EU Commission Proposal
On 5 July 2023, the European Commission proposed a new legislative initiative regarding plants obtained by certain new genomic techniques (NGTs) and food and feed containing them. The proposal would adapt the EU’s current GMO framework and, according to the Commission, make NGTs subject to the “appropriate level of regulatory oversight”. The new framework is specifically targeted at regulating GMOs obtained by targeted mutagenesis and cisgenesis and related products following their deliberate release into the environment or when they are placed on the market. The European Commission expressed concern that failure to adapt the EU’s regulatory framework to NGTs could leave the EU at risk of being largely excluded from the technological developments and economic, social and environmental benefits that these new technologies can potentially generate.
The Regulation distinguishes between two categories of NGT plants:
- ‘Category 1 NGT plants’: Those that could also occur naturally or be produced by conventional breeding techniques, and their offspring obtained by conventional breeding techniques.
- ‘Category 2 NGT plants’: Any plants that fall outside of the scope of Category 1 NGT plants.
The proposal requires that Category 1 NGT plants be treated as plants that have occurred naturally or have been produced by conventional breeding techniques, based on their similar nature and risk profile. This categorisation means that Category 1 plants will not fall within the scope of the EU’s GMO legislation, in effect loosening the requirements and restrictions around these plants. Instead, these plants will be subject to less onerous regulatory requirements. Category 2 NGT plants will remain within the scope of the EU’s GMO legislation due to the complex nature of modifications that are made to the genome of the plant.
The proposal follows a study undertaken by the Commission in 2021 on new genomic techniques, which concluded that the authorisation procedure and risk assessment requirements for GMOs under the EU GMO legislation are not adapted to the range of potential organisms and products that can be obtained with some NGTs, specifically targeted mutagenesis and cisgenesis (including intragenesis), and therefore these requirements can be “disproportionate or inadequate”.
The patentability question
In the proposal, the Commission noted that many stakeholders raised the issue of patents on NGTs. Breeders’ organisations raised concerns about the need to ensure breeders’ access to patented genetic material and farmers’ organisations raised concerns about the access of farmers to plant reproductive material (PRM) from NGT plants. Despite these concerns, the Commission’s proposal did not address the patentability of NGT plants or intellectual property rights more generally. This means that, despite the distinction between Category 1 and Category 2 NGT plants being made by the Commission, patent applications for NGTs will be considered by the European Patent Office (EPO) under the same criteria that GMOs have been assessed under to date.
The position in the UK
Like the EU, and in line with current international trends, the UK has also been loosening requirements for NGT plants. This is evident through the Genetic Technology (Precision Breeding) Act which passed in March of this year. The UK Act, like the Commission’s proposal, seeks to reduce regulatory burdens for those developing new precision breeding technologies like NGTs.
Like the proposed EU framework, the UK framework is also silent on the intellectual property position and issues of patentability of NGT plants. As a general rule, under section 76A of the Patents Act 1977, any variety of animal or plant or any essentially biological process for the production of animals or plants, not being a micro-biological or other technical process or the product of such a process, is not a patentable invention. Inventions which concern plants or animals may be patentable if the technical feasibility of the invention is not confined to a particular plant or animal variety. Inventions may also be patentable if they are not exclusively obtained by means of an essentially biological or microbiological process. This reflects the decision of the European Patent Office Enlarged Board of Appeal (EBA) (G3/19, “Pepper”). In all cases, the usual requirements for patentability (novelty, inventive step and industrial application) must be met.
If a patent is not available, it may be possible to acquire rights in connection with a plant variety, including genetically modified varieties, by applying for plant breeders’ rights (PBR) through the Animal and Plant Health Agency (APHA) in the UK.
What next for the UK?
Despite the rapid development of new gene-editing techniques and the UK government’s apparent inclination to follow the trend of loosening the regulatory requirements around breeding technologies, the Government has not confirmed whether it intends to amend plant breeders’ rights. The Government also has not indicated the direction in which it may head in terms of biotechnological patentability. It remains to be seen, therefore, whether the UK Government will adopt a similar approach to the EU Commission and remain silent on the issues of patentability and intellectual property or whether it will take a more direct approach and deal with these issues head on.