5.4.2 Essentially biological processes for the production of plants or animals
A revised version of this publication entered into force.
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, interbreeding, 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. Also selfing of a transgenic plant is excluded from patentability, as selfing, like crossing, is the mixing of entire genomes. These methods remain essentially biological and thus excluded from patentability even if they contain an additional feature of a technical nature, for example the use of genetic molecular markers to select either parent or progeny. Patent protection is available for any such additional technical steps per se which are performed either before or after the process of crossing and selection. However, such steps are ignored when determining whether or not the process as a whole is excluded from patentability under Art. 53(b) EPC (see G 1/08, G 2/07).
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 must 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 (T 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).
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 abbreviation NBT stands for "new breeding techniques". This is not a technical term, but a general one which is used for a variety of methods, some clearly technical but others either comprising or consisting of essentially biological processes. Therefore it is not suitable to differentiate whether claimed subject-matter is allowable under Art. 53(b) and has no relevance in terms of patentability.