Broccoli, tomatoes and pepper: Why the EU may block protection of GM plants

A vote on controversial proposals to stop patent protection for plants derived from ‘New Genomic Technologies’ will have a big impact on agritech, explains Richard Maclennan of Appleyard Lees.

Can you get patent protection for a new plant variant? As long as the plant is not produced by essentially biological processes, then yes. However, change might be on the way.

In this article, we discuss the proposed EU regulation for the release of plants produced by new genomic technologies.

We also look at how this regulation might affect the previously established Biotech Patent Directive, and patent protection available for new plant variants.

Prior to July 1, 2017, patents for products and plants formed by “essentially biological processes” were patentable, as confirmed by European Patent Office (EPO) appeal decisions G2/13 and G2/12 of March 2015 (commonly referred to as “Tomatoes II” and “Broccoli II”).

However, the European Parliament then stated that this was not the intention of the Biotech Patent Directive 98/44/EC, and that the directive was intended to exclude from patentability those products and plants that are obtained by means of essentially biological processes.

A subsequent EPO Board of Appeal decision (G3/19 “Pepper”) confirmed that products obtained by essentially biological processes are not patentable in Europe, a more detailed review can be found here.

Agritech and patent practitioners are used to taking these provisions into account when drafting patent specifications, and discussing IP strategy, over the last few years. Industry and patent practitioners reasoned that the debate had been settled for the time being, but the European Parliament has other ideas.

Proposals to exclude genomic plants from patentability

In January 2024, the European Parliament voted on the first reading of a new draft R regulation for plants produced by certain “New Genomic Technologies” (NGT). The proposal by the European Commission aims to provide a framework for the deliberate release of NGT plants, and the marketing of products such as food and feed derived from NGT plants.

As part of the proposal, amendments to the Biotech Patent Directive have been suggested, which include excluding from patentability all NGT plants (plants obtained by new genomics techniques such as targeted mutagenesis and cisgenesis) as well as plants obtained by random mutagenesis or cell fusion.

The exclusion would extend to plant parts, and plant material thereof, as well as to genetic information and process features found in such plants. In addition, the exclusion would include biological material possessing the same characteristics as a patented plant but which is obtained independently of the patented plant and also to biological material obtained from such material through propagation or multiplication. This exclusion is in addition to the current exclusion of products and plants obtained by means of essentially biological processes.

The proposed exclusion to patentability as a consequence of amendments to the Biotech Patent Directive could affect European patents granted after the date of entry into force of the amendments. The European Patent Convention (EPC) specifically refers to the Biotech Patent Directive (Rule 26 EPC) and the amendments would presumably be adopted by the European Patent Office (EPO), which would cause the proposed exclusions to affect European patents.

Monopoly issue

According to the European Commission Committee on Environment, Public Health and Food Safety (ENVI), the amendments and exclusions to patentability have been proposed because “allowing for new genomic techniques and their results to be patented risks giving multinational seed companies even more power over farmers’ access to seeds” and that “in a context where large companies already have a monopoly on seeds and increasingly control natural resources, this would deprive farmers of all freedom of action by making them dependent on private companies“.

It should be recognised that current patent protection for plants is limited by a general research exemption and by plant breeders’ exemptions implemented by many EU Member States, EPC Contracting States and the new Unitary Patent system.

For example, the UK Patents Act 1977 makes it clear that farmers are permitted to propagate and multiply seeds that result from their own harvest if the original seeds were obtained from the patent proprietor for the purposes of agriculture without the risk of infringing the proprietor’s patent. This exclusion to infringement is an attempt to balance the need for innovation in the field of agriculture often carried out using large investments in R&D expenditure with the needs of farmers and food security of the UK.

Since the proposed amendments are to the Biotech Patent Directive it is not expected that there would be any impact on Plant Variety Rights (PVRs) which are another form of intellectual property available in Europe and the UK.

It is therefore possible that if the amendments to the Biotech Patent Directive are adopted PVRs may become an increasingly important way of protecting intellectual property relating to plants. Further information regarding the plant variety system can be found here, and in this podcast.

Whether or not the European Parliament incorporate the amendments to the Biotech Patent Directive, there is sure to be extensive lobbying both for and against these proposed amendments and we will be keeping an eye on developments.

Richard Maclennan is a trainee patent attorney at Appleyard Lees.