October 2, Munich - the European Patent Office ("EPO") upheld the European patent EP 2 384 110 of Carlsberg Breweries A/S and Heineken Supply Chain B.V., relating to a barley plant with reduced lipoxygenase (LOX) activity and beverage prepared therefrom, having an increased flavour stability. The barley plants have been obtained from a process comprising a step of chemical mutagenesis. Chemical mutagenesis is a form of mutagenesis, resulting in random modifications of the genome of the plant (as opposed to targeted mutation or 'gene editing' methods, such as CRISPR/Cas).
Photo: Photo by Ruslan Zh on Unsplash
Over the past years, there has been uncertainty in the EU about the patentability of plant material obtained from essentially biological processes, including conventional breeding by crossing and selection. Article 53(b) of the European Patent Convention ("EPC") provides that essentially biological processes for the production of plants are excluded from patentability. In the well-known Broccoli I (G2/07) and Tomato I (G1/08) cases, the Enlarged Board of the EPO ruled that a process for the production of plants, which is based on the sexual crossing of the whole genomes and on the subsequent selection of plants, whereby technical measures merely serve to enable or assist the performance of the process steps, remain excluded from patentability. There should be an additional technical step that introduces a trait in a genome or modifies a trait in a genome of the plant produced, in order for a process for the production of a plant to be patentable. Article 53(b) EPC expressly excludes essentially biological processes but does not explicitly exclude plants obtained from such processes. In the following Broccoli II and Tomato II cases, the Enlarged Board of the EPO held that plants obtained from an essentially biological process are patentable. However, in June 2017 the EPO followed the opinion to the contrary of the European legislator and introduced a new rule, clarifying that plants exclusively obtained by means of an essentially biological process are excluded from patentability.
In the present matter, the opponents argued, among other things, that the claims relating to the barley plant did not only cover the plants resulting from the patented process but also plants inheriting the same or similar genetic conditions and phenotypical characteristics stemming from native traits or other methods applied in conventional breeding. Furthermore, according to the opponents the decisions of the Enlarged Board in the Broccoli I and Tomato I cases should be understood in such a way that only if the introduction or modification is targeted and not derived random, the process should not be excluded from patentability. The EPO upheld the patent in amended form, allowing the disclaimer 'with the proviso that the barley plant has not exclusively been obtained by means of an essentially biological method'. The outcome is in line with the Guidelines (November 2018) of the EPO on the exclusion of patentability, in which it is stated that both targeted mutations and random mutagenesis are considered technical processes.
The written decision of the EPO is expected in a few weeks. The decision will be open to appeal within two months after notification of the decision.
About the author: Fleur Tuinzing-Westerhuis is a Counsel at Houthoff. She specialises in technology-related Intellectual Property matters, with a focus on Patents and Plant Variety Rights. In her daily practice, Fleur represents a wide variety of domestic and international companies that are active in technology-intensive business sectors, such as agrifood and biotech. Fleur is an experienced patent litigator and is one of only a handful of lawyers in the Netherlands with extensive experience in litigation relating to national and Community plant variety rights. Read more...