breeding methods (such as CRISPR technologies) is rapidly changing, it is important to get updated information from the public patent databases such as the Worldwide Espacenet or Patentscope.
How can patents on plants made with gene editing affect plant breeding?
Depending on national patent laws, the techniques and/or the characteristics resulting from gene editing may or may not be eligible for patents. Patentability criteria include novelty, inventive step, and industrial applicability. All patent rights are time limited and are published, they have geographical limitations and, while some countries do not permit breeding with plants containing patented characteristics, many allow research and breeding with patented elements.
ISF and its members are committed to creating an environment that fosters innovation whilst protecting the investments by plant breeders. This includes supporting the development of tools and approaches that facilitate access to improved seeds whilst balancing the need to protect investments – for example company licensing initiatives or licensing platforms.
IP Licensing initiatives used by the seed sector increase transparency about relevant patent portfolio and offer opportunities for plant breeders, large and small to access trait innovations, including those developed through gene editing, on fair conditions. Some seed companies offer electronic licensing systems as well as standard licenses which aim to make contract processing user-friendly, limit the transaction efforts and costs to a minimum and support compliance.
The mutual granting of intellectual property rights between actors in the value chain (so-called cross-licensing) can also be handled via some of these initiatives. The needs of small breeding companies especially are also supported by the approaches adopted by some individual seed companies.
For more information, see the ISF View on Intellectual Property.
How will intellectual property rights on plant products made with gene editing methods affect farmers’ ability to save seed?
Intellectual property protection rights are equally applicable to varieties developed using conventional methods or plant breeding innovation like gene editing. Therefore, the ability for farmers to save seeds of a variety, will depend on the variety’s IP protection status and the national legal framework.
If companies can identify their gene edited varieties for intellectual property purposes such as with patents or plant variety protection, how is that different than identification for marketing purposes?
The foundation of variety identification for plant variety protection is based on phenotypical characteristics and therefore genetic sequence information or molecular markers may not automatically be available or used in variety protection. Additionally, the genetic information when used in supporting plant variety protection is not necessarily associated with specific sequence change that may or may not be introduced through gene editing.
Does regulatory status affect the intellectual property protection of plant breeding innovation?
No. The regulatory status for plants resulting from the latest breeding methods is not linked to the question if they can be protected by intellectual property rights such as patents. These are unrelated questions and governed by different legal frameworks each having different objectives.
For example, if a gene-edited product is excluded from national GMO/biotechnology regulations it may still be protectable by an IP right, and vice versa. If a product falls under GMO/biotechnology regulation it may not meet the criteria to obtain an IP right.
Products resulting from the latest breeding methods as well as certain breeding tools can be protected under applicable intellectual property protection system(s) (depending on national law) if they meet the criteria of the specific IPR system, such as novelty, distinctness, stability, uniformity for PVP inventive step, industrial applicability and/or enabling disclosure for patent.
Further reading: https://worldseed.org/document/gene-editing-fact-sheet-3/
What is “Benefit Sharing”?
The concept of equitable sharing of the benefits arising from the use of genetic resources has gained official recognition with the adoption of the Convention on Biological Diversity. It has several components depending on the type of genetic resources. The main components are:
- exchange of information, transfer of technology and capacity building (non-monetary benefits)
- sharing of commercial benefits (monetary benefits)
The most important aspects for suppliers of genetic resources, in particular for those based in developing countries, are access to information and technology and capacity building. If well used, non-monetary benefits ñ access to information and technology, and capacity building ñ may be more useful than monetary benefits as they have far reaching impacts for the future. In addition, ISF considers that the provision provided under UPOV whereby commercially released varieties are available without authorisation of the owner as germplasm for further breeding or research purposes is in itself a benefit.
According to a survey carried out in 2001 among ISF (then ASSINSEL) members, many breeding companies have developed collaborative activities with national and/or international programs. About two thirds of the respondents assist national programs, also in developing countries/countries with economies in transition, in maintaining evaluating and characterising PGRFA, either technically or financially, and one third provide assistance to international programs.
Technology transfer, as it relates to the maintenance of plant genetic resources for food and agriculture (PGRFA), is also an important commitment for many ISF members. While some members are based in developing countries, others have breeding programs there and some also conduct training and collaborative research programs for subsistence crops beyond their commercial portfolios. More than 40% of ISF members grant licenses free of charge to developing countries. Some companies also participate in international programs for technology transfer.
ISF has been proactive in the matter of commercial benefit sharing. The spirit of a position paper adopted in 1998 by ASSINSEL forms the basis of Article 13.2.d(ii) of the International Treaty on PGRFA. It is important to mention that commercial products arising from the use of PGRFA after the CBD came into force are still in the developmental stages and therefore, sharing from the benefits thereof is limited to date
What is “In the Form Received”?
Article 12.3.d of the recently adopted international treaty on Plant Genetic Resources for Food and Agriculture states that ëRecipients [of PGRFA accessed from the Multilateral System] shall not claim any intellectual property or other rights that limit the facilitated access to the PGRFA, or their genetic parts or components, in the form received from the Multilateral System.
ISF interprets this article, in particular the term ëin the form receivedí as follows:
- it is not possible to claim any intellectual property or other rights that limit the facilitated access to the PGRFA, or their genetic parts or components, in the form it was received from the Multilateral System.
- it is possible to claim intellectual property or other rights that limit access to the genetic parts or components isolated or derived from the material received provided that the patentability criteria are fulfilled, in particular the one dealing with utility. However, the rights granted should not limit access to the initial genetic material. A genetic sequence without any proven research or developmental step should not be eligible for patent protection.
What is a “Material Transfer Agreement (MTA)”?
A Material Transfer Agreement (MTA) is a contractual agreement signed between the supplier and the recipient of a resource and sets out the rights and obligations of both parties. As any contract, it is binding on the parties and in the case of a dispute subject to contract laws.
An MTA for plant genetic resources for food and agriculture (PGRFA) should define:
- activities allowed with the accessed germplasm (e.g. breeding and research)
- what is protectable by intellectual property rights and the limits to these rights (e.g. material that is the result of a breeding or development process)
- how benefits arising from the use of the accessed germplasm will be shared (e.g. access to characterization and evaluation data, access to improved germplasm, sharing of some commercial benefits)
An MTA may be agreed upon on a multilateral basis, such as in the framework of the International Treaty on PGRFA, or bilaterally on the basis of mutually agreed terms between the supplier and the recipient of the PGRFA. (See also the ISF position paper on MTAs for the Multilateral System of FAO’s International Treaty on Plant Genetic Resources for Food and Agriculture).
What is the Purpose of “Variety Registers/Catalogues”?
When a variety has fulfilled the criteria for Plant Breeder’s Rights (novelty, distinctness, sufficient homogeneity, stability), it is listed in a national register or catalogue. Such registers/catalogues have no purpose other than to make publicly known that the variety is protected. They exist in every country that has a plant variety protection scheme in place.
These registers/catalogues should not be confused with the national lists/catalogues developed by some countries on which varieties must be listed before they receive the authorization to be placed on the market. The criteria for being listed on such catalogues are also distinctness, sufficient homogeneity and stability and some crops, mainly field crops, must also meet the set criteria for cultural use, known as VCU (Value for Cultivation and Use).
VCU registers/catalogues may have a negative impact on the diversity of material available to farmers.
What is an “Essentially Derived Variety” ?
The concept of essentially derived variety was introduced into the 1991 Act of the UPOV Convention in order to avoid plagiarism and to fill the gap between Plant Breeder’s Rights and patents, a gap which was becoming important due to the increasing use of patented genetic traits in plant varieties introduced through genetic engineering.
An essentially derived variety is a variety, which is distinct and predominantly derived from a protected initial variety, while retaining the essential characteristics of that initial variety.
Essentially derived varieties may be obtained, for example by the selection of a natural or induced mutant, or of a somaclonal variant, the selection of a variant individual from plants of the initial variety, backcrossing, or transformation by genetic engineering.
The commercialization of an essentially derived variety needs the authorization of the owner of the rights vested in the initial variety.
The concept of essentially derived variety does not at all abolish the Breeder’s Exemption, as free access to protected plant varieties for breeding purposes is maintained. It is not a threat to biodiversity. On the contrary, it favors biodiversity, encouraging breeders to develop and market new varieties.
Are “Farmers’ Rights” and “Plant Breeder’s Rights” Compatible?
In ISF’s view Farmer’s Rights as defined by the International Treaty for PGRFA (see Farmer’s Rights) and Plant Breederís Rights as defined by UPOV (see Plant Breeder’s Rights) are compatible in the following cases:
Crop production
Farmers choose varieties, landraces or improved, best suited to their conditions and retain their right to choose varieties and crops. The incentive provided to plant breeders through rights (accorded by UPOV or other effective sui generis systems) makes available an increasing number of improved varieties to farmers, widening the choice at their disposal.
If a farmer chooses to buy seeds of a protected variety, the breeder receives the benefit through the plant breederís rights and allows him/her to continue breeding and providing farmers with improved varieties.
Plant Breeding
Both farmers and professional breeders have the right to do breeding. Assuming that a number of farmers are continuing to select at harvest or even crossing varieties for breeding purposes, there is no provision in the UPOV Convention that prevents farmers from doing so. On the contrary, even protected varieties can be used to do so. Nor are they prevented from freely using the new varieties they have created, except if they are considered to be essentially derived. If these new varieties are distinct, sufficiently homogeneous and stable (in order to recognize/identify them) they are protectable under UPOV or other effective sui generis systems.
Farm Saved Seed
As far as the poorest farmers in the least developed countries (i.e. subsistence farmers) are concerned, they benefit from the exception to Plant Breederís Rights for acts done privately and for non-commercial purposes. They can save seed produced on their farm for re-sowing on the same farm.As to farmers integrated in a commercial chain, each country may, according to its economic and social situation, take special dispositions authorizing the use of farm-saved seed on a case-by-case basis, under specific conditions, whilst safeguarding the legitimate interests of the breeder. The only absolute restriction is the prohibition of selling farm-saved seed of protected varieties.
Crop Biodiversity
As farmers can use both improved varieties and landraces, diversity in the material they use does not decrease. On the contrary it increases.There is no correlation between the possible decrease of crop diversity and Plant Breeder’s Rights. The fact that a variety is private or public has no influence whatsoever on biological diversity. Plant Breeder’s Rights favour diversity by:
- better controlling dissemination of improved varieties
- encouraging competition between breeders and thus making more varieties available
- preventing commercialization of near identical varieties through the implementation of the concept of essentially derived varieties
- encouraging evaluation of breeding material and use of greater genetic diversity
Lastly, it is worth mentioning that if legislations concerning Farmers’ Rights are aimed at establishing an international fund for improving the conservation and sustainable use of plant genetic resources for food and agriculture, Farmersí Rights are not incompatible with Plant Breederís Rights.
What is “Farmers’ Exemption”?
Contrary to Farmers’ Rights with which it is frequently confused, Farmers’ Exemption (also called Farmers’ Privilege) is very well defined. It is a consequence of an exception to Plant Breederís Rights as per the UPOV Convention.
The 1978 Act of the UPOV Convention states that the production of seed of a protected variety for purposes of commercial marketing is restricted. That means a contrario that, except if national laws are more stringent than the UPOV Convention (a a minima convention) (see Plant Breeder’s Rights), farmers are allowed to produce seed of protected varieties for their own use.
The 1991 Act of the UPOV Convention states that private acts for non-commercial purposes are not covered by Plant Breederís Rights. In addition, the 1991 Act of the UPOV Convention provides for an optional exception to Plant Breederís Rights indicating that each contracting party may, within reasonable limits and subject to the safeguarding of the legitimate interests of the breeder, restrict the plant breeder’s right in relation to any variety. This is in order to permit farmers to use for propagating purposes on their own holdings, the product of the harvest, which they have obtained by planting on their own holdings, the protected variety. Most of the national laws and regional regulations allow such exceptions.
These exceptions provided for in the 1978 and the 1991 Acts of the UPOV Convention are known as “Farmers’ Exemption” and the seed so produced is known as “farm-saved seed”.
It must be noted that, in no case, the Farmers’ Exemption provided for in the UPOV Convention allows farm-saved seed of protected varieties to be sold. Of course, farmers continue to have the right to sell seed of non-protected varieties.
Is a “Farmer’s Variety protectable by Plant Breeder’s Rights”?
A variety developed by a farmer is eligible to be protected by a Plant Breeders Right (PBR) if it meets the requirements of distinctness, uniformity, and stability. Eligibility will also be determined by the requirements of the national PBR Act and regulations in the country of application including provisions of prior sale and duration of rights.
What are “Plant Breeder’s Rights”?
Plant Breeder’s Rights are intellectual property rights given to a person who has developed a variety. The variety must be:
- new
- clearly distinguishable from any other variety whose existence is a matter of common knowledge
- sufficiently uniform in its relevant characteristics, and
- stable
The duration of a right is always limited in time. Its scope and the duration are defined a minima in the various acts of the UPOV Convention. There are certain compulsory exceptions and Plant Breeder’s Rights don’t extend to acts done:
- privately and for non-commercial purposes (subsistence farmers are not bound by Plant Breeder’s Rights)
- for experimental purposes
- for the purpose of breeding new varieties from the protected variety. The newly bred varieties, if not essentially derived from the initial one, may be freely commercialised by their developers
Given the above definition of Plant Breeders Rights, ISF does not consider it possible to protect mere discoveries from resources of common knowledge and a fortiori genetic resources deposited in genebanks, as they are not distinct. Neither does ISF consider Plant Breeders Rights to be an appropriation of the genome of a species.
What is “Plant Genetic Resource”?
Any genetic material of plant origin that is of potential value for creating improved germplasm is a plant genetic resource. Plant genetic resources for food and agriculture are, in general, sub-divided in the following five categories:
- wild and weed species that are closely related to cultivated species
- landraces
- special genetic stocks including elite and current breeders’ lines
- cultivated varieties
- obsolete varieties
The two first categories are often termed exotic germplasm by plant breeders, since such materials require long-term pre-breeding programmes in order to gradually transfer their attractive characteristics into an improved and adapted genetic background that can be used in variety breeding.
Today due to genetic engineering, genes from unrelated species are also considered as plant genetic resources. Examples of such genetic resources include Arabidopsis from which genes of interest are being introduced into pea and legumes whose ability to form nodules is a characteristic of interest in tomato.
Not all genetic resources have the same immediate utility. Much depends on the crop and the trait of interest. Wild relatives of cultivated species, for instance, require extensive adaptation and pre-breeding before they can be used in breeding of cultivated varieties. Public or private breeders use mostly germplasm from adapted and productive commercial varieties in the creation of new varieties.
What is a “Variety”?
ISF considers the definition used in the 1991 Act of the UPOV Convention to be the most appropriate. It reads as follows:
Variety means a plant grouping within a single botanical taxon of the lowest known rank, which grouping, irrespective of whether the conditions for the grant of a breederís right are fully met, can be:
- defined by the expression of the characteristics resulting from a given genotype or combination of genotypes,
- distinguished from any other plant grouping by the expression of at least one of the said characteristics and
- considered as a unit with regard to its suitability for being propagated unchanged
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What is plant breeding?
Put simply, plant breeding improves plants in order to grow better crops with desired characteristics. We have been improving plants for thousands of years – long before breeding existed as a formal discipline. Plant breeding is based on this long history of experience, and the tools that help to achieve these improvements continue to evolve as we learn more about plant biology and genetics.
Why do we need plant breeding?
Plant breeding lets us adapt plants so we can maintain and increase productivity and improve product qualities considering changing climatic, agricultural and market conditions. Plant breeding has significantly contributed to reducing environmental footprint of plant production, increasing the diversity of products and improving the economic situation of agriculture.
The continued development of new varieties is vital to meet farmer needs, market requirements and consumer demands. By domesticating wild species, we have developed fruit and vegetables with desired characteristics, such as colour, shape, size and taste. Ultimately, plant breeding helps to feed future generations by securing a sustainable, nutritious food supply. Without plant breeding we would not have the variety and quality we see in today’s marketplace.
What do plant breeders do?
Plant breeders develop new plant varieties by improving and combining different useful characteristics. For farmers, these characteristics may be disease resistance or drought tolerance; for consumers, nutritional quality, flavour or appearance; for food manufacturers and retailers, baking quality or shelf life.
Today’s plant breeders integrate knowledge from a range of scientific disciplines, such as plant biology, genetics, physiology, statistics, bioinformatics, and molecular biology. Breeding programs are often managed by teams of scientists from many different fields of expertise. To develop new varieties, plant breeders use a variety of tools ranging from cross-breeding to gene editing, as illustrated in the ISF ‘Milestones’ infographic, which is available in English, French, Spanish and Dutch, in the ISF Resource Bank.
Other resources include various short films produced by Euroseeds and the American Seed Trade Association (ASTA), and available on their respective You Tube channels:
To meet some plant breeders and find out more about their work, have a look at these plant breeder profiles from around the world by CropLife International: Food Heroes.
For information about plant breeding innovation, with a focus on gene editing, and its benefits for our planet, health and food you can visit the site: Innovature
How has plant breeding evolved?
Since the first seed was planted, farmers selected and grew the best and heartiest crops from one year to the next. As the world and science progressed, plant breeding developed into a formal discipline with breeders continuing to have a better understanding of plants and the breeding process.
Among the scientific breakthroughs, the following three had a significant impact on plant breeding and formed the basis of plant breeders’ learning from nature to improve plants.
- Camerarius proved in 1696 that – like animals and humans – plants have sex organs. This knowledge led to cross-breeding, which gave rise to greater diversity from which to select desirable plants. It took until the 19th century, however, before this knowledge was applied to major field crops.
- Mendel’s Laws of Heredity (1865) described the principles governing inheritance in plants. This turned plant breeding into a science because the outcome of a cross could now be predicted quantitatively. This allows for more efficient selection methods.
- Watson & Crick (1953) described the structure of DNA which later became the basis of various applications of molecular biology in plant breeding, such as the use of molecular markers, which greatly increase efficiency in selection; and gene editing which allows for targeted mutagenesis.
Over time, an increased understanding of plant biology and genetics has enabled plant breeders to develop more efficient breeding methods and to identify, study and utilize positive characteristics available within the plant, such as disease resistance, drought tolerance or product qualities such as colour, taste, and shelf life. These discoveries enable the continuous development of new plant varieties better adapted to meet current and future challenges that agriculture and society are facing.
See the ISF ‘Milestones’ infographic which charts the evolution of plant breeding from crop domestication to gene editing – available in English, French, Spanish and Dutch, in the ISF Resource Bank.
What does ‘plant breeding innovation’ mean?
‘Plant breeding innovation’ is the term used by the international seed sector and plant scientists worldwide to describe the continuous evolution of plant breeding methods. Breeders use many methods in their breeding programs to increase genetic variability, increase breeding efficiency and evaluate their breeding materials.
Today’s innovations in plant breeding utilize sophisticated methods and disciplines, such as cell biology, genome and proteome research, gene mapping and marker-assisted breeding, which have enabled the development of other innovative methods such as gene editing to generate variation.
The term ‘plant breeding innovation’ is not limited to a particular group of methods, nor it is defined by them, but rather reflects the continuum of innovation in plant breeding[1].
[1] In some parts of the world, terms like new breeding techniques (NBT) or new genomic techniques (NGT) may also describe a group of tools that would be considered plant breeding innovation
What are the benefits of plant breeding innovation?
With a global population that is estimated to reach 10 billion by 2050 (according to www.world.population.co.uk), and increasingly scarce arable land, one of the most significant benefits of plant breeding innovation is supporting sustainable agriculture and food security.
Plant breeding has always played an important role in adapting crops to meet new and evolving demands. Changes in agriculture, consumer and societal demands are occurring at an increasing speed and therefore rely on continuously improving the efficiency of plant breeding processes as well. Plant breeding innovations are key enablers as breeders strive to meet the needs of consumers, a changing climate and increasing population.
a) Farmer benefits
- Plant breeding innovation provides farmers with improved seeds adapted to their needs, which leads to more reliable harvests and stable incomes and increased market access.
- Plant breeding innovation can be used to produce plants that can better resist pests and diseases, enabling more choice and flexibility for farmers, and potentially requiring fewer crop inputs.
- As a result of innovations in plant breeding, breeders can improve efficiency and effectiveness of delivering improved seeds to farmers and subsequently to consumers, by reducing the development time of new varieties; by rapidly adapting crops and plant varieties to a changing climate, as well as increasing options for weed, disease and pest management.
b) Environmental benefits
- Plant breeding innovation results in improved seed that can increase yields that can support decreasing greenhouse gas emissions and reducing the environmental impact of crop production. This also means more land that supports flora and fauna biodiversity can remain untouched by agricultural production, helping to preserve natural habitats.
- By creating improved plant varieties that are better able to withstand attacks from pests and diseases, farmers can reduce and optimize the applications of crop inputs supporting a smaller environmental footprint for agriculture.
- Plant breeding innovation has been integral to improving and developing new energy [or dual use] crops for the biofuels industry.
c) Consumer benefits
- Plant breeding innovation enables breeders to meet consumer expectations more readily with improved plants that provide longer-lasting, fresh, nutritious and affordable food, as well as fuel, feed and fibre.
- Plant breeding innovation contributes to the health and well-being of consumers, for example, low-gluten cereal varieties for people with sensitivities, and fruits and vegetables with improved nutritional value. Additionally, it has the potential to enhance quality of life through the development of flowers, trees and turf for sustainable green spaces.
- Plant breeding innovation can help protect crops such as banana, orange, coffee and cocoa that are in danger of being wiped out by diseases for which there is no current treatment, and ensures they remain plentiful and affordable.
For additional information, please visit the following resources: ISF online Resource Bank, Innovature, Best Food Facts, Nature Nurtured.
How does plant breeding and, more specifically, gene edited crops contribute to sustainable farming systems?
Agriculture involves a series of choices, which are necessary to balance environmental impacts, farmers’ livelihoods, and the need to grow more food for the growing world population in a sustainable way. When farmers can choose seeds most adapted to their land and farming system, it raises the likelihood of better yields. Diversity of seed choices also helps farmers fight pests and disease, and allows them to adjust their farming systems to changing climate patterns.
Access to improved seeds ensures farmers can participate in more sustainable agricultural systems that integrate precision agriculture and digital tools. In the future, gene-edited crops can play an important role in enhancing the sustainability of many different agricultural systems; regenerative practices, precision technology, and organic farming practices may be able to leverage advancements in gene-edited crops.
How do plant breeders deliver safe and high quality seeds to farmers?
Plant breeders have a long track record of developing high-quality and safe varieties. A defining feature of plant breeding is the extensive and rigorous official and private testing of candidate varieties to ensure the release of new products that meet breeding objectives for better quality and taste, agronomic performance, climate resilience or harvestability and processing.
The development of new plant varieties involves the selection of plants with the desired characteristics after iteratively crossing existing varieties to create new genetic combinations. Importantly, most of these existing varieties are derived from varieties with a long history of safe use.
Plant breeders test for a range of characteristics to meet consumer needs like taste, colour and texture. They also test for characteristics that are less obvious to consumers like yield, pest resistance and consistency of performance in diverse environments and conditions. In certain crops, functional characteristics are evaluated to assure that the variety will be suitable for specific food or feed uses.
Because the environment can influence the expression of certain characteristics, plant breeders typically evaluate candidate varieties in multiple environments over several years or plant generations to ensure consistency of performance. The scrutiny that plant breeders routinely apply to the development of new varieties is the foundation for a food supply that is safe, nutritious and diverse.
What is gene editing and how is it used by plant breeders?
One of the latest innovations in plant breeding is gene editing. Gene editing is a group of methods that enables plant breeders to make precise changes to the plant’s own genetic material (DNA), which can improve their productivity and sustainability. The genetic variation made with gene editing often mirrors changes that could occur in nature or through traditional breeding. The most recent and widely researched gene editing method uses a system termed CRISPR-Cas. CRISPR stands for Clustered Regularly Interspaced Short Palindromic Repeats.
To see how gene editing and CRISPR work, you can find short films on YouTube:
Plant scientists and breeders are working on CRISPR-edited versions of crops, with improved characteristics for farmers and consumers.
What is the difference between gene editing and older methods of plant breeding?
Gene editing is part of the continuum of plant breeding innovation and builds on years of scientific advances and the increased understanding of plant genetics. Gene editing allows breeders to work within a plant’s own gene pool to reach the same endpoint as they would through more traditional breeding methods–but with greater precision and efficiency than older methods of plant breeding.
Are there any gene edited crops that are commercially available?
Yes. As of early 2022 there are two gene edited products commercially available include soybeans, lettuce, and tomato. The first product, a high oleic soybean, was launched in 2019 and it was marketed in the Upper Midwest United States. In 2021, a gene-edited tomato was commercialized in Japan. The tomato contains high levels of gamma-aminobutyric acid (GABA), an amino acid believed to aid relaxation and help lower blood pressure.
Will newer gene editing methods make older plant breeding methods obsolete?
No. Plant breeding innovation is based on accumulated knowledge and experience over hundreds of years. Gene editing is an additional tool in the plant breeder’s toolbox that is used to generate genetic variation that is needed to develop new plant varieties with characteristics to address environmental and consumer needs.
The development of newer plant breeding methods has not led to a replacement of the older methods, nor will it do so in the future. Depending on the problems plant breeders are trying to solve, they must be able to choose the tools that enable them to reach their breeding goals in the most efficient and specific way. The bottom line is that working with plants in the field still remains the core of the plant breeding process.
For more information, visit the ISF infographic ‘Plant breeders’ response to global challenges’ in the ISF Resource Bank or Euroseeds infographic about Plant Breeding Innovation as part of Breeding Cycle.
How do Intellectual Property Rights (IPRs) help foster and protect innovation in the seed industry?
A strong intellectual property protection system fosters innovation because it rewards risk-taking and investment with a limited period of exclusive use, after which the product is in the public domain.
Plant breeding innovation plays a key role in driving long-term agricultural productivity, rural development, and environmental sustainability by encouraging the creation of new solutions. The seed sector (public and private) is one of the world’s most research and development-intensive industries. As is the case for other research-intensive sectors, companies, and public research institutes involved in innovation depend on a stable environment for the protection of intellectual property to ensure further R&D investments and maintain a strong innovative base.
Who owns the patents on tools for plant breeding innovation?
Worldwide, many of the patent holders on latest plant breeding methods (such as CRISPR technologies) are universities and research institutes. The patent landscape for gene editing is dynamic and rapidly evolving in key countries and globally. Since the early days of CRISPR use, the number of patents describing these tools has increased. These patents originate from Asia, Europe and the United States.
Since the patent landscape for latest plant breeding methods (such as CRISPR technologies) is rapidly changing, it is important to get updated information from the public patent databases such as the Worldwide Espacenet or Patentscope.
Who has access to the latest plant breeding innovation tools? What is the mechanism that plant breeders can use to access Crispr?
In general, the latest plant breeding tools could be available to plant breeders through licensing, including those at academic and public research institutes, and companies of all sizes, from multinationals to small and medium-sized enterprises.
The seed sector is encouraging the use of licensing platforms to promote the dissemination of knowledge and facilitate access to innovation at fair conditions. In most countries, intellectual property-protected breeding tools like CRISPR, are available to plant breeders through licensing agreements. Most IP holders have established out-licensing policies and processes that facilitate access that support further innovation. For example, early developers involved with CRISPR technology have created partnerships with newly formed companies, or established industry players, to out-license gene editing technologies for medical, agricultural, and industrial applications. In the case of CRISPR, certain patent holders provide free licenses for academic and not-for-profit research. They also provide non-exclusive, royalty-bearing licenses to breeding companies that want to use CRISPR for commercial purposes.
It is important to keep in mind that, even though there may be broad access to gene editing methods, successful application to develop plants with specific characteristics depends on the availability of genetic information, an understanding of gene function, and the availability of enabling methodologies like tissue culture and plant regeneration methods.
How can patents on plants made with gene editing affect plant breeding?
Depending on national patent laws, the techniques and/or the characteristics resulting from gene editing may or may not be eligible for patents. Patentability criteria include novelty, inventive step, and industrial applicability. All patent rights are time limited and are published, they have geographical limitations and, while some countries do not permit breeding with plants containing patented characteristics, many allow research and breeding with patented elements.
ISF and its members are committed to creating an environment that fosters innovation whilst protecting the investments by plant breeders. This includes supporting the development of tools and approaches that facilitate access to improved seeds whilst balancing the need to protect investments – for example company licensing initiatives or licensing platforms.
IP Licensing initiatives used by the seed sector increase transparency about relevant patent portfolio and offer opportunities for plant breeders, large and small to access trait innovations, including those developed through gene editing, on fair conditions. Some seed companies offer electronic licensing systems as well as standard licenses which aim to make contract processing user-friendly, limit the transaction efforts and costs to a minimum and support compliance.
The mutual granting of intellectual property rights between actors in the value chain (so-called cross-licensing) can also be handled via some of these initiatives. The needs of small breeding companies especially are also supported by the approaches adopted by some individual seed companies.
For more information, see the ISF View on Intellectual Property.
How will intellectual property rights on plant products made with gene editing methods affect farmers’ ability to save seed?
Intellectual property protection rights are equally applicable to varieties developed using conventional methods or plant breeding innovation like gene editing. Therefore, the ability for farmers to save seeds of a variety, will depend on the variety’s IP protection status and the national legal framework.
If companies can identify their gene edited varieties for intellectual property purposes such as with patents or plant variety protection, how is that different than identification for marketing purposes?
The foundation of variety identification for plant variety protection is based on phenotypical characteristics and therefore genetic sequence information or molecular markers may not automatically be available or used in variety protection. Additionally, the genetic information when used in supporting plant variety protection is not necessarily associated with specific sequence change that may or may not be introduced through gene editing.
Are products of plant breeding innovation regulated?
A growing number of countries have policies based on an overarching principle that plants resulting from latest breeding methods with genetic changes comparable to the outcomes that could occur spontaneously in nature or via traditional breeding are not differentially regulated from traditionally bred plants. These countries follow the generally accepted legal principle of non-discrimination, so that that like products are regulated in the same way. Nevertheless, this doesn’t mean that these plants are unregulated. All plant varieties are regulated, regardless of the method used to develop them, through systems including variety registration, seed laws and regulations, phytosanitary regulations, general environmental safety/liability laws as well as general food/feed laws and regulations for food products derived from these plants.
Why are there differences among countries as to how to handle products of plant breeding innovations?
ISF believes that alignment around the scope of regulatory oversight for gene edited products is critical to fostering innovation and competitiveness. A key component of government evaluations is the intent of their current legislative frameworks and with this the interpretation of their GMO or other associated definitions. Most countries are considering how or if these definitions apply to plants developed with the latest breeding methods.
Why is it important to have regulatory policies for plant breeding innovations that are globally aligned?
The seed sector is an international business. Countries should consider the global impacts that different regulatory processes may have on global seed movement, exchange and access to germplasm globally, agriculture, trade and research collaborations. If policies for plants developed through plant breeding innovations are not aligned globally, this will limit the ability of researchers and commercial developers to use the entire range of innovative plant breeding tools.
Different regulatory approaches for plants resulting from the latest breeding methods could also lead to enforcement difficulties, trade limitations and disruptions, and put some operators at a competitive disadvantage, with further negative consequences. This includes the creation of technical barriers to trade, potentially leading to disputes between countries. Regulatory barriers would particularly affect small and medium-sized enterprises (SMEs) and small-scale operators seeking to gain market access with products from new breeding methods, even though many stakeholders see opportunities for them in this sector.
Should plant varieties developed by the latest plant breeding innovations be regulated as GMOs?
As products of plant breeding innovation began to near commercialization it raised the question of whether these plant varieties should be assessed and managed under existing GMO/biotechnology regulations, or whether they should be regulated in the same way as traditional plant varieties.
The International Seed Federation promotes innovation in plant breeding, and advocates for government policies that are based on sound scientific principles. Consistent science-based policies regarding products of plant breeding innovation are necessary to ensure that farmers and consumers around the world can have full and timely access to the benefits of plant varieties developed through the latest breeding methods.
ISF advocates for the application of consistent criteria in government policy based on the following principle:
‘Plant varieties developed through the latest breeding methods should not be differentially regulated if they are similar or indistinguishable from varieties that could have been produced through earlier breeding methods or could occur in nature.’
Does regulatory status affect the intellectual property protection of plant breeding innovation?
No. The regulatory status for plants resulting from the latest breeding methods is not linked to the question if they can be protected by intellectual property rights such as patents. These are unrelated questions and governed by different legal frameworks each having different objectives.
For example, if a gene-edited product is excluded from national GMO/biotechnology regulations it may still be protectable by an IP right, and vice versa. If a product falls under GMO/biotechnology regulation it may not meet the criteria to obtain an IP right.
Products resulting from the latest breeding methods as well as certain breeding tools can be protected under applicable intellectual property protection system(s) (depending on national law) if they meet the criteria of the specific IPR system, such as novelty, distinctness, stability, uniformity for PVP inventive step, industrial applicability and/or enabling disclosure for patent.
Further reading: https://worldseed.org/document/gene-editing-fact-sheet-3/
What can be done to minimize unintended mutations when using gene editing tools?
Although unintended mutations do not pose unique safety concerns, plant breeders use well-established plant breeding and selection practices for new plant variety development that effectively identify and remove off-type plants while retaining plants with the desired, improved characteristics. Off-types due to introduced mutations, regardless of whether they are spontaneous, induced, or through gene editing, will similarly be removed and not be selected for commercialization.
Breeders take a number of measures to minimize unintended changes when using gene editing tools. These measures include applying a combination of biology and computer science (bioinformatic) tools to ensure specific, targeted changes and to minimize off-target edits. Plant scientists continue to develop improved design and evaluation strategies and tools to increase the precision and accuracy of gene editing applications.
Unintended mutations that result in undesirable new characteristics are considered by plant breeders as “off-types” and breeders have long standing breeding practices that are effective in eliminating these off-type plants. These standard practices have been refined throughout the history of plant breeding and are commonly implemented regardless of what types of breeding tools are used.
Further reading: https://worldseed.org/document/gene-editing-fact-sheet-2/
If the use of latest breeding methods can shorten the time for obtaining desired characteristics for breeding, are we compromising on safety of the resulting products?
Plant breeders use recent advancements such as gene editing to develop improved crops that are important to the agriculture food chain and the consumer, all while using well-documented and thorough quality management processes. As much as plant breeding is a process of selecting beneficial plant characteristics, it’s also a process of eliminating undesirable characteristics. That continues to be true for new varieties developed when the genetic variation is generated using gene editing tools.
Before any new plant variety, including those developed using gene editing, is made commercially available, it undergoes a series of evaluations and tests over the course of multiple generations. This includes geographic adaptation trials—ensuring that the gene-edited candidate variety can grow in different areas and climates without adversely affecting the crop’s performance.
For more information visit: Plant breeding is safe by design
What are unintended effects and are they specific to the use of latest breeding methods like gene editing?
Unintended effects are, as the term suggests, effects other than those which are desired. Unintended effects can be caused by unintended mutations. In the context of traditional breeding unintended effects can result from spontaneous mutations or from classically induced mutations through irradiation/chemicals. These unintended mutations can be numerous and can occur at random locations. With gene editing, off-target mutations can also occur; however, they are much less numerous, and can be mitigated with the proper design of gene editing reagents, which are continuously being improved.
Do seed companies share information about plant breeding innovation?
The seed sector is encouraged to provide information about breeding methods that are used for various crops to a diversity of stakeholders including regulators, the agricultural value chain and the public. Due to different expectations from value chains and consumers around the world, there is no ‘one size fits all’ approach to information sharing that will work for all stakeholders in all countries.
The seed sector recognizes that different stakeholders will desire different types and levels of information. The information shared by seed companies may vary from company to company, by stakeholder group, and by geography depending on the intended audience for that information.
Irrespective of the breeding method used, individual seed companies are also encouraged to share information on their commercial products with their customers and third parties according to their business, marketing, and commercialization plans while respecting confidential business information.
Does the seed sector inform stakeholders about new gene-edited crops coming to the market?
Seed companies are encouraged to consult with stakeholders (including regulators and the value chain) when the use of gene editing is for the development of a commercial product and not purely for research and discovery purposes.
Can gene-edited products be detected?
Yes. Gene-edited products can be detected, but it is more difficult than detection of GMOs. Generally, to detect a gene-edited product, additional information about the specific change and its location in the genome is required
Gene edits often can result in changes that are indistinguishable from variation that could have arisen by various means (traditional breeding tools, or as a result of spontaneous genetic variation from generation to generation.)
How is detection of GMOs different?
GMO detection relies on the presence of a ‘transgene’ or ‘GM event’ in the plant. This transgene provides a unique sequence for the development of DNA-based detection methods. Gene editing may not result in a DNA sequence change that is large enough, or unique enough to develop a detection method that is reliable for regulatory purposes.
When genetic changes from gene editing aren’t identifiable, how can consumers make informed choices?
Value-added products for which there is no specific detection methods are not new, or unusual. For example, free-range eggs, shade-grown coffee, grass fed beef, and anything sold as organic all inform consumer choice without relying on detection methods. Rather, these products rely on either traceability or certification schemes through the value chain.
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What is “Food Security”?
The United Nations Food and Agriculture Organisation (FAO) defines food security as a situation that exists when all people, at all times, have physical, social and economic access to sufficient, safe and nutritious food that meets their dietary needs and food preferences for an active and healthy life.í From this definition, food security can be said to have three components: food quantity, food quality and food safety, each of which is necessary to improve a population’s health. Plant breeders and the seed industry have an important role to play in improving global access to quality food through the production of varieties:
- with improved yields and better ability to resist biotic and abiotic stresses
- with improved nutritional value (e.g. fatty acid balance, iron and vitamin A content)
- that limit the development of fungi producing toxins (e.g. mycotoxins on Bt maize)
These contributions from the private sector, complemented by strong public investments in additional agriculture research, institutional capacity, market incentives, effective intellectual property protection, and infrastructure, are helping to meet the full challenge of food security around the world.
What is “Organic Agriculture”?
Sensu stricto, ìorganic agricultureî is an agricultural management system without any input resulting from a synthesis process. More recently, various regulatory definitions have been given to organic agriculture, mainly based on restrictive use of off-farm inputs.
Organic agriculture, sensu stricto or sensu lato, may or may not be sustainable according to the way it is implemented, and to socio-economical environment in which it is developed. For instance in many parts of the world where population is growing at a high rate, and seen from the perspective of food security and environmental protection organic agriculture is probably not going to be a sustainable solution.
What is “Monoculture”?
The term monoculture is used in the two following contexts:
- agricultural system(s) where the same crop is grown over several seasons on the same field, without crop rotation. An extreme example is some forms of paddy rice cultivation where rice has been grown over several centuries on the same field. Monoculture has developed in parallel with the industrial revolution in countries with fewer and fewer farmers and an increasing urban population to feed. Uniformity of crop is generally sought to facilitate mechanization and improve the quality of the harvested product
- in opposition to ëassociated cultureí, mainly in tropical countries, where a single crop is grown in a field, regardless of crop rotation. According to some views, associated culture would better exploit soil, water and incident sunlight resources. However, it makes agriculture mechanization very difficult, if not impossible
Both monoculture and ëassociated cultureí can be extensive or intensive, and have the same level of sustainability. The choice does not depend on sustainability factors, rather on socio-economic ones.
How does ISF respond to the demand for “Organic Seed”?
Organic seed has different meanings and, depending on people, may refer to:
- Seed of any variety produced organically, i.e., according to organic production standards
- Seed of varieties specially adapted to organic agriculture and developed through any breeding techniques, except recombinant DNA, available to plant breeders
- Seed of so-called ëorganic varietiesí bred using methods that donít ìbreak the continuity between the soil and the plantî. This definition of breeding methods prohibits all in-vitro techniques (see also ISFís position paper on Plant Breeding for Organic Farming)
Recently many countries have passed legislations that call for the compulsory use of seed that has been organically produced (category a. above) (see European Union and US legislations) for crops to be certified as having been produced organically.
During the international Organic Seed Conference held in Rome in July 2004 several speakers reported that the production of organic seed in sufficient quantity, quality and varietal diversity is challenging for several reasons: lower yields/ha, seed quality concerns such as germination and vigour, seed health and physical purity. Nevertheless, production in most cases is possible although in many cases more expensive.
In response to the demand from the organic sector, companies of ISF members have been supplying organic seed. However, they have incurred additional investment (e.g. start-up and inventory) and faced regulatory and market uncertainties. Inconsistency in the enforcement of regulatory requirements has been a particularly difficult issue. Reducing uncertainties through a consistent enforcement of regulations and producing organic seed under contract would encourage companies to increase the availability and range of organic seed.
How does ISF understand “Sustainable Agriculture”?
ISF understands sustainable agriculture as the evolving management and conservation of the natural resource base in any given region, and the global orientation of technical and institutional change, in such a manner as to ensure the steady attainment and continued, safe satisfaction of human needs for present and future generations.
A sustainable agriculture must attempt to sustain all biodiversity through a blending of innovation and traditional local knowledge.
A balanced diversity of sustainable systems must be encouraged which share the objectives of reasonable environmental management, conservation of land, water, air, plant, animal and energy resources, technical appropriateness, economic feasibility and social acceptability.
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WSC
World Seed Congress
WTO
World Trade Organization
WIPO
World Intellectual Property Organization
WFO
World Farmers Organization
VO
Vegetable and Ornamental Section (of ISF)
VCU
Value for Cultivation and Use (of UPOV)
UPOV
Union pour la Protection des Obtentions Végétales (International Union for the Protection of New Varieties of Plants)
UNCLOS
United Nations Convention on the Law of the Seas
UN
United Nations
TWV
Technical Working Group Vegetables (of UPOV)
TWO
Technical Working Group Ornamentals (of UPOV)
TWA
Technical Working Group Agricultural Crops (of UPOV)
TRIPS
Trade-related Aspects of Intellectual Property Rights
TC
technical committee (related to UPOV)
TAS
Tree and Shrub Group (of ISF)
TARC
Trade and Arbitration Rules Committee (of ISF)
Syn-Bio
Synthetic Biology
SMTA
Standard Material transfer Agreement (related to the ITPGRFA)
SBSTTA
Subsidiary Body on Scientific, Technical and Technological Advice (related to the CBD)
SB
Synthetic Biology
SAT-Com
Seed Applied Technologies Committee
SAC
Sustainable Agriculture Committee
SAA
Seed Association of the Americas
R&D
Research and Development
RSA
Regional Seed Association
RPLI
Regulated Pest List Initiative
PVP
Plant Variety Protection
PIC
Prior Inform Consent (related to the transfer of genetic resources)
Phyto Committee
Phytosanitary Committee (of ISF)
PGRFA
Plant Genetic Resources for Food and Agriculture
PBR
Plant Breeders Rights
PBI
Plant Breeding Innovation
OECD
Organisation for Economic Co-operation and Development
NSA
National Seed Association
NPPO
National Plant Protection Organization
NP
Nagoya Protocol
NGS
Next Generation Sequencing
MTA
material transfer agreement (related to the transfer of genetic resources)
MOP
Meeting of Parties (often related to the Nagoya Protocol of the CBD)
MLS
Multilateral System (related to the ITPGRFA)
MAT
Mutually Agreed Terms (related to the transfer of genetic resources)
LLP
Low Level Presence
IYPH
International Year of Plant Health
ITPGRFA
International Treaty on Plant Genetic Resources for Food and Agriculture
ISTA
International Seed Testing Association
ISPM
International Standard for Phytosanitary Measures
ISHI-Veg
International Seed Health Initiative for Vegetable Crops
IPR
Intellectual Property Rights
IPPC
International Plant Protection Convention (of FAO)
IPC
intellectual property Committee (of ISF)
IP
Identity Preserved
IP
Intellectual property
ILP
International Licensing Platform
IGTC
International Grain Trade Coalition
ICC
International Chamber of Commerce
IAFN
International Agri Food Network
GURT
Genetic Use Restriction Technologies
GRULAC
Group of Latin America and Caribbean Countries (United Nations regional group)
GRIT
Genetic Resources Information Tree (developed by ISF)
GRFA
Genetic Resources for Food and Agriculture
GR
genetic Resources
GMO
Genetically Modified Organism
GMBSM
Global Multilateral Benefit Sharing Mechanism (related to Nagoya Protocol)
GM
Genetically Modified
GB
Governing Body (often related to the ITPGRFA)
GE
Genetic Engineering
HTS
High Throughput Sequencing (also called NGS)
FTO
Freedom to Operate
FSS
Farm Saved Seeds
FRAND terms
Fair, Reasonable and Non Discriminatory
FR
Farmers’ Rights
FCS
Field Crop Section (of ISF)
FAO
Food and Agriculture Organization (of the United Nations)
EXN
Explanatory notes (related to UPOV Convention)
Euroseeds
European Seed Association (formerly ESA)
EPPO
European and Mediterranean Plant Protection Organization
EPO
European Patent Office
EDV
Essentially Derived Varieties (related to UPOV Convention)
EC
Executive Committee (of ISF)
EAF
Electronic Application Form (= PBR application tool from UPOV = PRISMA)
DUS
Distinctness Uniformity Stability (of a variety)
DSI
Digital Sequence Information
DNA
Deoxyribonucleic Acid
CPVO
Community Plant variety Office
COP
Conference of Parties (often related to the CBD)
CLI
Crop Life International
CGIAR
Consortium of International Agricultural Research Centers
CBD
Convention on biological Diversity
CAJ
Conseil Administratif et Juridique (Legal and Administrative Committee related to UPOV)
BOD
Board of Directors (of ISF)
BMT
Biochemical and Molecular Techniques (UPOV working group)
BE
Breeders exemption (related to UPOV Convention)
BC
Breeders Committee (of ISF)
APSA
Asian Pacific Seed Association
AFSTA
African Seed Trade Association
ABS CHM
Access and Benefit Sharing Clearing House Mechanism (website of the CBD)
ABS
Access and Benefit Sharing (related to genetic resources)
AHTEG
Ad Hoc Technical Expert Group