440-600-1992

EPO Denies Patents for Essentially Biological Breeding Processes

Last month, the European Patent Office (EPO) Enlarged Board of Appeals issued its ruling in what has been commonly referred to as the "broccoli"[i] and tomato"[ii] cases. These cases, issued in joint and identical opinions, revolve around the interpretation of European Patent Convention (EPC) Article 53(b), which states in part, "European patents shall not be granted in respect of: (b) plant or animal varieties or essentially biological processes for the production of plants or animals."[iii] The primary question at issue in these cases was, "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?"[iv]

Upon reviewing the two cases' history, the submissions by all involved parties, and the third party submissions, the Board reviewed the applicable law and how it explored the function of EPC Article 53(b).[v] The Board found the following elements to be relevant to determine if a process is or is not essentially biological:

1. The totality of human intervention and its impact on the result achieved is to be determined.

2. This has to be judged on the basis of the essence of the invention.

3. The impact must be decisive.

4. The contribution must go beyond a trivial level.

5. The totality and the sequence of the specified operations must neither occur in nature nor correspond to the classical breeders' processes.

6. The required fundamental alteration of the character of a known process for the production of plants may lie either in the features of the process, i.e. in its constituent parts, or in the special sequence of the process steps, if a multistep process is claimed. In some cases the effect of this can be seen in the result.[vi]

Basing their decision primarily on legislative intent,[vii] the Board concluded that "a process for the production of plants which is based on the sexual crossing of whole genomes and on the subsequent selection of plants, in which human intervention, including the provision of a technical means, serves to enable or assist the performance of the process steps, remains excluded from patentability as being essentially biological within the meaning of Article 53(b) EPC."[viii] However, the Board did leave the door open for "a process of sexual crossing and selection [which] includes within it 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."[ix] A process of that type "leaves the realm of the plant breeding, which the [legislature] wanted to exclude from patentability" and, therefore, would not be excluded by Article 53(b).[x]

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