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CRISPR Technology in Agriculture: A Patent and Regulatory Update | Celent Jones Day

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The ability to edit eukaryotic DNA comes with an almost limitless ability to alter the genetic make-up of the plants that serve as our food. Recently, there has been scientific interest in applying novel CRISPR-based gene-editing techniques to food crops to introduce commercially desirable traits. Gene-edited crops can have a positive impact on food productivity, quality, and environmental sustainability, and CRISPR has been recognized for its relative simplicity, robust flexibility, cost-effectiveness, and unique in a wide range of applications. The increasing use of CRISPR in agriculture has endless applications, the results of which were just recently analyzed.

CRISPR and the power of gene editing

The term CRISPR generally refers to a class of gene-editing mechanisms derived from prokaryotic immune systems. These mechanisms have two main components: they guide RNA molecules that direct the second component, the CRISPR-associated (“Cas”) proteins, to target regions of cellular DNA. These Cas proteins induce double-strand breaks in DNA, allowing targeted manipulation of the genetic code of interest. The CRISPR-Cas system has incredible versatility, fine-tuning a large number of different Cas proteins to activate or deactivate individual genes, or target genomes for genes from other organisms.

The flexibility of CRISPR contrasts with previous generation gene editing technologies such as Zinc Finger Nucleases and Transcription Activator-Like Effector Nucleases (“TALENs”). These technologies require a large amount of preemptive research and development and are much more limited in scope. of use. This simultaneous precision and flexibility therefore offers ample opportunities. Gene-editing optimization of food crops In some instances, for example, browning resistant mushroomIn the second half of 2021, in Japan, First CRISPR-edited food A CRISPR-inactivating gene has introduced tomatoes to the global market that contain high levels of the naturally occurring neurotransmitter GABA.

The power of CRISPR has amazing potential for innovation, but the rights and regulations associated with CRISPR are elusive and sometimes controversial. CRISPR’s breakthrough technology has been the subject of a series of patent priorities, inventors, and ownership disputes between prominent research institutions. These recent results have significant implications for the world’s food supply.

patent landscape

Like most state-of-the-art technology, the invention of CRISPR prompted a surge in patent filings in the United States and elsewhere as researchers who brought CRISPR to light sought to protect and monetize their rights as inventors. Accompanied. Harvard and MIT Broad Institute, University of California, University of Vienna, University of Vilnius, Rockefeller University, and ToolGen, Inc., Sigma-Aldrich (Millipore Sigma), Caribou Biosciences, Inc., Editas Medicine, Inc., Keygene NV, Numerous institutions and companies, including Depixus, Blueallele Corp., and CRISPR Therapeutics AG, have secured US and foreign patent rights related to the application of CRISPR technology. As the use of CRISPR continues to expand, the complexity of the patent landscape will almost certainly continue to grow, especially in the case of CRISPR-edited agriculture, which circumvents many regulations that other GMO foods cannot.

EU regulatory status

In general, the EU applies a full suite of genetically modified organism (“GMO”) premarket approval, safety and labeling requirements to agricultural products edited with CRISPR technology. Key EU regulations on points, Directive 2001/18/EC (“GMO Directive”) was promulgated by the European Parliament and the Council of the European Union in 2001. The GMO Directive requires all EU Member States to make appropriate precautions regarding the release of GMOs on the market. However, the definition of GMOs in the GMO Directive explicitly excludes CRISPR modifications, stating that GMOs are “non-human organisms whose genetic material has been altered.” in a way that does not occur naturally By mating and/or natural recombination. “

It was in 2018 that the EU addressed this gap in the GMO Directive. In July 2018, the Court of Justice of the European Union explained: Case C-528/16 Organisms obtained by mutagenesis shall be GMO within the meaning of the GMO Directive. “Only organisms obtained by mutagenesis techniques/methods which have been used for many purposes in the past and which have a long safety record are excluded from the scope of the Directive.”

The following year, November 2019, EU Council formally requested The European Commission “submits research in light of the judgment of the Court of Justice in Case C-528/16 on the status of novel genomic technologies under European Union law and makes recommendations where appropriate in view of the results of the research.” to submit.of 117 pages of research will be published in April 2021 and ultimately endorsed the retention of case C-528/16, stating that “this study reveals that the organism was obtained through new genomic techniques.” [including CRISPR] Subject to GMO law. ” Based on the findings, The European Commission has asked for public opinion On proposed legislation against “Plants obtained by targeted mutagenesis and cisgenesis, and their food and feed products.”of Hearing period has ended July 22, 2022. The European Commission plans to finalize the proposed framework in 2023.

US regulatory landscape

In contrast to the EU approach, the US does not currently regulate CRISPR-edited agricultural products as GMOs. The United States considers food biotechnology and genetic engineering to be a “coordinated framework“Between the United States Department of Agriculture (“USDA”), the Food and Drug Administration (“FDA”), and the Environmental Protection Agency (“EPA”).

At a high level, USDA regulates the use of biotechnology in plant products. plant protection law. of USDA explains The Plant Protection Act authorizes the Department of Agriculture’s Animal and Plant Health Inspection Service (“APHIS”) to provide “organisms and organisms known to be plant pests or suspected of posing a plant pest risk, including The product is “authorized to regulate” or is produced by genetic engineering. Additionally, in 2018, USDA’s Agriculture Marketing Service: National Bioengineered Food Disclosure Standard, 7 CFR Part 66 (“BE Disclosure Standard”), “New National Mandatory Biotechnology [] Food Disclosure Standard effective January 1, 2022 and related recordkeeping requirements. [DNA]In particular, the USDA has not made clear whether CRISPR-edited produce is considered “bioengineered food” and subject to the BE disclosure standard. , Presentations from 2020The USDA said it “will determine on a case-by-case basis whether a particular modification is considered ‘discovered in nature’ or obtained through ‘conventional breeding.'” (For more information on BE disclosure standards, see Jones Day in his May 2022 publication. Are your labels up to date? Ensure compliance with the USDA’s National Biotechnology Food Disclosure Standard.)

Additionally, the FDA regulates the use of biotechnology in plants with a focus on ensuring food is safe for human consumption. In 1992, the FDA Policy Statement on Foods Derived from New Varieties of Plantsin which the FDA states:[t]The regulatory status of a food, regardless of how it was developed, depends on the objective characteristics of the food and the intended use of the food (or its ingredients). In the context of food additives, FDA approval is required to use a food additive (“GRAS”) unless the food additive is generally recognized as safe. A GMO is not GRAS if the substances are “substantially different.” In contrast, if the GMO is “naturally occurring” in the food, the GMO is GRAS, even if its molecular structure does not affect nature or “safety.” If there is a ‘small change in’. As explained at the beginning, CRISPR technology differs from traditional gene editing because it does not introduce new substances into the product that do not exist in nature.t. Therefore, CRISPR-edited produce is generally not regulated by the FDA as a food additive.

EPA is also considering the use of biotechnology in plants. Regulating the distribution, sale and use of pesticides To ensure that it “does not pose an undue risk to human health or the environment when used in accordance with label directions”. Additionally, when the EPA evaluates plant-incorporated protectants (“PIPs”), which are genetically engineered pesticides, the EPA “considers numerous factors, including risks to human health, non-target organisms, and the environment. requires extensive research, including the potential for gene flow’; and the need for an insect resistance management plan. As such, CRISPR-edited pesticides may be regulated as PIPs by the EPA.

Conclusion

The patent and regulatory landscape for the use of CRISPR technology in food continues to evolve around the world. Agricultural companies and the broader agricultural industry must therefore pay close attention to all developments.

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