FEBRUARY 2012 KWS in DIALOG MODERN PLANT BREEDING – INFORMATION UPDATE FOR DECISION-MAKERS Dear Readers, Variety protection and biopatents – Protecting industrial property rights promotes innovation the public debate on the controversial subject of “patents on life” is often a very emotional one. Unfortunately, that means that aspects concerning the protection of industrial property rights in relation to plants, animals and people are often ignored – since they are so complex. We want to remedy that here. This issue of KWS in Dialog is a not very simple, yet very exciting read that will give you a little better grasp of this topic. Modern plant breeding can make a valuable contribution to solving questions vital to our future. Some of the key topics – which are not treated in any detail here – include securing food supplies, adaptation to climate change and the need for renewable energy. Plant breeding is not an ad-hoc business – it takes ten years or more of intensive and costly research before new developments are ready for the market. Year after year, plant breeders like KWS spend up to 15 % of their net sales on breeding and research. Of course, launching new research projects always involves an entrepreneurial risk. However, a company must be able to rely on achieving a calculable return on the money it spends if and when its work reaps success. And that is where vari- ety protection and patents play an important role. The free availability of genetic resources in existing plant vari- eties is and will remain a top priority for us as a breeder. The breeder’s exemption in the variety protection law of many countries is an excellent means of ensuring that. In an open source system, as it were, all varieties on the market can be used without impediment by all companies for further breeding so that something better can be made out of them. Our experience is that this drives innovation and further developments and so helps us address the above-mentioned questions vital to our future: better resistance, higher yield, improved quality, etc. That must not be called into question. Breeding processes based on crossing and selection (termed “essentially biological processes”) must be excluded from patentability. Extensive patent protection here would hinder progress. You have probably heard of the broccoli patent dispute. This is where things get more complicated. To put it simply, the burning question is: In what cases can patents be granted? We believe patents can be justified only if a new trait for a plant is developed using special technical methods, i.e. not “essentially biological processes.” Since that requires considerable cost and effort, the results need special legal protection, which must nevertheless not restrict the free use of the genetic resources of a variety into which the trait in question has been introduced. However, if this technically created trait can also be obtained by breeding, patent coverage must not extend to the result of this breeding work. In the following information update, we provide a deeper insight into the interrelationships between variety protection and biopatents. We look forward to a stimulating dialog with you. Dr. Léon Broers Member of the Executive Board of KWS SAAT AG Research and Breeding, Energy Crops
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FEBRUARY 2012
KWS in DIALOGMODERN PLANT BREEDING – INFORMATION UPDATE FOR DECISION-MAKERS
Dear Readers,
Variety protection and biopatents – Protecting industrial property rights promotes innovation
the public debate on the controversial subject of “patents on life” is often a very emotional one. Unfortunately, that means that aspects concerning the protection of industrial property rights in relation to plants, animals and people are often ignored – since they are so complex. We want to remedy that here. This issue of KWS in Dialog is a not very simple, yet very exciting read that will give you a little better grasp of this topic.
Modern plant breeding can make a valuable contribution to solving questions vital to our future. Some of the key topics – which are not treated in any detail here – include securing food supplies, adaptation to climate change and the need for renewable energy. Plant breeding is not an ad-hoc business – it takes ten years or more of intensive and costly research before new developments are ready for the market. Year after year, plant breeders like KWS spend up to 15 % of their net sales on breeding and research. Of course, launching new research projects always involves an entrepreneurial risk. However, a company must be able to rely on achieving a calculable return on the money it spends if and when its work reaps success. And that is where vari-ety protection and patents play an important role.
The free availability of genetic resources in existing plant vari-eties is and will remain a top priority for us as a breeder. The breeder’s exemption in the variety protection law of many countries is an excellent means of ensuring that. In an open source system, as it were, all varieties on the market can be used without impediment by all companies for further breeding so that something better can be made out of them.
Our experience is that this drives innovation and further developments and so helps us address the above-mentioned questions vital to our future: better resistance, higher yield, improved quality, etc. That must not be called into question. Breeding processes based on crossing and selection (termed “essentially biological processes”) must be excluded from patentability. Extensive patent protection here would hinder progress.
You have probably heard of the broccoli patent dispute. This is where things get more complicated. To put it simply, the burning question is: In what cases can patents be granted? We believe patents can be justified only if a new trait fora plant is developed using special technical methods, i.e. not “essentially biological processes.” Since that requires considerable cost and effort, the results need special legal protection, which must nevertheless not restrict the free use of the genetic resources of a variety into which the trait in question has been introduced. However, if this technically created trait can also be obtained by breeding, patent coverage must not extend to the result of this breeding work.
In the following information update, we provide a deeper insight into the interrelationships between variety protection and biopatents.
We look forward to a stimulating dialog with you.
Dr. Léon BroersMember of the Executive Board of KWS SAAT AGResearch and Breeding, Energy Crops
Effective protection of intellectual property in plant breeding –Two complementary legal systems
Continuously developing and improving varieties is vital to the commercial success of a plant breeding company like the more than 150-year-old KWS. Plant breeding is not a short-term, ad-hoc business. Plant breeding must look a long way ahead and correctly assess what requirements will be demanded of agriculture in the future. That is because it takes ten years or more of intensive and costly research before a new development reaches market maturity. The results of many years of investment in research and devel-opment – some 15% of net sales year after year – are the plant breeder’s intellectual property and must be protected by statutory regulations. At the same time, the free and unhindered access to genetic diversity is essential if breed-ers are to innovate.
Two complementary legal systemsNational and international variety protection guarantees the breeder the sole commercial right to use a plant variety that has demonstrably new properties. To ensure that breed-ers can continue using the best material, there is what is termed the breeder’s exemption in variety protection: Plant breeders may also use the latest varieties of other breeding companies solely to further develop new varieties.
Patent law basically regulates protection of new technologi-cal inventions. Since the 1980s, high-tech methods have increasingly been used in plant breeding alongside the con-ventional methods of crossing and selection. In particular, properties such as dry weather tolerance, greater efficiency
in nutrient uptake or certain resistances to disease cannot be obtained solely by crossing and selection. That is where plant breeders resort to genetic engineering. At the EU level, the directive on the legal protection of biotechnological inventions (98/44/EC) has been in force since 1998.
This European Biopatent Directive 98/44/EC, its interpre-tation as regards the granting of patents and its imple-mentation in national law have sparked an extensive debate on biopatents. Under this directive, essentially biological processes for the breeding of plants or animals are not patentable. Article 2.2 states that a breeding process is essentially biological “if it consists entirely of natural phenomena such as crossing or selection.” What is meant by “entirely” in this connection has not yet been clarified. Moreover, the interface between naturally and technologi-cally created plant traits has not been taken into sufficient account.
That has led to a situation where patents are increasingly granted for genetic traits that are essentially natural and have been produced using conventional breeding methods. That, in turn, could undermine variety protection and severe-ly restrict access to genetic diversity for further breeding. An example from breeding practice will illustrate what variety protection and patent protection specifically mean and also present an approach to a solution in this debate.
KWS in DIALOG
Example of breeding resistance to rhizomania in sugarbeetRhizomania, or root madness, is the name of a disease in sugarbeet which is caused by a virus (beet necrotic yellow vein virus, BNYVV) and is transmitted via a fungus (Polymyxa betae) that lives in the soil. In breeding resistance to rhizomania, KWS pursues two approaches – one conventional, the other using genetic engineering.
In the conventional breeding approach, a resistance source existing in wild beet was crossed into elite sugarbeet lines. The breeder then tests whether the resistance source has been integrated successfully in the elite line. This selection process also involves various biotechnological methods such as marker-assisted selection, which cannot be patent-ed under European patent law. The lines with rhizomania resistance are then used in the further process of breeding hybrid varieties. These hybrid varieties must subsequently undergo further, official testing before they are approved and are thus subject of variety protection. The breeder’s exemption described above already applies in this regard: The variety can be used by other plant breeders to further develop their own new varieties without a license.
In case conventional resistance to rhizomania were to break down one day, KWS not only applies this conventional breed-ing method, but also a genetic engineering approach.
Some viruses, like the rhizomania virus, can no longer multi-ply in plants if certain harmless parts of the pathogens are already in the plant cells. Resistance of plants to viruses can be improved by transferring genes that encode specific coat or transport proteins of the virus to plant cells. Both the genetic construct and the method of transferring the gene can be protected by patent.
After the gene has been transferred, tests are performed to determine whether the resistance gene is also present in the sugarbeet and results in the desired resistance to the virus.
This is followed by the process familiar from conventional breeding, such as selection of the elite lines with the desired presence of virus resistance, breeding of hybrid varieties and approval of the varieties. The result is a new variety that has both variety protection and patent protection for the new trait.
European patent law does not provide for a breeder’s exemp-tion. There is a breeder’s exemption in German patent law, but it is restricted in comparison with variety protection. A variety containing genetic information protected by patent may be used to breed a new variety. However, if the patent-ed property is still contained in the newly bred variety, the patent holder must consent to its commercial use and can demand royalties for use of its patent.
KWS UK-LT/HO
Beispiel: Rizomania Resistenzzüchtung
Genetic engineering approach
Identification and isolation of a suitable resistance gene
Transfer of the gene to the sugarbeet
Patent protection
Patent protection
New variety
Testing
Variety approval
Elite line with new resistance gene
Selection and trial with rhizomania infestation
Selection and testing for yield, resistance, etc.
Crossing with elite line
Variety protection with breeder’s exemption
Patent protection for the new trait
Conventional approach
Identification of a suitable resistance source
New variety
Testing
Variety approval
Elite line with new resistance gene
Selection and trial with rhizomania infestation
Selection and testing for yield, resistance, etc.
Crossing of the resistance source with the elite line
Variety protection with breeder’s exemption
Variety protection and biopatents – Protecting industrial property rights promotes innovation
KWS UK-LT/HO
Beispiel: Rizomania Resistenzzüchtung
Genetic engineering approach
Identification and isolation of a suitable resistance gene
Transfer of the gene to the sugarbeet
Patent protection
Patent protection
New variety
Testing
Variety approval
Elite line with new resistance gene
Selection and trial with rhizomania infestation
Selection and testing for yield, resistance, etc.
Crossing with elite line
Variety protection with breeder’s exemption
Patent protection for the new trait
Conventional approach
Identification of a suitable resistance source
New variety
Testing
Variety approval
Elite line with new resistance gene
Selection and trial with rhizomania infestation
Selection and testing for yield, resistance, etc.
Crossing of the resistance source with the elite line
Variety protection with breeder’s exemption
Example: Breeding of rhizomania resistance
Sortenschutz und Biopatente – Innovationen fördern durch gewerblichen Rechtschutz FEBRUARY 2012
Would you like to actively participate in this dialog?Then do so! Let’s discuss this together!
Your contact:
Dr. Henning von der OheHead of Corporate Development and Communications
To ensure that intellectual property is still protected effec-tively and that plant breeders retain sufficient access to genetic diversity, solutions must be found within the existing legal framework.
This is possible, and KWS has a clear stance on this issue:
• Existing variety protection safeguards a quantifiable return for plant breeders from their new products. However, we greatly value the fact that newly approved,
commercial varieties can then immediately be used by all other companies for further breeding (breeder’s exemp- tion) – in principle in an open-source system. That drives the progress in breeding that we need in order to make our contribution towards those burning questions, vital to our future.
• Genetic diversity within one species is not enough to develop specific traits. Conventional plant breeding cannot offer any solutions here. The desired objectives must be achieved by other methods, such as green biotechnology. This technology enables genes to be transferred from another species. Such specific traits developed by means of green biotechnology need to be protected by patent. That is the only way of ensuring a viable return on the high costs entailed by this technology.
• In modern plant breeding, biotechnological methods are increasingly used to transfer genes from the same species in order to develop specific traits. In this case, we advocate patent protection only for traits not devel- oped using a conventional plant breeding method. It is imperative that the genetic diversity of these plants remains freely available in accordance with the provisions on variety protection.
Combined in this way, variety protection and patenting offer effective protection of industrial property rights and promote urgently needed innovations in plant breeding. “Simple” demands like “no patents on life” do not do justice to this complex issue. Instead, it is worthwhile taking a closer look at the matter, which admittedly is not simple, and discussing it in detail.
