24 - Innovating Food, Innovating the Law - Sven Bostyn

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SVEN BOSTYN (University of Liverpool, United Kingdom) Challenges and opportunities in patenting agro-food: recent developments Innovating Food, Innovating the Law. Conference. Universit Cattolica del Sacro Cuore Piacenza, October 14-15, 2011 Video: http://vimeo.com/31476780

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<ul><li> 1. The unbearable complications of patenting agro food products Innovating Food, Innovating the Law, Conference, Piacenza,14-15 October 2011 Dr. Sven J.R. Bostyn, LL.M www.liv.ac.uk/laws.bostyn@liv.ac.uk</li></ul><p> 2. Il men di oggi a Piacenza 3. 4. Patents for plants: relevant provisions </p> <ul><li>Art. 53(b) EPC: [ European patents shall not be granted in respect of:] (b)plant or animal varieties or essentially biological processes for the production of plants or animals; this provision does not apply to microbiological processes or the products thereof.</li></ul><ul><li>Rule 23(b) (5) EPC (Rule 26(5) EPC 2000):A process for the production of plants or animals is essentially biologicalif it consists entirely of natural phenomena such as crossing or selection .</li></ul><p> 5. Plant variety: definition UPOV 1991 </p> <ul><li><ul><li> variety shall be taken to mean 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 plant variety right are fully met, can be:</li></ul></li></ul><ul><li><ul><li><ul><li>- defined by the expression of the characteristics that result from a given genotype or combination of genotypes,</li></ul></li></ul></li></ul><ul><li><ul><li><ul><li>-distinguished from any other plant grouping by the expression of at least one of the said characteristics and</li></ul></li></ul></li></ul><ul><li><ul><li><ul><li>- considered as a unit with regard to its suitability for being propagated unchanged. </li></ul></li></ul></li></ul><p> 6. Taxonomy </p> <ul><li>+Hierarchy of taxonomic classes (hierarchy is given starting from the highest ranking and descending to the lowest ranking):</li></ul><ul><li>regnum (kingdom),</li></ul><ul><li>phylum (division),</li></ul><ul><li>classis (class),</li></ul><ul><li>ordo (order),</li></ul><ul><li>familia (family),</li></ul><ul><li>genus,</li></ul><ul><li>species,</li></ul><ul><li>[varietas (variety)].</li></ul><ul><li>Taxonomy based on the International Code of botanical nomenclature (Tokyo Code), adopted by the 15th International Botanical Congress, Aug. - Sept. 1993. </li></ul><p> 7. 8. Legislative history Art. 53(b) EPC </p> <ul><li>Is based on Art. 2(b) Strasbourg Patent Convention (SPC): </li></ul><ul><li><ul><li>"the Contracting States shall not be bound to provide for the grant of patents in respect of plant varieties </li></ul></li></ul><ul><li>UPOV member States were allowed under Article 2(1) UPOV Convention 1961 to recognise the right of the breeder by the grant of either a special plant breeders' right or of a patent; however, simultaneous protection for the same botanical genus or species was not allowed (no double protection, no longer present in UPOV 1991 version) </li></ul><ul><li>In several countries, patent protection was available for plant varieties, at least for those for which no protection was provided under plant variety right legislation (UPOV 1961 did not oblige its member States to protect varieties belonging to all botanical genera and species but provided in its Article 4 for the progressive application of its provisions) </li></ul><p> 9. Legislative history Art. 53(b) EPC </p> <ul><li>In summary, it is clear from Article 2(b) SPC and its implementation by some of its Contracting States that this provision was not based on the concept that there should be no patent protection for plant varieties. Rather, it was intended to ensure that Contracting States should not be bound to grant patents for subject-matter for which patents were excluded under the ban on dual protection in the UPOV Convention 1961.</li></ul><ul><li>This leaves open the question whether the purpose of Article 53(b) EPC differs from the corresponding SPC provision. </li></ul><p> 10. Legislative history Art. 53(b) EPC </p> <ul><li>It was not appropriate for the legislator to allow the grant of patents for plant varieties in general because some EPC Contracting States offered plant variety protection under the UPOV-System and were prevented under the ban on dual protection from granting patents. Nor was it possible under the EPC to exclude patent protection only in respect of those varieties for which a plant breeders' right was available. Plant breeders rights at a European level were not available and at the national level the availability of plant breeders rights differed from country to country. </li></ul><ul><li>To take account of the specific situation in each designated State for each individual application would have been contrary to the principle of uniform patent protection in all Contracting States (cf Article 118 EPC). </li></ul><ul><li>For these reasons, the most obvious choice was to make full use of the possibility in Article 2(b) SPC to exclude the grant of patents in respect of plant varieties entirely. </li></ul><p> 11. Legislative history Art. 53(b) EPC </p> <ul><li>This historical background shows at least an intention to protect by the plant breeders' rights system biological developments for which the patent system was less suited and to keep technical inventions related to plants within the patent system. </li></ul><ul><li>There is nothing in the travaux prparatoires to suggest that Article 53(b) EPC could or even should exclude subject-matter for which no protection under a plant breeders rights' system was available. </li></ul><p> 12. 13. Patents for plants </p> <ul><li>The invention which is the subject matter of a patent will in the real world always be embodied in a plant variety, as the only tangible object is a plant variety, a plant being a mere abstract concept </li></ul><ul><li>The invention which is the subject matter of a patent is not confined to a plant variety, but will be a technology of general applicability, for instance herbicide resistance: the gene causing the resistance will be patented, and any plant containing such gene will be claimed </li></ul><ul><li><ul><li>The examples in the patent application will show the application of the generic technology to some real life plant varieties </li></ul></li></ul><ul><li><ul><li>A plant defined by single recombinant DNA sequences is not an individual plant grouping to which an entire constitution can be attributed (G 1/98) </li></ul></li></ul><ul><li><ul><li>It is not a concrete living being or grouping of concrete living beings but an abstract and open definition embracing an indefinite number of individual entities defined by a part of its genotype or by a property bestowed on it by that part (G 1/98). </li></ul></li></ul><ul><li><ul><li>The taxonomic category within the traditional classification of the plant kingdom to which the claimed plants belong is not specified, let alone the further characteristics necessary to assess the homogeneity and stability of varieties within a given species (G 1/98). </li></ul></li></ul><ul><li>The invention does as such not create a new plant variety </li></ul><p> 14. Patents for plants </p> <ul><li>This also means that it does not define a multiplicity of varieties which necessarily consists of several individual varieties. In the absence of the identification of specific varieties in the product claims, the subject-matter of the claimed invention is neither limited nor even directed to a variety or varieties (G 1/98). </li></ul><ul><li>Whereas in the case of a plant variety, the breeder has to develop a plant grouping fulfilling in particular the requirements of homogeneity and stability, this is not the case with a typical genetic engineering invention in a claim such as that referred to earlier. The inventor in the latter case aims at providing tools whereby a desired property can be bestowed on plants by inserting a gene into the genome of those plants (G 1/98). </li></ul><p> 15. G 1/98 </p> <ul><li>Question 2: plants embracing plant varieties </li></ul><ul><li> Clearly, it is not the wording but the substance of a claim which is decisive in assessing the subject-matter to which the claim is directed. However, it does not follow that the subject-matter of a claim may be equated with the scope of a claim. In assessing the subject-matter of a claim, the underlying invention has to be identified. In this respect, it is relevant how generic or specific the claimed invention is [] If he has made an invention of general applicability, a generic claim is not the consequence of the verbal skill of the attorney, as the referring decision seems to suggest [], but of the breadth of application of the invention.</li></ul><ul><li> The invention at stake refers to an invention which can be applied by modifying plants which may or may not be plant varieties. The invention is not limited to plant varieties, even though it is admitted that one of the main applications is plant varieties.But the result of the modification by genetic transformation is not necessarily a plant variety.</li></ul><p> 16. G1/98 contd. </p> <ul><li>What is important for a plant variety is the expression of the characteristics that results from a given genotype or combination of genotypes. This implies in turn a reference to the entire constitution of a plant or a set of genetic information.</li></ul><ul><li>And the EBA continues: In contrast, a plant defined by single recombinant DNA sequences is not an individual plant grouping to which an entire constitution can be attributed. Such an invention is not a concrete living being or grouping of concrete living beings but an abstract and open definition embracing an indefinite number of individual entities defined by a part of its genotype or by a property bestowed on it by that part. </li></ul><p> 17. G1/98 contd. </p> <ul><li> In summary, according to Article 53(b) EPC, a patent is "in respect of plant varieties" and shall not be granted if the claimed subject-matter is directed to plant varieties. In the absence of the identification of a specific plant variety in a product claim, the subject-matter of the claimed invention is not directed to a plant variety or varieties within the meaning of Article 53(b) EPC. This is why it is, contrary to the conclusions of the referring Board, in agreement with the rules of logic that a patent shall not be granted for a single plant variety but can be granted if varieties may fall within the scope of its claims. The conclusion of the referring Board is based on the premise that a claim is necessarily "in respect of" a certain subject if it may comprise this subject. </li></ul><p> 18. 19. Essentially biological processes- Relevant provisions </p> <ul><li>Art. 53(b) EPC: [ European patents shall not be granted in respect of:] (b)plant or animal varieties or essentially biological processes for the production of plants or animals; this provision does not apply to microbiological processes or the products thereof.</li></ul><ul><li>Rule 23(b) (5) EPC1973 (Rule 26(5) EPC 2000): A process for the production of plants or animals is essentially biologicalif it consists entirely of natural phenomena such as crossing or selection .</li></ul><p> 20. G 2/07: Essentially biological processes for the production of plants </p> <ul><li>T 0083/05, EP 1069819 </li></ul><ul><li>Claim 1 main request oral proceedings TBA: </li></ul><ul><li><ul><li> A method for the production of Brassica oleracea with elevated levels of 4-methylsulfinylbutyl glucosinolates, or 3methylsulfinylpropyl glucosinolates, or both, which comprises: (a)crossing wild Brassica oleraceaspecies selected from the group consisting of Brassica villosa and Brassica drepanensis with broccoli double haploid breeding lines; (b)selecting hybridswith elevated levels of 4methylsulfinylbutyl glucosinolates, or 3-methylsulfinylpropyl glucosinolates, or both, elevated above that initially found in broccoli double haploid breeding lines; (c) backcrossing and selecting plants with the genetic combination encoding the expression of elevated levels of 4methylsulfinylbutyl glucosinolates, or 3-methylsulfinylpropyl glucosinolates, or both; and (d) selecting a broccoli line with elevated levels of 4methylsulfinylbutyl glucosinolates, or 3-methylsulfinylpropyl glucosinolates, or both, capable of causing a strong induction of phase II enzymes, </li></ul></li></ul><ul><li><ul><li>Wherein molecular markers are used in steps (b) and (c) to select hybrids with genetic combination encoding expression of elevated levels of 4methylsulfinylbutyl glucosinolates, or 3-methylsulfinylpropyl glucosinolates, or both, capable of causing a strong induction of phase II enzymes </li></ul></li></ul><p> 21. G 1/08 - EP 1 211 926 </p> <ul><li>Claim 1 main request: </li></ul><ul><li>"A method for breeding tomato plants that produce tomatoes with reduced fruit water content comprising the steps of: </li></ul><ul><li><ul><li>crossing at least one Lycopersicon esculentum plant with a Lycopersicon spp. to produce hybrid seed; </li></ul></li></ul><ul><li><ul><li>collecting the first generation of hybrid seeds; </li></ul></li></ul><ul><li><ul><li>growing plants from the first generation of hybrid seeds; </li></ul></li></ul><ul><li><ul><li>pollinating the plants of the most recent hybrid generation; </li></ul></li></ul><ul><li><ul><li>collecting the seeds produced by the most recent hybrid generation; </li></ul></li></ul><ul><li><ul><li>growing plants from the seeds of the most recent hybrid generation; </li></ul></li></ul><ul><li><ul><li>allowing fruit to remain on the vine past the point of normal ripening; and </li></ul></li></ul><ul><li><ul><li>screening for reduced fruit water content as indicated by extended preservation of the ripe fruit and wrinkling of the fruit skin." </li></ul></li></ul><p> 22. Interpretation of Art. 53(b) EPC </p> <ul><li>T 320/87:</li></ul><ul><li><ul><li>whether or not a (non- microbiological) process is to be considered as "essentially biological" within the meaning of Article 53(b) EPChas to be judged on the basis of the essence of the invention taking into account the totality of human intervention and its impact on the result achieved .</li></ul></li></ul><ul><li><ul><li>The applicability of the exclusion had to be judged on the basis of the essence of the invention, taking into account the totality of human intervention and its impact on the result achieved. Although the board considered that the exclusion had to be narrowly construed, the necessity of human intervention in itself was not regarded as a sufficient criterion for the process not being "essentially biological". Human interference might only mean that the process wasnot a "purely biological" process, without contributing anything beyond a trivial level. </li></ul></li></ul><p> 23. G 2/07 </p> <ul><li>Case law leads to following parameters of relevance: </li></ul><ul><li><ul><li>1. The totality of human intervention and its impact on the result achieved is to be determined. </li></ul></li></ul><ul><li><ul><li>2. This has to be judged on the basis of the essence of the invention. </li></ul></li></ul><ul><li><ul><li>3. The impact must be decisive. </li></ul></li></ul><ul><li><ul><li>4. The contribution must go beyond a trivial level. </li></ul></li></ul><ul><li><ul><li>5. The totality and the sequence of the specified operations must neither occur in nature nor correspond to the classical breeders processes. </li></ul></li></ul><ul><li><ul><li>6. The required fundamental alteration of the character of a known process for the production of plants may lie either in the features of the process, i.e. in its constituent parts, or in the special sequence of the process steps, if a multistep process is claimed. In some cases the effect of this can be seen in the result. </li></ul></li></ul><p> 24. Meaning of the term crossing an selection </p> <ul><li>It was argued in the proceedings that crossing and selection should be understood to mean only crossing and selection as they take place in nature. In particular, the term selection did not address the selection made by man in a breeding process but only the selection that takes place in nature and is not controllable by man, and that determines which plants survive in nature, depending also on the particular environmental conditions involved. </li></ul><ul><li>A definition which completely disregards the fact that the context of the terms crossing and selection in the said provisions is given by the processes for theproduction of plants (German version: "Zchtung von Pflanzen", Frenchversion "obtention de vgtaux"), i.e. the breeders' activity, cannot be the right one. </li></ul><p> 25. Meaning of the term crossing an selection </p> <ul><li>In that context the terms "crossing" and "selection refer to acts performed by the breeder. These are characterised by the fact that the breeder intervenes in the processes in order...</li></ul>