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Inari Agriculture NV

Develop more productive crop varieties which require less land and inputs such as water and fertilizer.

Lobbying Activity

Response to Evaluation of the EU legislation on plant variety rights

14 Mar 2025

Inari is thankful for the opportunity to provide input in the context of the evaluation on the implementation of the European Unions Community Plant Variety Right Regulation 2100/941 (CPVR Regulation) and the operation of the Community Plant Variety Protection Office (CPVO). A document with our complete argumentation is attached to this summary. Inari emphasizes that the CPVR Regulation must provide equitable protection for all new plant varieties irrespective of how they are developed, whether by conventional crossing and selection, mutation breeding, or using NGTs. This is especially important in view of the current debate on patents on NGT-derived plants in the EU. As essentially all plants which can be cultivated in the EU may not be protectable by patents, the CPVR would become the sole intellectual property right (IPR) for new plant varieties in the EU. While Inari supports such policy change, it is of critical importance that plant varieties obtained by NGTs are - like conventionally bred varieties - primarily assessed based on their phenotype both for protectability and scope of protection. If CPVRs are the sole IPR for NGT-derived plants, two risks gain importance: (1) The risk of being considered non-distinct and not entitled to protection, and the risk of being considered an essentially derived variety (EDV); (2) The CPVR can only be considered an effective IPR for NGT-derived varieties, if those risks are mitigated. Otherwise, there is a significant risk that highly innovative NGT-derived varieties fall through the cracks: They would neither be patentable, nor entitled to equitable protection by CPVRs. Inari suggests the following adjustments to the CPVR Regulation framework: I. Adapting the guidelines for Distinctness, Uniformity and Stability (DUS) to precision breeding (see in attached PDF under I.). II. Aligning the CPVR with the UPOV 19912, clear definition of EDVs, and clear guidelines for the assessment of essential characteristics (see in attached PDF under II.). III. In the long-term: Holistic revision of the CPVR to adapt it to the rapidly changing technological environment but also to factors like climate change (see in attached PDF under III) Recommendations: (i) Clearly define EDV: Reduce legal ambiguity by aligning the CPVRs EDV definition to the wording in the UPOV 1991 Act. (ii) Provide clear guidelines for essential characteristics: Escaping the EDV definition requires a change of endogenous genes resulting in a change of an essential characteristics of great significance or value. Inari suggests that the assessment should have both quantitative and qualitative elements. More than one (i.e., at least two) endogenous genes should be changed, creating a significant added value.The threshold for the added value should be neither too low nor too high, which is essential for a fair and balanced EDV approach which creates an incentive for true breeding innovation. TRIPS Agreement Art.31(l)(i) refers to an important technical advance of considerable economic significance, i.e., a technical advance and an economic added-value resulting therefrom. For varieties the added value should factor in economic, ecological, and sustainability considerations. While clear guidelines could be a meaningful first step, a case-by-case consideration by courts is unavoidable and appropriate.
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Meeting with Irene Sacristan Sanchez (Head of Unit Health and Food Safety)

10 Mar 2025 · Exchange on plant innovation and NGT proposal

Meeting with Asger Christensen (Member of the European Parliament, Shadow rapporteur for opinion)

12 Dec 2023 · Agriculture

Meeting with Erik Poulsen (Member of the European Parliament)

12 Dec 2023 · New Genomic Techniques

Meeting with Christine Schneider (Member of the European Parliament)

12 Dec 2023 · NGT

Meeting with Asger Christensen (Member of the European Parliament, Shadow rapporteur for opinion) and CropLife Danmark

3 Nov 2023 · Agriculture

Response to Legislation for plants produced by certain new genomic techniques

26 Oct 2023

1. Inari, the SEEDesign company, pioneers innovative seed technology aligning with the European Green Deals objectives for innovation and sustainability. Leveraging new genomic techniques (NGT), our goal is to amplify yield of soybeans, maize, and wheat by 10-20% without requiring additional land or inputs. We also aim to curtail water and nitrogen fertilizer requirements for maize cultivation by 40%. 2. We welcome the above-mentioned regulatory proposal and hereby submit our feedback to the Commission on the current version. A regulation with pragmatic and predictable stipulations, fostering the adoption of innovative seed products in the EU, is crucial. 3. Our feedback primarily addresses Category 1 NGT Plants as prescribed in the current proposal. Category 1 NGT Plant 4. We endorse the categorization of NGT plants, recognizing them as analogous to conventionally bred plants. This view corresponds with global jurisdictions, including Argentina, Brazil, Canada, Japan, Philippines, and the USA, which perceive NGTs as extensions of conventional breeding techniques, meriting similar regulatory oversight. 5. We urge the Commission to clarify the interpretation of a single genetic modification, by defining a genetic modification to include multiple gene editing within the criteria of equivalence of Category 1 NGT plants to conventional plants. 6. Improving traits like yield enhancement, efficient water and fertilizer usage requires editing multiple genes (multiplex) simultaneously. Such beneficial changes can be developed using NGTs on the plants' native DNA, producing outcomes similar to conventional breeding. Yet, NGTs achieve this with greater precision, in less time and reduced costs, thus enabling SMEs to develop sustainable innovative seed products. European research has showcased this multiplexing technology, developing maize plants with 48 edited genes influencing yield [Lorenzo et al., 2023]. Without multiplexing capabilities, rapid development of plants, optimized for traits like water or nitrogen use, faces hindrance. 7. Consider maize's nitrogen-use efficiency which requires multiple gene edits. Each modification requires inserting a 12-nucleotide native maize sequence, repeated 2 to 3 times, resulting in a sequence ranging from 24 to 36 nucleotides. This sequence, also found in other maize genome areas, enhances gene expression without protein alteration [Claeys et al., 2023]. We advocate inserting this 12-nucleotide sequence, repeated in the maize genome's promoter region, aligns with the 20 nucleotides limitation and qualifies as a singular genetic modification, adhering to the equivalence criteria in Annex I. 8. Plant genomes are known to have gene duplications and polyploidization [Adams & Wendel, 2005]. Most genes are present in duplicate or more, e.g., 75% of soybean genes exist in pairs [Schmutz et al., 2010]. Hexaploid wheat, originating from the natural fusion of ancestral diploid wheat, contains three identical gene copies across its A, B, and D genomes [IWGSC, 2014]. Enhancing traits in wheat, such as yield, requires editing of each gene copy influencing the trait. In such cases, each trait targeted should classify as a singular genetic modification, in line with Annex I equivalence criteria. Conclusion 9. Genome editing's agricultural potential is immense, with technological strides being made continuously. We strongly request the Commission to ensure that regulations remain adaptive to embrace technological innovations. These are paramount for developing plants to address the environmental and food-related challenges in the EU. This regulation should acknowledge multiplex gene editing for Category 1 NGT Plants, providing a regulatory framework that empowers companies, including SMEs like Inari, to invest, innovate, and introduce pioneering seed products to the EU market.
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Meeting with Juozas Olekas (Member of the European Parliament, Shadow rapporteur for opinion) and Rud Pedersen Public Affairs Brussels

5 Oct 2023 · New plant breeding techniques

Meeting with Michaela Šojdrová (Member of the European Parliament, Shadow rapporteur for opinion)

3 Oct 2023 · New Genomic Techniques

Meeting with Irène Tolleret (Member of the European Parliament)

3 Oct 2023 · Rencontre avec INARI sur les NGTs

Meeting with Jan Huitema (Member of the European Parliament, Shadow rapporteur)

28 Sept 2023 · New Genomic Techniques

Meeting with Michaela Šojdrová (Member of the European Parliament) and Rud Pedersen Public Affairs Brussels

24 May 2023 · New Genomic Techniques

Meeting with Maria Arena (Member of the European Parliament)

11 May 2023 · New Genomic Techniques