In November 2025, China issued a revised version of its Patent Examination Guidelines, which took effect on January 1 2026. The revision introduces significant changes to the examination standards for patent applications in the field of biological breeding, with particular emphasis on plant-related inventions.
These amendments mark an important step towards strengthening patent protection for innovations in plant breeding and improving coordination between the patent system and the plant variety protection (PVP) regime.
Background and purpose of the amendments
Plant breeding is inherently capital-intensive and time-consuming, with long R&D cycles and high technical risk. Intermediate breeding materials often constitute the essential foundation for developing new plant varieties, but they are highly susceptible to replication and misappropriation. In recent years, the widespread application of transgenic and gene-editing technologies has generated a large number of breeding intermediates with substantial technical and commercial value.
Under the previous version of the Patent Examination Guidelines, however, the scope of plant varieties was defined in such a broad manner that, in practice, it operated to exclude virtually all individual plants and their reproductive materials from patent protection. As a result, many valuable breeding-related innovations fell into a protection gap between the patent system and the PVP regime, undermining incentives for technological investment in the breeding industry.
The current revision seeks to address this long-standing issue by clarifying the definition of plant variety and refining the boundaries of patent-eligible subject matter in the plant breeding field.
Revised definition of plant variety
To remedy the practical over-exclusion caused by the earlier definition, the revised guidelines redefine “plant variety” as a plant population that:
Has been artificially bred or discovered and subsequently improved;
Exhibits uniform morphological and biological characteristics; and
Possesses relatively stable genetic traits.
This population-based definition replaces the earlier formulation, which focused on individual plants and their reproductive materials and effectively precluded patent protection for most plant-related inventions. By contrast, the revised definition limits the concept of plant variety to plant populations that meet clear requirements of uniformity and genetic stability.
Importantly, the revised guidelines align the definition of plant variety with the corresponding definitions under China’s Seed Law and the Regulations on the Protection of New Varieties of Plants. This alignment enhances coherence between the patent system and the PVP regime, reduces regulatory overlap, and helps avoid gaps in intellectual property protection.
In practical terms, the revision narrows the scope of subject matter excluded as plant varieties and creates greater room for patent protection of plant-related technologies that do not constitute specific, uniform, and genetically stable plant populations.
Treatment of naturally occurring wild plants
The revised guidelines further clarify the treatment of naturally occurring wild plants. They explicitly provide that wild plants found in nature, without any technical intervention, constitute scientific discoveries within the meaning of Article 25(1)(1) of the Patent Law and therefore are not eligible for patent protection.
At the same time, the guidelines distinguish such scientific discoveries from situations in which wild plants have been artificially bred or improved and demonstrate industrial applicability. In the latter case, the plant itself is no longer regarded as a mere scientific discovery and may fall within patent-eligible subject matter.
This clarification follows the examination logic already applied to wild micro-organisms and naturally occurring genes or DNA fragments, and it provides clearer guidance for assessing the patent eligibility of plant-related inventions derived from natural resources.
Principles for determining whether claimed subject matter constitutes a plant variety
The revised guidelines set out explicit principles for determining whether claimed subject matter should be regarded as a plant variety. The determination is made based on the technical solution defined in the claims, in light of the disclosure of the application as a whole.
In particular, examiners are instructed to assess whether the claimed plant or its reproductive material, at the population level, exhibits:
Uniformity, meaning that the relevant characteristics or traits are consistent among individuals within the population, except for predictable natural variation; and
Stability, meaning that the essential traits remain unchanged after repeated propagation or at the end of a specific propagation cycle.
For example, where a claim explicitly seeks protection for a specific plant variety or its reproductive material – such as “a transgenic soybean variety” – the subject matter generally falls within the scope of a plant variety.
By contrast, claims directed to a broad plant population defined primarily by the presence of a particular DNA sequence or functional protein typically do not satisfy the population-level requirements of uniformity and genetic stability and therefore fall outside the concept of a plant variety. For instance, a claim directed to “a drought-resistant rice plant comprising an exogenous gene as shown in SEQ ID NO:1” does not constitute a plant variety.
Transgenic plants under the revised guidelines
Following the narrowing of the plant variety concept, the revised guidelines clarify that a transgenic plant constitutes a plant variety only if it exhibits uniform morphological and biological characteristics and relatively stable genetic traits at the population level.
This clarification has important implications for patent prosecution strategies in agricultural biotechnology. It underscores the need to distinguish between claims directed to specific, stabilised plant varieties and those directed to broader technical solutions involving genetic traits, constructs, or breeding methods.
Practical implications for IP practice
Overall, the amendments significantly strengthen patent protection for technological innovation in the field of plant breeding. As a general rule, plant-related inventions that do not involve a specific plant variety as defined under the PVP regime, and that are not naturally occurring wild plants without technical intervention, may constitute patent-eligible subject matter.
For intellectual property professionals, the revised guidelines highlight the importance of careful claim drafting, strategic coordination between patent protection and plant variety rights, and a nuanced understanding of population-level uniformity and stability. The changes provide greater legal certainty and create a more balanced and innovation-friendly framework for protecting breeding-related technologies in China.
