Our current food system is facing a myriad of critical challenges. The United Nations predicts that the world population will reach 9.3 billion people by 2050, which means that we will need to produce 60% more food to feed the world in the next decades.[1] Current food production processes are not up to the task, and furthermore, producing the amount of food needed using traditional farming practices will take a heavy toll on our natural resources and cause increased climate change.[2] The Nobel Prize winning CRISPR/Cas gene editing technology (“CRISPR”) offers a possible solution to our food system problems.
CRISPR stands for “clustered regularly interspaced short palindromic repeats”. CRISPR consists of two components: a guide RNA (gRNA) and a non-specific CRISPR-associated endonuclease (Cas). CRISPR is able to precisely target genes using its specifically targeted gRNA to delete or modify genes, which offers several advantages to food industry manufacturers. As of October 2024, there are over 2,000 granted patents and published patent publications directed towards CRISPR technology in general in the U.S.[3] The majority of CRISPR patents and patent applications are not specifically directed towards food uses. As of October 2024, there are over 260 granted patents and published patent publications directed towards CRISPR technology classified under A01,[4] A21,[5] A22,[6] A23[7] in the U.S. Patent & Trademark Office (USPTO) records.[8]
CRISPR technology can be used in several ways to improve our food system. For example, the benefits include the deletion of certain allergens, increasing food production by reducing harvest times or enhancing rate of growth,[9] enhancing the nutrition or taste of existing foods,[10] reducing health concerns associated with current food production processes,[11] and reducing food waste.[12]
CRSIPR’d Crops
Agriculture, the backbone of our global food system, continually grapples with the threat of pests and diseases jeopardizing crop yields and food security. CRISPR presents a promising solution by enabling the creation of high-yield and/or disease-resistant crops and many companies and academic institutions are exploring the possibility of using this technology to modify crops.
As of October 2024, there are over 65 granted patents and published patent publications directed towards using CRISPR technology to modify crops in the U.S.[13] These patents and patent applications are directed to, for example, modifying a soybean plant to reduce phytoestrogen content and/or increased protein content;[14] modifying a rice plant to increase yield;[15] and modifying a maize plant to enhance tolerance to salt stress and/or drought conditions.[16] Given the wide variety of possible plant species to be modified, and the wide breadth of possible beneficial modifications that can be made, the patent landscape is wide open for new entrants to carve out new intellectual property positions covering valuable agricultural products.
While genetically modified crops (“GM crops”) predate CRISPR, unlike previous methods, CRISPR offers a more precise and safer way to alter genomes.[17] CRISPR also offers a faster, more cost-effective, reproducible and efficient way to improve crops compared to traditional breeding techniques. However, regulatory frameworks surrounding CRISPR-edited crops vary across different regions. While the U.S. distinguishes between GM and genetically edited (“GE”) crops, the European Union (EU) currently evaluates them under the same regulatory framework.[18] However, the EU regulatory scheme is in the process of being reevaluated.
The European Commission published a study in 2021 regarding the status of new genomic techniques under EU law, which concluded that GE crops can have a similar risk profile compared to crops obtained with conventional breeding techniques and that there is strong indication that current legislation needs to be adapted to new scientific and technological progress.[19] In 2023, the European Commission released a draft proposal aiming, in part, to accelerate genetic editing research directed towards increasing the resilience of crops to climate change, pests, and diseases.[20] To achieve this goal, the European Commission proposes to deregulate “New Genomic Techniques” including gene-editing CRISPR technology.[21] This deregulation “will cut red tape and increase efficiency and efficacy of the registration and certification systems” for evaluating GE crops.[22]
The draft proposal, if passed into law, will exempt GE crops from genetically modified organism (“GMOs”) law if the GE crop’s genetic modification is equivalent to what can be achieved using conventional plant breeding techniques.[23] Notably, while this draft Regulation will relax the regulation of GE crops, it will likely limit the patentability of GE crops. On February 7, 2024, the European Parliament voted on the draft Regulation and proposed new amendments.[24] Strikingly, 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.[25]
CRISPR’d Meat and Seafood
Interestingly, CRISPR-edited meat faces the same regulatory uncertainties as GE crops. Unlike traditional GMOs, including animals and crops, CRISPR-edited animals may involve only minimal edits of the host organism’s own genes. In the U.S., the Food and Drug Administration (FDA) has indicated that it will evaluate CRISPR-edited animals on a case-by-case basis to determine their safety and regulatory status.[26]
In March 2022, the FDA cleared short-haired genome-edited cattle, known as PRLR-SLICK cattle, for human food consumption after determining that the product is low-risk and does not raise any safety concerns.[27] These cattle were developed by Acceligen and were produced using CRISPR to disrupt the PRLR gene, resulting in a slick coat that enhances heat tolerance.[28] Beyond the United States, other countries have also embraced CRISPR-edited animals for human consumption. Japan, for instance, has approved two CRISPR-edited fish, a Red Sea Bream (“Madai”) and a Tiger Puffer (“22-seiki fugu”) produced by Kyoto-based start-up Regional Fish Co., Ltd. for sale in Japan.[29] Additionally, a UK company, Genus PLC, is developing a CRISPR edited, virus-resistant pig and plans to seek regulatory approval by the end of this year or in early 2025.[30]
Another promising use of CRISPR technology in the meat industry is to use CRISPR to modify animal cells rather than creating a genetically edited animal. Recently, cultivated meat products have reached major milestones in regulatory approvals. The U.S. FDA approved Upside Foods, Inc.’s (“Upside Foods’”) and Good Meat’s (a subsidiary of Eat Just) cultivated chicken products for sale in the U.S. market.[31] Singapore and Israel have also approved Eat Just’s cultivated chicken and Aleph Farms’ cultivated beef steaks, respectively, for their respective markets.[32] This rising popularity and the regulatory successes of cultivated meat has sparked interest in using CRISPR to tailor these products to decrease costs and improve the production process of cultured meats. For example, genetically edited cultivated meat cell lines can be modified to improve growth. Upside Foods has filed a patent application on a method to use CRISPR to inactivate two proteins and increase the replicative capacity of cultivated meat cells.[33] Upside Foods plans to include the CRISPR-enabled cell line in a future regulatory filing.[34]
Conclusion
CRISPR technology represents a paradigm shift in food production, offering precise, efficient, and sustainable solutions to combat pests, diseases, and the impacts of climate change. However, the intersection of food regulation and CRISPR technology presents a complex and evolving global landscape. In light of this rapidly accelerating environment, it is crucial for companies to adopt a proactive approach to both global regulatory compliance and patent protection strategy. Collaborating with experienced counsel can help ensure strategic patent filings and regulatory submissions, while mitigating the risks of regulatory non-compliance and loss of patent rights. By staying ahead of patent portfolio management and regulatory challenges, companies in the foodtech field can safeguard their breakthroughs, bring their products to market and position themselves for long-term success.
Disclaimer: The information contained in this posting does not, and is not intended to, constitute legal advice or express any opinion to be relied upon legally, for investment purposes or otherwise. If you would like to obtain legal advice relating to the subject matter addressed in this posting, please consult with us or your attorney. The information in this post is also based upon publicly available information, presents opinions, and does not represent in any way whatsoever the opinions or official positions of the entities or individuals referenced herein.
[1] Oksana Sapiga, Towards a waste-free future, FAO Regional Office for Europe and Central Asia (Mar. 2023), https://www.fao.org/europe/news/detail/towards-a-food-waste-free-future/en.
[2] Id.
[3] Source: Search of U.S. patent database October 9, 2024 (patent and patent application results generated using the keyword query: CL=(“CRISPR” or “clustered regularly interspaced short palindromic repeats”) AND TAB=(“CRISPR” or “clustered regularly interspaced short palindromic repeats” or “gene editing”)).
[4] Relating to agriculture, forestry, animal husbandry, hunting, trapping and fishing.
[5] Relating to baking and edible doughs.
[6] Relating to butchering, meat treatment, processing poultry or fish.
[7] Relating to foods or foodstuffs and treatment thereof, not covered by other classes.
[8] Source: Search of U.S. patent database October 9, 2024 (patent and patent application results generated using the keyword query: CL=(“CRISPR” or “clustered regularly interspaced short palindromic repeats”) AND TAB=(“CRISPR” or “clustered regularly interspaced short palindromic repeats” or “gene editing”) AND ACP=((A01) OR (A21) OR (A22) OR (A23))).
[9] 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/.
[10] 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/.
[11] Risk Assessment Summary, Food and Drug Administration, https://www.fda.gov/media/155706/download (last visited Mar. 24, 2024).
[12] 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/.
[13] Source: Search of U.S. patent database October 9, 2024 (patent and patent application results generated using the keyword query: CL=(“CRISPR” or “clustered regularly interspaced short palindromic repeats”) AND TAB=(“CRISPR” or “clustered regularly interspaced short palindromic repeats” or “gene editing”) AND (CTB=((“crops” or “agriculture” or “crop” or “food” or “edible”) and (“plant” or “plants” or “seed” or “seeds”)) OR (ACP=((A01) OR (A21) OR (A22) OR (A23)) AND CTB=(“plant” or “plants” or “seed” or “seeds”))).
[14] US20220106604A1 (2023-07-10)
[15] US20230365634A1 (2023-03-14)
[16] US20170268016A1 (2016-05-25)
[17] Gabriel Rangel, From Corgis to Corn: A Brief Look at the Long History of GMO Technology, Science in the News (Aug. 9, 2015) , https://sitn.hms.harvard.edu/flash/2015/from-corgis-to-corn-a-brief-look-at-the-long-history-of-gmo-technology/; GEiGS, Tropic Biosciences UK Ltd, https://www.geigs.com/ (Last visited Mar. 24, 2024) (“GEiGS® technology does not involve the insertion of DNA sequences from other organisms (‘Foreign DNA’) into the host genome and does not impact the sequence of proteins.”).
[18] C- 528/16, Confédération Paysanne a.o., 2018 E.C.R. 583 (the European Court of Justice has interpreted the EU regulatory regime in a way that defines organisms altered by means of site-directed mutagenesis like CRISPR/Cas9 as a GMO).
[19] 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 Mar. 24, 2024).
[20] European Green Deal: more sustainable use of plant and soil natural resources, European Commission, https://ec.europa.eu/commission/presscorner/detail/en/ip_23_3565 (last visited Oct. 9, 2024).
[21] Id.; see also New techniques in biotechnology, European Commission, https://food.ec.europa.eu/plants/genetically-modified-organisms/new-techniques-biotechnology_en (last visited Oct. 9, 2024).
[22] Id.
[23] Id.
[24] 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)), 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)) (last visited Oct. 14, 2024).
[25] Id. (“a plant product containing or consisting of genetic information obtained by a patentable technical process shall not be patentable if it is not distinguishable from plant products containing or consisting of the same genetic information obtained by an essentially biological process.”).
[26] Q&A for Consumers on Intentional Genomic Alterations in Animals, Food and Drug Administration, https://www.fda.gov/animal-veterinary/intentional-genomic-alterations-igas-animals/qa-consumers-intentional-genomic-alterations-animals#market, (last visited Mar. 24, 2024) (“FDA’s regulatory system is science and risk-based. For products that are low risk, FDA may not expect submission of an approval application. For those products that go through the approval process, data requirements are proportionate to the risks of the product, for example an IGA in a non-food animal will not require food safety data. For those IGAs that are seeking an approval from FDA, the agency also assesses potential risks from approval of the IGA to the environment under the National Environmental Policy Act (NEPA).”).
[27] Risk Assessment Summary, Food and Drug Administration, https://www.fda.gov/media/155706/download (last visited Mar. 24, 2024) (“FDA also does not intend to object to Acceligen introducing cattle containing the IGA into the food supply.” ).
[28] See e.g. id.; and U.S. Patent Application No. 20220042017 (filed Oct. 29, 2021).
[29] Japan embraces CRISPR-edited fish. 40 Nat Biotechnol 10 (2022).
[30] See e.g. Sarah Kuta, Gene-Edited Pork Could Be Coming Soon to Your Dinner Plate, Smithsonian Magazine (Feb. 27, 2024) https://www.smithsonianmag.com/smart-news/gene-edited-pork-could-be-coming-soon-to-your-dinner-plate-180983846/; and U.S. Patent Application No. US20200296941 (filed Jun. 8, 2020).
[31] Good Meat, GOOD Meat Gets Full Approval in the U.S. for Cultivated Meat,https://www.goodmeat.co/all-news/good-meat-gets-full-approval-in-the-us-for-cultivated-meat, (last visited Mar. 24, 2023); and Upside Foods, UPSIDE Is Approved for Sale in the US! Here’s What You Need to Know, https://upsidefoods.com/blog/upside-is-approved-for-sale-in-the-us-heres-what-you-need-to-know, (last visited Mar. 24, 2023).
[32] Andy Coyne, Eat Just Eyes Cultivated-Meat Scale-Up after New Singapore Nod, Just Food (Jan. 18, 2023), https://www.just-food.com/news/eat-just-eyes-cultivated-meat-scale-up-after-new-singapore-nod; Ari Rabinovitch, Aleph Farms Gets Approval to Sell Cultivated Steaks in Israel, U.S. News (Jan. 17, 2024), https://www.usnews.com/news/world/articles/2024-01-17/aleph-farms-gets-approval-to-sell-cultivated-steaks-in-israel.
[33] See e.g. U.S. Patent Application No. 20220251550 (filed Dec. 8, 2021).
[34] Elaine Watson, Eat Just CEO: Large-scale cultivated meat production requires a new operating model, AFN (Mar. 6, 2024), https://agfundernews.com/eat-just-ceo-large-scale-cultivated-meat-production-requires-a-new-operating-model.