Validity of patents for plant breeding processes

09 February 2011

Amy Williams

Decision of EPO Enlarged Board of Appeal, 9 December 2010, Referrals G 2/07 & G 1/08

The Enlarged Board of Appeal recently heard the combined cases of G 2/07 and G 1/08 in which patents for the sexual crossing and subsequent selection of broccoli and tomato plants, respectively, were opposed on the basis of Article 53(b) of the European Patent Convention (EPC). This article specifically excludes from patentability “essentially biological processes”.

G2/07 (EP 1 069 819) concerned the crossing and selection of haploid broccoli plants with the aim being to produce a broccoli plant with increased cancer preventing compounds.  Molecular markers were used for selecting specific hybrids, considered a routine step in modern breeding processes.

G 1/08 (EP 1 211 926) concerned breeding tomatoes for low water content, involving crossing tomato plants followed by allowing the tomatoes to remain on the vine past the point of normal ripening and a screening step for determining those tomatoes with reduced water content.

Both references by the Technical Board of Appeal concerned the Article 53(b) exclusion from patentability and the extent of the requirement for a “technical step” to create a patentable process.

Article 2(2) of the EC Biotechnology Directive (98/44/EC), referred to as a supplementary means of interpretation, defines an “essentially biological” process as one which “consists entirely of natural phenomena such as crossing or selection.”  Consequently, processes for the production of plants based on the 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, are excluded from patentability pursuant to Art. 53(b) EPC.

The Enlarged Board concluded that the amount and effect of the human intervention determined whether the process escaped the exclusion of patentability. The impact from the human intervention must be decisive and the contribution must be more than trivial.  A technical step which cannot be carried out without human intervention and which by itself introduces a trait into the genome or modifies a trait in the genome of the plant produced, such 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, is a process that is no longer considered plant breeding: it is not “essentially biological” and is a potentially patentable technical teaching.

The Enlarged Board made clear that the above reasoning applies only when the technical step is performed within the steps of sexually crossing and selection, otherwise the Art 53(b) exclusion could be circumvented by simply adding steps before or after the process of crossing and selection.