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EPO – Enlarged Board of Appeal decides on the exclusion from patentability of “essentially biological processes”

Posted: December 16th, 2010

EPO, Enlarged Board of Appeal, decision of 9 December 2010 in consolidated cases G 2/07 – Broccoli/PLANT BIOSCIENCE and G 1/08 – Tomatoes/STATE OF ISRAEL

The Enlarged Board of Appeal (EBA) answered the question referred to it by Technical Board of Appeal in T 83/05 (OJ EPO 2007, 644) and T 1242/06 (OJ EPO 2008, 523) 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.”

The inventions underlying the referring decisions concern methods of producing vegetables with desired properties, the methods comprising steps of crossing and selection. In the broccoli case molecular markers are used for selecting appropriate candidates, in the tomato case the fruit remains on the vine past the point of normal ripening in order to be screened for desired properties. On the basis of the criteria laid down by the EBA in its answers, Technical Board of Appeal 3.3.04 will have to decide whether the processes are directed to patentable subject-matter.

Continue reading G 1/08:

At the outset, the EBA states that it is within the competence of the Administrative Council to determine the boundaries of patentable subject-matter in the Implementing Regulations, the only limit being Article 164(2) EPC according to which in case of conflict the provisions of the Convention itself prevail.

As to the interpretation of Rule 26(5) EPC (identical to Article 2(2) Biotech Directive) stipulating 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 EBA states that the provision is ambiguous if not contradictory since crossing and selection are given as examples of natural phenomena, whereas systematic crossing and selection are in fact implemented by means of human intervention. An extensive examination of the legislative history of the Biotech Directive only leads to the result that the contradiction between the terms of the provision cannot be further clarified. In the absence of any further guidance, the EBA interprets the provision on its own authority. From the term “essentially” it is deduced that the provision cannot be interpreted that any technical feature, irrespective of its importance for an otherwise biological process is sufficient for escaping the exclusion. On the other hand, criteria linking the decision to the state of the art are not considered appropriate since the considerations relevant for patentability must not be conflated with those for novelty and inventive step.

Examining the purpose of Art. 53 b) EPC on the basis of the historical documentation, the Board concludes that the legislator’s intention was to exclude from patentability the kind of plant breeding processes which were the conventional methods of that time which were characterised by the fact that the traits of the plants resulting from crossing were determined by the underlying natural phenomenon of meiosis, i.e. the breeding result was achieved by the breeder’s selection of plants having the desired traits. Finally, the Board concludes that 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 step only serves to perform the process steps of the breeding process.

However, if an additional technical step by itself introduces a trait into the genome or modifies a trait in the genome of the plant, the process leave the realm of plant breeding and the process is note excluded. In order to exclude circumvention this applies only if the additional step is performed within the steps of sexually crossing and selection, independently from their number of repetitions. Any additional steps performed before or after crossing or selection have to be ignored when determining whether a process is excluded under Art. 53 b) EPC.

Read decision G 1/08 (in English, text identical to G 2/07) here.

Headnote and summary: Rudolf Teschemacher

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