Gene-Edited Crops And The Law - Integrating CRISPR Into Plant Variety Protection Frameworks

Author: LawSphereX

Category: General Law

Published: 2026-08-23T19:57:35.162242+00:00

Updated: 2026-08-26T17:11:24.603+00:00

GENE-EDITED CROPS AND THE LAW: INTEGRATING

CRISPR INTO PLANT VARIETY PROTECTION

FRAMEWORKS

Janani Gopinath & Pavithra Ramkumar, VITSOL, VIT, Chennai

ABSTRACT

CRISPR- Cas9 has emerged as a transformative gene-editing technology with applications across agriculture, medicine, and biotechnology. ITs rapid development has triggered unprecedented intellectual property (IP) disputes, most notably the high-profile patent battle between the University of California, Berkeley and the Broad Institute, which has led to a fragmented global IP landscape. This article examines the legal and commercial implications of CRISPR patenting, focussing on issues such as overlapping patent claims, exclusive licensing practices, and the formation of dense patent thickens that restrict access to foundational gene-editing tools. It explores how competing ownership models influence downstream research, innovation, and equitable access to gene-editing applications, particularly in developing countries.

The analysis further addresses ethical concerns related to monopolization, public-interest access, and the governance of human and agricultural gene editing applications, particularly in developing countries. The analysis further addresses ethical concerns related to monopolization, public-interest access, and the governance of human and agricultural gene editing. Drawing on comparative perspectives from the United States, European Union, China, and India, this article argues that the current IP framework risks reinforcing global inequities unless complemented by open licensing, patent pools, and humanitarian access policies. The study concludes by proposing regulatory and policy reforms to balance innovation incentives with ethical, social, and public-health considerations.

Keywords: CRISPR- Cas9, gene editing, patent disputes, biotechnology regulation, ethical implications, Intellectual property rights

INTRODUCTION

The twenty-first century has witnessed an unprecedented convergence between biological innovation and legal regulation, particularly within the realm of agriculture. 1Among these innovations, CRISPR- Cas9 technology has emerged as a transformative tool that enables precise and efficient genome editing without the need for introducing foreign genetic material. This represents a paradigm shift from traditional genetically modified organisms (GMOs), as CRISPR- short for Clustered Regularly Interspaced Short Palindromic Repeats allows for the targeted alteration of endogenous plant genes to enhance yield, resistance, and nutritional value (Doudna &Charpentier, 2014). In essence, CRISPR’s simplicity, affordability, and accuracy have democratised genetic engineering, offering unprecedented potential to address issues such as climate change resilience and food insecurity.

2In India, the agricultural sector continues to play a pivotal role in economic stability and livelihood, employing over 40% of the population. With increasing climatic volatility, CRISPR holds immense promise in creating crops resilient to drought, salinity, and pest stress. Yet, this technological potential collides with an intricate web of intellectual property, biosafety, and ethical concerns. At the heart of this debate lies the Plant Variety Protection and Farmer’s Rights Act, 2001 (PPVFR Act), which governs the protection of new plant varieties in India. Enacted to balance breeders’ rights with farmers’ traditional practices, the Act predates the advent of CRISPR and gene- editing technologies. Consequently, it lacks clarity on whether CRISPR- edited crops- those that do not introduce foreign DNA- qualify as “new varieties” under its framework.

The question, therefore, is both scientific and jurisprudential: How does India’s existing plant variety protection regime address the ownership and regulation of gene edited crops? This paper seeks to explore the intersection- analyzing how the PPVFR Act interacts with CRISPRbased plant varieties, identifying legal ambiguities, and proposing regulatory reforms aligned with global best practices. 1 Chaturvedi, S. (2022). Gene Editing and the Future of Plant Variety Rights in India. Indian Journal of Law and Technology, 18(2), 45–68. 2 Department of Biotechnology (DBT). (2022). Guidelines for Genome Edited Organisms, 2022. Government of India.

THE LEGAL FRAMEWORK: UNDERSTANDING THE PPVFR ACT, 2001:

The Protection of Plant Varieties and Farmers’ Rights Act, 2001 (PPVFR Act) represents one of India’s most significant legal efforts to harmonize international intellectual property obligations with its own domestic agricultural realities. Framed in response to commitments under the TRIPS Agreement and the Convention on Biological Diversity (CBD), the PPVFR Act sought to create a system that could recognize and protect the innovations of plant breeders while also preserving the age-old rights of Indian farmers to save, reuse, exchange, and sell seeds. Unlike traditional patent regimes that prioritize corporate breeders, the PPVFR Act aimed to reflect India’s agrarian ethos and the centrality of farmers in its seed system. As M. S.

Swaminathan (2002) observed, the Act embodies India’s attempt to “blend modern science with traditional wisdom,” by balancing breeders’ intellectual property interests with the socioeconomic conditions of small and marginal farmers who form the backbone of Indian agriculture. A. Core Provisions of the Act

3At the heart of the PPVFR Act lies the definition of a “variety” under Section 2(j) a plant grouping that can be distinguished by one or more identifiable characteristics and remains uniform and stable across generations. To qualify for legal protection, a variety must meet the internationally recognized DUS criteria : Distinctiveness, Uniformity, and Stability and also demonstrate novelty at the time of registration. This registration system was designed in the early 2000s, a time when plant breeding was dominated by conventional methods such as hybridization and induced mutation. The assumption then was that innovation in plant breeding involved cross-breeding existing lines or using mutagenesis, rather than directly editing genes at the molecular level.

Consequently, the law’s technical framework does not account for the rise of CRISPR-Cas9 and other genome-editing technologies that now enable targeted and precise changes in plant DNA. 3 Smith, J. , & Krattiger, A. (2021). Gene editing, intellectual property, and global access to innovation. World Intellectual Property Organization (WIPO) Research Paper No. 68.

Another crucial provision, Section 29, deals with the concept of “essentially derived varieties” (EDVs). An EDV is a variety that is predominantly derived from an existing one but retains its essential genetic features. This provision was originally designed to prevent breeders from making small, cosmetic changes to an existing variety and passing it off as an entirely new invention. However, the introduction of gene-editing technologies has complicated this distinction. In CRISPR-edited crops, a single base-pair change can yield a dramatically different phenotype for example, disease resistance or drought tolerance while still maintaining most of the original genetic composition. This raises an important question: should such an edited variety be treated as an EDV, thereby tying it legally to the parent variety, or as a completely new variety deserving independent rights?

The PPVFR Act currently provides no clear answer. B. Institutional Framework and Challenges in Implementation

4The Protection of Plant Varieties and Farmers’ Rights Authority (PPVFRA) is the institutional body tasked with administering the Act. It oversees the registration of plant varieties, maintains the National Register of Plant Varieties, and promotes collaboration among breeders, farmers, and researchers. In addition, it supports farmers’ participation in conservation and breeding programs, reflecting the Act’s unique dual purpose: protecting intellectual property while also acknowledging farmers as custodians of biodiversity. However, the PPVFRA’s procedures are deeply rooted in phenotypic testing that is, evaluating plants based on observable characteristics such as leaf shape, flower color, or plant height. While this method is well suited for conventional breeding, it struggles to address molecularlevel innovations like gene editing.

CRISPR modifications can introduce precise genetic changes that may not manifest as visible differences, making it difficult to assess “distinctiveness” under the existing DUS criteria (Chaudhuri, 2021). This creates a practical challenge: the Authority’s current testing system, while rigorous, cannot always detect or verify innovations that occur at the genetic level but do not produce visible changes in the plant. Without molecular assessment tools or revised legal definitions, the 4 PPVFR Authority (Government of India). (2001). The Protection of Plant Varieties and Farmers’ Rights Act, 2001.

PPVFR framework risks becoming obsolete in the face of emerging biotechnologies. C. The Scope and Limitations in the Era of Gene Editing

5When it was enacted, the PPVFR Act was considered a pioneering law. It went further than most global systems by explicitly recognizing farmers’ rights alongside breeders’ rights a progressive step compared to purely patent-based systems. Yet, over two decades later, the Act has remained largely static, while plant breeding technology has evolved rapidly. One of the most significant limitations of the PPVFR Act is its silence on gene editing. It contains no explicit reference to genome modification, molecular breeding, or synthetic biology, all of which are now integral to agricultural innovation. This legal gap raises two fundamental questions:

1. Should gene-edited plants be treated as “new varieties” or as “essentially derived

varieties”?

2. Do farmers who grow or modify such gene-edited crops retain their traditional rights to

save and replant seeds? The lack of clarity has created uncertainty for breeders, researchers, and policymakers alike. Moreover, the intersection between traditional agricultural practices and modern biotechnology is becoming increasingly complex, especially in a country where millions of farmers depend on saved seeds rather than commercial hybrids. Recognizing these challenges, the Department of Biotechnology (DBT) issued the “Guidelines for Safety Assessment of Genome-Edited Plants” in 2022. These guidelines introduced a scientific classification system distinguishing between three categories of edits: ● SDN-1: Simple edits without foreign DNA insertion (e. g. , point mutations) ● SDN-2: Small edits guided by a template but still without foreign DNA ● SDN-3: Edits involving insertion of foreign DNA sequences 5 National Academy of Agricultural Sciences (NAAS). (2021).

Policy Brief on Genome Editing and Indian Agriculture. NAAS Policy Paper No. 98.

6According to the 2022 guidelines, SDN-1 and SDN-2 edits are exempted from India’s strict GMO regulations, as they do not introduce foreign genetic material (DBT, 2022). This was a welcome move for scientists and breeders, as it eased the regulatory burden for simple geneedited crops. However, these guidelines are not legally binding within the PPVFR framework; they function as scientific directives rather than amendments to statutory law. As a result, India now finds itself in a fragmented regulatory landscape. Biotechnology policy is moving rapidly toward encouraging innovation and research freedom, while the legal infrastructure governing plant variety protection remains anchored in early-2000s assumptions about plant breeding.

This disconnect not only complicates the registration of CRISPR-edited plants but also creates uncertainty for farmers, breeders, and investors working at the intersection of agriculture and biotechnology. CRISPR’S LEGAL AMBIGUITY: ARE GENE-EDITED CROPS “NEW VARIETIES”?

7CRISPR poses a unique challenge to the PPVFR Act, one that goes beyond simple legal interpretation; it questions the very definition of what makes a plant a “new variety.” Traditional plant breeding methods—like crossbreeding, mutation, or hybridization create new traits through natural genetic variation. CRISPR, on the other hand, works directly at the molecular level, making precise edits to an organism’s existing genes without adding foreign DNA. These subtle tweaks can lead to plants that are more drought-tolerant, more nutritious, or resistant to disease. Yet, from a genetic standpoint, these CRISPR-edited plants are almost identical to their original versions (Kumar & Bansal, 2021).

A. The DUS Dilemma

8Under the PPVFR Act, a plant variety must show clear, distinguishable characteristics known as DUS (Distinctness, Uniformity, and Stability) to be eligible for registration. The problem is that CRISPR-based changes often result in differences too minor to detect through traditional observation. For instance, a CRISPR-edited tomato engineered to contain higher lycopene levels might look exactly the same as its parent plant (Zsögön et al. , 2018). This raises a critical 6 Srivastava, S. , & Goyal, A. (2022). CRISPR in Indian agriculture: Regulatory gaps and future prospects. Journal of Intellectual Property Studies, 7(2), 101–127. 7 Tvedt, M. W. , & Dalrymple, D. (2020). The Regulation of Gene-Edited Plants: A Global Review. Frontiers in Plant Science, 11, 574356. 8 Sprink, T. , Eriksson, D. , Schiemann, J. , & Hartung, F. (2016).

Regulatory hurdles for genome editing: The case of the European Union. Plant Cell Reports, 35(7), 1493–1506.

question: if a plant’s unique traits are hidden at the molecular level, how can those differences be proven under the existing framework? Currently, the PPVFR Authority bases its testing on visible, morphological features rather than molecular or genomic data. Without modernized testing protocols that account for DNA-level edits, many CRISPR-modified plants may fail to qualify as “distinct,” even though they represent scientific advancements. Since the Act was written back in 2001, long before technologies like CRISPR existed, this gap highlights what legal experts call a “regulatory lag” , a situation where technological innovation moves faster than the law can keep up (Kesan & Gallo, 2020).

B. Comparative Perspectives: How Other Countries Handle Gene-Edited Crops

Across the world, countries differ in how they approach the regulation of CRISPR-edited plants. In the United States, the Department of Agriculture (USDA) makes a clear distinction between gene-edited crops and genetically modified organisms (GMOs) when no foreign DNA has been introduced. A well-known example came in 2016, when the USDA ruled that a CRISPR-edited mushroom that doesn’t brown easily was not subject to GMO regulations because no transgenic material had been added (USDA APHIS, 2016). Japan’s Ministry of Environment and Argentina’s CONABIA have taken a similar position, using science-based policies that exempt certain types of precise edits known as SDN-1 and SDN-2 from the strict rules that apply to transgenic crops (Tagliabue, 2021). 9In contrast, the European Union has adopted a far more cautious approach. In the 2018 Confédération Paysanne v.

Premier Ministre case, the Court of Justice of the European Union (CJEU) ruled that organisms produced through mutagenesis, including CRISPR-based methods, fall under the EU’s GMO Directive (2001/18/EC). This means CRISPR-edited plants are treated the same way as traditional GMOs, requiring lengthy and expensive approval procedures (CJEU, 2018). Critics argue that this rigid stance discourages agricultural innovation and leaves European researchers at a disadvantage. As a result, the European Commission has been re-examining whether the Directive should be updated to better reflect advances in gene-editing technology (European Commission, 2021).

9 CJEU. (2018). Case C-528/16, Confédération Paysanne v. Premier Ministre.

10India, meanwhile, sits somewhere between these two extremes. The Department of Biotechnology (DBT) issued 2022 guidelines that exempt certain types of gene edits from the

1989 Rules governing genetically engineered organisms. However, the PPVFR Act does not

address gene editing at all. This creates a legal and administrative grey area: a CRISPR-edited crop might be recognized by scientists as non-transgenic but still fail to qualify as a “new variety” under current protection laws.

C. The Debate Around Essentially Derived Varieties (EDVs)

11The concept of Essentially Derived Varieties (EDVs), borrowed from the 1991 UPOV Convention, plays a crucial role in discussions about CRISPR regulation. EDVs are plant varieties that mostly originate from an existing variety but show limited differences just enough to set them apart. CRISPR-edited crops, which might vary from their parent plants by only one gene, fit neatly into this category. However, if every gene-edited crop were automatically classified as an EDV, breeders using CRISPR would constantly need permission from the original variety’s owner, potentially stifling innovation. Experts note that the PPVFR Act’s EDV provision was originally designed for traditional hybrid breeding not for precise molecular-level techniques like CRISPR (Ravi & Roy, 2022).

If the law is applied too rigidly, it could discourage domestic researchers and biotech startups from exploring CRISPR-based agricultural solutions. To avoid this, India should consider updating or reinterpreting Section 29 of the Act to distinguish between “substantial” and “molecular-level” derivation. This would ensure that small genetic edits leading to major agricultural benefits are treated as genuine, independent innovations rather than mere derivatives of existing varieties.

INTELLECTUAL PROPERTY AND ETHICAL CONCERNS

The use of CRISPR - Cas9 technology in modifying plant genetic material has indeed raised complex intellectual property and ethical issues on a global level. The main concern revolves around the patent ownership of the CRISPR system itself and its application in the agricultural sector looking at this issue from an IP perspective. This technology has been at the center of a 10 Li, T., Liu, B., Spalding, M. H., Weeks, D. P., & Yang, B. (2012). High-efficiency TALEN-based gene editing produces disease-resistant rice. Nature Biotechnology, 30(5), 390–392.

11 Ramaswamy, R., & Rao, S. R. (2020). Genome editing and regulatory oversight in India: Balancing

innovation and biosafety. Indian Journal of Biotechnology, 19(1), 1–10.

major patent battle. 12An example can be the patent dispute between UC Berkeley institute and Broad institute, where each group had filed competing patents claiming they were the first to invent the CRISPR - Cas9 application, leading to an interference proceeding before the United States Patent and Trademark Office. The core disagreement was regarding whether UC Berkeley's team early filings covered use in eukaryotic cells, which Broad Institute’s team had patented. This now creates an uncertainty over who controls licensing rights and therefore who can authorise agricultural, medical, and commercial CRISPR applications. Patent holders have the exclusive right to refuse or grant licenses for CRISPR technology, where the owner can deny access for any purpose, including uses they ethically disagree with.

13One thing to note is that, the power of licensing holds force only in countries that enforce patent rights, where countries like China, or Brazil may bypass licensing through compulsory licensing or weak enforcement. Hence, since there are variations in the implementation of regulations, this may create unequal global access while still giving patent holders disproportionate influence over research directions in countries that enforce IP strongly. CRISPR - modified plants are increasingly being patented now, not only for the editing technique but also for the new traits introduced (drought resistance, higher yield, etc). 14This gives companies exclusive control over the seed market, hence exploiting the rights of farmers. Patent owners can prevent farmers from saving, replanting or exchanging seeds, pushing them towards dependence on seed companies, season after season.

Companies increasingly patent not just the CRISPR method but also the traits in plants, such as drought tolerance, pest resistance, improved shelf life, or higher yield. This allows corporations to monopolise genetically improved crops, restricting seed access and preventing farmers from saving or reusing CRISPR - edited seeds. Gene drives can spread a generic trait rapidly through plant populations. While promising for controlling invasive species, they pose risks for irreversible ecological change, unintended species interactions, and global environmental consequences. The absence of a global regulatory framework makes gene drives especially ethically sensitive.

12 Faculty: Jennifer A. Doudna, U. CALIF. BERKELEY, http://chemistry.berkeley.edu/faculty/

chem/doudna [https://perma.cc/GMZ9-P95C]

13 Kevin Outterson, Fair Followers: Expanding Access to Generic Pharmaceuticals for Low- And Middle-

Income Populations, in Power of Pills 164, 164 (Jillian Clare Cohen et al. eds., 2006) 14 Baylis, F. (2020). Ethical Licensing of CRISPR Technologies. Journal of Agricultural & Environmental Ethics.

The use of CRISPR and other New Genomic Techniques (NGTs) in plant breeding has generated significant IP related challenges, particularly relating to the patentability of gene edited alleles, which are versions of genes that have been intentionally altered by CRISPRcas9. 15While traditional alleles obtained through crossing or random mutagenesis are excluded from patent protection as “essentially biological process:” CRISPR - derived alleles can be patented when they are transferable across varieties. Many CRISPR modifications are small targeted changes that may be indistinguishable from naturally occurring mutations, which creates a legal ambiguity regarding what is novel and how infringement can actually be detected.

Breeders and farmers may find it difficult to prove that a trait had arisen through natural means rather than gene editing, hence making the process more difficult and complicated.

POLICY PATH FORWARD FOR INDIA

Currently India regulates genetically modified organisms under the Rules for Manufacture, Use, Import, and Export and Storage of Hazardous microorganisms/genetically engineered organisms (1989), but CRISPR - edited plants fall in a regulatory grey area. India must establish specific guidelines for genome - edited plants without foreign DNA and traditional GMOs to avoid unnecessary restrictions. Streamlining IP protection for CRISPR innovations while ensuring access for Indian farmers and researchers and encouraging licensing models that allow small - scale farmers to benefit from CRISPR is a forward looking path. India should encourage licensing models, that makes CRISPR innovations accessible to small - scale farmers while promoting domestic research to reduce dependency on foreign patents.

Government funding and incentives for R&D in CRISPR - based agricultural solutions will be critical, alongside public - private partnerships to translate laboratory discoveries into field - ready applications. Ethical and societal considerations should guide policy development, with transparent public consultations and ethical review committees ensuring that CRISPR applications align with environmental sustainability, economic equity, and public trust. By integrating regulatory

15 Lukasiewicz, Joanna M., Clemens C.M. van de Wiel, Lambertus A.P. Lotz & Marinus J.M. Smulders,

Intellectual Property Rights and Plants Made by New Genomic Techniques: Access to Technology and Gene‐Edited Traits in Plant Breeding, 53 Outlook on Agriculture 205 (Sept. 2024)

clarity, research support where India can chart a responsible and forward - looking path for CRISPR technology.

CONCLUSION

CRISPR - CAS9 represents a paradigm shift in plant biotechnology, offering precise, efficient, and cost - effective tools for crop improvement. Its potential to address challenges such as climate change, pest resistance and food security is immense, particularly for a country like India, where agriculture underpins the livelihoods of millions. Yet, the rapid advancement of gene - editing technologies has outpaced existing legal frameworks, leaving significant ambiguities in intellectual property protection, regulatory oversight, and ethical governance. The PPVFR Act, 2001, while pioneering in recognizing farmer’s rights, does not adequately address genome - edited crops. Creating uncertainty over the classification of new and essentially derived varieties.

Likewise the global CRISPR patent landscape, marked by overlapping claims and exclusive licensing, underscores the need for balanced IP policies to prevent monopolization and ensure equitable access. By proactively addressing regulatory gaps and fostering an inclusive innovation ecosystem, India can position itself as a global leader in responsible CRISPR applications, ensuring that the transformative potential of gene editing benefits both agriculture and society at large.