On December 16, 2026, the Legislative Branch of Uruguay enacted Law No. 20,446 (“Law on the National Budget of Salaries, Expenses and Investments. Fiscal Year 2025-2029”) which modified the plant variety protection regime enshrined in Law No. 16.811, dated February 21, 1997 (“Seed Law”), expressly recognizing the concept of “essentially derived varieties” (“EDV”) and granting protection over the same to the owner of the initial variety.
A) What are Essentially Derived Varieties?
Act 91 of the UPOV Convention states that a variety shall be essentially derived from the “initial variety” when:
- is predominantly derived from the initial variety,
- retains the expression of the essential features resulting from the genotype (or combination of genotypes) of the initial,
- is clearly distinguishable from the initial, and
- except for the differences derived from the act of derivation, it conforms to the initial one in the expression of these essential characteristics.
B) Background. General comments on the amendment to the Seed Law.
The reform represents an innovation in Uruguay’s legal framework on plant varieties – which did not recognize EDV – and brings national regulation closer to the approach of the UPOV Act 91.
The relevant regulatory framework in Uruguay is provided by the Seed Law and its Regulatory Decrees, as well as by Law No. 16.580 of September 21, 1994, by which Uruguay acceded to and ratified the UPOV ’78 Convention.
As is known, there are two acts of the UPOV Convention, Act ’78 and Act ’91, the second granting a higher degree of protection than the first to the rights of breeders.
Although to date Uruguay has not acceded to Act 91 of the UPOV Convention, this reform aligns the Uruguayan legal regime of breeders’ rights with this norm, in particular with regard to the logic of extending the scope of the breeder’s right with respect to certain “derivative” varieties that retain the essential characteristics of the initial variety. and constitutes an advance in the protection of breeders’ rights.
The legislative modification was promoted by the Uruguayan Plant Variety Office (Instituto Nacional de Semillas – INASE) in order to align national legislation with the most modern international standards on the subject – whose adoption is often required in multilateral trade agreements – and recognizing the relevance of the foundations that led to the incorporation of the EDV regime in Act ’91 of the UPOV Convention.
In this line, the Executive Director of INASE, Eng. Agr. Daniel Bayce, publicly explained that the incorporation of EDV seeks to place Uruguay in line with international standards, and that the logic is to require agreement with the owner of the original variety to determine how rights or royalties will be distributed when the new variety originates from a pre-existing one
He also linked the reform to the technological evolution of plant breeding, highlighting that today it is possible to achieve specific modifications in shorter periods of time (for example, via gene editing) without altering the rest of the agronomic and quality characteristics.
C) New legal regime of EDV introduced by Law No. 20.446.
The reform introduced by Law No. 20.446 adopts: (i) a definition of EDV and (ii) a rule extending the breeder’s right to EDV that are at the core of the regulation of Act ’91 of the UPOV Convention.
Definition of EDV and techniques for obtaining them
Article 256 of Law No. 20.446 incorporates into the Seed Law a legal definition of “essentially derived variety” that is similar to that established in Article 14 5 b) of Act ’91 of the UPOV Convention.
“19) Essentially derived variety (EDV). A variety is considered to be essentially derived from another variety (“the initial variety”) if:
(a) is derived primarily from the initial variety, or from a variety which is itself derived primarily from the initial variety, while retaining the expression of the essential traits resulting from the genotype or combination of genotypes of the initial variety;
(b) is clearly distinguishable from the initial variety, and
(c) except for the differences resulting from the derivation, it is in accordance with the initial variety in the expression of the essential characters.
Essentially derived varieties may be obtained by any genetic improvement technique, including, but not limited to, selection for natural or induced mutants, somaclonal variants, variant individuals within the initial variety, backcrossing, or by genetic engineering.”
In short, the elements that make a EDV are: i) main derivation from an initial variety, (ii) clear distinction, (iii) conformity in essential characters except for the derived differences.
Finally, in wording almost identical to that established in Article 14 (5) (c) of Act ’91 of the UPOV Convention, Article 256 includes a mention that EDV can be obtained by any genetic improvement technique, including (but not limited to) natural/induced mutant techniques, somaclonal variants, variant individuals within the initial variety, backcrosses or genetic engineering.
Scope of the rights of the owner of the initial varieties in the EDVs
Article 257 of Law No. 20,446 amends Article 71 of the Seed Law in order to expressly clarify that the rights conferred by the Property Registration Title of a protected plant variety to its owner also extend to the EDV.
Article 71 establishes the rights granted over registered plant varieties, stating that the owner of a plant variety registered with the INASE Cultivar Property Registry has the right to enter into all legally admissible legal transactions, conferring exclusivity to authorize the exploitation of the typical acts of cultivar: production/reproduction, preparation, offer for sale, sale/marketing, export, import, donation and possession for these purposes, referring to sexual reproduction material or vegetative multiplication, “in their capacity as such”.
The amendment expressly clarifies that the “provisions of this article shall also apply to varieties essentially derived from the initial protected variety, when this is not, in turn, an essentially derived variety.”
With the modification introduced, the breeder’s right of the initial variety “reaches” the EDV, so that the acts listed with respect to the propagation material of the EDV are also under the authorization of the owner of the initial variety (if it is protected in Uruguay).
By saying “when the initial variety is not, in turn, a EDV”, the UPOV 91 logic of preventing a variety that is already derived from becoming an “initial variety” is reproduced in order to generate a “stepped” extension of rights downwards (the extension is anchored in the initial non-derived variety).
Therefore, it may be the case that for the exploitation of a EDV that has its own Registration Title (because it complies with the registration conditions), in order to commercially exploit the propagation material of that EDV, it may be necessary to (i) authorize the owner of the EDV and (ii) authorization of the owner of the initial variety, as long as the latter’s right is in force.
Finally, it should be noted that, although the reform does not expressly clarify it, EDV can receive plant breeder’s rights like any other cultivar as long as they meet the conditions for their registration provided for in the Seed Law (Novelty, Distinctiveness, Homogeneity and Stability).
D) Final Comments. Practical aspects to take into account.
The recognition of the protection of EDV by Uruguayan legislation will undoubtedly constitute an instrument of great relevance for breeders to protect their efforts and investments in the genetic improvement of cultivars and obtain the protection of their rights in Uruguay.
The fact that the regime adopted broadly follows the regulation of the EDV provided for in Act ’91 of the UPOV Convention is positive and will help to facilitate harmonization in the application of this institute.
Likewise, for the purposes of the application of this institute, the criteria that the authority – INASE – or the regulation may establish on practical aspects such as what are the criteria to determine whether a variety is a EDV according to the definition adopted, as well as the criteria of burden of proof and the technical resolution mechanisms that can be used in the determination of the existence or not of a EDV, will be extremely important.
Finally, the protection of EDV has practical implications for all players involved in the cultivar´s generation and exploitation:
– From a contractual point of view, it is important to review the licensing or co-licensing models of protected cultivars to contemplate these figures, as well as royalty schemes for the exploitation of EDV.
– Plant breeders and breeders should review their R&D strategies considering the risk of qualifying their developments as EDV, as well as strengthen due diligence when incorporating third-party germplasm into their development.
– Owners of protected varieties must monitor the market to detect potential EDV and activate proactive licensing mechanisms and policies for their varieties.
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The Intellectual Property team of FISCHER Abogados is available to analyze the risks, implications and opportunities that this new EDV protection regime may have for your company and/or your clients.
