The United States Department of Agriculture (USDA) has been hard at work developing regulations to implement the 2018 Farm Bill. The Bill introduces unprecedented changes to the United States PVP system with respect to asexually reproduced plants and hemp. Proposed regulations to implement changes for asexually reproduced plants will soon be published for comment. Those of us with an economic interest the plant industry, both domestically and internationally, need to review and comment to ensure that our PVP system remains viable and strong.
The first change in the Farm Bill was the legalization of hemp production. Following suit, the USDA quickly adapted and went live with a variety specific form for hemp characteristics. They began accepting PVP applications for sexually produced hemp varieties on April 25, 2019.
Second, and perhaps more sweeping, the Bill directed the USDA to implement PVP protection for asexually reproduced plants. Numerous issues arise with expansion of the process to asexually reproduced plants, not the least of which is deposit. Seed deposits are made with every PVP application, but seed from an asexually reproduced plant will not be true to type, they are instead propagated by cuttings, etc. The proposed regulations will address the deposit issue. The issue of infringement also becomes complicated, as well as the breeders and saved “seed” exemptions. All will be published for discussion in the near future.
The United States does have prior legislation granting patent-like protection to asexually reproduced plants, The Plant Patent Act. The Act eased the patent enablement requirements and does not require a deposit of plant material. Instead a morphological description with an accompanying photograph is all that is required. The Act also provides that a plant patent includes only a single omnibus claim “a(floribunda rose bush) as shown and described herein”. The Doctrine of equivalents may expand the scope of this omnibus claim some.
With the expansion of the PVP, breeders will have coverage not only to the variety, but also to “essentially derived varieties”. While this term remains undefined, this is at least verbiage that expands protection beyond a single variety.
Finally, the Unites States continues to lead world and the UPOV (Union for the Protection of New Varieties) in a proposition for use of genetic markers to establish distinctness. Currently, the PVP office will allow submission of marker data, but it is not examined.
Proposed regulations should come out later this summer and the USDA hopes to have the regulations in place to start accepting applications in early 2020. As a member of the USDA National PVP Advisory Board, I am privileged to have been a part of some of this discussion, and I will post again when the regulations are available for comment.