On 9 December 2010 the Enlarged Board of Appeal (EBA) of the European Patent Office (EPO) gave judgment on the patentability of certain plant breeding methods. The EBA ruled that breeding methods consisting of the sexual crossing of plants and subsequent selection could be excluded from patentability as being “essentially biological processes” under Art. 53 (b) European Patent Convention (EPC) even if technical steps were involved in the breeding method.
In case G 2/07, the opposed patent, EP 1 069 819, concerned inter alia methods for breeding of certain broccoli plants allegedly having a cancer prevention effect. In the claimed method molecular markers were used for the selection of specific hybrids. This was considered to be a routine step in modern breeding processes.
In case G 1/08, the opposed patent EP 1 211 926 concerned breeding methods for tomatoes having a low water content, which are easy to process industrially. These tomatoes have become known as so-called “wrinkled tomatoes”. The claimed breeding method involved a step of allowing the fruit to remain on the vine past the point of normal ripening. Furthermore, it encompassed a screening step for determining the reduced fruit water content as extended by preservation of the ripe fruit and wrinkling of the fruit skin.
The patents were opposed by competitors of the patentees. The EPO Technical Board of Appeal referred certain questions to the EBA concerning the exclusion from patentability of “essentially biological processes” for the production of plants pursuant to Art. 53 (b) EPC.
According to Rule 26(5) EPC 2000, a process for the production of plants is “essentially biological” if it consists entirely of natural phenomena such as crossing or selection. The EBA came to the conclusion that the provision of a technical step in a process based on sexual crossing of plants and subsequent selection would not cause the claimed invention to escape the exclusion of patentability should that step only serve to perform the breeding process.
The EBA held that the clear intention of the legislator by choosing the expression “essentially biological” could not be ignored, given that the wording of the provision had remained unchanged over time. The mere fact of using a technical device in a breeding process should not be sufficient to give the whole process a technical character. Processes for the production of plants based on the sexual crossing of whole genomes and on the subsequent selection of plants, in which human intervention served to enable, or assist, the performance of process steps otherwise based on biological forces, would remain excluded from patentability pursuant to Art. 53 (b) EPC.
The EBA indicated that the exclusion under Art. 53 (b) EPC would not apply if the additional technical step in itself introduced a trait into the plant’s genome or modified such trait within a genome, without being the result of merely mixing the genes of the plants chosen for selection. The technical step must be performed within the steps of sexually crossing and selection. Additional steps dealing, for example, with the preparation of the plants to be crossed, or with the further treatment of the plants resulting from such crossing and selection process, would not suffice. These measures such as genetic engineering techniques would per se be patentable, however, respective claims should not include the sexual crossing and selection process.
The EBA further emphasised that when determining the presence of an “essentially biological process” it was not relevant whether a technical step was new or known, whether it was trivial or a fundamental alteration of a known process, whether it could occur in nature or whether it would provide the essence of the invention.
There was no discussion by the EBA of ethical or moral considerations of the patenting of natural material. In patent law it is acknowledged that micro-organisms, plants, biological material including genes and even animals are generally patentable as technical inventions in certain circumstances. In relation to plants and animals this is explicitly stipulated in Recital 29 of the Biotechnology Directive 98/44/EC. Any technical teaching, which can be reproduced by the person skilled in the art can be an invention generally subject to patent protection (Federal Court of Justice, decision of 27 March 1969, IIC 1970, 136 - Red Dove).
In summary, in cases G 2/07 and G 1/08 the EBA provided some guidelines as to whether and when a process for the production of plants is considered to be “essentially biological”. However, the question whether the exclusion under Art. 53 (b) EPC applies will continue to be decided on a case-by-case basis.