What we do is so diverse that we decided to use these Frequently Asked Questions to explain some of the concepts involved in 'Our Work'.
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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:
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.
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.
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:
- clearly distinguishable from any other variety whose existence is a matter of common knowledge
- sufficiently uniform in its relevant characteristics, and
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
- 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