5.4.2
Essentially biological processes for the production of plants or animals 

A process for the production of plants or animals which is based on the sexual crossing of whole genomes and on the subsequent selection of plants or animals is excluded from patentability as being essentially biological. This applies even if the process comprises human intervention, including the provision of technical means, serving to enable or assist the performance of the process steps or if other technical steps relating to the preparation of the plant or animal or its further treatment are present in the claim before or after the crossing and selection steps (see G 1/08 and G 2/07). To take some examples, a method of crossing, inter-breeding, or selectively breeding, say, horses involving merely selecting for breeding and bringing together those animals (or their gametes) having certain characteristics would be essentially biological and therefore excluded from patentability. This method remains essentially biological and thus excluded from patentability even if it contains an additional feature of a technical nature, for example the use of genetic molecular markers to select either parent or progeny.

On the other hand, a process involving inserting a gene or trait into a plant by genetic engineering does not rely on recombination of whole genomes and the natural mixing of plant genes, and hence is patentable. However, claims directed to such processes may not contain crossing and selection steps.

However, if a process of sexual crossing and selection includes within it an additional step of a technical nature, which step by itself introduces 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, then such a process is not excluded from patentability under Art. 53(b) but qualifies as a potentially patentable technical teaching (see G 1/08, G 2/07).

Genetic engineering techniques applied to plants which techniques differ profoundly from conventional breeding techniques as they work primarily through the purposeful insertion and/or modification of one or more genes in a plant, are patentable (see T 356/93). However, in such cases the claims should not, explicitly or implicitly, include the sexual crossing and selection process.

Processes for selecting plants or animals using genetic molecular markers without crossing the plants or animals are not excluded from patentability. Technical means, such as genetic molecular markers, used in such processes are not excluded, either.

A process for producing triploid seedless melon fruit which involves the pollination of sterile female flowers of a triploid plant, unable to carry out successful meiosis, with pollen of the diploid polliniser plant and which therefore does not concern sexually crossing two whole genomes of plants (implying meiosis and fertilisation) and the subsequent selection of plants is not an essentially biological process and is hence not excluded from patentability (1729/06).

A process of treating a plant or animal to improve its properties or yield or to promote or suppress its growth e.g. a method of pruning a tree, would not be an essentially biological process for the production of plants or animals since it is not based on the sexual crossing of whole genomes and subsequent selection of plants or animals; the same applies to a method of treating a plant characterised by the application of a growth-stimulating substance or radiation. The treatment of soil by technical means to suppress or promote the growth of plants is also not excluded from patentability (see also G‑II, 4.2.1).

If a process of sexual crossing and selection contains within the steps of crossing and selection an additional step of a technical nature, which by itself introduces a trait into the genome or modifies a trait in the genome of the plant or animal produced, so that the introduction or modification of that trait is not the result of the mixing of the genes of the plants or animals chosen for sexual crossing, then the process is not regarded as an essentially biological process under Art. 53(b).

Claims to breeding methods leaving out an explicit reference to either a crossing or selection step, but where such a step is an essential feature, lack clarity and support (Art. 84).

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 a fruit or plant parts. 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 the exclusion from patentability of essentially biological processes for the production of animals (see also F‑IV, 4.12).

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