Ban on European Patents for Plants Engineered by "New Genomic Techniques" Nearing Reality

Jones Day

The European Parliament has adopted an amended European Commission proposal to regulate plants engineered using techniques such as CRISPR/Cas and ban any patenting of plants, plant parts, material, genetic information, or methods resulting from these techniques.

In July 2023, the European Commission (the "Commission") proposed a new Regulation on plants obtained by certain new genomic techniques and their food and feed, amending existing Regulation (EU) 2017/625 (colloquially referred to as the New Genomic Techniques or NGT proposal). NGTs include molecular scissor techniques such as CRISPR/Cas, which can quickly and easily modify an organism's genome.

On January 24, 2024, before it was due to come up for a vote in the European Parliament, the parliamentary Committee on Environment, Public Health and Food Safety (the "Committee") decided to amend the text to be voted upon by the full chamber.

The Committee agreed with the Commission's proposal to regulate plants obtained by NGTs by separating them into two categories. "NGT 1 plants" (e.g., plants that could have occurred naturally or by conventional breeding) are considered equivalent to conventional plants and therefore not subject to the requirements of European genetically modified organism ("GMO") legislation. "NGT 2 plants" are more extensively modified or contain insertions of foreign genetic material and would be treated as GMOs.

The surprise came with the Committee's amendment aiming to ban all patents on NGT plants, plant parts, or material, as well as the genetic information they contain or processes to obtain them. According to the proposal, NGT plants should be protected only by the Community Plant Variety Rights system, as laid down in Council Regulation (EC) No 2100/94. It has been suggested that this ban could have a retroactive effect. Allegedly, this ban is intended to avoid legal uncertainties, increased costs, and dependencies on agritech companies for farmers and breeders. However, this is debated, as such groups already enjoy significant exemptions from patent restrictions, which are provided in the Directive 98/44/EC (the "Biotech Directive"), in national laws of EU Member States, and in the Unified Patent Court Agreement.

On February 7, 2024, the European Parliament voted in favor of the proposal as amended by the Committee (307 to 263, 41 abstentions). The proposal will now have to be negotiated with the EU Member States in the European Council.

Should the proposal be adopted, the patent ban could be implemented by amendment of the Biotech Directive, which has already been transcribed into national laws of EU Member States and the Implementing Regulations of the European Patent Convention ("EPC"). These EPC regulations are relatively easy to change by a vote of the European Patent Office's Administrative Council, which will want to align EPC regulations with EU legislation.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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