Article 53(b) EPC states that “European patents shall not be granted in respect of ... plant or animal varieties or essentially biological processes for the production of plants or animals; this provision does not apply to microbiological processes or the products thereof”.

Rule 23b(5) EPC provides a definition of what is meant by “essentially biological processes”, stating that a “process for the production of plants or animals is essentially biological if it consists entirely of natural phenomena such as crossing or selection”.

The originally granted patent, EP 1069819, relates to a method for producing plants such as broccoli with elevated levels of chemicals called glucosinolate derivatives, which have anti-cancer properties. This is done by crossing wild broccoli species with broccoli breeding lines. Hybrids of the two which have an elevated level of 4-methylsulfinylbutyl and/or 3-methylsulfinylpropyl glucosinolates are identified using molecular markers.

The Enlarged Board of Appeal is to decide whether or not this method falls within the Article 53(b) exclusion. The questions which have been put to the Enlarged Board of Appeal are:

1. Does a non-microbiological process for the production of plants which contains the steps of crossing and selecting plants escape the exclusion of Article 53(b) EPC merely because it contains, as a further step or as part of any of the steps of crossing and selection, an additional feature of a technical nature?

2. If question 1 is answered in the negative, what are the relevant criteria for distinguishing non-microbiological plant production processes excluded from patent protection under Article 53(b) EPC from non-excluded ones? In particular, is it relevant where the essence of the claimed invention lies and/or whether the additional feature of a technical nature contributes something to the claimed invention beyond a trivial level?

The Patentee has argued that the exclusion should be interpreted narrowly, and that use of the molecular markers constitutes a technical step over and above the production of the hybrid broccoli. The method is not just an “essentially biological process” as it consists of a step which is not a natural phenomenon. In addition, the patentee argued that the method is patentable as it requires the use of a non-natural starting material, and because the wild strains require human intervention to being them into contact with the broccoli breeding lines.

The Appellants (who were the Opponents in the earlier Opposition Proceedings) have argued that the use of the molecular markers is insufficient to escape the exclusion provisions of Article 53(b). It was argued that Rule 23b(5) does not contain an exhaustive definition of the excluded processes and that Article 53(b), which has a higher legislative rank than Rule 23b(5) according to Article 164(2) EPC, only excludes “essentially biological processes”. This definition includes the method of EP 1069819, even including the use of the molecular markers.

Despite a review of the legislative history behind Article 53(b) and Rule 23b(5) EPC, the Technical Board of Appeal felt unable to reach a decision regarding the interpretation of the exclusion to patentablility.

The Board pointed out an anomaly in that, according to Rule 23b(5) EPC, only processes which consist entirely of natural phenomena are considered to be essentially biological processes for the production of plants (Rule 23b(5) EPC). In addition, crossing and selection are given as examples of natural phenomena, when, in traditional plant breeding, the systematic crossing and selection would not occur without human intervention.

The review of case law relevant to the issue at hand identified that the mere requirement of human intervention in itself in a non-microbiological process was not necessarily sufficient for a process to not be “essentially biological”, but significant technical modifications to a process have been held to be sufficient. However, there has to date not been a Decision which deals explicitly with the limits of the exclusion.

This Enlarged Board of Appeal Decision is currently pending under the reference number G 2/07. A final Decision is not expected for at least a year.

For further information on this issue, please contact a member of our Life Sciences and Chemistry Group.

Chris McDonald
Life Sciences and Chemistry Group
September 2007