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March 19, 2024 - Agtech, Intellectual Property, United States

UPOV Updates Explanatory Note on Essentially Derived Varieties (EDVs)

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In October 2023, the International Union for the Protection of New Varieties of Plants (UPOV) published a long-awaited updated Explanatory Note on Essentially Derived Varieties (EDVs). The UPOV Convention outlines a popular sui generis form of IP protection for plant varieties and was first established in 1961; EDVs have been a provision of the UPOV Convention since 1991. However, the bounds of what can constitute an EDV have often been difficult to devise in practice, and stakeholders have long been requesting clarification from UPOV, particularly in light of modern breeding techniques that may incorporate, for example, gene editing. This new guidance represents UPOV’s response to these concerns.

What Are EDVs?

The legal concept of an “essentially derived” variety serves to effectively extend the reach of a Plant Variety Right (PVR; often also used synonymously with Plant Breeders’ Rights, or PBRs) issued under a PVR scheme that is based on the 1991 UPOV Convention. Thus, in order to understand the concept of EDVs, it is first necessary to understand what a PVR is.

PVR certificates are a form of IP protection that are separate from patents and are designed specifically for new plant varieties. PVRs protect against unauthorized commercial activity or use of a protected variety, with over 150,000 total active titles worldwide as of 2022. The most common legal framework for PVR protection is outlined in the UPOV Convention. Each UPOV Member jurisdiction ultimately provides and implements its own PVR laws and regulations that are consistent with the UPOV Convention to which they are signatory, but UPOV’s “Explanatory Notes” (which provide non-binding guidance for understanding and implementing various terms or provisions of the UPOV Convention) can influence how a Member implements and interprets its PVR laws.

There are two current versions of the UPOV Convention, 1978 and 1991, which have some differences in PVR requirements and the scope of protection. One key difference is that the 1991 UPOV Convention introduces the concept of EDVs and provides coverage to the certificate owner of a protected variety over varieties essentially derived from the protected variety (i.e., EDVs).

The core definition of an essentially derived variety (EDV) comes from Article 14(5)(b) of the 1991 Act of the UPOV Convention (emphases added):

A variety shall be deemed to be essentially derived from another variety (“the initial variety”) when:

(i) it is predominantly derived from the initial variety, or from a variety that is itself predominantly derived from the initial variety, while retaining the expression of the essential characteristics that result from the genotype or combination of genotypes of the initial variety

(ii) it is clearly distinguishable from the initial variety and

(iii) except for the differences which result from the act of derivation, it conforms to the initial variety in the expression of the essential characteristics that result from the genotype or combination of genotypes of the initial variety.

By way of example, the U.S. Plant Variety Protection law (which is administered by the U.S. Department of Agriculture and is in line with the 1991 UPOV Convention) provides a non-exhaustive list of how EDVs can be made, including by: 1) the selection of a natural or induced mutant or of a somaclonal variant, 2) the selection of a variant individual from plants of the initial variety, 3) backcrossing, 4) transformation by genetic engineering, and 5) other methods. (7 USC 57 §2401 (a)(4)(A)).

The third and most recent EDV Explanatory Note was published on October 27, 2023, and was prepared to address the fact that the previous EDV Explanatory Note, which was published in April 2017, no longer reflected breeders’ common practices in understanding EDVs and was insufficient to address the development of new breeding technologies (e.g., gene editing). The updated guidelines provide additional guidance for two key terms used in the definition of an EDV: “predominantly derived” and “essential characteristics.” Each of these is outlined below.

Predominantly Derived

The Explanatory Note explains that “predominant” derivation means that more of the genome of the initial variety is retained than would be retained by normal crossing and selection with different parents. This definition reinforces that a variety should only be considered predominantly derived from the initial variety if it retains almost the whole genome of its initial variety. Varieties with a single parent (“mono-parental” varieties) are considered per se predominantly derived from their initial varieties. Mono-parental varieties include varieties that are the result of mutations, gene editing, and the like. The Explanatory Note also states that there is no upper limit on the number of characteristic differences between an initial variety and a variety predominantly derived from the initial variety. Thus, predominant derivation is primarily defined by the genetic similarity between the derived and initial varieties rather than changes in characteristics.

Essential Characteristics

Regarding “essential characteristics,” the Explanatory Note reinforces that these are characteristics that contribute to the “principal features, performance, or value” of a variety. Examples of essential characteristics include morphological, physiological, agronomic, industrial, biochemical, and commercial attributes of a variety. In addition, the Explanatory Note states that a “predominantly derived” variety can still be an EDV of an initial variety even if it doesn’t completely share the essential characteristics of the initial variety, as long as the missing essential characteristics are missing as a result of the act of derivation. The Explanatory Note also allows for essential characteristics to evolve over time.

Concluding Thoughts

This third EDV Explanatory Note appears to elevate the importance of genetic similarity between an EDV and the initial variety and opens the possibility that essential characteristics may not always be 100% shared between an EDV and the initial variety. This new guidance therefore may provide more latitude for creative “essential characteristics” arguments, but, on the other hand, may also narrow the options for “predominantly derived” arguments. On a practical level, these guidelines will most likely impact both traditional breeders of multi-parental varieties and gene editors who make targeted genetic changes in an initial protected variety to produce a new variety. This Note appears to increase the avenues for such edited varieties to be considered EDVs of their initial varieties, which means that, while a developer producing such an edited plant could still seek their own PVR protection for their edited (i.e., derived) variety (assuming it meets all the requirements for protection, e.g., distinctness, uniformity, and stability), depending on how the updated guidance reads on the technical changes in the derived variety, the developer of the derived variety may still face freedom-to-operate concerns regarding the PVR holder of the initial variety. That being said, and as noted above, UPOV Notes are non-binding guidance; it remains to be seen how various jurisdictions with EDV provisions on the books (e.g., the U.S. and many others) will react and how such issues may play out in infringement disputes.

Overall, these updates should make the concept of EDVs more straightforward to apply to varieties produced by new breeding technologies. For more updates on plant variety rights, see our other recent post on PBRs in the U.S., Canada, and Japan, and subscribe to our blog.