Our food system is facing an imminent challenge: feeding a global population projected to reach 9.3 billion by 2050. Achieving this goal requires a 60% increase in food production, which will be challenging to achieve sustainably using traditional agricultural practices. [1]

CRISPR/Cas gene-editing technology (CRISPR) presents a possible solution to this impending crisis. However, incorporating CRISPR into agriculture and food production requires navigating complex regulatory frameworks that could determine how widely these innovations are adopted.

CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) is a groundbreaking advancement in gene-editing that has transformed our genetic engineering capabilities. CRISPR enables scientists to make precise edits to an organism’s genetic material. In agriculture and food production, CRISPR offers numerous advantages, such as the ability to eliminate allergens, increase nutritional content,[2] improve growth rates,[3] increase disease resistance, and reduce food waste.[4]

With climate change posing increasing threats to agriculture, CRISPR can engineer crops that require less water, can tolerate extreme temperatures, or thrive in soil where traditional crops might fail. And by tailoring crops to be more resistant and less dependent on chemical inputs, CRISPR can help reduce agriculture's environmental footprint, promoting sustainable farming practices.

For example, CRISPR-modified tomatoes have been developed to improve yields, increase fruit size, enhance resistance to disease and increase nutritional content.[5] As another example, CRISPR-modified cacao plants have been developed to increase yield, reduce production costs and improve the nutritional content.[6] Experts predict that CRISPR-modified foods will start to reach the market in approximately five to 10 years, offering solutions to some of the world’s food production issues.[7]

The Patent Landscape

Patents are at the heart of this technological revolution, providing both the incentive for innovation and the framework for its distribution. Patents grant exclusive rights to use or sell a new technology, encouraging investment in research and development. Companies and institutions are more likely to invest in CRISPR if they can own the rights to their innovations.   

As of December 2024, there are close to 2,000 patents and patent applications granted or pending at the U.S. Patent and Trademark Office (USPTO) related to CRISPR technology,[8] more than 1,000 of which have agricultural applications,[9] and 69 of which are directed towards using CRISPR technology to modify crops.[10]  

However, patents can also restrict access. When a company holds a patent on a CRISPR-edited crop, it might limit its cultivation to those who can afford licensing fees. Some argue that this type of behavior can potentially lead to a new form of “genetic colonialism” where only wealthier entities benefit from advanced seeds.  

The CRISPR patent landscape is complex and contentious, with multiple entities claiming rights over different aspects of the technology. This has led to high-profile legal battles, particularly between the Broad Institute, UC Berkeley, Toolgen, University of Vienna and others.  

Patent laws vary by country, affecting how CRISPR technologies are shared globally. Some countries might not grant or allow enforcement of patents in the same way or to the same entities (sometimes awarding patents to opposing parties in direct contrast to other countries), leading to disparities in technological adoption and advancement.

The Regulatory Landscape

The distinction between genetically modified organisms (GMOs) and genetically edited (GE) crops, such as CRISPR-edited crops, lies in how the genetic modifications are made. GMOs typically involve introducing foreign DNA into an organism, often from another species, and can result in random integration of genes into the genome. CRISPR, on the other hand, allows for precise, targeted edits to the plant’s own genetic material. This makes CRISPR gene editing a more accurate, safer and more efficient method of modifying crops.[11]

Accordingly, this distinction has significant regulatory implications because CRISPR-edited crops are considered more natural and less controversial than GMOs. In the U.S., regulatory agencies distinguish between genetically modified and GE crops.

Under the Plant Protection Act, the U.S. Department of Agriculture (USDA)’s Animal and Plant Health Inspection Service (APHIS) oversees the environmental risks associated with GE organisms.[12] In 2020, USDA introduced the SECURE rule (Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient) codified at 7 C.F.R. part 340 under the Plant Protection Act. 85 Fed. Reg. 29790 (May 18, 2020), which evaluates biotechnology products based on their characteristics rather than their method of modification. Since that time, the USDA has implemented revised regulations.[13] Under the revised biotechnology regulations, categories of modified plants, which could have been developed through conventional breeding techniques, are exempt from the regulations in 7 CFR part 340.

The U.S. Food and Drug Administration (FDA) is tasked with ensuring the safety of all foods that are consumed by people or animals, including those produced through genetic engineering.[14] The agency evaluates food safety based on the final product’s characteristics rather than the method used to create it. For example, if a CRISPR-edited food does not differ significantly in structure, function or composition from traditional food, it is regulated in the same way as food developed through traditional plant breeding.[15]

The U.S. Environmental Protection Agency (EPA) is responsible for overseeing plant pesticides, including plant-incorporated protectants (PIPs) that result from genetic engineering. The protein and its genetic material introduced using genetic engineering methods, such as CRISPR, are evaluated by the EPA to ensure their environmental safety.[16]

The Future of Food with CRISPR

Looking ahead, we might see the rise of super crops that not only feed more people but do so in a way that is more ecofriendly. Farming could become more personalized with crops designed for specific regions or consumer needs, enhancing local food security. The ethical use of gene editing, consumer acceptance and regulatory frameworks will need to evolve to keep pace with science.

CRISPR technology represents a revolutionary shift in our approach to food production. In the U.S., the regulatory approach to CRISPR crops has been more lenient compared to GMOs. However, this approach is not currently used by all countries. For example, in Europe, regulators evaluate GE organisms and GMOs under the same regulatory framework, although that framework is currently under review.[17] Additionally, Japan, which had low public support and consumer acceptance for GMOs, is now emerging as a leader in GE crops.[18] 

In this changing regulatory landscape, pioneers in this space should continue to monitor updated global regulations and consider how these regulatory changes will affect their global intellectual property strategy.

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