5.4
Plant and animal varieties or essentially biological processes for the production of plants or animals 

The list of exceptions to patentability under Art. 53(b) also includes "plant or animal varieties or essentially biological processes for the production of plants or animals".

Rule 28(2) excludes products (plants/animals and plant/animal parts) exclusively obtained by non-technical, i.e. essentially biological, processes. This exclusion regarding plants and animals exclusively obtained by means of an essentially biological process applies to patent applications with a filing date and/or a priority date after 1 July 2017. It does not apply to patents granted before that date or to pending patent applications with a filing date and/or a priority date before 1 July 2017 (see G 3/19, OJ EPO 2020, A119).

Thus the The exclusion extends to plants and animals exclusively obtained by means of an essentially biological process where no direct technical intervention in the genome of the plants or animals takes place, as the relevant parental plants or animals are merely crossed and the desired offspring is selected for. This is the case even if technical means are provided serving to enable or assist the performance of the essentially biological steps. In contrast, plants or animals produced by a technical process which modifies the genetic characteristics of the plant or animal are patentable.

The term exclusively is used here to mean that a plant or animal originating from a technical process or characterised by a technical intervention in the genome is not covered by the exclusion from patentability even if in addition a non-technical method (crossing and selection) is applied in its production.

Determining whether a plant or animal is obtained by exclusively biological means entails examining whether there is a change in a heritable characteristic of the claimed organism which is the result of a technical process exceeding mere crossing and selection, i.e. not merely serving to enable or assist the performance of the essentially biological process steps.

Thus transgenic plants and technically induced mutants are patentable, while the products of conventional breeding are not.

Both targeted mutation, e.g. with CRISPR/Cas, and random mutagenesis such as UV-induced mutation are such technical processes. When looking at the offspring of transgenic organisms or mutants, if the mutation or transgene is present in said offspring it is not produced exclusively by an essentially biological method and is thus patentable.

Furthermore, for living matter to be patentable, it must be possible to reproduce it in a way that has exactly the same technical features. Reproducibility can be assured for example:

(1) 
By a deposit of the living matter (seeds, microbiological strains). The deposited material must be publicly available and such that the invention can actually be reproduced starting from it. If, for example, a novel and inventive trait is due to a single transgene, a skilled person can reproduce the invention from a living sample. If, instead, the claimed trait is dependent on a large number of structurally undefined loci in the genome, these will segregate in subsequent generations and it will be an undue burden to reproduce the invention from the deposited sample (T 1957/14).
(2) 
By disclosing in the application as filed the gene sequence responsible for the claimed trait together with instructions on how to reproducibly introduce by technical means such an altered sequence in a target organism (e.g. by CRISPR-Cas). 

If a technical feature of a claimed plant or animal, e.g. a single nucleotide exchange in the genome, might be the result of either a technical intervention (e.g. directed mutagenesis) or an essentially biological process (a natural allele), a disclaimer is necessary to delimit the claimed subject-matter to the technically produced product in order to comply with the requirements of Art. 53(b) and Rule 28(2). Otherwise the application is considered to relate to excluded subject-matter and is to be refused on the basis of Art. 53(b) in conjunction with Rule 28(2). A disclaimer is required in all cases and, in particular, even if the description only mentions a technical method of production and is silent on the use of an essentially biological process. If, on the other hand, the feature in question can unambiguously be obtained by technical intervention only, e.g. a transgene, no disclaimer is necessary.

This should apply also if such a disclaimer relates to subject-matter that was not disclosed in the application as filed. In such a case the disclaimer fulfils the requirements laid down in G 1/03, G 2/03 and G 1/16 because it is introduced to exclude subject-matter not eligible for patent protection (for the general principles governing disclaimers see also H‑V, 3.5, and H‑V, 4).

Such a disclaimer will only be necessary for patent applications with a filing date and/or a priority date after 1 July 2017. A disclaimer will not be required for patents granted before that date or for pending patent applications with a filing date and/or a priority date before 1 July 2017 (see G 3/19, OJ EPO 2020, A119).

The technicality of a claimed plant or animal product may lie in a non-heritable physical feature imparted directly to the claimed organism, e.g. a seed coated with a beneficial chemical.

The technical method of production of the plant or animal may be included in the claims, in the form of product-by-process claims (see F‑IV, 4.12).

Plant products that are not propagation material, such as flour, sugars or fatty acids, have to be considered on the basis of their chemical properties only. Thus provided the general patentability requirements are fulfilled, it will not be relevant whether the subject-matter (e.g. a sugar molecule) is isolated from a product (e.g. a living plant) of an essentially biological process or is produced in a laboratory.

Examples are provided below under G‑II, 5.4.2.1.

This exclusion regarding plants and animals exclusively obtained by means of an essentially biological process does not apply to patents granted before 1 July 2017 or to pending patent applications with a filing date and/or a priority date before 1 July 2017 (see G 3/19, OJ EPO 2020, A119).

For these applications and these granted patents, the exclusion from patentability of essentially biological processes for the production of plants does not have a negative effect on the allowability of a product claim directed to plants or plant material such as seeds or other plant propagation material. This applies even if the only method available at the filing date for generating the claimed plants or plant material is an essentially biological process for the production of plants, and also if the claimed product is defined in terms of such a process (product-by-process claim, see F-IV, 4.12). In this context 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 (see G 2/12 and G 2/13). The same principle applies mutatis mutandis with regard to animals produced by means of essentially biological processes (see also F-IV, 4.12).

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