Co-authored by Sheena Wang and Ellie Purnell of HGF limited, “CRISPR and Agriculture” was originally published by Food and Drink Technology on January 29, 2025. To access the article on the Food and Drink Technology website, please click here.
Modern gene-editing technology, such as CRISPR/Cas technology, represents a ground-breaking advancement that has transformed our genetic engineering capabilities and has enormous potential for revolutionising medicine, food production, research, and bioenergy production.
In the agricultural field, CRISPR/Cas technology offers numerous advantages, such as the ability to eliminate allergens,1 increase nutritional content,2 improve growth rates,3 and reduce food waste.4 However, this technology faces a complicated and evolving regulatory framework and patent landscape in Europe.
Regulatory challenges in the EU
Despite its potential, CRISPR/Cas technology has faced significant regulatory hurdles in the European Union (EU) in the agritech sector. Under the EU’s Directive 2001/18/EC (“the GMO Directive”), all genetically modified organisms (GMOs) are subject to stringent premarket approval, safety, and labelling requirements.5
Initially, the GMO Directive’s definition of GMOs did not explicitly cover CRISPR/Cas technology. However, in 2018, the Court of Justice of the European Union clarified in Case C-528/16 that organisms obtained by mutagenesis — including CRISPR/Cas-edited organisms — fall under the GMO Directive.6
Since this judgement, experts in this space have engaged in a heated debate over new genomic techniques (NGTs), such as CRISPR/Cas technology, and its regulatory framework. In that regard, the European Commission conducted a study regarding the status of NGTs under EU law. The study concluded that there is strong indication that current legislation needs to be adapted to accommodate NGTs.7
Following the study, the European Commission released a draft proposal in July 2023 aimed to “cut red tape and increase efficiency and efficacy of the registration and certification systems”.8
This proposed regulation distinguishes between NGT plants “considered equivalent to conventional plants” (NGT 1 plants) and all other plants obtained through NGTs (NGT 2 plants).9 Under this proposed framework, NGT 1 plants will be exempt from the GMO regulations and NGT 2 plants will be subject to the GMO regulations with some adaptations.10
On February 7, 2024, the European Parliament proposed new amendments and voted in favour of the proposal as amended.11
Notably, the new amendments would exclude from patentability plant products containing or consisting of genetic information obtained by a patentable technical process, if those plant products are not distinguishable from plant products containing or consisting of the same genetic information obtained by an essentially biological process.12
Following this vote, the proposal will now have to be negotiated with the EU Member States in the European Council before it can be adopted. Thus far, there is significant pushback from certain member states due to the impact on patentability of NGT plants in Europe, and the resulting effects on the agritech industry. Even if the European Council were to approve the proposal, it will require amending the EU Biotech Directive,13 and would likely necessitate the EPO to change the European Patent Convention which directly refers to the EU Biotech Directive – both slow and difficult processes.
The EU CRISPR patent landscape: a complex battle
In the patent field, CRISPR/Cas technology has sparked intense patent battles in Europe, with significant implications for innovation and market competition in every technology sector that uses CRISPR/Cas technology. Multiple institutions, including the Broad Institute; the University of California-Berkeley, the University of Vienna, and Emmanuelle Charpentier (together, “CVC”); Vilnius University; Toolgen; and Sigma-Aldrich have sought to secure patents for various aspects of CRISPR/Cas technology. However, the Broad Institute and CVC remain the key players.
In Europe, several of the Broad Institute’s foundational patents were originally revoked over an issue with an invalid priority claim, where different parties were named as the applicants on the priority filings compared to the PCT filing. This meant that intervening publications became invalidating prior art.
However, in a surprise decision last year, the EPO Boards of Appeal reversed this decision, finding that assignment of the rights during the priority year was valid, and reverted the case back to the Opposition Division for further procedure.
It remains to be seen if the Broad Institute’s patents will survive the rest of the arguments at further opposition proceedings.
The CVC patents have largely been revoked. Most recently, the original parent patent and one divisional were surprisingly voluntarily revoked by the applicants prior to the Board of Appeal hearings in order to avoid a public negative decision, which looked likely. However, there are still a few divisional filings held by CVC remaining, on which opposition and appeal proceedings are expected but have not yet begun in earnest.
EU regulatory framework for new genomic techniques
NGT plants hold the promise of making crops more resilient and sustainable. However, current regulations for NGTs differ globally and fine tuning of the regulatory framework is still needed in many jurisdictions.
The draft proposal by the European Commission aims to create a more flexible regulatory framework that better accommodates the unique characteristics of NGTs and creates patent laws that foster innovation while maintaining a competitive agritech field in the EU.
The CRISPR patent landscape in Europe remains complex. Both the Broad Institute and CVC have suffered losses, but still have patent filings that are granted or pending with wide claims that sit over the original technology. Further battles before the EPO Boards of Appeal remain to determine who will come out with the strongest coverage, if any. Other parties such as Toolgen and Sigma-Aldrich also have patent portfolios that cover parts of the original technology. In short, there is no clear freedom to operate for companies in Europe yet.
1 See, e.g. Brackett, Nicole F., et. al., New frontiers: precise editing of allergen genes using CRISPR, 2 FRONTIERS IN ALLERGY 821107 (Jan. 17, 2022)
2 See, e.g. Megan Poinski, CRISPR-edited Conscious Greens officially debut in foodservice, Food Dive (May 16, 2023), https://www.fooddive.com/news/crispr-pairwise-conscious-greens-gmo-foodservice/650326/.
3 See, e.g. Cathy Siegner, How a new tomato variety could change urban farming and cultivation, Food Dive (Jan. 9, 2020), https://www.fooddive.com/news/how-a-new-tomato-variety-could-change-urban-farming-and-cultivation/569891/; Megan Poinski, SCiFi Foods reduces the cost of cell-based beef 1,000-fold, Food Dive (Jul. 13, 2022), https://www.fooddive.com/news/scifi-foods-cell-based-cultivated-beef-1000-cost-reduction/627122/.
4 See, e.g. Kristin Musulin, USDA and EPA set first-ever national food waste reduction goals, Food Dive (Jan. 9, 2020), https://www.fooddive.com/news/usda-and-epa-set-first-ever-national-food-waste-reduction-goals/405728/.
5 Council Directive 2001/18, 2001 O.J. (L 106).
6 C- 528/16, supra note 10.
7 EC study on new genomic techniques, European Commission, https://food.ec.europa.eu/plants/genetically-modified-organisms/new-techniques-biotechnology/ec-study-new-genomic-techniques_en (last visited Dec. 30, 2024).
8 Id.
9 Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625, COM (2023) 411 final (Jul. 5, 2023).
10 Id.
11 European Parliament, Amendments adopted on 7 February 2024 on the proposal for a regulation of the European Parliament and of the Council on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625 (COM(2023)0411 – C9-0238/2023 – 2023/0226(COD)).
12 Id. at Amendments 69, 291cp1, 230/rev1 and 291cp3 Proposal for a regulation Article 33 a (new) Directive 98/44/EC Article 4, Article 8 and Article 9.
13 Directive 98/44/EC, of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions, 1998 O.J. (L 213) (specifying which biotechnological inventions can be patented, including patentable plant varieties).