BREAKING NEWS: European Parliament has this week supported proposals by the European Commission to relax the regulatory requirements for certain categories of plants produced by new genomic techniques (NGT) [1].
Currently in the EU, NGT plants are classified as Genetically Modified Organisms (GMOs), leading to some of the strictest regulatory requirements anywhere in the world. However, MEPs have voted for a simpler process for regulating categories of NGT plants which may contain modifications comparable to those obtained by conventional breeding. The stated objective for these changes is to make the food system more sustainable and resilient by facilitating the development of improved plant varieties.
The EU’s approach may broadly mirror the recent approach of the UK Government, who last year passed into law the Genetic Technology (Precision Breeding) Act. This Act creates a simpler regulatory and approval process for “precision bred crops” in the UK.
This may appear good news for the Agri-tech sector in Europe. Importantly, however, European Parliament has gone beyond the European Commission’s earlier proposals [2]. This is because MEPs also want a ban of patents for “all NGT plants, plant material, parts thereof, genetic information and process features they contain”. They have requested a report by June 2025 on the impact of patents on breeders' and farmers' access to varied plant reproductive material as well as a legislative proposal to update EU rules on intellectual property rights accordingly.
This proposed ban has been criticized by industry, and still requires negotiations with EU member states on the final law. If patents are not available to adequately protect NGT plants, investment in this field of technology may become less favourable for companies in Europe, potentially defeating the earlier objective of the European Commission’s Green Deal to create a sustainable food system by promoting innovation in this area.
Background
As we have reported over the last few years [3] to [5], the patent eligibility of plants has long been unsettled in Europe, and this trend is set to continue in view of this latest intervention by the European Parliament.
Whilst transgenic plants are in principle patentable under the European Patent Convention (EPC) (G1/98), they are subject to laborious and expensive regulations, meaning that, in practice, few GM crops are commercialised in Europe. This has led to the emergence of new genomic techniques such as gene editing, to enable the rapid development of plants with improved characteristics, but without requiring the introduction of foreign genes from other species. Whilst gene-edited plants are currently classified as GMOs in the EU, it appears the regulatory and approval process for certain categories of such plants will be relaxed over the next few years.
To safeguard the activities of traditional plant breeders, patent claims that explicitly recite any method of sexual crossing of the whole genome are not patentable under Article 53(b) EPC. Following the G2/07 and G1/08 decisions of the EPO’s Enlarged Board of Appeal, this exclusion from patentability applies even if the method claims include technical steps to enable or assist crossing and selection (e.g. marker-assisted breeding) or any genetic engineering techniques to modify the plant (e.g., gene-editing) before or after crossing and selection.
It was unclear from these two decisions whether these exclusions also applied to plants obtained by methods involving steps of crossing and selection (so called “product-by-process” claims). Following an intervention by the European Commission, the Administrative Council of the EPO explicitly amended Rule 28 EPC to exclude plants exclusively obtained by means of an essentially biological process. This led to yet another referral to the Enlarged Board of Appeal, G3/19, which held that plants obtained (after 1 July 2017) exclusively by means of an essentially biological process, such as by traditional breeding techniques, are also excluded from patentability under Article 53(b) of the EPC.
After many years of uncertainly, the current EPC law therefore appeared to be more settled. Arguably, it seeks a balance between providing an incentive for companies to develop crops by new genomic techniques, whilst avoiding an impact on traditional plant breeding activities. This is because the EPO does allow patent claims to technical interventions such as gene-editing, so long as the claims avoid crossing and selection steps.
In assessing whether any gene-edited plants are novel and inventive, the EPO takes all relevant prior art into consideration when examining a patent application, including exchange of data with the Community Plant Variety Office (CPVO). Thus, it may be necessary to establish that plants obtained by gene-editing techniques can be distinguished (and are non-obvious) from plants obtained by conventional breeding techniques. Subject to such requirements, the current EPO Guidelines (G-II, 5.4.2.1) indicate the following subject matter may be patentable under Article 53(b) EPC:
- mutant of a plant carrying a heritable exchange in a nucleotide sequence effected by technical means, e.g. UV mutagenesis or CRISPR/Cas with the proviso that the plant is not exclusively obtained by means of an essentially biological process (EBP).
It appears this is the type of patent claim the European Parliament is now seeking to ban.
Next Steps
European Patents are examined and granted by the European Patent Convention (EPC) which falls outside of EU law. However, European Parliament is seeking to update the Biotech Patent Directive 98/44/EC to explicitly exclude from patentability NGT plants. This may ultimately affect European patent applications and patents, since the Implementing Regulations to the EPC, which regulate the grant of European patents by the EPO, specifically refer to this EU Directive (Rules 26 to 29 EPC).
If the European Parliament achieves a ban on the patenting of NGT plants, the European patent system may become less favourable for research organisations and companies to innovate in new genomic techniques. In practice, however, negotiations are still required with the EU Commission and EU member states in the Council before the Regulation could be adopted. It is also not clear whether any ban would only apply to the plants themselves (and resultant seed / crops), or also cover methods of gene-editing to initially develop them. There may remain some scope for patents in this area of technology (e.g., specific techniques to modify the genome), even if a ban of NGT plants is implemented.
Strictly, the EPO has no obligation to take account of any Directive because it is not an EU institution. However, it appears any changes to the EU Biotech Directive could again be implemented by the Administrative Council of the EPO (via the “back door” of amending the EPC Rules, rather than any revision of the Articles, which would require re-negotiation of the whole EPC treaty itself). How the EPO’s Boards of Appeal may react to such changes also remains unclear.
If the European Patent System becomes less favourable for NGT plants, then direct filings in non-EU countries such as the United Kingdom may become more attractive for companies in this sector. For instance, EPO decisions, whilst influential, are not binding on the UK Intellectual Property Office. Under UK patent practice, patents for plants generated by “technical processes” involving the introduction of a new trait through modification of the plant genome are in general allowable (provided they satisfy the normal requirements for patentability). If the EU Biotech Directive is amended to exclude NGT plants, this may not affect UK law which now falls outside the jurisdiction of the EU. The UK is also seeking to incentivise development of crops in this area, through last year’s Genetic Technology (Precision Breeding) Act.
We will provide further commentary once the implications on EPO practice are clearer. If you would like any further information, please contact us (docketing@secerna.com)
References:
[2] Farm to fork: Innovating to create a sustainable food system (secerna.com)
[3] Spring Update on the Patenting of Plants (secerna.com)
[4] Navigating the maize: developing innovative crops in Europe (secerna.com)
[5] Update on the patentability of plants (secerna.com)