T1854/07: plant varieties in European Patent Law
European patent EP-B-1 185 161 (which published as WO00/74469) had claims which were directed to sunflower seeds that contain a specific modified fatty acid composition obtainable by crossing a specific high stearic sunflower breeding line (CAS-3) with a high palmitic line and selecting seed of F2 generations in which the amount of palmitoleic and the amount of ascelpic acid are decreased to less than 4% based upon the total fatty acid content.
In summary the Technical Board of Appeal (TBA) in T1854/07 came to the following conclusions.
- Claims directed to a plant which are formulated as product-by-process claims are not excluded from patentability as essentially biological processes for the protection of plants even if the process could be considered as a classical breeding method consisting of crossing and selection.
- The TBA attempted to clarify the difference between a patentable “plant” and an unpatentable “plant variety”. A plant is considered to be a plant variety if it meets the criteria set out in the definition of Rule 26(4) EPC. The TBA found that the genetic equipment defining one specific trait [which is determined by a limited number of enzymes (and DNAs encoding them)] does not constitute the plants “genome”, which defines the plants entire genetic makeup. In T1854/07 the part of the genotype which was responsible for the claimed trait can be bestowed upon many different sunflower lines. Therefore the plant (seed) claims were not excluded from patentability as a plant variety.
- The TBA considered whether carrying out the method inevitably resulted in a plant variety. However, variations in the breeding lines used and the fact that claim 1 recited “selecting seed of F2 generations” (thus excluding stabilization of the desired phenotype through back crossing to achieve phenotypic homogeneity) lead the TBA to find that the claims do not claim a plant variety even though they may embrace plant varieties.
More detailed analysis of the decision
“Product-by-process” plant claims
The Appellant (Opponent) argued that Claim 1 referred to an essentially biological process for the protection of plants which was excluded from patentability according to Article 53(b) EPC. This was mainly because claim 1 referred to a product defined in terms of the process by which it is produced.
Article 53(b) EPC 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.
The technical board of appeal (TBA) confirmed that such “product-by-process” claims remain a product claim irrespective of the process it refers to and therefore the claim was not an essentially biological process for the production of plants which is excluded from patentability according to Article 53(b) EPC.
When is a plant a plant variety?
As the Enlarged Board of Appeal (EBA) observed in decision G 1/98 (OJ EPO 2000, 111); point 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 point 3.10 of decision G 1/98 the EBA states:
[t]hat 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. 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.
One of the questions (question 2) referred to the EBA and answered by it in decision G 1/98 (supra) reads:
Does a claim which relates to plants but wherein specific plant varieties are not individually claimed ipso facto avoid the prohibition on patenting in Article 53(b) EPC even though it embraces plant varieties?
The answer of the Enlarged Board to this question was the following:
A claim wherein specific plant varieties are not individually claimed is not excluded from patentability under Article 53(b) EPC, even though it may embrace plant varieties.
The Appellant (Opponent) argued that the case in T1854/07 was distinguished from G1/98 because G1/98 related exclusively to plant varieties produced by recombinant gene technology; whereas the claims in the present case referred to plants (seeds) produced by classical breeding methods consisting of crossing and selection.
The TBA in T1854/07 did not agree with the Appellant's interpretation of decision G1/98 (supra) for the reasons given below.
G1/98 (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 Rule 26(4) EPC (former Rule 23b(4) EPC), 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.
G1/98 (see page 17, first paragraph) 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.
G1/98 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.
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 Article 53(b), 1st half-sentence, EPC 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.
Thus, although it is evident that the actual technical situation underlying decision G1/98 refers to a plant produced by recombinant gene technology, in the TBA’s view in T1854/07 the decision does not contain any basis for the assumption that the findings of the EBA 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 Rule 26(4) EPC (former Rule 23b(4) EPC). 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.
The TBA found that 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.
In particular, in T1854/07 it was decided that the trait as claimed is determined by a limited number of enzymes (and DNAs encoding them) rather than by a complete genetic constitution. The part of the genotype which is responsible for the claimed trait can be bestowed upon may different 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” (R26(4)(a) EPC).
One further question considered by the TBA was also whether carrying out the method inevitably resulted in a plant variety.
The TBA indicated that since neither the CAS-3 line nor the “high palmitic” line referred to in claim 1 were restricted to any particular plant variety, then the only possible way in which the claimed progeny could result in a variety or group of varieties is if the stabilization of the desired phenotype through backcrossing lead to phenotypic homogeneity. Since claim 1 only required a single backcross (selecting seed of the F2 generation), the TBA held that the claims do not claim a plant variety even though they may embrace plant varieties
With no evidence that the CAS-3 breeding line and the high palmitic parent line have the same genetic backgrounds and no evidence that a single backcross would result in a plant variety the TBA found that carrying out the method had not been shown to inevitably result in a plant variety.
Therefore the patent in T1854/07 will be maintained.