1 Introduction

The application of genetically modified organism (GMO) technology has profoundly changed the modern agricultural production model. Crops improved by genetic engineering technology have not only significantly increased the yield per unit area, but also enhanced the ability to resist diseases and pests, while improving the nutritional quality of agricultural products (Kiran & Pandey, 2020). Under the dual pressure of the continued growth of the global population and the increasing scarcity of arable land resources, genetic modification technology has become one of the key solutions to meet the challenge of food security (Shan, 2024).

The breakthrough progress of modern biotechnology has enabled crops to gain stronger environmental adaptability, including resistance to abiotic stresses such as drought and salinity. This progress has greatly improved agricultural production efficiency and provided a new technical path for sustainable agricultural development (Singh et al., 2021). In this development process, the intellectual property protection system has played a vital role in promoting it. A sound patent system not only protects innovative achievements, but also encourages enterprises and research institutions to continue to invest in the research and development of genetic modification technology (Blakeney, 2011). It is worth noting that with the improvement of the intellectual property protection system, the focus of agricultural biotechnology research has gradually shifted from public research institutions to private enterprises, forming an innovation development pattern dominated by enterprises (Singh et al., 2021).

However, the rapid commercialization of transgenic technology has also triggered increasingly complex intellectual property disputes. These disputes mainly focus on the ownership of genetically modified crop variety rights and the differences in the enforcement standards of related rights in different jurisdictions (Garzón, 2022). In developing countries, this problem is particularly prominent: when multinational agricultural companies strictly enforce their intellectual property rights, they often conflict with the production methods of traditional small farmers, which in turn triggers extensive social discussions on food sovereignty and the protection of farmers' rights (Strauss, 2009; Garzón, 2022).

International rules on GMO use and intellectual property protection also vary. For example, the European Union adopts the "precautionary principle" and is more cautious about GMOs; while the United States takes a more open and relaxed attitude (Anyshchenko and Yarnold, 2020).

This study will explore the legal challenges posed by GMO intellectual property disputes, evaluate the global legal system, and propose possible paths to promote innovation while safeguarding the public interest. By analyzing the interaction between intellectual property law and GMO technology, this study hopes to show how the law can support agricultural progress and fairness at the same time.

2 Overview of Intellectual Property in GMO Technology

2.1 Types of Intellectual Property in GMO Technology

GM technology involves various types of intellectual property (IP), mainly patents and plant variety rights (PVP).

Patents are usually granted for gene sequences, specific introduced traits, and technical tools such as CRISPR-Cas9. These patents give inventors exclusive rights to use and sell their innovations (Carty and Tsui, 2000; Zanga et al., 2016). For example, the European Patent Convention allows patents to be granted for plants and animals as long as the invention can be applied to different varieties (Carty and Tsui, 2000).

Plant variety rights (PVP) are another form of intellectual property rights that protect new plant varieties and are administered by the International Union for the Protection of New Varieties of Plants (UPOV). The system gives plant breeders control over new varieties while also allowing others to use them for further breeding (Heifer, 2003). The relevant rules have been updated to adapt to new breeding technologies and support continued innovation (Kock, 2020).

2.2 Key stakeholders

Biotech giants such as Monsanto/Bayer and Syngenta are major players in the development of GM technology. These companies invest heavily in R&D and often hold patents on new GM crops. They play a key role in promoting new technologies and bringing products to market (Blakeney, 2011; Zanga et al., 2016).

Public research institutions and governments also play important roles. Research centers often work with private companies to develop new GM crops. Governments are responsible for developing and enforcing intellectual property laws and are concerned with technology safety and ethical issues (Blakeney, 2011; Parvin and Seyedin, 2017).

Farmers, especially smallholders, are deeply affected by intellectual property laws. Although these laws help introduce new technologies into agriculture, they can also make it more difficult or costly for farmers to access seeds and agricultural tools. In some cases, this can lead to legal risks or limited choices for farmers (Heifer, 2003; Tripp et al., 2007).

2.3 Economic and technological impacts

Intellectual property laws play an important role in encouraging research and development and promoting the entry of GM crops into the market. These laws help inventors protect their research results, thereby attracting investment and supporting the breeding of improved crops.

"Freedom to operate" (FTO) analysis is an important step before a new product is launched on the market. This process is used to check whether the product may infringe existing patents, and includes researching patent regulations and their legal status in different countries (Figure 1). For example, the Carolight project uses patent research to guide the sharing and sales of its technology (Zanga et al., 2016). This kind of work helps to improve agricultural production efficiency and support global food security (Blakeney, 2011; Zanga et al., 2016).

However, there are also some problems. Too strong intellectual property protection can lead to market monopoly. Large companies may control the entire market, making it difficult for small players and developing countries to benefit. This will hinder technological innovation and limit the spread of beneficial technologies (Heifer, 2003; Kock, 2020).

In addition, the cost of applying for and maintaining patents is very high. This is a significant barrier for smallholder farmers and public research institutions, reducing their ability to access markets (Tripp et al., 2007; Zanga et al., 2016).

3 IP Disputes in GMO Technology

3.1 Patent infringement cases

Lawsuits over GMO patents often occur when a company accuses others of using its seeds without authorization. Biotech giants like Monsanto often take legal action to protect their patented seeds. Such cases often involve farmers and are complex and costly (Listed, 2010; Kong et al., 2018).

A famous case is Monsanto v. Schmeiser. In that case, Monsanto sued Canadian farmer Percy Schmeiser, accusing him of planting its Roundup Ready canola without permission. Schmeiser argued that the seeds were blown onto his land by the wind. But the Supreme Court of Canada ruled in favor of Monsanto. The case set an important precedent for enforcing seed patents, even if farmers did not intentionally use patented seeds (Listed, 2010; Kong et al., 2018).

3.2 Licensing and access issues

Biotech companies often set strict licensing agreements for their patented seeds and technologies. These licenses are expensive, limited to specific users, and come with harsh terms. While this helps protect company investments, it can also prevent other researchers and small businesses from using the technology (Hussinger, 2006; Van Zimmeren et al., 2006).

The so-called "patent jungle" refers to multiple overlapping patents covering different parts of the same technology. This is common in GM research. If researchers want to use or improve a product, they may need to obtain permission from multiple patent holders at the same time. This process is time-consuming and expensive, and may even prevent the development of new ideas and slow down scientific research progress (Van Zimmeren et al., 2006; Borrell, 2010; Gątkowski et al., 2020).

3.3 Biosafety and genetic contamination conflicts

GM crops may accidentally hybridize with non-GM crops, which is called gene contamination. When this happens, even farmers who do not use GM seeds may have patent-protected traits in their crops. In some cases, they have even been sued for "unauthorized use."

As a result of such issues, intellectual property protection in agriculture has gradually shifted from public institutions to private companies. This shift has raised concerns about who should be held responsible when genetically modified traits are accidentally spread (Blakeney, 2011). The Cartagena Protocol on Biosafety focuses on the harm caused by transboundary genetically modified organisms and proposes the need to establish a liability and compensation mechanism.

The Nagoya-Kuala Lumpur Supplementary Protocol further clarifies the issue of liability, but the treatment of civil lawsuits is still not perfect. If farmers suffer economic losses (such as a drop in crop prices) due to genetic contamination, it is not clear who will bear the liability for compensation. Some experts suggest that biotechnology companies should bear more responsibility to avoid similar legal disputes in the future (Strauss, 2012).

3.4 Disputes in international trade

Countries have different regulatory standards for genetically modified technology, which often leads to trade disputes related to intellectual property rights, health or safety regulations. The World Trade Organization (WTO) resolves these disputes through rules such as the General Agreement on Tariffs and Trade (GATT), the Agreement on Technical Barriers to Trade (TBT), and the Agreement on Sanitary and Phytosanitary Measures (SPS) (Josling, 2001).

The problem is that different countries use different standards. For example, the EU and many developing countries have adopted strict environmental protection policies and restrict the import of genetically modified products based on the Biosafety Protocol in order to protect nature and public health. The United States and other major exporters of genetically modified crops believe that these rules hinder trade and violate WTO agreements. These opposing views make it difficult to establish unified global rules for genetically modified trade and intellectual property protection.

4 International Legal Frameworks Governing GMO IP

4.1 World trade organization (WTO)

The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) under the World Trade Organization sets out rules for intellectual property protection, including for GM technologies. It helps to bring together intellectual property laws in different countries, allowing biotech companies to protect their inventions globally. TRIPS requires countries to provide patent protection for biotech inventions, such as GM seeds (Moschini, 2003; Strauss, 2009).

But not everyone supports these rules. Many smallholder farmers in developing countries rely on traditional agricultural methods, and strict intellectual property rules may make it difficult for them to access new technologies and may exacerbate food security issues. The TRIPS agreement also includes some flexibilities, such as the ability for governments to bypass patents by issuing compulsory licenses in special circumstances such as public health crises (Moschini, 2003; McGIVERN, 2023).

Trade in GM products is also often controversial in the WTO. Some countries advocate the establishment of strict safety regulations, while others advocate free trade. These disputes usually focus on how to strike a balance between protecting health and complying with trade rules. The WTO's dispute settlement mechanism is often used to mediate such disputes (Strauss, 2009).

4.2 Convention on biological diversity (CBD)

The Cartagena Protocol on Biosafety under the Convention on Biological Diversity aims to regulate the safe management and use of genetically modified organisms (i.e., "living modified organisms"). The protocol aims to continue to support technological innovation while protecting the safety of humans and nature. It supports the "precautionary principle", that is, even in the absence of complete scientific evidence, countries can take measures to prevent possible harm caused by genetically modified products (Strauss, 2009).

The protocol requires countries to follow the "prior informed consent" (AIA) procedure to ensure that relevant countries can receive early warnings and review their safety data before genetically modified products are circulated across borders. This mechanism aims to strike a balance between patent protection and biosafety and promote the responsible use of biotechnology (Strauss, 2009).

4.3 International treaty on plant genetic resources for food and agriculture (ITPGRFA)

This treaty aims to regulate the use and sharing of plant genetic resources, supporting innovation and equity by providing researchers and breeders with easy access to seeds. It also requires that a fair share of the benefits from these resources be returned to the communities that provide them (Heifer, 2003).

However, problems arise when farmers’ rights conflict with corporate patents. Many small farmers are guardians of genetic diversity, but they often do not receive the rewards they deserve when the traditional crop genes they cultivate are used for commercial purposes by companies. This behavior is sometimes called "biopiracy", especially when companies do not share the benefits with the providers (Tansey, 2002). Although the treaty has a benefit-sharing mechanism, enforcement is still difficult due to differences in national laws (Brink and Van Hintum, 2020).

4.4 Regional agreements

The UPOV Convention protects new plant varieties by giving breeders exclusive rights over new varieties. This system encourages innovation because breeders can profit from their results (Gerstetter et al., 2007). However, UPOV has also been criticized for favoring large companies and developed countries. Many people believe that it fails to adequately protect small farmers and local traditional seed systems.

In addition, there are huge differences in the regulation of GM technology in different regions. For example, the European Union is cautious and pays more attention to health and environmental safety; while the United States is open to GM technology and supports accelerating its marketization. These differences have led to frequent trade frictions and increased the difficulty of formulating unified global GM intellectual property rules (Bass, 2015).

5 Ethical and Social Impacts of GMO IP Disputes

5.1 Issues of technology access

Intellectual property rights (IPRs) on GM technology may limit who can use the technology, especially in developing countries. Large biotech companies control much of the GM product market, so research is more dominated by private companies rather than public institutions. This shift makes it more difficult for small farmers to access or afford new GM crops (Blakeney, 2011).

When companies hold patents, the cost of seeds and supporting technologies tends to rise, making it difficult for poor farmers to benefit from GM technology. International intellectual property laws such as the TRIPS Agreement tend to protect large companies rather than small producers. This can lead to unfair access to technology and make it difficult for the benefits of GM technology to be shared equally (Fischer et al., 2015; Strauss, 2009).

5.2 Biopiracy

Biopiracy is the use of traditional knowledge or local plant varieties by companies without permission or compensation. It is a serious ethical issue in the field of GM. A famous case is Bt brinjal (GM eggplant) in India. India’s National Biodiversity Authority accused Monsanto and other companies of using local plant genes without formal approval.

This case shows that developing countries still face challenges in protecting their genetic resources. Although institutions such as the World Intellectual Property Organization (WIPO) are working to develop rules to prevent biopiracy, progress has been slow. Currently, many communities still lack strong legal protection.

5.3 Public perception and trust

Public attitudes towards GM technology are closely related to ethics and fairness. Many people worry that only a few large companies control too many resources. When these companies are seen as putting profits rather than the public interest, public trust will decline (Singh et al., 2021).

Some companies are seen as too aggressive in enforcing patents, and a lack of transparency has also exacerbated public skepticism about GM products (Garzón, 2022).

In Europe, the approval of GM crops is more cautious. The EU uses a tiered system: simple, low-risk GM crops can be approved more quickly, while more complex ones are subject to strict review. This system is designed to ease public concerns while encouraging technological innovation (Figure 2) (Bratlie et al., 2019).

However, these strict regulations also reflect the public's continued concerns about the safety and ethical issues of GM technology, which to some extent hinders the widespread acceptance of new technologies.

6 Case Studies

6.1 The Bt cotton controversy in India

The introduction of Bt cotton in India has sparked significant legal and social controversy. Monsanto established a proprietary system for royalties for its Bt cotton seeds. This system gave the company strong control over the use of the seeds, a control that has precedent in the United States, but India's intellectual property and seed laws are different from those in the United States (Peschard and Randeria, 2020).

Despite early opposition and criticism of the government's support for the technology, many Indian farmers adopted Bt cotton. Some accused the government of favoring biotech companies (Herring, 2015; Liu, 2024). Over time, concerns have grown about its impact on farmers' rights, food security, and local crop diversity (Garzón, 2022). This case shows how intellectual property laws and corporate control can profoundly affect farming communities.

6.2 Golden rice

Golden Rice was developed to help address vitamin A deficiency in poor areas. But the crop's introduction has been severely delayed due to intellectual property issues. The numerous patents covering the various components and development processes of Golden Rice make it difficult to use freely.

Golden Rice was originally developed for public health, not for profit. But the project's progress shows that complex intellectual property systems can hinder innovation even for humanitarian purposes. This case highlights the need for a more flexible intellectual property system so that life-saving technologies can benefit those who need them most (Stokstad, 2019).

6.3 South american soybean trade

In countries such as Brazil, trade disputes over genetically modified soybeans have raised widespread issues. Monsanto's "glyphosate-resistant" Roundup Ready soybeans are widely used, but their patent royalty system has been severely criticized. This system gives Monsanto great control over the market (Peschard and Randeria, 2020).

Non-governmental organizations and farmers' organizations have fought back. They questioned the legal basis of the relevant patents and the fairness of the patent royalties. These organizations also pointed out that excessive intellectual property protection is undermining farmers' rights, deepening dependence on large companies, and threatening crop diversity (Garzón, 2022).

7 Challenges in Resolving GMO IP Disputes

7.1 Balancing innovation and equity

Protecting new biotech inventions while making them available to farmers and researchers is a complex task. In the past, most agricultural research was led by public institutions; now it is mainly led by private companies seeking patent revenue (Blakeney, 2011; Singh et al., 2021).

This shift has made it more difficult for small farmers, especially those in developing countries, to access these technologies (Strauss, 2009; Garzón, 2022). Finding a fair balance means supporting innovation while ensuring that these technologies benefit those who need them most.

7.2 Harmonizing international standards

Different countries have different regulations on GM technologies and patents, which makes international cooperation difficult. Although the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) aims to unify global standards, there are still huge differences in the implementation of the agreement among countries (Kesan, 2000; Strauss, 2009).

Developed countries generally have stricter laws and more sophisticated enforcement mechanisms; while developing countries are relatively weak in legal resources, which puts them at a disadvantage in cross-border disputes (Chiarolla, 2019; Upreti, 2022). The establishment of more unified rules will help all parties participate fairly.

7.3 Litigation costs and power imbalances

Litigation costs involving GMO patents are high, and small farmers and research groups often cannot afford it (Garzón, 2022). In contrast, large biotechnology companies have strong legal teams and sufficient funds, making the litigation process extremely unequal (Blakeney, 2011; Singh et al., 2021).

Therefore, even if they are legally right, small institutions may give up their rights due to cost issues. This imbalance weakens the ability of small stakeholders to obtain new technologies and protect their own rights.

7.4 Monitoring and enforcement challenges

There are many difficulties in enforcing patent protection between different countries. Legal systems vary, and not every country has strong legal support or enforcement systems (Kesan, 2000; Chiarolla, 2019).

In addition, genetically modified seeds or pollen can easily spread across borders, making tracking and control more difficult. Solving these problems requires stronger international cooperation and better patent management and dispute resolution mechanisms (Upreti, 2022).

8 Future Directions

8.1 Advancing global consensus on GMO IP

The international community urgently needs to establish a unified GMO technology intellectual property standard system. The collaborative cooperation between the World Trade Organization (WTO) and the World Intellectual Property Organization (WIPO) will provide institutional guarantees for this. The WTO's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) has laid a legal foundation for intellectual property protection in various countries (Naim, 2020), while WIPO has effectively promoted cross-border patent protection through mechanisms such as the Patent Cooperation Treaty (Jorgenson and Fink, 2022).

The complementary advantages of the two major international organizations can promote the establishment of a more inclusive institutional framework, while protecting the rights and interests of technology innovators, while fully considering the actual needs of developing countries and small-scale agricultural producers (Abbott, 2000). This coordination mechanism will help build a new intellectual property governance system that adapts to the rapid iteration of technology.

8.2 Integrating emerging technologies

The breakthrough progress of gene editing technologies such as CRISPR and synthetic biology has put forward new adaptability requirements for the existing intellectual property system. The traditional patent protection framework is mainly designed based on the characteristics of early biotechnology, and it is difficult to fully cope with the characteristics of the new generation of gene editing technology (Okediji, 2008).

WIPO and the WTO should work together to revise the current rules system or consider formulating an international agreement specifically for new gene editing technologies. This kind of institutional innovation should not only ensure the reasonable return of rights and interests of researchers and developers, but also establish ethical norms and safety standards for technology application, and achieve a balance between scientific and technological innovation and risk management.

8.3 Promoting sustainable agriculture

GM technology has multiple values in promoting sustainable agricultural development: including improving land output efficiency, reducing dependence on chemical pesticides, and enhancing crop resistance. However, in order for these technological dividends to benefit global agricultural producers, especially small farmers with limited resources, it is necessary to embed a fair access mechanism in the intellectual property system.

The WTO and WIPO should jointly formulate global rules that both encourage innovation and promote technology sharing (Naim, 2020). These rules should be designed to integrate environmental protection dimensions, ensure that the application of GM technology meets ecological safety requirements, and form synergies with international environmental agreements such as the Convention on Biological Diversity (Abbott, 2000). By building an intellectual property system that takes into account innovation incentives, technology accessibility, and ecological protection, a solid institutional guarantee will be provided for sustainable agricultural development.

Acknowledgments

I sincerely thank the anonymous peer reviewers for their valuable comments and detailed suggestions.

Conflict of Interest Disclosure

The author affirms that this research was conducted without any commercial or financial relationships that could be construed as a potential conflict of interest.

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