LI Judan: Development of Biotechnology and Determination of Essentially Derived Varieties


Abstract: The system of Essentially Derived Varieties (EDV) is a key legal mechanism established under the 1991 Act of the International Convention for the Protection of New Varieties of Plants to curb “biopiracy” caused by “cosmetic breeding”. Traditionally, it was held that an EDV is constituted only when the derived variety exhibits very minor phenotypic differences from the initial variety. However, as biotechnology has significantly enhanced the capacity for plant improvement, improved varieties often show notable changes in multiple important traits, yet their genetic differences from the initial variety remain very subtle. After extensive discussions, the International Union for the Protection of New Varieties of Plants (UPOV) issued an explanatory note on EDV in 2023, clarifying that, subject to the condition of “distinctness”, genetic similarity should serve as the core basis for EDV determination, while excluding special circumstances such as sister lines and convergent breeding. International judicial practices in EDV cases indicate that relying solely on phenotypic differences for EDV determination tends to result in inconsistent standards, contradictory rulings, and protracted litigation. The essence of the problem lies in the confusion between the distinctness determination and the essential derivation determination, which serve different institutional functions. Currently, China is advancing the formulation of guidelines for EDV determination. To effectively curb the trend of variety homogenization, optimize the development of the seed industry, balance the interests of original innovation and improvement innovation, and ensure the objectivity of the determination method, it is advisable to establish EDV determination rules with genetic similarity as the core. Such rules would help clearly define the boundaries of rights and interests between original breeders and improving breeders, incentivize original breeding innovation, facilitate the lawful transformation and utilization of improved varieties, and provide institutional safeguards for the integrated development of traditional breeding and biotechnological breeding.

Keywords: biotechnology, essentially derived variety (EDV), initial variety, genetic similarity, phenotypic characteristic

Author: Li Judan, research fellow, CASS Institute of Law;

Source: 5 (2026) Chinese Journal of Law.