Rule 28(2) excludes products (plants/animals and plant/animal parts) exclusively obtained by non-technical, i.e. essentially biological processes. Thus 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.
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.
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).
TheAdditionally, 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).
For the general principles governing disclaimers by which plants and animals excluded from patentability are removed from protection, see H‑V, 3.5 and 4.
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, 18.104.22.168.