19 Mar 2018

T 1208/12 - Excluded plant variety

Key points

  • The date of the decision at the oral proceedings is 07.02.2017, the decision was published more than a year later on 27.02.2018. 
  • The Board decides that a claim for a hybrid plant seed produced by a cross of two types of Brassica plants, is directed to an excluded plant variety.
  • The present Board: " For analysing the ruling in decision G 1/98, the board considers it however relevant to emphasise a guiding initial principle established by the Enlarged Board of Appeal in point 3.1 of the reasons for the decision, namely that: "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" 



EPO T 1208/12 - link

Reasons for the Decision
1. The appeal is admissible.
The invention as claimed
2. The claimed invention (see section III) is a hybrid Brassica seed, and a plant grown therefrom, comprising a particular inheritable fertility restorer gene. The hybrid seed is further defined as resulting from a cross between a male parent plant and a female (male-sterile) parent plant.
[Claim 1 of the main request read:
"1. A hybrid seed comprising an inheritable and stable fertility restorer gene for ogura cytoplasmic male sterility, or hybrid plant thereof, produced by a cross between a plant obtained from seed deposited as Brassica napus olifiera 97SN-1650, 97SN-1651, 96FNW-1792-03 or 96FNW-1822-07 having the respective ATCC accession numbers 97838, 97839, 209001 or 209002 as a male parent and a second Brassica plant as a female parent, wherein the second Brassica plant has a glucosinolate level that is sufficiently low to ensure that the hybrid plant yields oilseeds having a total glucosinolate content of less than 30 mymol per gram dry weight."]

3. The male parent plant is defined as being obtained from seed from either of four particular (and deposited) Brassica napus olifiera varieties. The female parent plant is defined as being a Brassica plant having a glucosinolate level which is functionally defined, i.e. such a level that is sufficiently low to ensure that the hybrid plant yields oilseeds which have a total glucosinolate content of less than a certain defined (low) value (this value depending on the request under consideration, see section III).


4. Thus, from the definition of the female parent plant it follows that the desired result of the invention as claimed is a hybrid plant grown from the claimed hybrid seed which yields oilseeds having a total glucosinolate content of less than the required particular (low) value.
Exclusion of plant varieties from patentability
(Article 53(b) EPC and Rule 26(4) EPC)
5. Article 53(b) EPC provides that European patents shall not be granted in respect, inter alia, of plant varieties.
6. The notion of "plant variety" is defined in Rule 26(4) EPC as meaning "any 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:
(a) defined by the expression of the characteristics that results from a given genotype or combination of genotypes,
(b) distinguished from any other plant grouping by the expression of at least one of the said characteristics, and
(c) considered as a unit with regard to its suitability for being propagated unchanged."
The decision under appeal
7. In the decision under appeal the opposition division held that, since it was known to the skilled person that the glucosinolate content of Brassica oilseeds was a complex genetic trait, that person knew that the desired result of claim 1 (see point 4 above) could only be achieved by picking such a female parent plant for the cross referred to which was genetically stable with respect to the low glucosinolate content level trait. The requirements of Article 83 EPC were therefore met only by the choice of a female parent belonging to a low glucosinolate plant grouping which was a variety as defined in Rule 26(4) EPC.
8. Accordingly, the claimed hybrid seed resulted from a cross of parent plants which each belonged to a particular variety, and therefore each such cross resulted in a variety in accordance with the definition of Rule 26(4) EPC.
9. The opposition division reasoned that the conditions in parts (a) and (b) of Rule 26(4) EPC were complied with since (i) the cross of two distinct plant varieties necessarily resulted in the expression of specific characteristics, i.e. a specific phenotype, as the result of the combination of the two genotypes of the two parents, and since (ii) the plant could be distinguished from the parents and other plant groupings.
10. The opposition division further noted that in its Article 9 the UPOV 1991 Convention defined the conditions for a variety to be "stable" as required for protection under the UPOV breeder's rights convention (see Article 5 UPOV 1991 Convention), i.e. "A variety shall be deemed to be stable if the expression of the characteristics which are included in the examination for distinctness as well as any others used for the variety description, remain unchanged after repeated propagation or, in the case of a particular cycle of propagation, at the end of each such cycle." (emphasis added by the board). The opposition division was therefore satisfied that the claimed hybrid seed/plant was unchanged after a cycle of propagation, i.e. by each recurrent cross of two parent variety plants resulting in the hybrid seed and that hence the conditions of Rule 26(4)(c) EPC were met.
11. The opposition division concluded that the hybrid seed and plant as claimed were solely directed to specific hybrid plant varieties as defined in Rule 26(4) EPC and hence were not allowable within the meaning of Article 53(b) EPC.
Characteristics of the parent plants of the claimed hybrid seed
12. It has not been disputed by the appellant that the
male restorer parent plant defined in claim 1, i.e. obtained from seed of four deposited Brassica napus olifiera lines, was a plant belonging to one of four deposited varieties. It was submitted that the plant was homozygous for the male sterility gene for ogura cytoplasmic male sterility and had a low glucosinolate level.
13. The appellant has however disputed the pivotal point in the reasoning adduced by the opposition division for holding that the claimed subject-matter is excluded from patentability by virtue of Article 53(b) EPC, namely that each and every female parent plant to be used in the cross as referred to in claim 1 necessarily belongs to a plant variety. The appellant submitted that the cross referred to could be performed with any female Brassica parent plant - not necessarily only belonging to a variety - as long as it was capable of giving rise to hybrid plants setting oilseeds with the desired low glucosinolate content. Although the skilled person would use for the cross a female parent plant which was stable for low glucosinolate content, such a plant did not necessarily have to belong to a variety, as such female parent plants could well have e.g. varying herbicide or disease resistance profiles or different oil profiles. The group of such different suitable female plants was thus not limited and further new such suitable plants were constantly being discovered.
14. In the appeal proceedings, the parties have inter alia referred to documents D28 and D29 in the context of the required genetic properties of the female parent plant and in particular the required low glucosinolate trait. Document D29 discloses that the development of Brassica varieties having a stable low glucosinolate content was a tedious breeding undertaking involving extensive stabilisation of the trait (see page 191, lines 1 to 16) and teaches that at least eight different genetic loci or alleles, scattered throughout the Brassica napus genome, determine the variation between low and high seed glucosinolate content in Brassica napus (see page 194, lines 1 to 9). Document D28 also discloses that the required low glucosinolate level trait of oilseeds in Brassica napus is based on a highly complex pathway for glucosinolate biosynthesis and regulation and specifies the pathway as including at least 105 metabolic quantitative trait loci (QTL) dispersed throughout the genome.
15. The board considers that these teachings demonstrate that the required low glucosinolate level trait in the oilseeds of plants grown from the hybrid seeds as claimed appears to depend on an extensive genome-wide network of particular alleles, and only by combining these entire genomic networks of the male and female parent plants can the criteria as claimed be fulfilled. Accordingly, the board judges that a sine qua non for ensuring the required low glucosinolate level trait is that a female parent plant is used which is stable, and thus homozygous, in the particular alleles in the over 100 QTL involved in the highly complex pathway for glucosinolate biosynthesis and regulation. In fact, only such plants would succeed in providing oilseeds set on the claimed hybrid progeny with the desired effect of the claimed invention.
16. In the board's judgement, a plant with such a genomic set-up cannot be considered other than as belonging to a variety as defined in Rule 26(4) EPC (see point 6), as it belongs to a plant grouping within a single botanical taxon of the lowest known rank which can be defined by the expression of the characteristics that results from a given genotype or combination of genotypes, can be distinguished from any other plant grouping by the expression of at least one of the said characteristics, and can be considered as a unit with regard to its suitability for being propagated unchanged.
17. The board accordingly judges that each and every female parent plant used in the cross as referred to in claim 1 necessarily belongs to a plant variety.
Characteristics of the claimed hybrid seed resulting from the cross of the parent plants
18. The desired low glucosinolate level in the oilseed yielded by the hybrid plant grown from the hybrid seed resulting from the cross defined in the claims does not solely result from the genomic properties of the male parent plant, which belongs to a variety having a low glucosinolate level, but necessarily results from the combination of the male genomic properties with the genomic properties of the female parent plant.
19. From the conclusions in points 12 and 17 the board judges that the opposition division was correct in holding that the claimed hybrid seed can result solely from a cross of parent plants as defined in the claims which each belong to a particular variety as defined in Rule 26(4) EPC (see point 6 above).
20. The appellant has not contested the finding of the opposition division that the claimed hybrid seed complied with part (a) and (b) of the definition of plant variety pursuant to Rule 26(4) EPC (see point 6). The board concurs with the finding that a cross of two distinct plant varieties, i.e. a hybrid plant, expresses characteristics, i.e. a specific phenotype, as the result of the combined genotypes of the parents and can be distinguished from the parents and other plant groupings.
21. The appellant has however argued that the hybrid resulting from a cross between parent plants each belonging to distinct varieties is not necessarily a variety, as such a hybrid would not fulfill one of the requirements for being a variety in accordance with the provisions of Rule 26(4) EPC in that it could not be considered as a unit with regard to its suitability for being propagated unchanged.
22. The board notes that, in the technical field of plant breeding, the means by which a variety can be propagated unchanged as required by Rule 26(4)(c) EPC vary considerably. Some varieties are propagated unchanged from the plants of the variety itself, such as e.g. by cloning, by selfing, etc. Other varieties, however, such as "hybrid" varieties, are propagated unchanged by recurrent cycles of propagation involving plants other than those of the hybrid variety itself, namely parent plants belonging to particular varieties. If the cycle of propagation involves two defined parent plants, then it results each time in a so-called "simple hybrid". That is the case underlying the present invention.
23. The board notes that such simple hybrid varieties are protectable under breeder's rights as established for plant varieties under the UPOV 91 Convention and under Council Regulation (EC) No 2100/94.
24. The board can therefore not concur with the appellant and considers that the recurrent use of particular parent plants in the cross defined in the claim leads each and every time to a resultant hybrid seed and the plant grown therefrom which comply each separately with part (c) of, and consequently with the definition of plant variety given in, Rule 26(4) EPC.
25. The board therefore concludes that the hybrid seed and the plant grown therefrom as subject-matter of the claim each and every time belong to a particular plant grouping which complies with the definition of plant variety pursuant to Rule 26(4) EPC. The board notes furthermore in this context that it is immaterial for this finding that the hybrid seed covered by claim 1 does not necessarily belong to the same species.
Plant varieties - Article 53(b) EPC
26. The appellant has submitted that, in relation to the provision in Article 53(b) EPC that European patents are not to be granted in respect of plant varieties, the Enlarged Board of Appeal had held in its decision G 1/98 (OJ EPO 2000, 111) that a claim might "embrace" plant varieties, but that a claim which specifically identified a limited number of specific plant varieties was excluded from patentability.
27. The appellant therefore argued that, even if both parent plants of the cross as described in the claims were to belong to specific plant varieties, and even if the claim therefore covered a very large number (thousands) of hybrid plants, it did not identify any specific hybrid variety. Accordingly, it submitted that the claimed hybrid seed and the plant derived therefrom were therefore not excluded from patentability.
28. In point 3 of the reasons for its decision G 1/98, supra, the Enlarged Board of Appeal deals with question 2 referred to it and summarises its considerations in point 3.10, holding that: "[...] 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. [...] Article 53(b) EPC defines the borderline between patent protection and plant variety protection. The extent of the exclusion for patents is the obverse of the availability of plant variety rights. The latter are only granted for specific plant varieties and not for technical teachings which can be implemented in an indefinite number of plant varieties. [...] It is not sufficient for the exclusion of Article 53(b) EPC to apply that one or more plant varieties are embraced or may be embraced by the claims." The Enlarged Board accordingly answered question 2 by stating that: "A claim wherein specific plant varieties are not individually claimed is not excluded from patentability even though it may embrace plant varieties" (see decision G 1/98, supra, Headnote I).
29. The board agrees with the appellant that the Enlarged Board in decision G 1/98 did indeed deal in depth with the relevant legal notion in Article 53(b) EPC for the present case and that this decision needs to be taken into account when deciding whether or not the subject-matter claimed here is excluded from patentability.
30. For analysing the ruling in decision G 1/98, the board considers it however relevant to emphasise a guiding initial principle established by the Enlarged Board of Appeal in point 3.1 of the reasons for the decision, namely that: "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" (emphasis added by the board).
31. The board notes that the case underlying the referring decision T 1054/96 (OJ EPO 1998, 511) related to an invention which technically differed substantially from the invention underlying the present case. It related namely to an invention which provided transgenic plants and seeds thereof comprising in their genome particular foreign recombinant DNA sequences.
32. In view of the initial guiding principle referred to by the Enlarged Board of Appeal, the board considers that the Enlarged Board also analysed question 2 - namely whether a claim which related to plants but wherein specific varieties were not individually claimed ipso facto avoided the prohibition on patenting in Article 53(b) EPC, even though it embraced plant varieties (see question 2 in decision T 1054/96, supra, Headnote II), in point 3.10 of the reasons (see point 28 above) - in the context of transgenic plants.
33. This view of the board is corroborated by certain more detailed considerations of the Enlarged Board of Appeal earlier in point 3 of the reasons for the decision. In point 3.1, following the passage referred to in point 30, above, the Enlarged Board held in relation to the claimed invention underlying the referring decision and to definitions of the concept of "plant variety" that "... a plant defined by single recombinant DNA sequences is not an individual plant grouping to which an entire constitution can be attributed ... 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. As described in more detail in the referring decision, the claimed transgenic plants in the application in suit are defined by certain characteristics allowing the plants to inhibit the growth of plant pathogens (Reasons, point 11, Annex I, point 8). 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. Hence, it would appear that the claimed invention neither expressly nor implicitly defines a single variety, whether according to the definition of "plant variety" in Article 1(vi) of the UPOV Convention 1991, or according to any of the other definitions of "plant variety" mentioned above. 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." (emphasis added by the board).
34. Accordingly, the board considers that the highlighted passages referred to in point 33 demonstrate that the general conclusions and answers were provided by the Enlarged Board in decision G 1/98, supra, in the context of the particular technical situation underlying the invention in the referring decision leading to the subject-matter claimed, i.e. claims for plants defined by the genomic presence of a particular transgenic sequence.
35. As can be seen from point 25 above, however, the technical situation underlying the present case is different and has resulted in a different formulation of the claims, i.e. claims for a hybrid seed and a plant grown therefrom resulting from a particular cross and thus not for a seed or plant merely defined by the presence of a single recombinant DNA sequence. The definition of the claimed subject-matter thus does not fit the concept of "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" as the Enlarged Board referred to in relation to claims defining a plant by a single recombinant DNA sequence (see point 33), but rather defines a seed or a plant which necessarily belongs to a particular plant grouping which complies with the definition of plant variety pursuant to Rule 26(4) EPC, i.e. it relates exclusively to individual plant groupings to which an entire constitution can be attributed. The board considers therefore that in the present situation it cannot be concluded, as was the case with the plants defined by the genomic presence of a recombinant DNA sequence, that the claim "neither expressly nor implicitly defines a single variety" (see point 33) as the subject-matter of the claim, but that it rather defines "a multiplicity of varieties which necessarily consists of several individual varieties" (see point 33).
36. In view of the above finding the board furthermore cannot agree with the appellant that the technical feasibility of the claimed invention was not confined to a particular plant or animal variety and that therefore patentability for the claimed invention was provided by Rule 27(b) EPC. Indeed, the claim as drafted is solely for hybrid seed and plants which always belong to one of "a multiplicity of varieties which necessarily consists of several individual varieties" (see point 33), rather than a particular trait which can be transferred from one variety or plant to numerous other varieties or plants.
37. In summary, the board holds that the conclusions and considerations of the Enlarged Board in decision G 1/98, supra, have to be appreciated in the context of the technical situation of the invention that it had in mind when answering the questions referred to it. In case of the present invention the board concludes that the subject-matter of the claim is limited to and even directed to a variety or varieties.
38. Accordingly, it is decided that the subject-matter of claim 1 of each pending request is not patentable by virtue of Article 53(b) EPC.
Order
For these reasons it is decided that:
The appeal is dismissed.

No comments:

Post a Comment

Do not use hyperlinks in comment text or user name. Comments are welcome, even though they are strictly moderated (no politics). Moderation can take some time (I don't get emails about comments to be approved).