The EPO Enlarged Board of Appeal sets limits for plant biotech patents
December 13, 2010
In a 72-page opinion issued on 9 December 2010 in consolidated cases G2/07 and G1/08, the Enlarged Board of Appeal of the European Patent Office has decided what inventions are eligible for protection by a European patent in the field of plant biotechnology, and what is excluded by Article 53(b) EPC. Along the way, the Board criticizes the drafting of the EU Biotech Directive (98/44/EC), is inspired by German case law from 1969, looks at the history of the exclusion back to 1961, and finds an approach to what has to be one of the most contradictory provisions in the European Patent Convention, Rule 26(5) EPC.
Article 53(b) EPC stipulates that European patents shall not be granted in respect of “[…] essentially biological processes for the production of plants […]”. The questions referred to the Enlarged Board of Appeal in the "broccoli" (G 2/07) and "tomato" (G 1/08) cases concern the interpretation of this article, and in particular how to distinguish plant production processes excluded from patent protection from non-excluded ones.
The general function of the Implementing Regulations, the Rules, is to determine in more detail how the Articles should be applied. The Enlarged Board therefore sets off its analysis in Rule 26(5) EPC, wherein it is stipulated that a process for the production of plants or animals is to be considered essentially biological “if it consists entirely of natural phenomena such as crossing or selection”.
Like the referring Boards, the Enlarged Board concludes that the wording of Rule 26(5) EPC is ambiguous, since on the one hand, processes which consist entirely of natural phenomena are considered to be essentially biological processes for the production of plants, and on the other hand, crossing and selection are given as examples of natural phenomena, despite being measures implemented by means of human intervention.
As a next step, the Enlarged Board considers the Biotech Directive and its legal history in the hope of further clarifying the meaning to be given to Rule 26(5) EPC. This turns out to be a dead end, and the Enlarged Board concludes that the contradiction between the terms of the provision is not further clarified by the legislative history of the Biotech Directive.
The Enlarged Board therefore comes to the remarkable conclusion that Rule 26(5) EPC does not give any useful guidance on how to interpret the term “essentially biological process for the production of plants” in Article 53(b) EPC. Therefore, that term has to be interpreted on its own authority.
In this regard, the Enlarged Board goes all the way back to 1961 in seeking the legislator’s original intention with this Article. It is concluded that what was intended to be excluded from patentability was the kind of breeding processes applied by plant breeders in connection with the creation of new plant varieties, for which a special property right was to be introduced under the UPOV Convention. Such processes include the sexual crossing of plants (i.e. of their whole genomes) and on the subsequent selection of the plants having the desired traits(s).
Furthermore, the Enlarged Board establishes that the mere fact of using a technical device in a breeding process should not be sufficient to give the process as such a technical character. In other words, the provision of a technical step in a process which is based on the sexual crossing of plants and on subsequent selection does not cause the claimed invention to escape the exclusion, if that technical step only serves to perform the process steps of the breeding process.
However, if a process of sexual crossing and selection includes within it an additional step of a technical nature, that process may leave the realm of plant breeding, which the legislator wanted to exclude from patentability. This additional technical step should by itself introduce a trait into the genome or modify a trait in the genome of the plant produced, so 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. A process including such an additional technical step is not excluded from patentability under Article 53(b) EPC, but qualifies as a potentially patentable technical teaching.
Niklas Mattsson & Inga-Lill Andersson
European Patent Attorneys, Stockholm office
13 December 2010