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Contribution of ECVC to the debate on Patents on plant and animal materials in the EU

21 October 2016

Contribution of the European Coordination Via Campesina (ECVC)[1] to the debate on Patents on plant and animal materials in the EU   September 2016   PDF     IN ORDER TO STOP THE THEFT OF AGRICULTURAL BIODIVERSITY  PATENTS ON NATIVE TRAITS SHOULD BE BANNED   The Directive 98/44/EC on the legal protection of biotechnological inventions[2] promised to ban the patenting of plants and animals from traditional breedings. Essential for food security, these plants and animals must remain freely available to all: this promise has never been fulfilled.   Since 98 it was already bypassed by the Directive 98/44 itself, which allows patents on GMOs that contaminate fields and seeds of farmers or traditional breedings. In areas of Spain where GMO maize is grown, contamination has forced farmers to abandon their local varieties. Fortunately, the opposition of the European population has prevented the development of transgenic crops in most other European countries. But, in North America, for example, the spread of GMO crops allowed the patented seeds to take up over 90% of major industrial crops  (corn, soy, rapeseed, cotton, beetroots…) within 30 years. These patents have also caused an extreme concentration of the seed industry in the hands of a few very large multinational companies with the biggest technological tools and the most powerful business law firms.   HOW PATENTS SEIZE PLANTS AND ANIMALS   Following the Directive 98/44's ban of patents on plant varieties, animal breeds and essentially biological processes[3] one could believe that the patent remained used solely for GMOs, grown very little in Europe. It thus gave way to the PVPC[4], presented as much more ethical because it guarantees breeders free access to the varieties of their competitors. The industry was, however, careful to preserve a legal area to circumvent the ban on patenting plants and animals from traditional breedings. It developed these new accesses as soon as the two Directives – 98/44 and 2001/18 patent on GMOs – were approved.   1) The patent on genetic information. This patent does not protect a technique, a process, a biological material or any product, but a series of plants or animals very different from each other, that cannot be reduced to a single plant variety or one animal species. All might contain one similar genetic information and express a hereditary character or function associated with this specific genetic information (resistance to an insect or herbicide, precocity, nutritional quality, taste...). To meet the requirement of innovation imposed by the patent's laws, it is necessary that the industrial exploitation of this characteristic (for the cultivation, processing, trade...) is not yet known. The most common way to write a patent to meet this requirement is to describe the existence of the patented characteristic in non-cultivated wild plants and its interest in the industrial exploitation of crops where it was not known prior to filing of the patent application. The method used to incorporate is not of  importance because it is not part of the patent claims,just of the invention's description. As recalled by the European Patent Office (EPO) in March 2015 in its decision on patents on broccoli cabbage and wrinkled tomato, the non-patentability of essentially biological processes for the production of plants or animals containing such genetic information does not prohibit the patenting of products derived therefrom. Even if such a characteristic is already present in crops or livestock, since its industrial exploitation is not documented. Hence, the expression often used by patents for traits or “native” genes.   2) Hidden GMOs. GMO directives (90/220 and 2001/18) exclude the products issued by two techniques of modern biotechnology from their scope: mutagenesis and cell fusion. It can be difficult to distinguish between the selection of spontaneous mutants, which is an essentially biological process, and the mutagenesis induced in vivo on the whole plant, which is considered a patentable technical process by some authors and an essentially biological method by others.  Developed in vitro, mutagenesis and cell fusion are microbiological processes and therefore undoubtedly patentable as long as the invention is not limited to a single variety. The first plants patented this way are now widely cultivated in Europe. Those are mostly herbicide tolerant rapeseed and sunflower. But there are also wheat, corn, lettuces, etc. These patents go unnoticed because information on industrial property rights is not required when selling seeds that are not supposed to be labeled GMO either. In Europe, no farmer has been prosecuted yet for infringement for using farm saved seeds for plants protected by such patent: either because they are F1 hybrids which are not used to obtain farm saved seeds in Europe, or because the royalties are paid, in accordance with Directive 98/44, to the breeder of the PVPC who has already paid the license fee due to the patent holder.   Like patents on transgenic GMOs, these patents on hidden GMOs allow the appropriation of native seeds or seeds from essentially biological processes through contamination in the field or in the food chain. They can also allow direct patenting of biological materials and native or genetic information already present in varieties of traditional breeders. According to researchers who write patents, mutagenesis is a technique that allows to obtain faster  what could be obtained by crossing and selection. It would only accelerate the occurrence of natural mutations: therefore, biological materials and genetic information allowed to be patented would not differ from genetic information that may exist naturally or may be obtained exclusively through essentially biological processes. This seems plausible if we are satisfied with descriptions available in patents and research funded by industry. These descriptions only focus on the indication of claimed mutated genetic information, and on some genetic markers, or even on the sole indication of a new hereditary phenotypic trait. This lack of distinction is not applicable when we analyze the entire plant, which suffered multiple unintended mutations: in reality, mutagenesis amplifies and multiplies mutagenic stresses and their impact on the genome far beyond all that can occur naturally. But the patent does not cover the whole plant, therefore allowing other unintentional genetic modifications to be ignored. This lack of information, which would be needed in order to establish a distinction, allows the extention of the patent protection to any plant or animal material that contains a biological or genetic information similar to those patented, and which has properties or expresses the function claimed by the patent[5] It prevents in fact the alleged infringer from proving that its biological material is not issued by the reproduction of the patented invention since the description provided by the patent does not allow to make this distinction.   With the marker-assisted selection (MAS), mutagenesis is now a cheaper technique, and as effective as transgenesis. The new techniques of genetic modification (New Breeding Technique) are even simpler and especially more targeted. They allow to select the location of the genome that we want to modify. They do not eliminate other unintended changes, but those are always ignored in patent applications. If the products of these new techniques are still regulated as GMOs, the traceability requirement will force patent holders to indicate what distinguishes plants and animals issued by their inventions, or their reproduction, from other plants or animals already existent, or those that can exist without any use of the patented invention. If, on the contrary, these techniques are excluded from the application of the GMO regulation, they will allow, as for mutagenesis, patenting of biological materials or genetic information described in a way that does not distinguish the plants and animals issued directly by the claimed invention from plants or animals issued by essentially biological processes. Nothing would then prevent to extend the protection of such patents to all native genetic information essential for crop production.       FALSE SOLUTIONS   The research exception   This new way of patenting genes and "native" traits has raised numerous protest. In response, France, Germany and the Netherlands first introduced the research exception in their national laws. This exception prevents total blockage of research by authorizing free use of a genetic resource, of which we often do not know if it contains any patented biological material or patented genetic information. But if the researcher wants then to market the new seeds he*she has selected, he*she must first extract the biological material or genetic information patented from it, or negotiate a license fee. As for the farmer selling his crop, he*she does not possess the needed technology to extract the biological material or patented genetic information. According to the law, he*she is committing a commercial exploitation of the patented invention: he*she finds him*herself – often unknowingly – an infringer and could be threatened with seizure of his crop.   For the industry, the research exception also has the advantage that it allows the extension of the protection of these patents to seeds obtained from collections of the multilateral trading system of the ITPGRFA[6].. This indeed denies its beneficiaries access to the resources protected by intellectual property rights, by restricting access for research or selection. The research exception respects this obligation, but allows the patent to limit access to resources for crop production and market.   Required non-exclusive licenses and patent clubs   The 98/44 EU directive allows States to grant themselves a license right when it is refused by the patent holder. But the necessary conditions to benefit from such a compulsory license are such that this mechanism is not used. This is why some breeders wish that such licenses should be granted simply on request. But then a price too high could still constitute a hidden refusal to sell. To address this threat, an "independent" arbitration mechanism is offered to set the price in case of persistent disagreement. The research exception and compulsory licenses are indeed useful for a little more sustainable use of patents on the living, for the benefit of the industry, but ineffective to eliminate injustices that those patents generate at the expense of farmers.   The non-patentability of plants and animals issued by essentially biological processes Germany, the Netherlands and most recently France have also prohibited the patentability of "plants and animals exclusively obtained by essentially biological processes" in their national laws and wish to extend this ban to the European level. Unfortunately, this only solution will remain ineffective to face the majority of European patents on native traits. As a matter of fact, the claims of most of these patents do not relate to plants or animals or to the process for obtaining them, but on biological materials or genetic information, regardless of their method of production. The official depository of seeds, which some patents refer to, changes nothing, since the claims do not cover the plant as a whole, directly issued by the registered seeds, but only to any genetic information similar to that contained in registered seeds. This way of writing patents does not prevent the extension of their protection to any plant or animal that contains these patented biological materials or genetic information, and which express the characteristics or the claimed function[7]. These plants and animals are all different from each other, by all their genetic or phenotypic characteristics that are not directly related to the claimed biological or genetic information materials.   Of course, the protection of a patent on biological material extends only to "biological material derived from that biological material (which is patented) by reproduction or multiplication in an identical or different form and possessing those same properties.” But the alleged infringer, who would be prosecuted for having reproduced or sold vegetable or animal products, containing - naturally or exclusively by essentially biological processes -  biological material or genetic information similar to those patented, without a license, will not be able to cope with these lawsuits. If the patent is written in such a way that nothing can distinguish the patented characteristics from native characteristics of the plants or animals he*she used, then he*she will be sentenced   PROPOSAL OF ECVC REGARDING THE PATENT   The most simple solution would certainly be to ban all patents on living organisms. But pressure from the pharmaceutical industry is such that today, the European Parliament does not yet seem  ready to give up the patentability of biotechnological inventions. The rejection of the patentability of genes or "native" characteristics of plants and animals is, on the contrary, widely shared. It is therefore essential to now change European law to prohibit these patents which are recently increasing, thanks to the new possibilities offered by recent developments of modern biotechnology, and thanks to the shortcomings of the Directive adopted before these biotechnologies have developed. It is therefore suitable to:   1) – apply GMO regulation to "any living organism that possesses a novel combination of genetic material obtained through the (...) application of In vitro techniques in nucleic acids" and  products derived there from[8]. On a solely legal perspective, the EU must update the GMO regulation it adopted in 2001 to introduce the definition of the Cartagena Protocol which it ratified in 2003[9].  The Protocol excludes only cell fusion between sexually compatible organisms from its scope, but not the mutagenesis. The mutagenesis in vivo, meaning in the field, is not affected by the Protocol, but is not subject of patents either. Mutagenesis in vitro is, according to the Protocol,  a technique of production of GMOs. It is also claimed in the numerous patents on "native" traits. The new techniques of genetic modification all include at least one step in vitro. GMO regulation should therefore apply to the products of these techniques. It makes the indication of genetic identifiers or other tracking methods compulsory for distinguishing the modified products from any other product. This requirement makes it possible to distinguish the products issued from the patented invention from those which are not, and stop the abusive extension of the protection of numerous patents for "native" traits.   2) – to invalidate the patent protection for the adventitious presence of patented genetic information into a seed, livestock or products issued from it, in order to prevent the appropriation of plants or animals through contamination of patented genes[10].   3) – within the Article 4 of Directive 98/44, there is a need to expand the definition that consider patentable products exclusively the ones obtained by essentially biological processes, also to the elements which form these products and the genetic information that they contain.   4) – to complete the Article 8 of Directive 98/44 in order to prohibit the extension of patent protection on a biological material to biological material obtained exclusively by essentially biological processes[11].  To deal with malicious prosecution for infringement of a patent relating to biological material, it is therefore sufficient to show that the alleged infringing product was obtained exclusively by essentially biological processes. Such a demonstration is simple, so that, without this prohibition, the alleged infringer should demonstrate that he*she did not use the patented invention, which is impossible if the information given in the patent does not distinguish biological patented material from similar "native" biological material. And if the patent holder maintains his*her pursuit on behalf of the use by the alleged infringer of the patented invention, composed of this biological material, he*she must provide evidence him*herself, that its patent protects a component of a plant or an animal obtained exclusively by essentially biological processes and it would be therefore not in conformity with Article 4 of the modified Directive -  as proposed in 3) above -. He*she will then keep his*her patent only if he/she indicates what distinguishes his*her invention from any “native“ biological material.   5) - complete the Article 9 of Directive 98/44 in order that the protection conferred by a patent on a product containing genetic information or consisting of genetic information, does not extend to biological material obtained exclusively by processes essentially biological, or to products of such biological materials. In order to deal with malicious prosecution for infringement of a patent relating to genetic information, it is therefore sufficient to show that the alleged infringing product was obtained exclusively by essentially biological processes. Such demonstration is simple, while in the absence of the ban, the alleged infringer should demonstrate that he*she did not use the patented invention, which is impossible if the information given in the patent does not distinguish the patented genetic information from similar native genetic information. And if the patent holder maintains his*her pursuit on behalf of the use by the alleged infringer of the patented invention made by this*her genetic information, he*she must provide evidence him*herself that its patent covers a genetic information contained in a plant or an animal obtained exclusively by essentially biological processes and is therefore not in conformity with Article 4 of Directive - modified as proposed in 3) above -.  He*she will then keep his*her patent only if he*she indicates what distinguishes his*her invention from any native genetic information.   Picture credit: GRAIN ---------------- [1]  The European Coordination Via Campesina is a European grassroots organization which currently gathers 28 national and regional farmers, farm workers and rural organizations based in 18 European countries. Rooted on the right to Food Sovereignty, our main objective is the defence of farmers’ and field workers’ rights as well as the promotion of diverse and sustainable family and peasant farming. These principles in turn, demand food and agricultural policies based on legitimacy, fairness, solidarity and sustainability. These are necessary to ensure food security, food safety, public health, employment in rural areas and to tackle the issues of the global food crisis and climate change. We demand the development of a new and improved EU agricultural policy based on the above principles. [2]  The words in italics are the words used in their sense of their legal definition, especially directive 98/44/EC: http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1473413070747&uri=CELEX:31998L0044 [3] Art. 2.2 of the Derective 98/44; «A process for the production of plants or animals is essentially biological if it consists entirely of natural phenomena such as crossing or selection.» [4] PVPC: Plant Variety Protection Certificate [5]  Art. 8.1 of Directive 98/44: “The protection conferred by a patent on a biological material possessing, due to the invention of specific properties extends to any biological material derived from that biological material through propagation or multiplication in an identical or divergent form and possessing those same characteristics. " Art. 9: "The protection conferred by a patent on a product containing genetic information or consisting of genetic information shall extend to all material, subject to Article 5, paragraph 1, in which the product is incorporated and in which the genetic information is contained and performs its function.” [6] International Treaty on Plant Genetic Resources for Food and Agriculture [7] Art. 8 of Directive 98/44:"1. The protection conferred by a patent on a biological material possessing, due to the invention of specific properties extends to any biological material derived from that biological material through propagation or multiplication in an identical or divergent form and endowed with these same properties. (...) Art. 9: “The protection conferred by a patent on a product containing genetic information or consisting of genetic information shall extend to all material, subject to Article 5, paragraph 1, in which the product is incorporated and in which the genetic information is contained and performs its function. " [8] Art 3 of the Protocol: http://www.un.org/french/millenaire/law/cartagena.htm [9] The Protocol imposes minimum in the European Union to apply this definition to information must accompany all imports of seeds, breeding stock or other reproductive material of plants and animals on its territory and any export to countries Parties to the Protocol. [10] The French Parliament has incorporated this restriction in Article 2014 of the Rural Code L613-2-2 "the protection conferred by a patent on a product containing genetic information or consisting of genetic information (...) does not apply not for adventitious or accidental presence of genetic information into a patented seeds, plant propagating material, seedlings, plants or plant parts." [11] The French Parliament introduced in 2016 in Article L. 613-2-3 of the Intellectual Property Code a new paragraph: "The protection conferred by a patent on a biological material possessing, due to the invention of certain properties do not extend to biological materials with these specific properties, obtained independently of the patented biological material and essentially biological process or biological materials obtained from the latter, through propagation or multiplication.“  

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