In a vote held on 7 February 2024, the European Parliament (EP) approved a proposal to
- differentiate between two different categories of plants obtained by gene editing or New Genomic Techniques (NGT), which include gene editing using CRISPR/Cas, with NGT 1 plants being exempted from the strict requirements of the GMO legislation, and
- ban all patenting for NGT plants, plant material, parts thereof, genetic information and the process features they contain, regardless of which of the two new categories they may belong to.
The proposal creates two distinct pathways for NGT plants to be placed on the market:
- Category NGT 1 Plants, defined as such NGT plants that could also occur naturally or by conventional breeding would, provided they meet certain criteria verified in a verification procedure, be treated like conventional plants and exempted from the requirements of the GMO legislation. A public online list of all NGT 1 plants is intended.
- Category NGT 2 Plants, defined as all other NGT plants, would continue to be subject to current GMO legislation. That is, they would be subject to risk assessment and authorization prior to market approval, and would have to be traced and labelled as GMOs.
According to the European Commission, the proposal, adopted on 5 July 2023, not only aims to maintain a high level of protection of health and the environment, but also to steer developments towards contribution to sustainability goals in a wide range of plant species, especially for the agri-food system, and create an enabling environment for research and innovation, especially for SMEs.
In stark contrast thereto, the proposal, via an amendment introduced during the parliamentary process by the Committee on Environment, Public Health and Food Safety (ENVI) of the European Parliament, now also would establish a ban on all patenting for “NGT plants, plant material, parts thereof, genetic information and the process features they contain”, regardless of which of the two new categories the NGT plants in question may belong to. The amendment also proposes that the Biotech Directive 98/44/EC be amended accordingly and the members of the EP have requested a report on the impact of patents on breeders’ and farmers’ access to plant reproductive material as well as a legislative proposal to update EU rules on intellectual property rights accordingly that is due by June 2025. According to a press release from the European Parliament, the intention behind the amendment is to “avoid legal uncertainties, increased costs and new dependencies for farmers and breeders”. However, a complete lack of protection for NGT plans in the European Union may prevent European companies from investing in the development of NGT plants, who could not rely on a period of exclusivity in which to recoup their significant development investments. According criticisms have been voiced by, amongst others, Garlich von Essen, secretary general of seed industry association Euroseeds, in Science Business, and by epi, the Institute of Professional Representatives before the European Patent Office.
Notably, a ban on all NGT plant patenting is also in direct conflict with the European Patent Convention (EPC) and current practice and established case law of the European Patent Office (EPO), both of which operate independently of the European Union. In decision G3/19 (“Pepper”), the Enlarged Board of the EPO established that, while patenting of plants “exclusively obtained by means of an essentially biological process” based on sexual crossing and selection is not permissible, plants produced by a technical process that modifies the genetic characteristics of the plant, which includes NGTs, are patentable in Europe (as reflected in the EPO Guidelines for Examination).
While the vote means that the European Parliament is now ready to start negotiations with its member states on the final law, the Council of the EU must further approve the proposal for it to become law. A ban on all patents is not currently supported by all council members, so that it remains to be seen how quickly the proposal will progress, or if at all in its current form.
