Meaning of “plant varieties” (G 1/98 – Transgenic Plant)
The decision “Transgenic Plant” concerns a transgenic plant comprising recombinant DNA sequences encoding different lytic enzymes with anti-pathogenically effective activity. The transgenic plant may be a maize plant.
The first question to be answered was how plant varieties are defined. The current definition can be found under Article 1(vi) of the UPOV Convention 1991 and under Rule 26 (4) EPC 2000:
“ ‘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:
- defined by the expression of the characteristics that results from a given genotype or combination of genotypes,
- distinguished from any other plant grouping by the expression of at least one of the said characteristics, and
- considered as a unit with regard to its suitability for being propagated unchanged.”
With respect to the present case the Enlarged Board concluded that a plant defined by single recombinant DNA sequences is not an individual plant grouping to which an entire constitution can be attributed, 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. Therefore, the claimed transgenic plant is neither limited nor even directed to a variety or varieties. It follows that such an invention cannot be protected by a plant breeders’ right which is concerned with plant groupings defined by their whole genome but not by individual characteristics. In this context it is important to realize that Article 53 (b) EPC defines the borderline between patent protection and plant variety protection.
To sum up, 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 (Headnote I).
The next question concerns process claims which cover a plant variety as directly obtained products of the claimed process under Article 64 (2) EPC. This article stipulates that if the subject-matter of the European patent is a process, the protection conferred by the patent shall extend to the products directly obtained by such process. Here, it is essential to know that according to the established case law of the Boards of Appeal, the protection conferred by a process patent is extended to the products obtained directly by the process, even if the products are not patentable per se.
To sum up, the Enlarged Board decided that when a claim to a process for the production of a plant variety is examined, Article 64 (2) EPC is not to be taken into consideration (Headnote II).
The last question concerns plant varieties as products of processes using recombinant gene technology. Here, the Enlarged Board clarifies that it does not matter for the criteria of distinctness, homogeneity and stability whether a plant variety is the result of traditional breeding techniques, or whether genetic engineering was used to obtain a distinct plant grouping.
To sum up, plant varieties containing genes introduced into an ancestral plant by recombinant gene technology are excluded from patentability (Headnote III).
Meaning of “essentially biological processes I” (G 2/07 - Broccoli I and G 1/08 – Tomato I)
Broccoli I concerns a method for the production of Brassica oleracea with elevated levels of certain glucosinolates comprising the steps of:
- crossing wild Brassica oleracea species,
- selecting hybrids with elevated levels of such glucosinolates,
- backcrossing and selecting plant with the genetic combination encoding the expression of elevated levels of such glucosinolates, and
- selecting a broccoli line with elevated levels of such glucosinolates, wherein molecular markers are used in steps (b) and (c) to select hybrids with a genetic combination encoding expression of elevated levels of such glucosinolates.
Tomato I concerns a method for breeding tomato plants that produce tomatoes with reduced fruit water content comprising the steps of:
- crossing certain Lycopersicon plants to produce hybride seeds,
- collecting the first generation of hybrid seeds,
- growing plants from the first generation of hybrid seeds,
- pollinating the plants of the most recent hybrid generation,
- collecting the seeds produced by the most recent hybrid generation,
- growing plants from the seeds of the most recent hybrid generation,
- allowing fruit to remain on the vine past the point of normal ripening, and
- screening for reduced fruit water content as indicated by extended preservation of the ripe fruit and wrinkling of the fruit skin.
In this context it is important to know that the Board considers Rule 26 (5) EPC – the former Rule 23b (5) EPC is a copy of Art. 2 (2) of the so-called Biotech Directive of the European Union – “somewhat contradictory and difficult to understand” with respect to the term “natural phenomena”: “A process for the production of plants or animals is essentially biological if it consists entirely of natural phenomena such as crossing or selection (underlining added)”.
Therefore, the crucial issue to be decided by the Board was to determine what kind of human intervention is required to take the above processes outside the patentability exclusion.
In this respect, the Board observed that plant breeding processes are based on the sexual crossing of plants, i.e. of their whole genomes by the underlying natural phenomenon of meiosis. This kind of plant breeding process (including the subsequent selection of plants with or without technical means) is excluded from patentability under Article 53 (b) EPC.
An example of a biological process not excluded from patentability under Article 53 (b) EPC, is a process of sexual crossing and selection which includes within it an additional step introducing 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.
Another example of a biological process not excluded from patentability under Article 53 (b) EPC, is the pollination of a triploid plant by a diploid plant as pollinizer which produces sterile triploid plants. Such a process does not concern the successful meiosis of triploid plants and can, therefore, not be regarded as a conventional breeding method (T 1729/06).
For the above specified cases, it is clear that the (novel) genomes of the broccoli plant and the tomato plant were only obtained by mere sexual crossing of the plants. The additional (technical) steps serve only to select the desired plant line, but not to introduce a trait into or to modify a trait in the genome of the plant. Consequently, both claimed processes are excluded from patentability under Art. 53 (b) EPC.
Thereafter, the patent proprietors cancelled the process claims in both cases and restricted their requests to product claims which then led to the second referral, explained below.
Meaning of “essentially biological processes II” (G 2/12 - Tomato II and G 2/13 - Broccoli II)
Broccoli II concerns an edible Brassica plant produced according to a method for the production of Brassica oleracea with elevated levels of certain glucosinolates comprising the steps of:
- crossing specific wild Brassica oleracea species with broccoli double haploid breeding lines;
- selecting hybrids with levels of such glucosinolates, elevated above that initially found in broccoli double haploid breeding lines;
- backcrossing and selecting plants with the genetic combination encoding the expression of elevated levels of said glucosinolates; and
- selecting a broccoli line with elevated levels of said glucosinolates, wherein molecular markers are used in steps (b) and (c) to select hybrids with genetic combination encoding expression of elevated levels of said glucosinolates, capable of causing a strong induction of phase II enzymes.
Broccoli II also concerns an edible portion and to the seed of a Brassica plant produced according said method.
Tomato II concerns a tomato fruit of the species Lycopersicon esculentum which is
- naturally dehydrated, wherein natural dehydration being defined as wrinkling of skin of the tomato fruit when the fruit is allowed to remain on the plant after a normal ripe harvest stage,
- said natural dehydration being generally unaccompanied by microbial spoilage.
Another claimed tomato fruit of the species Lycopersicon esculentum is characterized by
- an untreated skin,
- dehydration of the fruit and wrinkling of the skin,
- said dehydration being generally unaccompanied by microbial spoilage.
The Enlarged Board summarizes that all the referred questions in Broccoli II and Tomato II is the issue of the legal scope of the process exclusion in Article 53 (b) EPC (“this provision shall not apply to microbiological processes or the products thereof”) and its impact on the patentability of product claims and product-by-process claims.
First of all, the Enlarged Board clarifies that the subject-matter of both, a product claim and a product-by-process claim, is the product as such, independently of the patentability of the process by which the product can be generated or is defined.
Applying the various methodical lines of interpretation of the exclusion in Article 53 (b) EPC, the Enlarged Board concluded that the process exclusion of Article 53 (b) EPC does not extend directly to a product claim or a product-by-process claim directed to plants or plant material such as a fruit, or to plant parts other than a plant variety, which means that product inventions where the claimed subject-matter is directed to plants or plant material such as a fruit or plant parts other than a plant variety, as such, are not excluded from being patented. In this respect it is of no relevance that the protection conferred by the product claim encompasses the generation of the claimed product by means of an essentially biological process for the production of plants excluded as such under Article 53 (b) EPC. Here, it is worth noting that, contrary to the case law under the EPC, the German Patent Law explicitly excludes any plant from patentability which is produced exclusively by an essentially biological process (§ 2a (1) 1. PatG).
The exception to patentability under Article 53 (b) EPC defines the borderline between patent protection and plant variety protection because European patents shall not be granted in respect of plant varieties or essentially biological processes for the production of plants.
The consequence of this borderline is that a transgenic plant containing a novel or modified trait in the genome – irrespective of the production process – is not excluded from patentability as long as the transgenic plant is neither limited nor directed to a plant variety. The general criteria of a plant variety are distinctness, homogeneity and stability. On the other side, a distinct, homogeneous and stable plant (plant variety) cannot be patented even if genetic engineering or other technical steps were used.
A further consequence of this borderline is that conventional methods for the breading of plant varieties as such, i.e. the sexual crossing of whole genomes of plants implying fertilization and meiosis, are still excluded from patentability. On the other side, a method which does not concern the successful meiosis of plants cannot be regarded as a conventional breeding method, and is not excluded from patentability.