GL G II 5.5.1 General remarks

As expressly stated in Art. 53(b), second half-sentence, the exception referred to in the first half-sentence does not apply to microbiological processes or the products thereof.[Art. 53(b); Rule 26(6); ]

"Microbiological process" means any process involving or performed upon or resulting in microbiological material.

GL G II 5.5 Microbiological processes

5.5.1 General remarks

5.5.2 Repeatability of results of microbiological processes

GL G II 5.4.2.1 Examples

The following subject-matter relates to essentially biological processes excluded from patentability:

– Method for the production of plants having trait X comprising crossing plants A and B and selecting progeny having marker X.

– Use of a (transgenic) plant for generating further plants by crossing and selection.

GL G II 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.

GL G II 5.4.1 Plant varieties

The term "plant variety" is defined in Rule 26(4). A patent is not to be granted if the claimed subject-matter is directed to a specific plant variety or specific plant varieties. The method for the plant's production, be it by recombinant gene technology or by a classical plant breeding process, is irrelevant for considering this issue (see T 1854/07).

GL G II 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".[Art. 53(b); ]

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 ess

GL G II 5.3 List of exceptions ( Rule 28 )

In the area of biotechnological inventions, the following list of exceptions to patentability under Art. 53(a) and Art. 53(b) is laid down in Rule 28.

GL G II 5.2 Patentable biotechnological inventions

In principle, biotechnological inventions are patentable under the EPC. For European patent applications and patents concerning biotechnological inventions, the relevant provisions of the EPC are to be applied and interpreted in accordance with the provisions of Rules 26 to 29. European Union Directive 98/44/EC of 6 July 1998 on the legal protection of biotechnological inventions (OJ EPO 1999, 101) is to be used as a supplementary means of interpretation.

GL G II 5.1 General remarks and definitions

"Biotechnological inventions" are inventions which concern a product consisting of or containing biological material or a process by means of which biological material is produced, processed or used. "Biological material" means any material containing genetic information and capable of reproducing itself or being reproduced in a biological system.[Rule 26(2); (3); ]