Essentially derived varieties in the age of genome editing: Striking a balance between innovation and protection

IF 0.8 Q2 LAW
Journal of World Intellectual Property Pub Date : 2026-07-07 Epub Date: 2025-11-12 DOI:10.1111/jwip.70009
Miguel A. Rapela
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引用次数: 0

Abstract

The concept of Essentially Derived Varieties (EDV) presents a critical challenge in plant variety protection, requiring a delicate balance between the Breeder's Exception (BE) and the rights of both initial variety developers and subsequent breeders who introduce genuine innovation. A balanced approach requires a transparent, flexible and science-based framework that considers genetic, phenotypic, and economic distinctiveness while mitigating risks, both those that may slow breeding progress and those that may compromise breeder rights. It is in this context that the UPOV explanatory note on EDV (EXP 2023) constitutes a potential further risk since all mono-parental varieties are classified as essentially derived and so the adoption of genome editing, and other new breeding technologies, would be restrictive. This risk would impede agricultural innovation and sustainability. The diverse proposals examined herein highlight different aspects—some emphasize economic and phenotypic mechanisms of differentiation while others call for a more organized and enforceable framework consistent with the pace of technological development. A significant issue relates to how we accurately define the so-called essential characteristics in scientific terms while ensuring that these remain flexible enough in the face of dynamic agricultural conditions and market demands. This calls for a classification system that is specific enough to hold threshold, counter-party and new technology accountable, but is flexible on the margins to address concerns with threshold clarity, perverse incentives, and technological disruptions. The suggested enhancements are either adjustment to existing criteria (Smith, Lawson, Kock, Van Lookeren et al. and Bostyn.) to the redefinition of the basic terms of plant variety protection (Rapela). In conclusion, a practical EDV framework must have a scientific basis in the genetics and physiology of the plant varieties involved while also possessing a sound legal footing to ensure that varietal protection mechanisms are proportionate and promote innovation, sustainability, and industry development in an ever-changing genetic and phenotypic environment. Based on these premises, the paper introduces a new functional-dependence model to clarify EDV status in modern breeding scenarios.

基因组编辑时代的衍生品种:在创新和保护之间取得平衡
本质衍生品种(EDV)的概念对植物品种保护提出了严峻的挑战,需要在育种者例外(BE)与最初的品种开发者和引入真正创新的后续育种者的权利之间取得微妙的平衡。一种平衡的方法需要一个透明、灵活和基于科学的框架,在降低风险的同时考虑遗传、表型和经济独特性,包括那些可能减缓育种进展和可能损害育种者权利的风险。正是在这种背景下,UPOV对EDV (EXP 2023)的解释性说明构成了潜在的进一步风险,因为所有单亲本品种都被归类为基本衍生品种,因此采用基因组编辑和其他新育种技术将受到限制。这种风险将阻碍农业创新和可持续发展。本文研究的各种建议强调了不同的方面——一些强调经济和表型机制的分化,而另一些则呼吁建立一个更有组织和可执行的框架,与技术发展的步伐相一致。一个重要的问题是,我们如何用科学的术语准确地定义所谓的基本特征,同时确保这些特征在面对动态的农业条件和市场需求时保持足够的灵活性。这需要一个足够具体的分类系统,使门槛、交易对手和新技术承担责任,但在边际上是灵活的,以解决门槛清晰度、不正当激励和技术中断等问题。建议的改进措施包括调整现有标准(Smith, Lawson, Kock, Van Lookeren等人和Bostyn),重新定义植物品种保护的基本术语(Rapela)。综上所述,一个实用的EDV框架必须在涉及的植物品种的遗传和生理方面具有科学依据,同时具有良好的法律基础,以确保品种保护机制的相称性,并在不断变化的遗传和表型环境中促进创新、可持续和产业发展。在此前提下,本文引入了一种新的功能依赖模型来阐明EDV在现代育种场景中的地位。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
1.50
自引率
0.00%
发文量
43
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