Variety protection and biopatents – Protecting industrial property rights promotes innovation FEBRUARY 2012KWS in DIALOGMODERN PLANT BREEDING – INFORMATION UPDATE FOR DECISION-MAKERS 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 legalDear Readers, protection, which must nevertheless not restrict the free use of the genetic resources of a variety into which the trait inthe public debate on the controversial subject of “patents question has been introduced. However, if this technicallyon life” is often a very emotional one. Unfortunately, that created trait can also be obtained by breeding, patentmeans that aspects concerning the protection of industrial coverage must not extend to the result of this breeding work.property rights in relation to plants, animals and peopleare often ignored – since they are so complex. We want to In the following information update, we provide a deeperremedy that here. This issue of KWS in Dialog is a not very insight into the interrelationships between variety protectionsimple, yet very exciting read that will give you a little better and biopatents.grasp of this topic. We look forward to a stimulating dialog with you.Modern plant breeding can make a valuable contributionto solving questions vital to our future. Some of the keytopics – which are not treated in any detail here – includesecuring food supplies, adaptation to climate change andthe need for renewable energy. Plant breeding is not an Dr. Léon Broersad-hoc business – it takes ten years or more of intensive Member of the Executive Board of KWS SAAT AGand costly research before new developments are ready for Research and Breeding, Energy Cropsthe market. Year after year, plant breeders like KWS spendup to 15 % of their net sales on breeding and research. Ofcourse, launching new research projects always involves anentrepreneurial risk. However, a company must be able torely on achieving a calculable return on the money it spendsif 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. Thebreeder’s exemption in the variety protection law of manycountries is an excellent means of ensuring that. In an opensource system, as it were, all varieties on the market canbe used without impediment by all companies for furtherbreeding so that something better can be made out of them.
KWS in DIALOGEffective protection of intellectual property in plant breeding –Two complementary legal systemsContinuously developing and improving varieties is vital to in nutrient uptake or certain resistances to disease cannotthe commercial success of a plant breeding company like be obtained solely by crossing and selection. That is wherethe more than 150-year-old KWS. Plant breeding is not a plant breeders resort to genetic engineering. At the EUshort-term, ad-hoc business. Plant breeding must look a level, the directive on the legal protection of biotechnologicallong way ahead and correctly assess what requirements will inventions (98/44/EC) has been in force since 1998.be demanded of agriculture in the future. That is becauseit takes ten years or more of intensive and costly research This European Biopatent Directive 98/44/EC, its interpre-before a new development reaches market maturity. The tation as regards the granting of patents and its imple-results of many years of investment in research and devel- mentation in national law have sparked an extensive debateopment – some 15% of net sales year after year – are the on biopatents. Under this directive, essentially biologicalplant breeder’s intellectual property and must be protected processes for the breeding of plants or animals are notby statutory regulations. At the same time, the free and patentable. Article 2.2 states that a breeding processunhindered access to genetic diversity is essential if breed- is essentially biological “if it consists entirely of naturalers are to innovate. phenomena such as crossing or selection.” What is meant by “entirely” in this connection has not yet been clarified.Two complementary legal systems Moreover, the interface between naturally and technologi-National and international variety protection guarantees cally created plant traits has not been taken into sufficientthe breeder the sole commercial right to use a plant variety account.that has demonstrably new properties. To ensure that breed-ers can continue using the best material, there is what is That has led to a situation where patents are increasinglytermed the breeder’s exemption in variety protection: Plant granted for genetic traits that are essentially natural andbreeders may also use the latest varieties of other breeding have been produced using conventional breeding methods.companies solely to further develop new varieties. That, in turn, could undermine variety protection and severe- ly restrict access to genetic diversity for further breeding.Patent law basically regulates protection of new technologi- An example from breeding practice will illustrate what varietycal inventions. Since the 1980s, high-tech methods have protection and patent protection specifically mean and alsoincreasingly been used in plant breeding alongside the con- present an approach to a solution in this debate.ventional methods of crossing and selection. In particular,properties such as dry weather tolerance, greater efficiency
Variety protection and biopatents – Protecting industrial property rights promotes innovationzüchtung Beispiel: Rizomania Resistenzzüchtung Conventional approach Genetic engineering approach Conven Identiﬁcation of a suitable Identiﬁcation and isolation Identint protection Patent protection resistance source of a suitable resistance gene rent protection Transfer of the gene Patent protection to the sugarbeet Crossing of the resistance source Crossing Crossing with elite line with the elite line wmania infestation Selection and trial with rhizomania infestation Selection and trial with rhizomania infestation Elite line Elite line with new resistance gene with new resistance gene withd, resistance, etc. Selection and testing for yield, resistance, etc. Selection and testing for yield, resistance, etc. New variety New variety Testing Testingrotection with Variety protection withs exemption breeder’s exemption Variety protection with Variety approval breeder’s exemption Variety approvalrotection Patent protectionew trait for the new trait KWS UK-LT/HO Example: Breeding of rhizomania resistance Example of breeding resistance to rhizomania Some viruses, like the rhizomania virus, can no longer multi- in sugarbeet ply in plants if certain harmless parts of the pathogens are Rhizomania, or root madness, is the name of a disease already in the plant cells. Resistance of plants to viruses can in sugarbeet which is caused by a virus (beet necrotic be improved by transferring genes that encode specific coat yellow vein virus, BNYVV) and is transmitted via a or transport proteins of the virus to plant cells. Both the fungus (Polymyxa betae) that lives in the soil. In breeding genetic construct and the method of transferring the gene resistance to rhizomania, KWS pursues two approaches – can be protected by patent. one conventional, the other using genetic engineering. After the gene has been transferred, tests are performed to In the conventional breeding approach, a resistance source determine whether the resistance gene is also present in the existing in wild beet was crossed into elite sugarbeet lines. sugarbeet and results in the desired resistance to the virus. The breeder then tests whether the resistance source has been integrated successfully in the elite line. This selection This is followed by the process familiar from conventional process also involves various biotechnological methods breeding, such as selection of the elite lines with the desired such as marker-assisted selection, which cannot be patent- presence of virus resistance, breeding of hybrid varieties ed under European patent law. The lines with rhizomania and approval of the varieties. The result is a new variety that resistance are then used in the further process of breeding has both variety protection and patent protection for the hybrid varieties. These hybrid varieties must subsequently new trait. undergo further, official testing before they are approved and are thus subject of variety protection. The breeder’s European patent law does not provide for a breeder’s exemp- exemption described above already applies in this regard: tion. There is a breeder’s exemption in German patent law, The variety can be used by other plant breeders to further but it is restricted in comparison with variety protection. A develop their own new varieties without a license. variety containing genetic information protected by patent may be used to breed a new variety. However, if the patent- In case conventional resistance to rhizomania were to break ed property is still contained in the newly bred variety, the down one day, KWS not only applies this conventional breed- patent holder must consent to its commercial use and can ing method, but also a genetic engineering approach. demand royalties for use of its patent.
Sortenschutz und Biopatente – Innovationen fördern durch gewerblichen RechtschutzKWS in DIALOG FEBRUARY 2012 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 andTo ensure that intellectual property is still protected effec- promote urgently needed innovations in plant breeding.tively and that plant breeders retain sufficient access to “Simple” demands like “no patents on life” do not do justicegenetic diversity, solutions must be found within the existing to this complex issue. Instead, it is worthwhile taking alegal framework. closer look at the matter, which admittedly is not simple, and discussing it in detail.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, Would you like to actively participate in this dialog? Then do so! Let’s discuss this together! Your contact: Dr. Henning von der Ohe Head of Corporate Development and Communications KWS SAAT AG | Grimsehlstraße 31 | P.O. Box 14 63 | 37555 Einbeck | Germany Telephone: +49 (0) 55 61 311-304 | Fax: +49 (0) 55 61 311-95 304 firstname.lastname@example.org | http://www.kws.com Picture credits: KWS Archives | fotolia