September 1, 2022
By Travis Bliss, Ph.D., Esq. and Stephany Small, Ph.D.

There is some good news for breeders considering obtaining Plant Variety Protection (PVP)
rights for an asexually reproduced plant variety. On August 31, 2022 the U.S. Department of
Agriculture (USDA) announced that it was indefinitely waiving the germplasm deposit
requirement for PVPs for asexually reproduced varieties. So any breeder seeking PVP
protection for an asexually reproduced variety is no longer burdened with the difficulty and
expense of making a tissue culture deposit of plant material, and will never be required to do so
for any applications filed during this indefinite waiver period. This is great news for the breeder
community and should lead to increased usage of the USDA PVP system for asexually
reproduced varieties. Additionally, this shows that USDA leadership is in tune with and
listening to the concerns of the breeder community.
Historically, PVP certificates, which are issued by the USDA, were only available for sexually
(seed) reproduced plant varieties and tubers; PVP protection could not be obtained for
asexually (vegetatively/clonally) reproduced varieties. This was due to the bifurcated
protection systems used in the U.S. – Plant Patents (issued by the U.S. Patent and Trademark
Office) for asexually reproduced varieties and PVPs for seeds and tubers. The 2018 Farm Bill
added the option of obtaining PVP protection for asexually reproduced varieties, as well. USDA
regulations had always required a germplasm deposit of seed or tuber material, so a germplasm
deposit requirement was also included in the regulations for asexually reproduced
varieties. The germplasm material for asexually reproduced varieties had to be in the form of a
tissue culture sample, which would be held in cryopreservation at an approved laboratory for
the required period of time – at least 20+ years (longer than the length of PVP protection).
This created several issues that made the PVP system much less attractive for breeders of
asexually reproduced varieties. First, the cost of the deposit was quite high, estimated at
$3,000-$4,000 per variety. Second, the USDA does not have the capacity to collect and store
cryopreserved tissue culture samples itself, and the there was only one lab approved by the
USDA for such storage as of early 2022. And third, it was technically infeasible to create and
store tissue culture samples for many varieties. During presentations and discussions by
industry and USDA personnel at some recent industry meetings, it was estimated that at least
50% of plant species that had been attempted were not able to be successfully cryopreserved
as tissue culture material.
Because of the technical infeasibility issue, the USDA had previously postponed enforcement of
the deposit requirement until January 6, 2023, to allow time for these issues to be
resolved. However, given the ongoing technical infeasibility and storage issues, the USDA made
the following announcement on August 31, 2022: “Due to continued and ongoing technical
challenges and infeasibilities, germplasm deposits of propagating materials for asexually
reproduced varieties are delayed until further notice; and will not be required
retroactively.” The announcement goes on to say that, when seeking a PVP for an asexually
reproduced variety, the applicant is required “to make a declaration that the propagating
material will be maintained at a specific physical location, subject to Plant Variety Protection
Office inspection when requested; and (ii) to make a declaration that propagating material will
be provided within three months of a request by the Plant Variety Protection Office. Failure to
provide propagating material as requested shall result in the certificate being regarded as
abandoned.” The complete USDA announcement can be found here.

This should make the USDA PVP system more attractive to breeders of asexually reproduced
varieties by alleviating many of the concerns that were making breeders reluctant to utilize the
system. Additionally, this shows that the USDA is listening to the concerns of the breeding
community and trying to make adjustments to alleviate those concerns when
possible. Through the efforts of the AmericanHort organization, which held meetings with
breeders and USDA leadership during its recent events, including its Cultivate ’22 trade show,
and the CIOPORA international breeders organization, which has included USDA leaders in
several of its recent meetings as well, including its 2022 Annual General Meeting, the breeder
community was able to have discussions with USDA leaders and voice their concerns about the
system. And the USDA has taken action to alleviate those concerns at least until technical
infeasibility issues can be resolved. This shows both the value of breeders taking an active role
in these types of organizations and the desire of USDA leadership to work with the horticultural
community to resolve issues the industry is facing.