European Parliament adopts an amended proposal on the marketing of certain plants obtained by New Genomic Techniques (NGT) but includes a total ban on patents for all NGT plants.
Koen Vanhalst, Caroline Hennin, Liesbet Paemen
On February 7, 2024, the European Parliament adopted an amended version of the European Commission proposal, originally presented on July 5, 2023, and directed to the marketing of plants obtained by New Genomic Techniques (NGT). The proposal is aimed at loosening EU’s strict GMO rules with respect to NGT plants, more particularly for those NGT plants that are considered to be “equivalent to conventional plants” (the so-called category 1 NGT plants). However, in the amended version of the proposal, IP provisions have been included which could significantly impact the patentability of plants in Europe.
Background
The term “New Genomic Techniques (NGTs)” is used to refer to techniques that alter the genetic material of an organism in a targeted way such as through gene editing tools like CRISPR/Cas9, Zinc Fingers, and TALENS, that have been developed over the past two decades after adoption of Directive 2001/18/EC. Currently, all plants obtained by NGTs are subject to the same EU marketing rules as was set by the 2001 Directive for genetically modified organisms (GMOs), which are among the strictest in the world (see EU GMO legislation).
In view of the EU “Green Deal”, the Commission is now of the opinion that certain NGTs could help make agriculture and the food sector more sustainable and ensure food security by allowing the development of improved plant varieties that are climate resilient, pest resistant, give higher yields or that require fewer fertilisers and pesticides. Following the opinion of the European Food Safety Authority (EFSA), and further to a thorough assessment, the Commission has adopted the position that it can lower the bar for allowing certain NGT plants on the European market, without compromising the safety of the food and feed system. It is clear that this is good news for the Ag-biotech sector.
Categories of NGT plants
The proposal classifies NGT plants as not comprising genetic material that does not exist within the gene pool for conventional breeding purposes, defined as “the total genetic information available in one species and other taxonomic species with which it can be cross-bred”. In other words, NGT plants are defined as not containing any genetic material originating from outside the Breeder’s gene pool. Annex I of the original EU proposal further specified the criteria for category 1 NGT plants to be classified as equivalent to conventional plants, including a limitation in the number of genetic modifications in the NGT plant to at most 20 per DNA sequence.
Current Annex 1 of the amended proposal now modifies the number of modifications from 20 modifications of specific types in a given type per DNA sequence, and now specifies that up to three of these may occur but only in a protein-coding sequence. The amended proposal also replaces the limitation to exclude genetic modifications that interrupt an endogenous gene by insertion or substitution of a given sequence, by specifying that the modifications should not result in a chimeric protein that is not present in species from the gene pool for breeding purposes. Thus it appears that the number of plants qualifying as category 1 NGT plants would be significantly limited by this amendment.
The registration as category 1 NGT
The proposal specifies that, before according the NGT plant the “category 1” status, a thorough review will take place. A request for classification as category 1 NGT will have to be submitted by the breeder, who will need to substantiate such request inter alia with technical information on at least one trait introduced in the plant, how the plant was obtained, disclosure of the sequence of genetic modification, an environmental risk assessment, and a monitoring plan for environmental effects.
Interestingly, the amended proposal now also envisages that “any granted patent or pending application for patent covering the whole Cat.1 NGT plant or part of it” will need to be specified. It is not clear what the consequences would be when failing to identify e.g. a third-party patent document that is later asserted against the NGT plant.
The request is then analysed by the responsible body within the European Commission, which – if deemed necessary – can consult the European Food Safety Authority (EFSA). Member states can send in reasoned observations as to why they do not agree with the categorisation and finally the European Commission will take a decision.
The NGT category 1 plants will need to be labelled for the sake of traceability and will need to be cultivated separately from conventional crops, such as by including buffer strips between these plants and conventional plants.
It is to be understood that for all other NGT plants that do not fulfil the criteria set out for the category 1 NGT plants, the rules and requirements of the current GMO legislation would still apply.
The provisions on intellectual property
The original proposal of the European Commission did not contain any provisions on intellectual property. Indeed the Q&A section of the EU on the proposal specifies that “the legislative proposal concerns the release and placing on the market of NGT plants but does not regulate the issues of intellectual property” [1]. It is stated that the Commission will assess, as part of a broader market analysis, the impact of patenting of plants and will report its findings by 2026.
However, as a result of an Opinion of the Committee on Agriculture and Rural Development for the European Parliament’s Committee on Environment, Public Health and Food Safety (ENVI), dated January 24, 2024, the Commission’s original proposal was amended and the current proposal contains a new Article 4a which in fact implies a full ban on patents on all “NGT plants, plant material, parts thereof, genetic information and process features they contain”. Remarkably, the exclusion from patentability is not limited to category 1 NGT plants. Moreover, it is unclear what could fall within the terms “genetic information” and “process features they contain”.
In one go (by way of new Article 33a), the proposal also includes an amendment of the Biotech Directive (98/44/EC) to expressly ban patent rights not only on all NGT plants, but also on plants obtained by classical mutagenesis or cell fusion. It is clear that this goes far beyond the intention of the original proposal of the Commission. The amendment of the Biotech Directive would imply that the exclusion is retroactive, i.e. it would also apply to any patent that has already been granted [2].
The amendment also provides a new Article 5a which calls on the Commission to report by June 2025 on the role and impact of patents on breeders’ and farmers’ access to varied plant reproductive material as well as on innovation, particularly on the opportunities for SMEs, to determine whether further legal provisions, in addition to Articles 4a and 33a would be necessary.
The anti-patent position of the MEP’s in the ENVI Committee is clear from the following statement in the amended proposal: “[new Article 45a] As current provisions do not provide for a full breeder’s exemption in patent law, it should be ensured that patents should not restrict the use of NGT plants by breeders and farmers. Hence, these plants should not be subject to patent legislation.../... NGT plants, their derived seed, their plant material, associated genetic material such as genes and gene sequences, and plant traits should therefore be excluded from patentability…/… In addition, the Commission should assess and address, in the announced forthcoming study [ì.e., the report requested for 2025 mentioned above], how the broader problem of patents being granted, directly or indirectly, on plant material despite previous efforts to close loopholes, should be further addressed.”
While the amended proposal is clearly aimed at protecting breeders’ rights, the added argument that it is intended to “implement rules that embrace innovation” (as stated in the January 24 press release) and address the requirement to consider the impact of patents on “opportunities for SME’s” is questionable. The patent system is crucial to bringing new developments to the market and is an important legal tool, including for SME’s and research institutes to compete with multinational players, in the food sector as in any sector. Ironically, while the amended proposal finally allows a certain type of NGT plants to be brought onto the European market, it takes away the incentive for industry to develop these plants.
While the original proposal of the Commission was intended to support the green transition of the agrifood section and support innovation in Europe as well as to entail more investments in agricultural biotechnology from the public sector, SMEs, and plant breeders in order to offer a broader variety of crops to farmers and citizens, the weakening of the patent protection for these products will inevitably lead to less rather than more EU-based innovation.
Due in part to the short time frame between the amendment of the proposal (January 24, 2024) and the presentation to the European Parliament, this amended proposal was in fact adopted as such during the plenary session on February 7, 2024. In a press release it was stated that this would “avoid legal uncertainties, increased costs and new dependencies for farmers and breeders”.
The proposal now goes to the Council of the European Union for further discussion with the member states and European Commission. It can only be hoped that the Commission and member states will take into consideration the potential impact of the IP aspects of this proposal not only on the competitiveness of the European Agbiotech industry but also on innovation in plant traits in general, and will ensure a broader consultation with all stakeholders.
[1] Q&A: Proposal on New Genomic Techniques (europa.eu); Question 15 “does the proposal address issues related to patents and intellectual property rights?”
[2] In line with ECJ Case C-428/08 ("Monsanto v. Cefetra")