USDA’s PVP System Embraces Transgenic and Gene Edited Plants

This is an excerpt from a longer piece. For more information on the history and landscape of PVPs on transgenic plants, read more.

Plant Variety Protection (PVP) is a form of intellectual property protection administered through the United States Department of Agriculture (USDA) for new varieties of plants. PVP certificates (PVPs), which have been available in the U.S. since the enactment of the Plant Variety Protection Act of 1970 (PVPA; 7 U.S.C. §§ 2321-2582), have historically been associated with traditional breeding. However, there are actually numerous granted PVPs covering transgenic plant varieties, and the USDA is now also granting PVPs to gene edited plants. This article describes a recently granted PVP for a gene edited plant, contextualizing this example PVP in the broader landscape of PVP certificates that are directed to plant varieties created using modern biotechnology.

As of this writing, there have been at least 1,952 granted PVPs covering transgenic plant varieties since 1998, when the USDA started collecting this information (Figure 1a). This represents roughly 20% of all PVPs granted during this time frame. PVPs covering transgenic varieties are identifiable by an affirmative answer in field 18 in the PVP ST-470 application form (Figure 1b). These transgenes are often used to confer traits that do not usually occur in a crop’s gene pool, such as herbicide tolerance or insecticidal protein synthesis.

Figure 1a

Figure 1a: PVP grants covering transgenic plant varieties by year. Data source: USDA, AMS, S&T, Plant Variety Protection Office, July 2022. The raw data consists of all PVP varieties where the answer to the question “Does the variety contain any transgenes?” is “Yes.” The bar graph was generated by filtering this raw data for records with an issue date, then sorting by issue year.

Figure 1b

Figure 1b: Field 18 of a PVP certificate, indicating the presence of inserted nucleic acids. Source: PVP application form for rape variety ‘KSR4652’. Note that the USDA changed the language in this field around 2018; an earlier version referred to “transgenes” rather than “biotechnology events” (for an example of the previous language, see field 18 in the PVP application form for rape variety ‘Cara’). According to the USDA, AMS, S&T, and Plant Variety Protection Office, this change was due to industry pressure for the field to be written more broadly, in order to better encompass newer methods of genetic modification (personal communication, July 2022). USDA-AMS, for its part, views the use of “transgenes” and “biotechnology events” in this context as synonymous, and it collects the information in field 18 in order to assist the National Laboratory for Genetic Resource Preservation in handling seed deposits after expiration (USDA, AMS, S&T, and Plant Variety Protection Office; personal communication, July 2022).

In addition to PVPs on transgenic varieties, which contain foreign DNA by definition, the USDA has also recently begun granting PVPs on gene edited plant varieties. Gene editing is a form of modern biotechnology used to make precise genetic changes, but which does not necessarily entail insertion of foreign DNA.

For example, the USDA recently granted a PVP certificate to GreenVenus, LLC for the ‘GVR-108XL’ lettuce variety, which was created using gene editing without transgene insertion. Thus, in contrast to the PVPs discussed above, field 18 in this Certificate is marked as “No.” The table below summarizes the bibliographic information of the ‘GVR-108XL’ lettuce PVP, including links to relevant documents.

GreenVenus, LLC’s romaine lettuce variety ‘GVR-108XL’ has edits to five polyphenol oxidase (PPO) genes, which are enzymes responsible for damage-related browning in fruits and vegetables, and negatively affect the shelf life of products such as pre-cut salads. As described in the publicly available description and data included with the published PVP application, the genetic edits in ‘GVR-108XL’ lettuce lower the activity of PPOs to delay browning, without the presence of transgenes in the plant’s genome. These edits were accomplished using a nuclease and guide RNAs to target multiple PPO genes. The nuclease and guide RNAs were originally introduced on a T-DNA using Agrobacterium-mediated transformation. This foreign DNA was integrated into the lettuce genome, thereby producing a transgenic lettuce plant that mediated its own gene editing. Once the transgenic nuclease and guide RNAs accomplished the desired edits to the PPO genes, the transgenic DNA was segregated out in subsequent generations by traditional breeding. The final ‘GVR-108XL’ lettuce plants thus include the PPO edits, but do not include foreign DNA (for more information, see pg. 8 and Exhibit B of the ‘GVR-108XL’ PVP application).

Options for plant IP protection and changes to PVPs

Although this post focuses on PVPs, it is useful to keep in mind that PVPs are one of three non-mutually exclusive forms of IP available for plants in the United States. The other two forms are utility patents and plant patents. Utility patents can have any number of claims, and can cover many different aspects a plant, including but not limited to plant lineages, parts, cells, varieties, and even sometimes traits. Plant patents are restricted to asexually propagated plants, and contain only one claim, which is limited to the particular plant described in the plant patent and clones thereof. Somewhat similarly, PVPs are limited to the protected variety, but have slightly broader coverage than plant patents in that they contain provisions regarding essentially derived varieties (EDVs). This means that permission must be granted by the Certificate holder in order to sell varieties deemed to be “essentially derived” from the protected variety, so long as the protected variety is not itself an EDV. Read a more in-depth discussion of EDVs.

What do we expect going forward?

We expect the number of PVPs granted on plants produced using biotechnology—whether transgenic or not—to only increase going forward. Given the recent updates to USDA’s regulatory process for assessing plants developed using genetic engineering under the SECURE rule, which we have summarized in a previous post, and the increasing technological ease with which such edits may be made, it is likely that there will be an increase in development of such plants in the US. This is likely to be particularly true for certain “simple” types of gene editing, such as targeted DNA breaks that are repaired without a template, and targeted single base pair substitutions, both of which are exempt from regulation under the SECURE rule.

Not only will significantly more GE plants likely be produced going forward, but the recent expansion in PVP coverage to also include asexually reproduced plants (summarized in a previous post) means that nearly all such plants are now potentially eligible for PVP coverage. We expect that the combination of these two factors will lead to a significant increase in both the number and proportion of PVPs granted on transgenic and gene edited plant varieties—though it remains to be seen how closely USDA will publicly track each of these categories.

As these technological and regulatory changes continue to settle in, it will be interesting to see how the industry adapts to the new regulatory atmosphere, and how use of the various forms of plant IP available in the United States continues to morph in parallel.