European Parliament Proposes a Ban on Patenting Gene-edited Plants
On 7 February 2024, the European Parliament voted in favour of a proposal to: (1) streamline the regulatory process for plants produced by new genomic techniques (NGTs) that are deemed equivalent to conventional plants; and (2) prohibit the patenting of NGT plants, plant material, parts thereof, genetic information and the process features they contain. However, it is currently unclear whether this proposal will come into force.
NGTs, which include gene editing using the CRISPR/Cas ‘genetic scissors’, enable more targeted and precise modifications to the genome than via conventional breeding or established genomic techniques. In 2020, this revolutionary technology earned Emmanuelle Charpentier and Jennifer Doudna the Nobel Prize in Chemistry for their work on CRISPR/Cas9.
The Parliament-approved proposal aims to streamline the regulatory process by considering so-called “category 1 NGT” plants equivalent to conventional plants and exempting them from the legislation on Genetically Modified Organisms. Such “category 1 NGT” plants would need to meet criteria based on the number and type of changes made to the genome. For the sake of transparency, the European Parliament has also proposed to set up a public online list of these plants.
Although the European Commission’s original proposal (published in July 2023) only briefly mentioned patents, an amendment was introduced during the parliamentary process to prohibit the patenting of: “NGT plants, plant material, parts thereof, genetic information and the process features they contain”. It was also proposed that the Biotech Directive 98/44/EC be amended accordingly. The European Parliament has additionally requested a report by June 2025 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.
This proposal conflicts with the European Patent Convention and European Patent Office (EPO) case law and, even if it is adopted into law, it is unclear whether or how the EPO (which is not an EU body) will adapt its practice with respect to NGT plants.
After a long line of cases, the patent-eligibility requirements for plant-related inventions were clarified in 2020 by the Enlarged Board of Appeal of the EPO in decision G3/19 (“Pepper”). In this decision, the Enlarged Board prohibited the patenting of plants obtained exclusively by means of an ‘essentially biological process’ based on sexual crossing and selection. In contrast, plants produced purely by a technical process, including NGT, that modifies the genetic characteristics of the plant are patentable in Europe (as reflected in the EPO Guidelines for Examination).
Further developments on this topic will be reported as more information becomes available.