By: Donnie DONG, Lucia LI & Cecilia DONG
With the official implementation of the Regulations on the Protection of New Varieties of Plants of the People’s Republic of China (hereinafter “the Regulations”), comprehensively revised in 2025, the “essentially derived variety” (hereinafter “EDV”) system has completed its transition from legal theory to legislation, and China’s system for the protection of new varieties of plants has taken another step toward the standards of the 1991 Act of the International Convention for the Protection of New Varieties of Plants. The boundary of rights between the plant breeder rights (hereinafter “PBRs”) in an initial variety and subsequent improvers consequently faces a new adjustment. This article briefly reviews the legislative framework and criteria for determining EDVs, as well as the system’s impact on avenues of intellectual property protection and commercial realities.
I. What Is the Essentially Derived Variety?
Essentially Derived Variety (hereinafter “EDV”) refers to a variety that is essentially derived from an initial variety or from a variety that is itself essentially derived from that initial variety. “Essentially derived” means that the new variety conforms to the initial variety in the expression of the essential characteristics resulting from the genotype or combination of genotypes of the initial variety, while being clearly distinguishable from the initial variety in its outward characteristics. In plain terms, it is a derivative variety bred by modifying and improving an existing bred variety.
The EDV system originated in the International Convention for the Protection of New Varieties of Plants (hereinafter “the 1991 UPOV”), adopted in 1991 by the International Union for the Protection of New Varieties of Plants (hereinafter “UPOV”).
In defining the scope of PBR, the 1991 UPOV expressly provides that the effect of such rights may extend to varieties essentially derived from a protected variety.[i] At the same time, the UPOV strictly defines the basic features of an EDV: an EDV must be derived from the initial variety, and although it can be clearly distinguished from the initial variety, it must retain the essential characteristics determined by the genotype or combination of genotypes of the initial variety.[ii]
II. Legislative Origins of the EDV System
The concept of EDVs is deeply tied to the origins of the plant variety protection system itself. Since its establishment, the plant variety system has protected the outward characteristics of plant varieties rather than their genetic combinations. With the development of biotechnology, gene editing has become a highly efficient way to create new varieties. A plant variety found to possess new distinctness under the basic method for assessing new plant varieties—the “DUS” test (“Distinctness, Uniformity and Stability”)—may nevertheless be almost indistinguishable from the initial variety at the genotypic level. This has created uncertainty for some companies that obtain new varieties through gene editing and other technological methods as to whether they may claim PBRs and whether they are obligated to share profits with the original breeder. Clear regulations were necessary to balance the interests of traditional breeders and modern biotech companies.
Ultimately, the EDV system serves as a legal remedy to the seed industry’s long-standing phenomenon of “modification breeding”. Under traditional breeding models, developing a breakthrough variety requires over a decade of research. However, by using modern gene editing and marker-assisted selection, a competitor can make a minor modification to a better variety—such as slightly changing flower color or enhancing lodging resistance—and quickly produce a new variety that meets the “distinctness” standard. Once it passes the DUS test, the competitor could secure PBRs and cannibalize the traditional breeder’s market.
China’s legislative framework for EDVs has evolved from “an absence of rules” to “full-chain alignment”. Because its domestic breeding foundation was historically weak, China initially adopted the 1978 Act of the UPOV (which did not address the EDV issue) instead of the 1991 UPOV when it joined the UPOV in 1999. As the need to protect innovation became urgent, the Seed Law of the People’s Republic of China, revised in 2021 (hereinafter “the Seed Law”), prospectively drew upon the 1991 UPOV and established the EDV concept at the statutory level for the first time. The 2025 revision of the Regulations then laid a foundation for implementation: it refined the determination criteria and extended protection from “propagating material” to directly sold “harvested material”, thereby building a comprehensive protection system from the genetic source to the commercial endpoint.
The original purpose of this institutional arrangement is to protect original innovation. Developing a good variety requires long-term experimental investment, accumulation of materials, and commercial risk. Allowing competitors to rapidly obtain exclusionary rights through partial modifications and completely seize the market, the function of the PBR system in incentivizing original breeding will be weakened. The EDV system therefore responds in practice to “low-level repetition” and “modification-based improvement” in the seed industry. The system does, of course, have limits. The interests of all parties must still be balanced in relation to the criteria for determination, application procedures, and commercial exploitation.
III. Criteria for Determining an EDV
Determining whether a variety is EDV generally hinges on three core elements designed to assess whether a subsequent variety is an independent innovation or merely dependent upon the initial one.
- Genetic Relationship of Derivation
It must first be determined whether the subsequent variety is dependent upon the initial variety in terms of its origin. In practice, phenotypic similarity alone is insufficient. The breeding method, selection process, parental sources, records of material transfers, and other factors must also be considered in determining whether the subsequent variety was in fact derived on the basis of the initial variety. If the PBR owner of the initial variety cannot prove this genetic relationship, the new variety cannot be classified as an EDV.
- Clear Distinguishability
Clear distinguishability requires an EDV to be a new variety distinguishable from the initial variety, rather than a mere copy. Completely identical varieties fall under identity-based infringement or unauthorized reproduction. A variety must exhibit a distinct difference—such as in disease resistance, color, or yield before it can be considered for EDV status. Whether these differences are sufficient to release it from the control of the initial variety depends on the third element.
- Conformity in Essential Characteristics
This criteria does not require the two varieties being completely identical. Instead, it requires that the derived variety maintain the “expression of the essential characteristics resulting from the genotype or combination of genotypes of the initial variety”. “Essential characteristics” refers to traits that significantly contribute to the variety’s overall features, performance, or use value, which vary depending on the crop species.
The core here is not to exclude a particular breeding method, but to determine whether the new variety has departed from the main genetic basis of the initial variety. For example, conventional crossbreeding generally introduces new genetic components and recombines and changes the variety’s main characteristics. It is generally inappropriate to identify a variety directly as an EDV of a particular parent merely because it is similar to that parent. However, if a breeder uses backcrossing to introduce just a few minor traits, leaving the overall genetic background largely identical to the initial variety, it will likely be deemed an EDV. Furthermore, even if a hybrid variety itself is not an EDV, its commercial production or reproduction may still require permission from the initial variety’s PBR holder if one of its parent lines is an EDV.
Therefore, the EDV system does not simply expand the original PBRs, it breaks down the concept of truly independent into three levels: origin, differences, and essential characteristics. The discussion of Chinese legislation below should likewise focus on this question: how does the law convert the foregoing assessment into enforceable provisions?
IV. Application Procedure for an EDV
Under the current legislation, breeders of an EDV can still apply for PBRs using the standard plant variety application procedure. In other words, the granting of PBRs does not factor in whether the variety is an EDV. Under the Draft Rules for the Implementation of the Regulations on the Protection of New Varieties of Plants (Agricultural Chapter) (hereinafter “the Draft Implementing Rules”), pending varieties must be published for 30 days prior to the granting of PBR. The published information includes the variety’s origin, and any third party can file an objection.
The publication and objection mechanism is intended to expose potential disputes over origin at an earlier stage. If a variety is officially deemed an EDV, its right owner may still secure PBRs, but must obtain permission from the PBR owner of the initial variety and pay the corresponding consideration agreed for subsequent commercial exploitation, including production, reproduction, sale, import, and export. Conversely, if the initial variety has not obtained PBRs, its breeder has no legal grounds to demand a share of the benefits merely because a new EDV has obtained PBRs.
V. Commercial Exploitation of EDVs and Dispute Resolution
Generally, the allocation of commercial benefits arising from an EDV should be resolved between the PBR owner of the initial variety and the EDV right owner through a license agreement, cooperation agreement, or prior arrangement. The Draft Implementing Rules introduce a compulsory licensing route where the PBR owner of the initial variety refuses to grant a license without justified grounds. This indicates that, while protecting the PBR owner of the initial variety, the system also seeks to prevent the initial right owner from completely blocking the exploitation of subsequent improvements.
If the EDV right owner engages in commercial exploitation without the consent of the PBR owner of the initial variety, this may constitute infringement. In disputes of this kind, practice generally uses two types of technical means to determine whether varieties are similar:
The first is molecular marker testing (DNA testing), which focuses on comparing the genetic backgrounds of varieties, including testing methods such as simple sequence repeats (SSR), single-nucleotide polymorphisms (SNP), and multiple-nucleotide polymorphisms (MNP).
The second is field observation testing, namely the process of conducting cultivation identification trials or indoor analytical tests on a plant variety for which protection is sought to assess its Distinctness, Uniformity, and Stability (the “DUS Test”). Compared with molecular marker testing, DUS testing focuses more on comparing the varieties’ performance in actual cultivation, such as plant architecture, fruit, flower color, and resistance.
If the results of these two tests conflict, field observation testing should prevail. However, field observation testing is not the only way of rebutting DNA results. For example, in the second-instance proceedings of the “Xianyu 508” case,[iii] the Supreme People’s Court ruled that, once DNA testing indicated similarity, the burden of proof shifted to the accused party to explain the discrepancies in traits and features, such as by explaining the seed cultivation process and the reasons for the similarity. Field observation testing was not the sole acceptable form of rebuttal evidence, and the court therefore rejected the party’s application for a further field test appraisal.
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Overall, the core of China’s EDV system is not to stifle genetic crop improvements, but to curb “freeriding” modification breeding and prevent others from circumventing original rights through limited changes. Current legislation turns this issue into more specific inquiries: whether the new variety is derived primarily from the initial variety, whether the differences are sufficient to change its essential characteristics, and whether the subsequent breeder can prove independent research and development. The EDV system thus strengthens the protection of investment in original breeding while imposing higher evidentiary and compliance requirements on subsequent breeders.
Given the complex evidence gathering and detailed assessments required to determine EDV status,, both initial PBR owners and biotech companies should consult intellectual property lawyers experienced in the protection of new varieties of plants and systematically complete legal preparations in advance. Detailed contracts and clearly defined rights will help both parties secure returns on their investments, fostering a thriving seed market and encouraging genuine, efficient innovation.
About the Authors
Donnie Hao DONG, Senior Partner, Hylands Law Firm
Practice Areas: Digital Technology and Internet | Intellectual Property | Compliance and Government Regulation
WeChat: BLAWGDOG; Email: donghao.sh@hylandslaw.com
Dr. Dong holds two doctoral degrees and is qualified to practice law in China and the State of New York, USA. He has 22 years of professional experience in intellectual property, data and privacy, and cross-border business. He has lived and worked for extended periods in Shanghai, Hong Kong, San Francisco, Boston, and other cities, and has successively worked at top global universities, leading international law firms, and major fintech companies. Since joining Hylands, Dr. Dong has been recognized as a “Top-Tier” lawyer talent in Shanghai Pudong, a Leading Lawyer (Tier 1) in the Guide to Premium Legal Services, and one of the “ALB China Top 15 Cybersecurity and Data Protection Lawyers,” and has received an exceptional appointment to the professional title of senior lawyer.
Lucia LI Associate
Practice Areas: Digital Technology and Internet | Intellectual Property | Compliance and Government Regulation
Graduated successively from the University of Macau (European Union Law), Soochow University (Taiwan), and Yunnan University. Has practical experience in intellectual property and cross-border dispute resolution, and has participated in foreign-related projects involving the enforcement and protection of new varieties of plants, cross-border compliance, and U.S. federal court litigation support.
Cecilia DONG Legal Assistant
Master’s candidate at the Institute of Comparative Law of China University of Political Science and Law; LL.M., Humboldt University of Berlin. Has participated in projects relating to entertainment law, intellectual property, and cross-border dispute resolution.
[i] UPOV Convention (1991 Act), Article 14(5)(a)(i).
[ii] UPOV Convention (1991 Act), Article 14(5)(b), providing the definition of an “essentially derived variety”.
[iii] Civil Judgment of the Supreme People’s Court of the People’s Republic of China, (2021) Zhi Min Zhong No. 1200.
