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.
Università Cattolica del Sacro Cuore
Piacenza, October 14-15, 2011

Video: http://vimeo.com/31476780

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24 - Innovating Food, Innovating the Law - Sven Bostyn

  1. 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/law  s.bostyn@liv.ac.uk
  2. 2. Il menù di oggi a Piacenza
  3. 4. Patents for plants: relevant provisions <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 biological if it consists entirely of natural phenomena such as crossing or selection . </li></ul>
  4. 5. Plant variety: definition UPOV 1991 <ul><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></ul><ul><ul><ul><li>- defined by the expression of the characteristics that result from a given genotype or combination of genotypes, </li></ul></ul></ul><ul><ul><ul><li>- distinguished from any other plant grouping by the expression of at least one of the said characteristics and </li></ul></ul></ul><ul><ul><ul><li>- considered as a unit with regard to its suitability for being propagated unchanged. </li></ul></ul></ul>
  5. 6. Taxonomy <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>
  6. 8. Legislative history Art. 53(b) EPC <ul><li>Is based on Art. 2(b) Strasbourg Patent Convention (SPC): </li></ul><ul><ul><li>&quot;the Contracting States shall not be bound to provide for the grant of patents in respect of plant varieties“ </li></ul></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>
  7. 9. Legislative history Art. 53(b) EPC <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>
  8. 10. Legislative history Art. 53(b) EPC <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>
  9. 11. Legislative history Art. 53(b) EPC <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 préparatoires 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>
  10. 13. Patents for plants <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><ul><li>The examples in the patent application will show the application of the generic technology to some real life plant varieties </li></ul></ul><ul><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></ul><ul><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></ul><ul><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></ul><ul><li>The invention does as such not create a new plant variety </li></ul>
  11. 14. Patents for plants <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>
  12. 15. G 1/98 <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>
  13. 16. G1/98 contd. <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>
  14. 17. G1/98 contd. <ul><li>“ In summary, according to Article 53(b) EPC, a patent is &quot;in respect of plant varieties&quot; 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 &quot;in respect of&quot; a certain subject if it may comprise this subject.” </li></ul>
  15. 19. Essentially biological processes - Relevant provisions <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 biological if it consists entirely of natural phenomena such as crossing or selection . </li></ul>
  16. 20. G 2/07: Essentially biological processes for the production of plants <ul><li>T 0083/05, EP 1069819 </li></ul><ul><li>Claim 1 main request oral proceedings TBA: </li></ul><ul><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 oleracea species selected from the group consisting of Brassica villosa and Brassica drepanensis with broccoli double haploid breeding lines; (b) selecting hybrids with 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></ul><ul><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></ul>
  17. 21. G 1/08 - EP 1 211 926 <ul><li>Claim 1 main request: </li></ul><ul><li>&quot;A method for breeding tomato plants that produce tomatoes with reduced fruit water content comprising the steps of: </li></ul><ul><ul><li>crossing at least one Lycopersicon esculentum plant with a Lycopersicon spp. to produce hybrid seed; </li></ul></ul><ul><ul><li>collecting the first generation of hybrid seeds; </li></ul></ul><ul><ul><li>growing plants from the first generation of hybrid seeds; </li></ul></ul><ul><ul><li>pollinating the plants of the most recent hybrid generation; </li></ul></ul><ul><ul><li>collecting the seeds produced by the most recent hybrid generation; </li></ul></ul><ul><ul><li>growing plants from the seeds of the most recent hybrid generation; </li></ul></ul><ul><ul><li>allowing fruit to remain on the vine past the point of normal ripening; and </li></ul></ul><ul><ul><li>screening for reduced fruit water content as indicated by extended preservation of the ripe fruit and wrinkling of the fruit skin.&quot; </li></ul></ul>
  18. 22. Interpretation of Art. 53(b) EPC <ul><li>T 320/87: </li></ul><ul><ul><li>“whether or not a (non- microbiological) process is to be considered as &quot;essentially biological&quot; within the meaning of Article 53(b) EPC has 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></ul><ul><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 &quot;essentially biological&quot;. Human interference might only mean that the process was not a &quot;purely biological&quot; process, without contributing anything beyond a trivial level. </li></ul></ul>
  19. 23. G 2/07 <ul><li>Case law leads to following parameters of relevance: </li></ul><ul><ul><li>1. The totality of human intervention and its impact on the result achieved is to be determined. </li></ul></ul><ul><ul><li>2. This has to be judged on the basis of the essence of the invention. </li></ul></ul><ul><ul><li>3. The impact must be decisive. </li></ul></ul><ul><ul><li>4. The contribution must go beyond a trivial level. </li></ul></ul><ul><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></ul><ul><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></ul>
  20. 24. Meaning of the term “crossing an selection” <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 the production of plants (German version: &quot;Züchtung von Pflanzen&quot;, French version &quot;obtention de végétaux&quot;), i.e. the breeders' activity, cannot be the right one. </li></ul>
  21. 25. Meaning of the term “crossing an selection” <ul><li>In that context the terms &quot;crossing&quot; and &quot;selection” refer to acts performed by the breeder. These are characterised by the fact that the breeder intervenes in the processes in order to achieve a desired result. Hence, in that context, crossing and selection are not natural phenomena but are method steps which generally involve human intervention. </li></ul><ul><li>Hence, in that context, crossing and selection are not natural phenomena but are method steps which generally involve human intervention. </li></ul>
  22. 26. Meaning of the term “crossing an selection” <ul><li>Admittedly, this result does not make the interpretation of Rule 26(5) EPC easier, since on the one hand (only) processes which consist entirely of natural phenomena are considered to be essentially biological processes for the production of plants. On the other hand, crossing and selection are given as examples of natural phenomena, but the systematic crossing and selection carried out in plant breeding are not natural phenomena but measures implemented by means of human intervention. Hence, the wording of Rule 26(5) EPC is ambiguous, if not contradictory. </li></ul><ul><li>This does not, however, justify the conclusion that the ambit of Rule 26(5) EPC is to define crossing and selection as natural phenomena by way of a legal fiction. </li></ul>
  23. 27. Meaning of the term “crossing an selection” <ul><li>The effect of combining the two elements of different concepts into a single definition and citing one of these concepts as an example of the other was to reinforce the contradiction in meaning of the provision, as compared to the earlier drafts mentioned above. </li></ul><ul><li>As a result, the legislative history of the Biotech Directive does not assist in determining what the legislator intended to say by the wording which was eventually adopted for Article 2(2) Biotech Directive. On the contrary, it must be concluded that the contradiction between the terms of the provision cannot be further clarified. </li></ul>
  24. 28. G 2/07 <ul><li>Conclusions on the impact of Rule 26(5) EPC on the interpretation of Article 53(b) EPC. </li></ul><ul><li>In order to enable the Article to which a Rule pertains to be interpreted by means of the Rule, such Rule must at least be clear enough to indicate to those applying it in what way the legislator intended the Article to be interpreted by means of that Rule. This is not the case for Rule 26(5) EPC. </li></ul><ul><li>The consequence of the self-contradictory wording of Article 2(2) Biotech Directive having been transposed verbatim into Rule 26(5) EPC is, regrettably, that Rule 26(5) EPC does not give any useful guidance on how to interpret the term &quot;essentially biological process for the production of plants&quot; in Article 53(b) EPC and therefore that term must be interpreted on its own authority. This is for the Enlarged Board to do. </li></ul><ul><li>Any attempt to determine a reliable literal meaning for the term &quot;essentially biological&quot; process appears futile. </li></ul>
  25. 29. G 2/07 <ul><li>It must be concluded that the legislator's intention was to exclude from patentability the kind of plant breeding processes which were the conventional methods for the breeding of plant varieties of that time. These conventional methods included in particular those (relevant for the present referrals) based on the sexual crossing of plants (i.e. of their whole genomes) deemed suitable for the purpose pursued and on the subsequent selection of the plants having the desired trait(s). </li></ul><ul><li>The application of technical means or other forms of human intervention in such processes which helped to perform them was already common. Nevertheless, the said processes were characterised by the fact that the traits of the plants resulting from the crossing were determined by the underlying natural phenomenon of meiosis. </li></ul>
  26. 30. G 2/07 <ul><li>Be that as it may, the Enlarged Board is unable to see why the legislator's decision to provide appropriate patent protection for &quot;secondary&quot; features such as technical devices or means (today e.g. markers) by allowing them to be patented in themselves but not to extend protection to the biological process in which they are used, would no longer be justified today, merely because today many more such technical possibilities exist. </li></ul><ul><li>Hence, it must be concluded that the provision of a technical step, be it explicit or implicit, in a process which is based on the sexual crossing of plants and on subsequent selection does not cause the claimed invention to escape the exclusion if that technical step only serves to perform the process steps of the breeding process. </li></ul>
  27. 31. G 2/07 <ul><li>Rule 27(c) EPC expressly provides that biotechnological inventions shall also be patentable if they concern a microbiological or other technical process. Hence, the excluded essentially biological processes stand in juxtaposition to the patentable technical processes. </li></ul><ul><li>Considered from the angle of technical character, a form of human intervention utilising the forces of nature (including even the intentional abstention from any intervention) while not being the application of a technical means stricto sensu, can be a measure which is equally as technical (see above under 6.4.2.1). Thus, in a chemical process, for instance, leaving substances in a vessel for a certain time in order that a desired reaction takes place is a technical measure, even though it is characterized by the - deliberate - abstention from any human intervention. Similarly, leaving tomatoes on the vine past ripening and determining by looking at them which ones are sufficiently wrinkled for the purpose of enabling or assisting selection of the suitable plants is a technical step, although it is not a technical means stricto sensu which is being applied. It is, however, a measure involving human intervention, in this case in the context of the selection step. Human intervention in a process in order to bring about a desired result is the essence of what an invention is, but breeding processes by their nature involve human intervention. </li></ul>
  28. 32. G 2/07 <ul><li>Hence, in more general terms, the conclusion to be drawn is that a process for the production of plants which is based on the sexual crossing of whole genomes and on the subsequent selection of plants, in which human intervention, including the provision of a technical means, serves to enable or assist the performance of the process steps, remains excluded from patentability as being essentially biological within the meaning of Article 53(b) EPC. </li></ul><ul><li>However, if a process of sexual crossing and selection includes within it an additional step of a technical nature, which step by itself introduces a trait into the genome or modifies a trait in the genome of the plant produced, so that the introduction or modification of that trait is not the result of the mixing of the genes of the plants chosen for sexual crossing, then that process leaves the realm of the plant breeding, which the legislator wanted to exclude from patentability. Therefore, such a process is not excluded from patentability under Article 53(b) EPC but qualifies as a potentially patentable technical teaching. </li></ul>
  29. 33. G 2/07 <ul><li>1. A non-microbiological process for the production of plants which contains or consists of the steps of sexually crossing the whole genomes of plants and of subsequently selecting plants is in principle excluded from patentability as being &quot;essentially biological&quot; within the meaning of Article 53(b) EPC. </li></ul><ul><li>2. Such a process does not escape the exclusion of Article 53(b) EPC merely because it contains, as a further step or as part of any of the steps of crossing and selection, a step of a technical nature which serves to enable or assist the performance of the steps of sexually crossing the whole genomes of plants or of subsequently selecting plants. </li></ul>
  30. 34. G 2/07 <ul><li>3. If, however, such a process contains within the steps of sexually crossing and selecting an additional step of a technical nature, which step by itself introduces a trait into the genome or modifies a trait in the genome of the plant produced, so that the introduction or modification of that trait is not the result of the mixing of the genes of the plants chosen for sexual crossing, then the process is not excluded from patentability under Article 53(b) EPC. </li></ul><ul><li>4. In the context of examining whether such a process is excluded from patentability as being &quot;essentially biological&quot; within the meaning of Article 53(b) EPC, it is not relevant whether a step of a technical nature is a new or known measure, whether it is trivial or a fundamental alteration of a known process, whether it does or could occur in nature or whether the essence of the invention lies in it. </li></ul>
  31. 36. Monsanto case ECJ, C-428/08 <ul><li>Patent covered DNA sequence coding for an enzyme which facilitated herbicide resistance, also covered plants thus modified </li></ul><ul><li>Soya meal was produced of genetically modified soya in country where there was no patent protection </li></ul><ul><li>Meal was imported into countries with patent protection for the herbicide resistance technology </li></ul><ul><li>Infringement was claimed, as the gene was present in the meal </li></ul><ul><li>Does protection extend to meal? </li></ul>
  32. 37. Relevant provisions <ul><li>Art. 9 Directive 98/44/EC: </li></ul><ul><li>“ the protection conferred by a patent on a product containing or consisting of genetic information shall extend to all material, save as provided in art. 5(1), in which the product is incorporated and in which the genetic information is contained and performs its function ”. </li></ul><ul><li>E.g. plasmids as vectors for gene expression, plant and animal cells, plant and animal genes etc. </li></ul><ul><li>Protection shall extend to the plants, animals etc. </li></ul><ul><li>As to compatibility with exclusion of plant varieties, see point 119-127 AG in case C-377/98 </li></ul>
  33. 38. Relevant provisions <ul><li>S. 60 UK Patents Act 1977 </li></ul><ul><li>(1) Subject to the provisions of this section, a person infringes a patent for an invention if, but only if, while the patent is in force, he does any of the following things in the United Kingdom in relation to the in-vention without the consent of the proprietor of the patent, that is to say-- </li></ul><ul><li>(a) where the invention is a product, he makes, disposes of, offers to dispose of, uses or imports the product or keeps it whether for disposal or otherwise; </li></ul><ul><li>(b) where the invention is a process, he uses the process or he offers it for use in the United King-dom when he knows, or it is obvious to a reasonable person in the circumstances, that its use there without the consent of the proprietor would be an infringement of the patent; </li></ul><ul><li>(c) where the invention is a process, he disposes of, offers to dispose of, uses or imports any product obtained directly by means of that process or keeps any such product whether for disposal or other-wise. </li></ul>
  34. 39. Monsanto case ECJ, C-428/08 <ul><li>On the basis of Art. 9 Biotech directive, it is clear that the gene no longer performs any function in the meal, hence scope of protection does not extend to meal </li></ul><ul><li>However, on the basis of national provisions of patent law, the gene is present in the meal, the gene is hence imported into a patent country, consequently this constitutes in principle an act of infringement </li></ul><ul><li>ECJ has held that the Biotech directive has created an exclusive system for biotech inventions, setting aside existing standard provisions of patent law, hence national provisions of Patents Act pertaining to product patents are not applicable in their entirety for biotech inventions (e.g. s. 60 UK Patents Act; Art. 53 Dutch Patent Act, etc.) </li></ul><ul><li>It can be questioned whether that is a correct interpretation, as the Biotech directive states: </li></ul><ul><ul><li>(8) Whereas legal protection of biotechnological inventions does not necessitate the creation of a separate body of law in place of the rules of national patent law; whereas the rules of national patent law remain the essential basis for the legal protection of biotechnological inventions given that they must be adapted or added to in certain specific respects in order to take adequate account of technological developments involving biological material which also fulfil the requirements for patentability; </li></ul></ul>
  35. 40. Monsanto case ECJ, C-428/08 <ul><li>Ruling of ECJ regarding purpose-bound patent protection for DNA sequences is incomprehensible, as the case did not ask for a judgement on this principle </li></ul><ul><li>Reasoning of the court in this context is flawed and based on erroneous principles and premises. </li></ul><ul><li>Is beyond the scope of this talk to elaborate on this issue </li></ul>
  36. 42. Patent protection v plant variety protection <ul><li>In member states EPC, plant varieties cannot be patented </li></ul><ul><ul><li>Historical reason, double protection not allowed under UPPOV 1961, negotiating parties to EPC were already bound by UPOV </li></ul></ul><ul><li>Art. 53(b) EPC does allow plants to be patented, essentially biological processes are however excluded from patentability </li></ul><ul><li>Can also be brought back to traditional dichotomy between technical innovations which are patentable, and simple breeding methods which are not </li></ul><ul><ul><li>This dichotomy is no longer valid today </li></ul></ul>
  37. 43. Patent protection v plant variety protection <ul><li>Patent protection for plants no longer desirable? </li></ul><ul><li>Plant variety rights the ideal alternative? </li></ul><ul><li>Rather conflicting developments: </li></ul><ul><ul><li>On the one hand, trend towards protecting by patents methods which are very close to biological processes (see G 2/07, broccoli and tomato case) </li></ul></ul><ul><ul><li>On the other hand, plant variety technologies are no longer confined to traditional “biological” breeding processes -> have also entered the reign of biotechnology </li></ul></ul><ul><ul><li>There seems to be convergence in the scope of subject matter aimed to be protected </li></ul></ul><ul><ul><li>That is only partly true, as a patent will always continue to protect an abstract technology, while a plant variety right will continue to protect a more concrete embodiment </li></ul></ul>
  38. 44. Patent protection v plant variety protection <ul><li>Consequently, if one would do away with patent protection for plants (allowed under TRIPs provided there is at least a sui generis right in place), an entire area of technology would no longer be capable of being protected: </li></ul><ul><ul><li>E.g., if it would no longer be possible to obtain patent protection for, for instance, plants which are herbicide resistant, the only alternative would then be to obtain separate plant variety rights for varieties which are herbicide resistant. -> offers a low level of protection, as others may develop/market other plant varieties which have herbicide resistance, but for which no PVR has been obtained. </li></ul></ul><ul><ul><li>Does not seem to be a fair solution </li></ul></ul><ul><ul><ul><li>Alternative of PVR protection does not lead to an adequate level of protection for technologies that go beyond the concrete embodiment of a plant variety </li></ul></ul></ul>
  39. 45. Patent protection v plant variety protection <ul><li>Plant variety protection alternative? </li></ul><ul><ul><li>Rather inflexible requirements </li></ul></ul><ul><ul><li>Weak enforcement </li></ul></ul><ul><ul><li>Many exceptions </li></ul></ul><ul><li>The above make it a less attractive right, and one may ask oneself whether PVR’s provide adequate protection for the innovations made in the first place </li></ul>
  40. 46. Vultures from patent land?
  41. 47. Alleged evils of patents for plants <ul><li>Protects methods which are close to biological (see earlier) </li></ul><ul><li>Scope of protection is very broad and hence there is no reasonable quid pro quo: </li></ul><ul><ul><li>Question is whether it is unfair to provide protection for a technology of general application, which can admittedly be applied to an unlimited number of plant varieties </li></ul></ul><ul><ul><li>Also remember that UPOV 1991 also provides broader scope of protection, with introduction of concept of “essentially derived variety” </li></ul></ul><ul><li>Will have detrimental effects on farmers: </li></ul><ul><ul><li>EU has farmers’ privilege, mitigating effects for farmers </li></ul></ul><ul><li>Development of technologies which have negative consequences for farming practices (e.g., terminator technologies (GURTs, Genetic Use Restriction Technologies), hybrid varieties): </li></ul><ul><ul><li>Question is whether such technologies would not equally have been developed in the absence of patent protection for plants, but for instance only plant variety protection </li></ul></ul>
  42. 48. Alleged evils of patents for plants <ul><li>Effects on biodiversity: e.g. genetically modified plants which generate higher yield might become so widespread that other traditional varieties are neglected and disappear </li></ul><ul><ul><li>Also here question whether that is exclusively due to patent system, or whether similar effects would have been witnessed if only plant variety protection </li></ul></ul>
  43. 50. Solutions? <ul><li>How do we prevent that obvious technologies become patent-protected? </li></ul><ul><ul><li>A clear-cut distinction between what is protectable subject matter and what is not under the current legislative framework (Art. 53(b) EPC) seems to be a futile exercise -> see G 2/07 </li></ul></ul><ul><ul><li>Do we really think that such technologies would lead to patent protection? </li></ul></ul><ul><ul><ul><li>Do they fulfil the patentability requirements of novelty and more important inventive step? </li></ul></ul></ul>
  44. 51. Solutions? <ul><li>Solution? </li></ul><ul><li>Qualify patent protection with more requirements/parameters? </li></ul><ul><ul><li>How should this exactly work? </li></ul></ul><ul><ul><li>Is such a solution TRIPs compliant? </li></ul></ul><ul><ul><li>Has the perfume of a sui generis right, and sui generis rights do not provide a proper and balanced IP protection -> see sui generis database right which protects virtually anything that does not seem to be protectable under copyright </li></ul></ul><ul><ul><li>How could one justify such a solution to create benefit to society? </li></ul></ul>
  45. 52. Solutions <ul><li>While we talk about solutions, why not throw into the discussion a more controversial point </li></ul><ul><li>For pharmaceutical products, there is possibility to obtain extension of patent protection for max. 5 years (SPC’s), due to effective loss of useful patent term for regulatory purposes </li></ul><ul><li>Bringing on the market a new plant/plant variety which is genetically modified requires very lengthy regulatory procedures </li></ul><ul><ul><li>-> is it unreasonable to suggest that right holders in the area also deserve an extra term of protection to compensate for the loss of effective protection for the duration of the regulatory process? </li></ul></ul>
  46. 53. Solutions? - COMPENSATORY LIABILITY REGIME <ul><li>Solutions outside the IPR area? </li></ul><ul><li>E.g., COMPENSATORY LIABILITY REGIME proposed by Reichman et al.: owners of genetic resources are granted for a limited period the following rights </li></ul><ul><ul><li>1) to prevent second comers from entering TK owners’ product market with a wholly unoriginal imitation of their product; </li></ul></ul><ul><ul><li>2) to reasonable compensation from follow-on innovators who make improvements upon the scientific knowledge of the TK owners; </li></ul></ul><ul><ul><li>3) to make use of second comers’ own technical improvements for purposes of further improving the TK owners’ original products </li></ul></ul>
  47. 55. Critique <ul><li>Also the alternative model gives reach-through rights: </li></ul><ul><ul><li>E.g., reasonable compensation from follow-on innovators for innovations made upon the TK scientific knowledge (very similar to traditional benefit-sharing systems) </li></ul></ul><ul><ul><li>Gives even further-reaching rights to TK owners, as they also obtain the right to use second comers’ own technical improvements (i.e., entitles TK owners to use without compensation innovations made by third parties based on the simple fact that at some point the TK owner has provided genetic resource to innovator on the basis of which an invention has been made) </li></ul></ul>
  48. 56. Critique <ul><li>Even though the authors admit that TK is sub-protectable, nevertheless, far-reaching user rights are given to TK owners, even without any inventive contribution made to such inventions </li></ul>
  49. 57. Conclusion <ul><li>It seems that the agro food industry has supplied a lot of problems to the IP community </li></ul><ul><li>IPR’s for plants are less than perfect, but it looks very difficult to conclude that patents are not desirable and PVR’s are. </li></ul><ul><li>Qualified rights are probably not a viable alternative </li></ul><ul><li>Other schemes such as compensatory liability regimes present problems in their own </li></ul><ul><li>One can actually question whether in practice the patent system is presenting that many problems: do we have reliable data that suggest that patent protection has had the alleged detrimental effects </li></ul><ul><ul><li>Do not forget that apart from the question whether something is patentable subject matter, there are also the patentability requirements of novelty, inventive step and enabling disclosure which might all have a potentially limiting effect on any patent granted </li></ul></ul><ul><li>Plant variety rights do not seem to be the alternative for patents, as they present problems in themselves </li></ul><ul><li>More research is required to come with the Holy Grail. </li></ul>
  50. 58. Thank you!

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