Summary
For vegetatively reproduced ornamental and fruit varieties, the EDV concept is crucial for the control of the commercialization (production, sales, export and import) of mutants and Genetically Modified Organisms (GMO) of protected Initial Varieties (= mother varieties). The absence of the EDV concept in the U.S. Plant Patent law does not only deprive titleholders of Initial Varieties of the ability to effectively exploit their rights, which is detrimental to innovative breeders in and outside of the U.S. but also contravenes the efforts of UPOV for worldwide harmonization of breeders´ rights. The matter can be solved e.g. by introducing the EDV Concept into the U.S. Plant Patent law or by opening the U.S. Plant Variety Protection Act to asexually reproduced crops. The industry must analyze which is the more efficient, more feasible and more desired solution for breeders. In this regard, it would be necessary to have a broad discussion about the topic within the U.S. and international communities of breeders of asexually reproduced ornamentals and fruits. In any case, anything less than a statutory provision will fall short of solving the problem.
1. The EDV Concept in the Plant Breeders´ Rights / UPOV system
The Essentially Derived Variety (EDV) concept was introduced into the Plant Breeders´ Rights (PBR) system through the UPOV 1991 Act. The concept was intended to broaden the scope of protection for breeders of Initial Varieties by way of creating a dependency between Initial Varieties and their EDVs, i.e. the EDVs shall be dependent upon its Initial Variety[1]. Under the EDV concept, an essentially derived variety falls under the scope of its (protected) Initial Variety and must not be commercialized without the consent of the title holder of the Initial Variety.
The very reason for the introduction of the EDV concept was to strengthen the breeders´ right, particularly by creating a balance between biotechnology inventors and traditional breeders and by bringing mutations under the scope of protection of their Initial Variety. Some also consider the EDV Concept as a tool to decrease plagiarism.
Biotechnology inventors can usually protect their inventions (biotech traits) by way of Patents which grant to the Patentee a strong exclusive right with very few exceptions. Most Patent laws do not contain the so-called Breeders´ Exemption, which consequently allows the use of (PBR-) protected plant material for further breeding. This, in turn, allows a Patentee to create a new, distinct variety (e.g. a GMO) by way of inserting the patented biotech trait into plant material of a PBR-protected variety. Without an EDV concept, the traditional breeder, whose variety has contributed more than 99% of the genome of the newly-bred GMO, cannot prevent the Patentee from exploiting the GMO; the Patentee, however, can prevent the breeder from doing so, based on his Biotech Patent.
Mutation breeding creates a comparable situation. Mutants are often developed from new and successful mother varieties. Often, not much discovering and developing work is required; there is a short process of evaluation, and the mutation takes the benefit of the already-known variety and is thus easy to launch. In the absence of an EDV concept, the breeder of the mother variety (Initial Variety) cannot prevent the breeder of the mutation from exploiting it, although the mutation is solely based on his previous – often time-consuming and costly – breeding work.
In order to provide for a more-balanced relationship between biotech inventors and mutation finders on one side and traditional breeders on the other side, the EDV concept has been incorporated into the UPOV 1991 Act. It is included in Article 14 (5) of the UPOV 1991 Act, that reads:
Article 14
Scope of the Breeder’s Right
(1) – (4) ….
(5) [Essentially derived and certain other varieties]
(a) The provisions of paragraphs (1) to (4) shall also apply in relation to
(i) varieties which are essentially derived from the protected variety, where the protected variety is not itself an essentially derived variety,
(ii) … (iii) ….
(b) 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.
© Essentially derived varieties may be obtained for example by the selection of a natural or induced mutant, or of a somaclonal variant, the selection of a variant individual from plants of the initial variety, backcrossing, or transformation by genetic engineering.
As one can see, the wording of the EDV Concept in UPOV is quite complicated and open for interpretation. In fact, UPOV has deliberated about explanatory notes on EDV for several years. The second version of these explanatory notes was recently published but it is still not final because of a dispute about the definition and requirements of an EDV. The two undisputed requirements for an Essentially Derived Variety are that it is predominantly derived from the Initial Variety and distinct from the Initial Variety. Some erroneously argue that an EDV must also be phenotypically very similar to the Initial Variety. Such entanglement of dependency and plagiarism is a mistake in the conception of the EDV provision. Plagiarism is not a question of derivation or dependency but rather a question of Minimum Distance and direct infringement. If a variety in its phenotype very much resembles a protected variety, it is not clearly distinguishable from the protected variety and its commercialization is a direct infringement, irrespective of whether the new variety is (essentially) derived from the protected variety or not.
2. Basic requirements and effects of the EDV concept for vegetatively reproduced ornamental and fruit varieties
In the area of vegetatively reproduced ornamental and fruit varieties, the EDV concept is mainly applicable to mutants and Genetically Modified Organisms (GMO). Additionally, the outcomes of repeated back-crossing are EDVs if they retain a very high genetic conformity to the Initial Variety.
2.1 Continued possibility to breed with protected plant material
The EDV concept in Plant Breeders´ Rights laws does not prevent breeders from using plant material of a PBR-protected variety for breeding or discovering and developing new varieties. Such new varieties belong to the person who bred it, even in the case of mutation and GMO. Such free use of protected material for further breeding is safeguarded by the so-called Breeders´ Exemption in the PBR laws. Only the commercialization of the so bred new varieties is limited, i.e. subject to the authorization of the title holder of the Initial Variety, if the new varieties are considered to be EDVs.
2.2 Restricted commercialization of EDV
If a variety is considered to be an EDV, the consequence is that all acts of commercialization of said variety requires the authorization / license of the titleholder of the respective Initial Variety. If the breeder of the EDV has acquired separate PBR protection for his EDV, his authorization is likewise required for the commercialization of the EDV[2].
Examples: If someone wishes to propagate a mutant of a protected Initial Variety within a country in which an EDV provision is in force, that individual requires a license from the titleholder of the Initial Variety (plus, if the mutant is protected on its own, a license of the titleholder of the mutant). If someone wishes to import propagating material of a mutant of a protected Initial Variety into a territory in which an EDV provision is in force a license of the titleholder of the Initial Variety (plus, if the mutant is protected on its own, a license of the title holder of the mutant) is required.
2.3 Clarification of the EDV Concept by CIOPORA
Some details regarding the EDV concept require further clarification. To support this need for clarification, CIOPORA adopted its new Position Paper on Essentially Derived Varieties in June 2016 (see here).
3. U.S. Plant Patent Act
The main IP protection system for vegetatively propagated ornamental and fruit varieties in the U.S. is the Plant Patent (U.S. Patent Act, 35 U.S.C, 161 – 164).
Although the U.S. has been a member of UPOV since 1981 and acceded to the UPOV 1991 Act in 1999, the U.S. Plant Patent Act is not a UPOV-style system[3].
The U.S. additionally has not adapted its Plant Patent law to the increased level of protection of the UPOV 1991 Act[4].
Therefore, no EDV concept has been included into the U.S. Plant Patent law. Contrary to the U.S. Plant Patent, the U.S. Plant Variety Protection Act has been adapted to the UPOV 1991 Act and the EDV concept has been likewise incorporated into this Act[5].
The U.S. Plant Patent provides that whoever invents or discovers and asexually reproduces any distinct and new variety of plant, including cultivated sports, mutants, hybrids, and newly found seedlings, other than a tuber propagated plant or a plant found in an uncultivated state, may obtain a patent therefor. In the case of a plant patent, the grant shall include the right to exclude others from asexually reproducing the plant, and from using, offering for sale, or selling the plant so reproduced, or any of its parts, throughout the United States, or from importing the plant so reproduced, or any parts thereof, into the United States.
The U.S. Plant Patent explicitly mentions mutants as protectable subject matter. This is in line with the understanding within the UPOV system that a mutant variety, in general, is eligible for PBR protection if it fulfils the general requirements for protection (if it is distinct, uniform and stable (DUS), novel and has a variety denomination).
However, while the UPOV 1991 Act with the EDV concept has an inbuilt corrective for mutants and GMOs, the U.S. Plant Patent Act does not.
While under the U.S. Plant Patent it might be easier, by way of contract, to prevent competitors from accessing and using protected plant material for further breeding, discovering mutations or developing GMOs, this is effective only for acts done in the U.S. territory. Mutations and GMO developed outside the U.S. can be freely commercialized inside the U.S. if they do not fall under the scope of an IP protection title.
Therefore, the absence of the EDV concept in the U.S. Plant Patent law deprives the breeders of innovative Initial Varieties (resulting from crossing and selection) of the ability to effectively exploit their rights, which is detrimental to the work of innovative U.S. and foreign breeders within the U.S. territory. This devaluates the U.S. Plant Patent and makes it less attractive for breeders.
Given that the primary market for U.S.-based breeders of ornamental and fruit varieties is the United States itself, said breeders are particularly disadvantaged. Their Plant Patent rights are jeopardized because mutations of their protected varieties can be freely grown in the country and material of mutant varieties can be freely imported into the U.S. The latter is particularly important in the case of cut-flowers such as roses which are imported to a huge extent from Latin American countries which, in some cases, have a low level of IP protection.
The advantages and the value of the EDV concept have been recognized by the U.S. legislature when implementing the concept in the U.S. Plant Variety Protection Act, and there exists no evident reason to treat breeders of vegetatively reproduced ornamentals and fruits different than breeders of sexually reproduced or tuber propagated plant varieties.
As previously mentioned, the EDV concept creates dependency between varieties. The concept of dependency is known in the U.S. Patent law, too. If a later patent can only be utilized if it is simultaneously used with an earlier patent, the later patent is dependent upon the earlier patent. The owner of the later patent can use his/her patent only with the consent of the owner of the earlier patent. The lack of a “dependency concept” in the Plant Patent law therefore discriminates breeders of asexually reproduced ornamentals and fruits against other inventors in the U.S.
4. U.S. Plant Variety Protection Act
The protection system for sexually reproduced or tuber propagated plant varieties in the U.S. is the Plant Variety Protection Act (7 U.S.C., chapter 57, §§ 2321-2582). The U.S. PVP Act is in line with the UPOV 1991 Act[6], to which the U.S. acceded.
The definition of EDV in the PVP Act is almost identical to the one in the UPOV 1991 Act. This means it also includes the contradiction in regard to the level of conformity in the expression of the essential characteristics that result from the genotype or combination of genotypes of the initial variety (Sec 2401 (3) (A) (i) and (iii)). In UPOV this expression of the essential characteristics that result from the genotype or combination of genotypes is understood as phenotype. This leads to the erroneous conclusion that an EDV must be phenotypically very similar to its Initial Variety.
5. Possible solutions for breeders of asexually reproduced ornamentals and fruits: EDV concept incorporation into the U.S. Plant Patent law or opening the U.S. Plant Variety Protection Act to asexually reproduced crops
If the EDV concept is made available for asexually reproduced ornamentals and fruit varieties in the U.S., two viable options exist: 1. introducing the EDV Concept into the U.S. Plant Patent law or 2. opening the U.S. Plant Variety Protection Act to include asexually reproduced crops. Before one can make a proposal on which direction is preferable, a deep and thorough analysis of the weaknesses and strengths of both systems and of the political feasibility is necessary.
Points to be considered in such analysis include:
· Scope of Protection
Which system offers a better scope of protection, i.e. which material and which acts are protected. The Plant Patent unconditionally covers the asexually reproduced plant and parts thereof, which includes flowers and fruits. The PVP-title covers propagating material and harvested material, obtained through the unauthorized use of propagating material of a protected variety, unless the owner of the variety has had a reasonable opportunity to exercise the rights provided under this Act with respect to the propagating material.
· Exemptions from Protection
The main weakness of the PVP Act is that it includes the so-called farmers´ exemption which allows farmers to keep grain from their harvested crop in order to use it as seed on their farm the following season. Such farmers´ exemption applied to vegetatively reproduced crops would make the protection very weak, if not completely useless. Additionally, the PVP Act includes a research exemption, which exempts from protection the use and reproduction of a protected variety for plant breeding or other bona fide research, while there exists no such statutory research exemption in the US (Plant) Patent.
· Duration of Protection
For Plant Patents, the protection lasts for 20 years from the date of filing the application, while the plant variety protection shall expire 20 / 25 years from the date of issue of the certificate.
Other points include the cost of protection as well as its enforceability.
Finally, a feasibility study must be conducted, including an analysis of the political landscape and the willingness of the U.S. legislature to change one of the regulations.
Most importantly, it must be determined which solution the breeders ultimately want. CIOPORA members are in favor of the EDV Concept. It would be necessary to have a broad discussion about the topic within the US and international communities of breeders of asexually reproduced ornamentals and fruits, as these breeders are most affected by the issue.
* Dr Edgar Krieger is the Secretary General of CIOPORA, the International Association of Breeders of Asexually Reproduced Ornamental and Fruit Plants.
[1] In order to avoid a chain of dependency, essentially derived varieties are dependent from the protected variety, where the protected variety is not itself an essentially derived variety. That means that a mutant cannot be dependent from another mutant.
[2] In many cases the title-holder of the Initial Variety will grant a general license to the breeder (and title-holder) of the EDV, so that a license of the latter is sufficient.
[3] This is possible because the U.S.A. made use of Article 35 (2) of the UPOV 1991 Act, which provides that if a UPOV member, as far as varieties reproduced asexually are concerned, provides for protection by an industrial property title other than a breeder’s right , it shall have the right to continue to do so when acceding to the 1991 Act.
[4] Except for the addition of “parts of plants” to the scope of protection by way of the Plant Patent Amendments Act 1998
[5] See below under point 4.
[6] The adapted PVP Act came into force on April 4, 1995.
