Home > Insights > Broccoli and wrinkly tomatoes

Author: Matthew Spencer
1 December, 2011

On 9 December 2010 the Enlarged Board of Appeal of the European Patent Office handed down its decision in consolidated proceedings based upon referrals G2/07 and G1/08. The referrals were made in an attempt to clarify the correct interpretation of Article 53(b) EPC relating to the exclusion from patentability of essentially biological processes for the production of plants (and animals).

Each of the two referred cases concerned claims to methods for the production of plants involving crossing and subsequent selection steps. The issue to be resolved was whether technical steps included in a crossing and selection process, or steps which were “non-natural” and thus required human intervention, when included in a claim, were sufficient to take that claim outside the exclusion from patentability under article 53(b) EPC. The Technical Board of Appeal referred two questions in each case, all of which were answered by the Enlarged Board.

The questions were as follows:

G2/07
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?

G1/08
1. Does a non-microbiological process for the production of plants consisting of steps of crossing and selecting plants fall under the exclusion of Article 53(b) EPC only if these steps reflect and correspond to phenomena which could occur in nature without human intervention?

2. If question 1 is answered in the negative, does a non-microbiological process for the production of plants consisting of steps of crossing and selecting plants escape the exclusion of Article 53(b) EPC merely because it contains, as part of any of the steps of crossing and selection, an additional feature of a technical nature?

The Enlarged Board received observations from all parties to the proceedings and also from the President of the European Patent Office together with a number of amicus curiae briefs. One of the difficult issues for the Enlarged Board to resolve was the apparent contradiction between the wording of Article 53(b) EPC and Rule 26(5) EPC, which serves to define the term “essentially biological process”. The definition of Rule 26(5) EPC suggests 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 Enlarged Board immediately appreciated the difficulty with this definition, namely that the terms “crossing” and “selection” refer to acts performed by a breeder and therefore rely upon an intervention which can not be considered a natural phenomenon. They reviewed the relevant legislative history and concluded that “regrettably, Rule 26(5) EPC does not give any useful guidance on how to interpret the term “essentially biological process for the production of plants””.

The Enlarged Board also confirmed that the exception from patentability of an essentially biological process for the production of plants could not be read as only applying where the result of the process was a plant variety. Thus, the exclusion applies to production of plants generally.

The Enlarged Board also placed emphasis on the clear intention of the legislator behind including the term “essentially” in the statute. On this basis, they indicated that the provision of a technical step, whether explicit or implicit, in a process which is based on 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. Thus, the term “essentially” appears much broader than the originally proposed term “purely” and inclusion of a technical step which simply assists with or enhances the biological steps of crossing and selecting will not suffice to avoid the exclusion under Article 53(b) EPC.

The answers given by the Enlarged Board were thus as follows:

1. A non-microbiological process for the production of plants which contains or consists of the steps of sexually crossing the whole genomes of plants and of subsequently selecting plants is in principle excluded from patentability as being “essentially biological” within the meaning of Article 53(b) EPC.

2. Such a process does not 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, a step of a technical nature which serves to enable or assist the performance of the steps of sexually crossing the whole genomes of plants or of subsequently selecting plants.

3. If, however, such a process contains within the steps of sexually crossing and selecting an additional step of a technical nature, which step by itself introduces a trait into the genome or modifies 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, then the process is not excluded from patentability under Article 53(b) EPC.

4. In the context of examining whether such a process is excluded from patentability as being “essentially biological” within the meaning of Article 53(b) EPC, it is not relevant whether a step of a technical nature is a new or known measure, whether it is trivial or a fundamental alteration of a known process, whether it does or could occur in nature or whether the essence of the invention lies in it.

Thus, it appears that the exclusion from patentability under Article 53(b) EPC will be interpreted broadly in cases where the invention aims at the production of plants through crossing or election procedures. Whilst the decision focuses solely on plant production, it is assumed the decision will be applied mutatis mutandis to processes for the production of animals. The only clear manner in which to avoid the exclusion lies in the inclusion of additional steps of a technical nature which somehow create a trait in the progeny which are not a direct result of the crossing, for example inclusion of a heterologous gene by recombinant DNA. For all other technical steps, it would appear to be necessary to direct claims to those steps per se, without reference to any crossing and selection steps in order to avoid the exclusion.

Author

Matthew Spencer
Partner

Phone this number +44 (0)1223 883000

Email this address mspencer@boult.com

CPC4 Capital Park
Cambridge Road
Cambridge
CB21 5XE