3.3.1 Essentially biological processes for the production of animals

In T 19/90 (OJ 1990, 476) the board agreed that the process claims for the production of transgenic non-human mammals through chromosomal incorporation of an activated oncogene sequence into the genome of the non-human mammal did not involve an "essentially biological process". The product claim for the genetically-manipulated animal included descendants not directly genetically manipulated themselves but produced by the essentially biological process of sexual reproduction. The board held that this was a product claim defined in terms of the process by which it was produced and that a product-by-process claim remained a product claim irrespective of the process it referred to.

In T 315/03 (OJ 2006, 15) the board held that the claimed process for producing transgenic mice, which included genetic manipulation, was not "an essentially biological process", the latter being defined in R. 23b(5) EPC 1973 (R. 26(5) EPC) as consisting "entirely of natural phenomena such as crossing or selection".

In T 1199/08 appellant II argued that if the technical teaching of the patent as a whole was taken into account, it became obvious that the only purpose of the claimed method was the production of an animal. The board rejected the argument that the "whole contents approach" developed in G 2/06 should be taken into consideration for a correct assessment of whether the claim in question would fall under the prohibition of Art. 53(b) EPC. It also decided that a claim to a method which allowed for the long-term preservation of sex-selected sperm did not qualify as an essentially biological process for the production of animals. Therefore, in line with the parallel reasoning developed in G 2/07 regarding processes for the production of plants (see below), it did not fall under the prohibition of Art. 53(b) EPC.

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