What are some biological patent issues

Guidelines for Examination

Essentially biological processes for breeding plants or animals

A method of breeding plants or animals which is based on the sexual crossing of entire genomes and the subsequent selection of plants or animals is excluded from patentability because it is essentially biological. This applies even if the process includes human participation including the provision of technical means that serve to enable or support the execution of the process steps, or if other technical steps are specified in the claim before or after the steps of crossing and selection Preparation of the plants or animals or for their further treatment (see G 1/08 and G 2/07).

Some examples are given below: A method of crossbreeding or crossbreeding or a selective breeding method, for example for horses, in which only those animals (or their germ cells) are selected for breeding and merging that have certain characteristics would be essentially biological and thus of excluded from patentability. Likewise, the selfing of a transgenic plant would be excluded from patentability, since selfing, like crossing, is a mixture of entire genomes. These methods remain essentially biological and excluded from patentability, even if they include an additional feature of a technical nature, such as the use of molecular genetic markers to select parents or offspring. All these additional technical steps, which are carried out either before or after the crossing and selection process, are available as such for patent protection. However, these steps should be disregarded when deciding whether a process as a whole is excluded from patentability under Art. 53 b) or not (see G 1/08, G 2/07).

However, if a process of sexual crossing and selection contains an additional technical process step which itself introduces a trait into the genome of the plant being bred or modifies a trait in its genome, so that the introduction or modification of this trait is not done by mixing the genes of the plant being grown If selected plants are crossed, such a process is not excluded from patentability according to Art. 53 b), but is to be regarded as a potentially patentable technical teaching (see G 1/08, G 2/07).

Genetic engineering methods used in plants, which differ significantly from conventional breeding processes because they are primarily based on the targeted introduction of one or more genes into a plant and / or the modification of their genes, are patentable (see T 356/93). In such cases, however, the process of sexual crossbreeding and selection must neither be explicitly nor implicitly the subject of the claims.

Processes for the selection of plants or animals using molecular genetic markers without crossing the plants or animals are not excluded from patentability. Technical means used in such procedures, such as molecular genetic markers, are also not excluded.

A method of making triploid seedless watermelons that involves pollinating sterile female flowers of a triploid plant that are unsuccessful in meiosis with pollen from the diploid pollinator, and thus not sexually crossing the entire genome of two plants (with meiosis and fertilization) and the subsequent selection of plants is not an essentially biological process and is therefore patentable (T 1729/06).

A method of treating plants or animals to improve their properties or their yields or to promote or suppress their growth, for example a method of pruning trees, would not be an essentially biological method because it is not based on the sexual crossing of entire genomes and the subsequent selection of plants or animals based; the same applies to a method for treating plants, which is characterized in that a growth-promoting substance or growth-promoting radiation is used. The treatment of the soil with technical means to suppress or promote the growth of plants is not excluded from patentability (see also G ‑ II, 4.2.1).

Claims to breeding processes in which either the crossing or the selection step is not expressly mentioned, although such a step is an essential characteristic, do not meet the requirements of clarity and support (Art. 84).

The abbreviation NBT stands for "new breeding techniques". This is not a technical term, but a generic term used to refer to a wide variety of processes, some of which are clearly technical, but others consist of or comprise essentially biological processes. It is therefore not appropriate to differentiate between whether the subject-matter of the claim is allowable under Art. 53 b) and irrespective of whether it is patentable.