Saturday, 11 June 2011

T 1854/07 – It’s Broad, Says The Board

The present decision deals with an appeal by the opponent (Greenpeace) against the decision of the Opposition Division (OD) to maintain the patent in amended form.

Claim 1 and 11 on file read:
1. Sunflower seeds that contain an oil having an oleic acid content of more than 5% and less than 65% by weight based upon the total fatty acid content, a linoleic acid content of more than 1% and less than 65% by weight based upon the total fatty acid content, a palmitic acid content of more than 20% and less than 40% by weight based upon the total fatty acid content, a stearic acid content of more than 3% and less than 15% based upon the total fatty acid content, characterized in that the palmitoleic acid content is less than 4% based upon the total fatty acid content, and the asclepic acid content is less than 4% based upon the total fatty acid content, obtainable by crossing the high stearic line CAS-3, deposited on 14 December 1994 with the ATCC under deposit accession number ATCC-75968 with a high palmitic line to introduce the stearoyl desaturase enzymatic activity of the high stearic line in the high palmitic line, and selecting seed of F2 generations in which the amount of palmitoleic is decreased to less than 4% based upon the total fatty acid content and the amount of asclepic acid is decreased to less than 3% based upon the total fatty acid content.

11. Seeds according to any one of claims 1-10, obtainable by crossing sunflower seeds of the mutant sunflower line IG-1297M deposited on 20 January 1998 with ATCC under deposit accession number ATCC-209591 with the mutant sunflower line CAS-3, deposited on 14 December 1994 with the ATCC under deposit accession number ATCC-75968.
The opponent argued inter alia that Claim 1 was excluded from patentability under A 53(b), in particular because it referred to an essentially biological process for the protection of plants, and because it was directed to and inevitably resulted in a plant variety.

The Board did not adopt this reasoning:

[4] For the purpose of the present decision, although claims 1 and 11 are directed to sunflower seeds, the latter will be interchangeably considered as plants, given that plants may be grown from seeds, which represent one stage in the life cycle of the plant.

[5] Claim 1 refers to a product defined in terms of the process by which it is produced. Such “product by process” claim remains a product claim irrespective of the process it refers to.

[Opponent’s] argument, that claim 1 refers to an essentially biological process for the protection of plants which is excluded from patentability according to A 53(b), must therefore fail.

[6] For the following consideration of the requirements of A 53(b), the board has to draw the parties’ attention to the exact wording of this Article, which reads:
“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 shall not apply to microbiological processes or the products thereof”.
[7] As the Enlarged Board of Appeal (EBA) observed in decision G 1/98 [3.3.1],
“[w]hereas the exclusion for processes is related to the production of plants, the exclusion for products is related to plant varieties. The use of the more specific term ‘variety’ within the same half-sentence of the provision relating to products is supposed to have some meaning. If it was the intention of the legislator to exclude plants as a group embracing in general varieties as products, the provision would use the more general term plants as used for the processes.”
In G 1/98 [3.10] the EBA states
“[t]hat A 53(b) 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. This is not a question of arithmetical logic but based on the purpose of plant variety rights to protect specific products which are used in farming and gardening.”
[8] One of the questions (question 2) referred to the EBA and answered by it in decision G 1/98 read:
“Does a claim which relates to plants but wherein specific plant varieties are not individually claimed ipso facto avoid the prohibition on patenting in A 53(b) even though it embraces plant varieties?”
The answer of the EBA to this question was the following:
“A claim wherein specific plant varieties are not individually claimed is not excluded from patentability under A 53(b), even though it may embrace plant varieties.”
[9] The [opponent’s] major argument in this appeal was that decision G 1/98 was exclusively concerned with plant varieties as products of recombinant gene technology and was therefore not applicable in the present case. The claims in the present case referred to plants (seeds) produced by classical plant breeding methods consisting of crossing and selection and were accordingly directed to plant varieties which were excluded from patentability by A 53(b).

According to the [opponent’s] interpretation of decision G 1/98 the EBA has decided that plants defined by the introduction (e.g. via a transgene) of a single identifiable trait (i.e. the claimed phenotype) were patentable whereas patenting was prohibited when the plants were the result of the interaction of several genetic components (including whole genomes), as occurs in traditional plant breeding by methods based on crossing and selection. The [opponent] concluded that the EBA considered plants to be patentable only when the genetic basis of their characterising trait (the underlying DNA) could be indentified, i.e. when the trait could be transferred between species.

[10] The board cannot agree with the [opponent’s] interpretation of decision G 1/98 and the conclusions drawn therefrom.

[10.1] The decision (in point [3.1]) cites the exact definition given for a “plant variety” in Article 1(vi) of the UPOV Convention 1991, which is identical in substance to the definition given in Article 5(2) of the EC Regulation on Community Plant Variety Rights and in R 26(4) (former R 23b(4)), which reads:
“(4) ‘Plant variety’ means 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 result 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.”
[10.2] The decision goes on to conclude that:
“The reference to the expression of the characteristics that results from a given genotype or combination of genotypes is a reference to the entire constitution of a plant or a set of genetic information.”
The decision then states that
“[i]n contrast, 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.”
[10.3] Decision G 1/98 is not concerned with methods or steps for obtaining a new plant, be it a variety or not, but exclusively with the issue whether this new plant is a variety or not. This becomes evident from the answer given by the EBA in response to question (4) referred to it, which answer reads:
“The exception to patentability in A 53(b), 1st half-sentence, applies to plant varieties irrespective of the way in which they were produced. Therefore, plant varieties containing genes introduced into an ancestral plant by recombinant gene technology are excluded from patentability.”
[10.4] Thus, although it is evident that the actual technical situation underlying decision G 1/98 refers to a plant produced by recombinant gene technology, in the present board’s view the decision does not contain any basis for the assumption that the findings of the EBA, particularly its answer to question (2) referred to it (see point [8] above), only apply to genetically manipulated plants.

On the contrary, decision G 1/98 makes clear beyond doubt that, whether or not a plant is considered to be a plant variety depends only on whether or not it meets the criteria set out in the definition in R 26(4) (former R 23b(4)). The method for its production, be it by recombinant gene technology or by a classical plant breeding process, is not relevant for answering this question. It is not called into question that a plant variety may be the product of crossing and selection […] but, contrary to the [opponent’s] view, it cannot be derived from decision G 1/98 that a plant by definition is not a variety when the claimed phenotype has been obtained by introduction of a transgene, whereas it is automatically a variety when the plant having the desired phenotype is achieved in a more traditional way, for example by mutagenesis or by crossing and selection.

[11] The presently claimed sunflower plants (seeds) are characterised by having a preferred fatty acid profile, mainly characterised by a high content of the desired oleic acid and a low content of the undesired palmitoleic acid. According to claim 1, they are obtained by a process including crossing the defined and deposited “high stearic line” CAS-3 with a “high palmitic line”, and selecting seeds of plants of the F2 generation. According to claim 11 the “high palmitic line” is the defined and deposited breeding line IG 1297-M.

[12] According to the [opponent], the claimed phenotypic trait (the fatty acid pattern) is not a result of a single transgene but of the interaction of a plurality of genetic components, or even of the entire genotype or combination of genotypes together with epigenetic effects and could only be stably transmitted by these as a whole and not as a single identifiable and transferable technical feature or genetic building block.

This would have the consequence that the plants (seeds) obtained by the process referred to in claim 1 meet all criteria of the definition of a plant variety given in R 26(4) (former R 23b(4)).

[13] The board disagrees with the [opponent’s] proposition. The trait as presently claimed (a change in the fatty acid composition of the sunflower plant) is determined by a limited number of enzymes (and DNAs encoding them) rather than by a complete genetic constitution […]. This part of the genotype which is responsible for the claimed trait can be bestowed upon many different sunflower lines. The lower stearoyl-ACP-desaturase gene from CAS-3 can indeed be introduced into “high palmitic” sunflower lines thus reducing the levels of palmitoleic and asclepic acids […]. Example 4 of the patent and post-published document D6 show that this trait can be bestowed upon different “high palmitic” sunflower lines.

The genetic equipment defining one specific trait of a plant (seed), namely its fatty acid pattern which is regulated by a limited number of enzymes, does not constitute its “genotype”, which defines its entire genetic makeup. The claimed plants (seeds) are not therefore “defined by the expression of the characteristics that result from a given genotype or combination of genotypes” (R 26(4)(a)).

[14] Following a different line of argument, the [opponent] maintained that a strict reading of R 26(4)(b) had to lead to the conclusion that a single phenotypic trait (e.g. in the present case the claimed fatty acid profile) was sufficient for the plant to fall within the definition of plant variety, provided the single phenotypic trait allowed the plants to be distinguished from any other plant grouping and the single phenotypic trait was stably passed on during propagation.

In the light of the board’s findings in point [13] above this argument is also without merit.

[15] It remains to be established whether carrying out the method recited in claim 1 (crossing the CAS-3 line with a “high palmitic” sunflower line, and selecting seeds of plants of the F2 generation) inevitably results in a plant variety, as the [opponent] argues.

[16] The parent CAS-3 line is a sunflower breeding line. The [patent proprietor] pointed out that an application for variety protection was not successful.

While a consensus seems to have existed between the parties during the opposition procedure that a “breeding line” contains more phenotypic variation than a plant variety […], in the oral proceedings before the board of appeal, the [opponent] took the view that a breeding line (in German “Linie”) and a variety (in German “Sorte”) defined the same entity with the only exception that a variety was registered and a breeding line not. No evidence was provided for this assumption.

The only further information relating to CAS-3 appears from the declarations of Juan Fernandez-Perez and Ricardo R. Siciliano Giner filed by the [patent proprietor] on 26 March 2007, stating that this line was not uniform.

Therefore, in the light of the evidence on file, the board has no reason to assume that the parent CAS-3 line is a plant variety.

The “high palmitic” line referred to in claim 1 is not restricted to any particular deposited line or variety. Thus the claim allows the use of any sunflower provided it has a high palmitic acid content. There is also no requirement in the claim that the genetic background of the high palmitic lines be the same as that of the high stearic line (CAS-3). Therefore, the only possible way in which the claimed progeny could result in a variety or group of varieties is if the stabilisation of the desired phenotype through backcrossing led to phenotypic homogeneity. In the present case, the wording of the claim (“selecting seed of the F2 generation”) only requires a single backcross. There is no evidence before the board that this single backcross would result in a plant variety.

[17] In claim 11 the “high palmitic” parent line is defined as being the deposited line IG 1297-M. This line does not possess the same genetic background as CAS-3, and is not uniform […]. There is no evidence before the board, either, that a single backcross, as required by the claims would result in a plant variety.

[18] Accordingly, the board arrives at the decision that both claims 1 and 11 do not individually claim a plant variety even though they may embrace plant varieties.

Therefore, following decision G 1/98 […] the subject-matter of these claims, as well as that of claims 2 to 10 and 13 to 15, is not excluded from patentability under A 53(b).

To read the whole decision, click here. The file wrapper can be found here.