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The big problem is the regulatory issues. It is the sticking point. Originally, I thought it might be the case with gene editing as well, but the regulatory issues seem to be sorting themselves out a lot more quickly than they ever did with transgenics.—Informant 20 (scientist/NGO representative)

1 Introduction

In this chapter we examine how governance structures and regulatory frameworks can respond to emergent new breeding techniques, exploring how emerging techniques may pose challenges for regulatory frameworks. We touch on the difficulties of governing the unknown, but also highlight the regulatory tools that may help policymakers better anticipate developments in a rapidly evolving regulatory space. We argue that using deliberative elements of governance will help stakeholders better identify opportunities and respond to future, unknown technologies. Finally, we take a closer look at the patent and licensing landscape for CRISPR technologies and how this space is in a state of flux. Can deliberative governance offer clues as to how to streamline and simplify the patent and licensing landscape?

We begin by discussing the principles of deliberative governance as it pertains to gene editing in the agrifood system. We then move on to what is currently changing in notable regulatory systems around the world with respect to emergent gene editing techniques and platforms. Finally, we take a closer look at the current patent and licensing landscape to provide a general overview of the legalities of innovation, and how this can help or hinder scientific advancements in gene editing applied to agrifood research and product development.

2 Regulating Future Technologies

One of the most influential documents published about the future of gene editing in the agrifood system is the National Academy of Sciences, Engineering and Medicine’s report Preparing for Future Products of Biotechnology (NASEM, 2017a).Footnote 1 Though the recommendations are directed toward US agencies responsible for regulating biotechnology, there are lessons to be drawn from NASEM meetings and subsequent publications that may be relevant to other countries (NASEM, 2024). Though much has changed since its publication, there are several actions outlined in the document that regulators today can implement to make their regulatory systems as effective as possible. The authors of the document cover the science behind gene editing but also the regulatory environment for gene edited agrifoods. In their Conclusions and Recommendations, the NASEM committee offers advice for how regulators could deal with future technologies as they move through the proof-of-concept stage towards commercialization. Those recommendations are worth examining here.

A key conclusion included in the final chapter of the NASEM document notes that:

The risk-assessment endpoints for future biotechnology products are not new compared with those that have been identified for existing biotechnology products, but the pathways to those endpoints have the potential to be very different in terms of complexity. (NASEM, 2017a: 20).

Thus, regulatory frameworks may take different approaches to evaluating novel gene editing techniques or platforms, but the principles of safety assessment remain consistent with current ways of evaluating risks pertaining to human, animal, and environmental safety.

The committee observes that regulatory systems are likely not prepared for the number of emergent innovative technologies and applications on the horizon and may not have the necessary infrastructure, human resources or streamlined evaluation mechanisms in place. The committee recommends policy makers invest in public outreach and research and development within the agrifood sector. Outreach strategies that engage with stakeholders is an effective way of gathering information about what is in the pipeline, giving regulators some indication as to how to handle applications for approvals of novel agrifoods. Having an idea of what is in the pipeline gives regulators the ability to tweak the approval process to find a balance between stakeholder access to useful innovations, fostering economic development, while ensuring rigorous risk assessments to ensure the health and safety of humans, animals, and the environment.

Identifying and developing strategies for mitigating any potential harms while acquiring and maintaining social license and legitimacy are also issues policymakers need to consider. Not an easy task for any regulatory system, but the NASEM committee suggests investing in three primary areas that will enhance the regulatory ability to respond to emergent gene edited agrifoods. Broadly, the committee recommended a commitment of resources in key areas of expected growth of biotechnology, an increase investment in public and private research, and increase investments in regulatory science (NASEM, 2017a: Chapter 6 ‘Conclusions and Recommendations’).

The committee’s recommendations stress that increasing resources for policy, decision and social science research are necessary to improve the risk analysis processes that follow. Foresighting, scenarios and simulations have undoubtedly become easier with the advent of AI and big data to identify and predict potential bottlenecks and risks to health and safety before a product enters risk assessment. Whether regulatory agencies are using these tools is another question. They can be useful tools to help predict how a given regulatory framework may behave in the face of applications for approval of yet unknown gene editing applications. Foresighting is a systematic and purposeful process of future-oriented deliberation between actors with a view to identifying actions to be taken today for a better future tomorrow (Keenan, 2006, slide 4). These techniques can be used to adapt new foresight processes extending beyond the known risks to future issues and opportunities that face gene editing in agrifood. Foresighting can help identify future goals and criteria, as well as strategic opportunities.

The scenario method involves identification of drivers of change in a system, categorized by importance and uncertainties. These variables are used to form matrices of options for policy actions (Sharpe & van der Heijde, 2007). The NASEM committee also suggested that having a better understanding of the social, legal, and ethical implications associated with future gene editing techniques is crucial to having a responsive regulatory system. Consultations with stakeholders such as laypersons, as well as experts in the fields of public policy, innovation, agriculture, and gene editing may aid in this effort. It may also help improve the ways claims and counterclaims are handled to develop more inclusive approaches for determining “weight of evidence” in how data is interpreted (NASEM, 2017b: 37).

Improving science communication and knowledge exchange among stakeholders is foundational to improving preparedness for future advancements in biotechnology. On the practical side, bolstered field trials and pilot projects will provide real-world data through testing and information gathering. The last suggestion is to strengthen dialogue between regulatory agencies and trading partners to limit redundancies, and work towards policy harmonization to ease the regulatory burden and approve or reject emergent gene edited agrifoods as efficiently as possible to limit trade disruptions and costly misunderstandings, inaccurate or incomplete information.

This list of suggested changes and improvements to regulatory frameworks is no mean feat. Changing regulatory frameworks is costly. Allocating additional resources for future technologies takes resources away from other worthy issue areas for which governments are responsible. But there is a cost to maintaining the status quo and dealing with challenges on an ad hoc basis. It is important for regulators to decide how best to prepare for future uncertainties in the gene editing space that do not stall innovation, but also treat the inclusive, deliberative elements as equally important as the risk assessment of the actual organism or product. One notable point from the OECD (2018: 33) report on gene editing is that “what does not happen in one country, will likely happen in another.” If governments are not prepared for innovation within their jurisdictions, they will have little say in how innovations develop abroad and land on their doorsteps with a possibly different set of standards and evaluations. Collectively, these are all approaches to help manage future uncertainties. They are also important components of deliberative governance, as defined by Hendriks (2009: 173), which in essence, is policy making that involves consultation with ‘institutions, agencies, groups, activists and individual citizens coming together to deliberate a pressing social issue’.

2.1 Deliberative Governance

The suggestions from NASEM and the OECD largely reflect the principles for responsible governance laid out by Gordon et al. (2021) and include three areas: transparency and access; private and public management; and equity & inclusion. These are all elements of what we label deliberative governance, which puts effective, inclusive, and transformative communication at the heart of the governance of gene edited agrifoods. The ‘transparency’ aspects include publicly accessible information about the gene edited agrifoods that are being assessed for novelty, risk and health and safety; what the NASEM (2017a) report refers to as the ‘data commons’. ‘Private and public management’ includes science-based regulation as well as voluntary best practices in conjunction with regulatory oversight. ‘Equity and inclusion’ cover risk avoidance and acquiring social license, as well as deliberative, inclusive social engagement and consultation.

Each of these components are equally important and deserve equal attention from regulators. Having a functional and effective regulatory system for gene edited agrifoods requires critical evaluation of what currently works in risk assessment platforms, and what needs to change in response to emergent technologies. Flexibility, and grounding evaluations on science-based information appear to be two key elements to effective systems that meet several overlapping objectives to approve or not approve products based on the scientific risks they may (or may not) pose to humans, animals, and the environment. Whether novel products stoke uncertainties regarding their economic implications once commercialized (who will benefit, who may not) or cause concerns regarding the scope of intellectual property rights in the food system, these issues are not considered relevant to risk-based assessments of novel organisms or products. Yet, questions regarding the socio-economic implications of technological shifts are important and deserve attention within the deliberative governance approach.

2.2 The Precautionary Principle

A major issue is the future role of the Cartagena Protocol on Biosafety (CPB) in regulatory frameworks for new breeding techniques. Many countries have based their regulatory systems on the Precautionary Principle, which is a foundational part of the document. But there are limitations placed on regulatory systems adhering to the Protocol that do not necessarily reflect the realities of the risks inherent in using gene editing. Informant 5 (a research scientist) provided an insightful assessment of the ability for regulatory systems to reform when the CPB is embedded in their regulatory approach. Informant 5 observed,

The issue is trying to come up with a way to move forward… countries find that they sign this international agreement on biosafety. And of course, they’re also members of the Convention on Biological Diversity so that’s meant that they have international obligations. And they built up this national biosafety framework and they tended to be kind of verbatim copies of Cartagena Protocol and in fact, the precautionary principle was in almost all of them. So, what that meant is that they based the national biosafety framework, their regulations, their laws, and their policies on this precautionary language, and part of the issue here is that they are stuck in a sense…what that means is that if you want to do something, you have to comply with that, and in some cases, particularly in Africa, that means a Parliamentary Act approved by Parliament and so trying to modify that means another 5 years, 10 years of discussions, until finally Parliament makes a decision.

The marriage of regulatory systems to the CPB may curb the ability for regulatory systems to assess emergent technologies accurately and effectively and be prepared for what lies ahead. Future breeding techniques will be subject to the risk assessments protocols designed for previous techniques and applications, that may not be relevant depending on the innovation. The lack of flexibility in strict precautionary approaches to evaluating new breeding techniques may stall innovation, restricting the ability for economies to be competitive and for producers and consumers to access useful innovations.

3 Change Afoot? The EU’s Approach to Regulating Future Biotechnologies

In 2022, the European Parliamentary Research Service’s Scientific Foresight Unit (STOA) published a document entitled, ‘Genome-edited crops and the twenty-first century food system challenges.’Footnote 2 In it, the authors state that the emergent gene editing techniques (New Breeding Techniques (NBTs)) have the potential to meet the objectives of the EU’s Green Deal, specifically the Farm to Fork and biodiversity strategies. The authors were supportive of the reassessment of how gene editing agrifoods are regulated in the EU (EPRS-STOA, 2022). They did note, however, that the potential benefits from gene editing were often regarded by critics of biotechnology as hypotheticals and “achievable by means other than biotechnology” (EPRS-STOA, 2022: 22). This report was published before the European Commission (EC) proposal to reopen the dialogue regarding the regulation of NBTs similarly to GMOs. The proposal that was published in the summer of 2023 by the EC reinforced the points made in the early EPRS-STOA report and took the discussion a step further to re-open the debate regarding the EU’s regulatory approach to gene editing.

With respect to risk to human and animal health and the environment, The European Food Safety Authority (EFSA) document outlining the proposed amendment to legislation pertaining to gene edited agrifoods concluded that there are no specific hazards linked to targeted mutagenesis or cisgenesis (EFSA, 2023). EFSA also concluded that in targeted mutagenesis, the potential for unintended effects, such as off-target effects, may be significantly reduced compared to transgenesis or conventional breeding. Therefore, due to how these novel techniques work, and compared to transgenesis, less data might be needed for the risk assessment of these plants and products made from them (EFSA, 2023: 2). The document states that the EU Directive 2001/18 which covers GMOs does not accurately reflect the risks posed by new breeding techniques using SDN1.

The Commission… concluded that there are strong indications that the current European Union GMO legislation is not fit to regulate plants derived from using new breeding techniques obtained by targeted mutagenesis or cisgenesis, and products (including food and feed) derived from them and that that legislation needs to be adapted to scientific and technical progress in this area. (EFSA, 2023: 3).

Crucially, this document signals a need for reevaluation of how the current EU regulatory framework treats NBTs that have a different risk profile than GMOs (according to the committee), and that also offer profound potential to meet the EU’s sustainability goals within the Farm to Fork Strategy. The proposal’s ‘general objectives’ are very similar to the elements of deliberative governance as described by Gordon et al. (2021), including rigorous risk assessment to mitigate harms to humans, animals, and the environment, fostering innovation and economic competitiveness, and contributing to a sustainable agrifood system.

The proposal is now in the hands of member governments that must decide whether to proceed with proposed changes to the coverage of EU Directive 2001/18. There are several EU members that want a different set of regulations for NBTs, while there are also a number of members that wish to continue using the precautionary principle to evaluate NBTs in a similar fashion to GMOs.

Considering these recent developments and the speed with which this issue is progressing, it was important to include questions about the EU’s proposal in our interviews. Informants had quite a lot to say about the EU situation and offered insights into how things may proceed now that it is up to member state governments to decide whether or not they are in favour of changes to how NBTs are regulated. US-based Informant 20 (a scientist working for an NGO) sees the proposal as an important first step, saying:

Denmark has been rumored, for example, as changing policies and even France. I mean there’s a lot of research going on genome editing in France and the President himself has come out and supported it. I think it’s positive but it is going to take some time just because of the political structure.

Despite the optimism held by some informants that came with this announcement, Informant 11 (an academic researcher), who lives in the EU and researches issues related to agricultural biotechnology, had valuable insights into whether or not member states will approve this proposal. They seemed somewhat skeptical that this regulatory change would pass at the European Commission level, stating:

Spain is pushing, the Netherlands are pushing, Sweden is pushing. But this is not enough… the problem with the NBTs is, that the Council would require a qualified majority by member states for any changes and, it’s not likely that a qualified majority will be reached. Member states such as Germany have already abstained in the voting, so not voting in favor. Austria already has said that they are against any liberalization on the release of NBTs into the environment so they will vote no with France. And Italy can also be expected to abstain and just with 4 countries you cannot get a qualified majority anymore. A qualified majority requires that at least 15 member states vote in favour. And, that 55% of the population will be represented by those in favour. In France, Italy and Germany have already more than 55% of the population. And then under the EU rules these 3 big countries cannot block anything, you need at least a fourth country in the voting and that is Austria. They have already declared that they will vote against any liberalization. (Informant 11).

Outside of the EU there appears to be optimism, but inside the EU the perspective seems to be quite different. Informant 8 (a private sector representative based in the US) took issue with the arbitrariness of the 20 genetic changes that is the proposed threshold for whether a NBT would be subject to EU 2001/18. They said,

So there are regulators who have said things like, if you make more than 20 nucleotide changes on the plant that has a regulatory consequence, and scientifically, that’s nonsense. You can change one nucleotide and have a big effect, or you can change a thousand, and have not much at all. It’s the result that matters.

Other informants had little faith that the EU would change how it regulates NBTs and stated that it would take a food security crisis for the hold-out member states to rethink their position. Informant 17 (a research scientist) commented,

The only way perspectives on that will change in Europe for example is if there’s true food scarcity or skyrocketing costs in Europe. That’s the only way that they would change. And if it was recognizable that an edited crop would help alleviate that crisis, that’s when it would make a difference. But many of the players that are driving their resistance to edited crops in Europe are very comfortable. Well, they have very comfortable lives and so they don’t think it’s an issue.

The direction the EU chooses to go has implications for other countries. Several Informants were critical of the influence of EU regulations on how countries in the developing world, namely in Africa, have developed their own regulations for gene edited agrifoods. As discussed in Chap. 3, many African countries are in the midst of developing regulatory frameworks, and some are working towards getting gene edited (and GMO) crops into the ground to reap the benefits of these revolutionary technologies. However, the negative influence of EU opposition to biotechnology in the domestic policy making space in other countries frustrated some of the Informants, most notably an Informant situated in an African country. Informant 19 observed,

…you see that much of what is happening in Africa in sub-Saharan Africa, for example is influenced by Europe’s stand on the issue. And if Europe is saying we are going to regulate edited products as GMOs that is going to have an effect on many countries in Africa and this is because of the complicated history of Europe and Africa. There is still that colonial idea, like if Europe has gone this way, Africa should also go this way and there’s also the aspect of activities of very sophisticated activism for Africa to design its regulatory framework in a way that resembles those of Europe because it makes no sense because Africa trades with Europe more than it trades with the US…Europe’s approach to this is going to have a ripple effect in much of Africa.

Several African countries are in the midst of developing harmonized guidelines that would cover any gene edited agrifood seeking approval in their jurisdictions. Kenya, Uganda, Tanzania, Rwanda, and South Sudan are in the latter stages of finalizing their regulatory frameworks for NBTs. Informant 19, who is contact with stakeholders in the above countries, said that harmonization of regulations may be the best way to move forward. They believe a move by the EU to differently regulate NBTs will have a positive effect on African countries’ regulations, “whatever happens in Europe really has a major impact on what happens in sub-Saharan Africa.” (Informant 19).

The world will have to wait and see what direction the EU goes in terms of how it assesses and regulates gene editing agrifoods. Various international organizations have offered suggestions as to how best to prepare for future new breeding techniques. As we discussed in Chap. 3 (Sect. 3.4), Canada has embraced the deliberative governance model in its handling of gene edited agricultural plants. Another significant issue to consider is the patent and licensing landscape that governs gene editing in the agrifood system.

4 Patents, Licenses and Freedom to Operate

The patent and license landscape for CRISPR and other gene editing technologies is complex, and continually changing. In the context of this book, we explain the basics of intellectual property law pertaining to patents, licensing and ‘freedom to operate’ as they relate to gene editing in the agrifood system. We also discuss some of the more substantive details of what entities are using gene editing technologies, like CRISPR, to conduct research and product development in the agrifood space. We discuss the race to file patented agrifood plant traits as regulatory burdens ease on the use of gene editing in the agrifood system and more gene edited foods become commercially available.

4.1 Intellectual Property Law and Patents: The Basics

Gene editing techniques are considered Intellectual Property (IP). Discoveries from using gene editing techniques are also considered patentable. Patents apply to techniques and the genetic traits that are outcomes of using these techniques. To protect IP, patents must be secured. Patents allow for owners to control others from making, using, selling, or importing the patented invention. Patents are territorial, and obtaining patent recognition is expensive and time consuming. They must be registered in each country or region the owner wants their property rights protected. Claim scopes may vary across countries or regions based on how the application is examined and the substantive laws in the country/region (Bagley & Candler, 2023). Before a patent is issued, the invention will be analyzed for novelty, invention step, proper description, and subject matter eligibility by the state or regional authority granting patent protection.

Countries have different legislation pertaining to what type of organisms can be patented. For example, in Canada, animals—even those with traits derived from gene editing—cannot be patented. The Supreme Court of Canada ruled on the ‘Harvard Mouse’ case in 2002.Footnote 3 Harvard argued that the oncomouse, which was genetically modified to have cancer-promoting genes for research purposes, required a patent in Canada. The Supreme Court ruled that higher life forms cannot be patentable, though in other jurisdictions (US, Japan) the Harvard Mouse was patented. There were worries at the time that this Supreme Court decision could chill biotech investment in Canada. This has not been the case.

Freedom to Use or Freedom to Operate (FTO) refer to the same thing. That is, the ability for an entity to use a patented technology. Freedom to Operate is defined as “the ability to proceed with research, development and commercialization of a product, while fully accounting for any potential risks of infringing activity, i.e., whether a product can be made, used, sold, offered for sale, or exported, with a minimal risk of infringing the unlicensed Intellectual Property Rights (IPR) or Tangible Property Rights (TPR) of others” (Kowalski et al., 2011: 12).

One cannot freely use a patented invention in a jurisdiction that does not have a patent on file without taking significant risk. Genome editing techniques, novel traits and relevant genes are patented in various jurisdictions around the world. Each country has its own set of criteria to judge the validity of a patent claim. Patent infringement liability may be claimed by the owners of the patent if such things were to occur. Other related patents may be filed in the country/region that could be used to prove infringement. If infringement is suspected, the burden of proof is on the accused infringer, as per the World Trade Organisation’s Agreement on Trade Related Aspects of Intellectual Property (TRIPS), Section 5, Article 34. It states,

…if the subject matter of a patent is a process for obtaining a product, the judicial authorities shall have the authority to order the defendant to prove that the process to obtain an identical product is different from the patented process. (WTO, 1994).Footnote 4

Though the WTO and the World Intellectual Property Organization (WIPO) administer treaties related to IP, they do not provide standards for the patentability of inventions.

Licenses are required to use patented genes/traits. The 2004 Supreme Court Canada (Schmeiser vs. Monsanto)Footnote 5 set the precedent that using plants with novel traits (derived from genetic modification or otherwise) require the user to pay a licensing fee regardless of whether the producer utilized the patented gene or not. Producers must pay licensing fees and pay royalties when required and gene edited plants use the same IP model as transgenics.

4.2 Who Owns CRISPR?

There have been several claims of inventing CRISPR, the most widely known of the gene editing techniques. Up until 2022, ‘who owns CRISPR?’ was unsettled. We would argue that this remains the case. After years of litigation, in February 2022 the United States Patent and Trademark Office (USPTO) named the Broad Institute as first to invent the use of CRISPR-Cas9 in eukaryotic cells.Footnote 6 The University of California Berkely (Dr. Jennifer Doudna), University of Vienna and Dr. Charpentier (CVC) dispute this claim, but today, the Broad Institute (of Harvard and MIT) legally holds the rights to the CRISPR-Cas9 patent in the US, though CVC holds over 55 patents related to CRISPR-Cas9 that are upheld. CVC holds the broadest foundational patents in the EU, Brazil, Canada, and Australia. The initial Broad patent for CRISPR-Cas9 in the EU has been revoked, with no appeals available. However, the European Patent Office (EPO) Opposition division in 2023 upheld three of Broad’s patents for CRISPR-Cas12a (Sandys, 2023).

Obtaining a license for using CRISPR for commercialization is the path usually taken by developers. Licenses can include future royalties and milestone payments if a product is intended to be commercialized. However, obtaining a license, as Bagley and Candler (2023: 42) note, is not always straightforward. Patents are not published until 18 months after the earliest effective filing date. A potential user may not have knowledge of what entity or entities they must obtain a license from to use a specific CRISPR tool. Using patented techniques can also lead to discoveries. Researchers using licensed CRISPR tools may discover an invention for which they themselves would have to seek a patent. There are also licensing issues for tools that facilitate CRISPR (promoters, agrobacterium) that users will have to navigate before using the technique.

The licensing landscape continues to change, so keeping up with patents and licenses is required to avoid potential infringement (Bagley & Candler, 2023: 48). If US agrifood researchers wish to use CRISPR-Cas9 in their research and product development, they must get a license from the Broad Institute or Corteva (formally Dow DuPont Pioneer), as they both hold licenses for CRISPR-Cas9. If a researcher is in Canada, Brazil, Australia, or the EU, they must get a license from CVC. If a developer wishes to commercialize a product in a particular jurisdiction, they must obtain a license from the recognized license-holder, in addition to the license-holder where the R&D was conducted. There is no guarantee that obtaining a license from one entity will protect a researcher or developer from infringement in the future, as patents are continually filed regarding CRISPR techniques around the world.

In 2014, there were 90 CRISPR patent landscapes. As of August 2022, according to Swiss-based CENTREDOC (previously IPStudies) there were 15,000 patent families and over 400 licensing agreements. This number includes all CRISPR patents and licenses. Patents that apply to agriculture specifically are more difficult to pin down. The information available to us is from January 2021 where 1400 patents were filed for agrifood plant advances (CENTREDOC, 2023). In the case of CRISPR, there is currently a patchwork of patents with varying claims dependent on where the patent was filed. According to CENTREDOC, in 2023 there were 200-plus CRISPR patent families published every month. Most notably, the majority of CRISPR application patents in the agriculture as well as therapeutics areas originate in state-owned Chinese research institutions (CENTREDOC, 2023). According to Bagley and Candler’s (2023: 38) analysis, the Chinese Academy of Agricultural Sciences (189), Chinese Academy of Sciences (112) and US-based Corteva (96) collectively filed 397 patents for agrifood plants using CRISPR in 2020 (as of January 2021). It is unclear currently whether either of the Chinese institutions have licenses for these patented discoveries, as they are either not published, or not accessible to those conducting Internet searches outside of China. It is also possible that some of the collaborators in these studies have licenses for jointly patented agrifood plants.

Corteva Agriscience (formally Dow DuPont Pioneer) and the Broad Institute control a significant proportion of the licenses for CRISPR-Cas9 for agrifood plants, as well as Cas12a and Cas12b. Each nuclease has a separate license, because the family of patents have different co-owners due to inventor collaborations. In 2017, they announced a partnership agreement that created a joint-licensing framework for CRISPR-Cas9 technology in agriculture. These include foundational CRISPR patents and products and techniques reliant on the Cas9 system. Corteva has the right to sub-license CRISPR-Cas9 patents for agrifood held by several entities, including the Broad Institute. Non-exclusive licenses for the IP for commercial agricultural research and product development are a core component of this agreement. Because of this, Corteva can offer licenses in a bundle, giving users rights to access several CRISPR-Cas9 technologies.

Academic and non-profit researchers can freely use the CRISPR-Cas9 technology without paying the licensing fee that commercial endeavors would be required to pay. The technology, however, is prohibited to be used for CRISPR gene drives, sterile seeds, or tobacco for human use (Broad Institute, 2017). Despite the dispute over the CRISPR-Cas9 patent, the creation of the licensing pool added some certainty over access to CRISPR-Cas9 IP for researchers and developers. But as Informant 7 (a research scientist) stated,

…CRISPR-Cas9 which is the most popular gene editing technique that belongs to the Broad Institute…and they are happy for people to use it for research purposes. But anything beyond that, it becomes a real challenge, and there’s still a lot of uncertainty.

The Broad Institute and Corteva are not the only patent and license holders in the CRISPR field. Benson Hill Biosystems holds licenses to what it labels as “CRISPR 3.0”. CRISPR-Cms1, which uses a different nuclease from Cas9, Cas12a or Cas12b, is owned by Benson Hill and it positions itself as offering a cost-effective alternative to CRISPR-Cas9. Cms1’s simpler RNA structure allows for more efficient gene editing, according to the company’s website. The company states that

(the) uncertainty around the CRISPR intellectual property landscape presents a barrier to entry for innovators wishing to utilize genome editing solutions for those interested in accessing this powerful tool… Benson Hill aims to empower innovators with clear intellectual property rights and a licensing model that is transparent and simple. In the past year we’ve licensed our Cms1 nucleases in wide range of applications and fields, ranging from microbial applications to crops such as soybeans, wheat and rice. (Benson Hill Biosystems, 2019).

Bayer (Monsanto), BASF and Syngenta hold non-exclusive rights to the CRISPR-Cas12 licenses held by the Broad Institute for agricultural applications. Bayer is currently collaborating with the company Pairwise to use CRISPR-Cas9 for several crops, like wheat, canola, and soybean. Pairwise is part of the licensing agreement that allows the company to use and commercialize agrifood products developed using CRISPR-Cas9 techniques.

As mentioned in Chap. 2 (Sect. 2.2), other genomic techniques continue to be useful to agrifood researchers, such as TALEs. The 2Blades Foundation is a US-based non-profit that partnered with the scientists in Germany who first published on TAL Code in 2009. 2Blades grants licenses for the use of TALENs in agrifood plants for research and commercial applications. Informant 16 (a research scientist) was concerned about the IP issues related to CRISPR-Cas9. They observed,

in terms of freedom to operate, it’s very important for that generated technology to be widely available just because it won’t be restricted to large companies that have resources but will be available to academia and will be available to government to small companies with good ideas, but that they don’t have resources to go all the way through. To pay licenses fees for the technology. But that’s when we talk about CRISPR technology there are other technologies like the TALENs.

According to the non-profit International Service for the Acquisition of Agri-biotech Applications (ISAAA) website, 2Blades claims that the licensing/use of TALENs technology generated 650 million USD in 2019 (ISAAA, 2023). TALENs has successfully been used to edit the genomes of soybeans, rice, potato, maize, and wheat. 2Blades has given a no-cost license to the International Rice Research Institute to help facilitate food security efforts (ISAAA, 2023).

The licensing landscape for CRISPR-Cas9 is continually evolving. Bagley and Candler (2023) discuss the current licensing of CRISPR technologies used in agriculture, providing a snapshot of which entity holds the licensing rights to CRISPR technologies, the types of licenses and the financial terms. As of 2023, the three main license holders are Corteva Agriscience, The Broad Institute and Benson Hill Biosystems. Corteva and The Broad Institute share licensing rights over CRISPRCas-9 for agricultural use. They have several types of licensing agreements including internal R&D, commercial seed and crop trait products and commercial licenses for other agricultural products. Both institutions charge licensing fees, including annual maintenance fees, commercial milestone payments and royalties. The fee structures are determined on a case-by-case basis. For example, academic and non-profit institutions seeking licenses for non-commercial use or R&D do not pay the same fees as for-profit entities. Similar license types and fee structures apply to The Broad Institute’s licensing agreements for CRISPR-Cas9, CRISPR-Cas12a, and CRISPR-Cas12b technologies. Benson Hill Biosystems holds the license for the CRISPR-Cms1 technology. Benson Hill negotiates agreement individually based on economic potential and the financial circumstances of the institution applying to use the technology. Licensing may involve up-front fees, milestone payments and/or royalties (Bagley & Candler, 2023: 49).

Though the field is a bit less complicated today, hurdles do remain that create uncertainty for researchers and product developers seeking to use the power of CRISPR to develop new agrifood traits. Some have flagged the patenting of publicly funded research results as problematic, questioning why they are not freely available (Scheinerman & Sherkow, 2021). The fluid nature of the patent environment also concerns research scientists like Informant 7. They stated,

at (their organization) they do allow us to use CRISPR-Cas9 for research, but I get the feeling that they are almost becoming a bit reluctant even for that. Just because they’re unsure, our intellectual property officers are like, ‘is it okay to use for research purposes?’…people have been using it for many years, but I think they just worry. And what happens if it goes to court again, and then someone else gets it, and then it’s not okay and I think there’s just a lot of uncertainty there. And commercialization, that’s not easy. For us, we would need to go through some company that has a license to use it. So that is limiting as well, I’d say.

4.3 What Does the Future Patent/License Landscape Look Like?

Questions have been raised as to the patenting and licensing of techniques (‘the process’), as opposed to organisms and products as is the case with transgenics (Gehrke, 2019). There are others who argue that patenting and licensing of CRISPR increases the concentration of power in the agrifood R&D sector. Several informants had quite a lot to say about ‘freedom to operate’ and the challenges faced by research scientists. Informant 3 (a former academic researcher) stated,

I’m very concerned that with the IP environments, we’re going to be locked again in a situation where only large companies that have the financial means will be able to commercialize product derived from these technologies. In Canada we do not have these large national and international companies like you see in Europe, like you see in US…But even on the public side, a lot of the innovation is generated by our universities from Canada, but we do not have the freedom to operate and, in fact, we cannot use CRISPR-Cas9 for the purpose to develop a new plant trait based in the environment in Canada.

CRISPR-Cas9 is one of over 100 variants of CRISPR enzymes. As such, there continues to be a race to secure IP exclusivity for newly discovered nucleases. Gene edited plants are much more difficult to trace, because there is no modified gene ‘tag’ that indicates whether or not an organism was developed using gene editing techniques like CRISPR. Detecting genome edited DNA sequences is far more difficult than tracing transgenic sequences. There are, however, organizations working on techniques to identify gene edited organisms. If a mutation is novel, it is possible to develop a test for detection. Analyzing seed samples and enforcing patent rights will become more important as more gene edited agrifoods become commercialized (the purpose of the Seeds Database proposed in the Canadian legislation covering gene edited agrifoods, see Chap. 3, Sect. 3.4). As for stacked traits, it is more difficult to protect IP. Holders of IP will have to rely on regulations to enforce their proprietary rights by using plant breeder’s rights and trade secrets for commercial protection from infringement (CBAN, 2022). Paraphrasing one Informant, “it’s difficult to track things that don’t have markers (like transgenics). People are not sure how to monetize things that aren’t necessarily enforceable.”

5 Conclusion

This chapter has examined the principles of deliberative governance, along with current changes taking place in some regulatory systems. Several policy areas remain unsettled, and (at the time of writing) we have yet to see how and if the EU will modify its regulatory stance on gene edited agrifoods. The decisions made by the EU will have a ripple effect throughout the world, as countries in sub-Saharan Africa, for example, continue to work towards building robust regulatory systems that foster innovation, while giving smallholder farmers access to safe and valuable agrifood technologies.

In this chapter, we have also taken a closer look at the current patent and licensing landscape and examined some of the implications for researchers and regulatory frameworks as new techniques and applications continue to emerge around the world. Regulatory systems need to be prepared for whatever the future may hold in terms of gene editing. Governments also need to consider the shifting landscapes of patents and licenses that govern who gets to use certain technologies, what it costs, and the implications for commercializing a gene edited agrifood plant that could positively contribute to food security and climate change mitigation strategies.