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January 23, 2020 - United States, Agtech, Regulatory, Intellectual Property

Plant Variety Protection Office Now Accepting Applications For Asexually Reproduced Plants

Planting the Seeds of Change

On January 6, 2020, the Plant Variety Protection Office (PVPO) released the final version of its much-anticipated rule to open Plant Variety Protection (PVP) to asexually reproduced plants. Publication of this rule means that the PVPO is now accepting applications for all species of asexually reproduced plants for the first time.

Extending PVP rights to all asexually reproduced plants means that breeders of plants, such as fruit trees, which are typically propagated asexually rather than by seed, may now obtain PVP certificates for their varieties in the United States. This addition is also notable for breeders of hemp—the regulated production of which was legalized by the 2018 Farm Bill—because hemp can be reproduced both asexually and by seed.

The 2018 Farm Bill Extended PVPA Protection to Asexually Reproduced Plants

The new PVPO rule was prompted by the 2018 Farm Bill (Public Law No: 115-334, Sec. 10108), which dramatically expanded the scope of the U.S. Plant Variety Protection Act (PVPA) to include protection for asexually reproduced plant varieties. Prior to this amendment, the PVPA had been limited to sexually reproduced plants (i.e., seed-bearing plants) and tuber‑propagated plants. Although the Farm Bill was passed over a year ago, the PVPO needed time to revise the Plant Variety Protection Regulations (7 C.F.R. part 97; “Regulations”), which guide the implementation of the PVPA, prior to accepting applications for asexually reproduced plant varieties. A draft rule proposing such revisions was published for comment in the Federal Register in July 2019 (84 Fed. Reg. 33176, 33178), and comments closed in September 2019. In the intervening period, the PVPO revised the draft into a final rule, which was reviewed and approved by the PVPO Administrator and the Secretary of Agriculture before being released on January 6, 2020.

The 2018 Farm Bill included the following amendments to the PVPA: 1) the sections on rights provided (7 U.S.C. § 2402), infringement (7 U.S.C. § 2541), and false marking and cease and desist orders (7 U.S.C. § 2568) were revised to include language for asexually reproduced plants and 2) the definitions section (7 U.S.C. § 2401(a)) was revised to provide a definition for the term “asexually reproduced.” Specifically, the PVPA now defines “asexually reproduced” as “produced by a method of plant propagation using vegetative material (other than seed) from a single parent, including cuttings, grafting, tissue culture, and propagation by root division.” (2018 Farm Bill, Public Law No: 115-334, Sec. 10108, 132 Stat. 4906 (Dec. 20, 2018).)

In implementing these changes, the PVPO’s new rule demonstrates how the Office will handle PVP applications for asexually reproduced plants. Many of the changes merely broaden the Regulations’ existing language to include asexually reproduced plants. For instance, with regard to the publication of pending applications, amended § 97.19(c) states that information relating to pending applications shall show the “name of the crop” rather than the “name of the kind of seed.” Notably, however, there are two key areas that Applicants interested in obtaining PVP protection for their asexually reproduced varieties should be sure to understand: 1) the testing requirements and 2) the deposit requirements (discussed in detail below).

Distinctness, Uniformity, and Stability (DUS) Testing

As is the standard for sexually reproduced and tuber-propagated plants, the PVPO will not conduct its own DUS trials for asexually reproduced plants. Rather, Applicants will perform DUS testing themselves and provide their data to the PVPO using new Exhibit C forms that the Office has developed for asexually reproduced plants. These new Exhibit C forms are based on the Test Guidelines Table of Characteristics from the International Union for the Protection of New Varieties of Plants (UPOV). The PVPO’s new forms are available on the PVPO website and through the ePVP online application system. Additionally, the PVPO may also accept DUS reports from other countries on a case-by-case basis.

Deposit Requirements

For PVP applications directed to seed-reproduced and tuber-propagated varieties, the PVPO currently requires Applicants to submit a biological deposit of the candidate variety. When the PVPA was extended to asexually reproduced plants, the PVPO had planned to require deposits for asexual reproduced species as well. However, in response to feasibility concerns raised in the public comment period, the final rule provides for a three-year delay in enforcement of the deposit requirement for asexually reproduced plants. Thus, deposits of propagating material for asexually reproduced plants will not be required until January 6, 2023. In the intervening period, the PVPO will examine the technical feasibility of making deposits for asexually reproduced plants.

Therefore, from January 6, 2020, until January 6, 2023, Applicants are not required to make a biological deposit for PVP applications for asexually reproduced plants, though they may do so voluntarily. However, Applicants who choose to not make deposits during this period are required to submit declarations stating that: 1) propagating material will be maintained at a specific physical location that the PVPO can inspect (7 C.F.R. § 97.7(d)(2)(i) 2020) and 2) the propagating material will be provided within three months of a request by the PVPO (7 C.F.R. § 97.7(d)(2)(ii) 2020).

The final rule envisions that, after January 6, 2023, deposits will be required for PVP applications for asexually reproduced plants within three months of notice of certificate issuance. As with sexually reproduced and tuber-propagated plants, Applicants seeking protection for asexually reproduced plants will be required to submit a declaration stating that the deposit will be maintained for the duration of the certificate.

Although deposits are currently envisioned to become required and enforceable after January 6, 2023, Applicants may request waivers that, if granted by the PVPO, will allow for delayed submission of the deposit. Two types of waivers will be available for asexually reproduced plants:

  1. Waiver for “good cause, such as delays in obtaining a phytosanitary certificate” (7 C.F.R. § 97.7(d) 2020); and
  2. Waiver to withhold deposit due to technical infeasibility.

If a technical infeasibility waiver is granted by the PVPO, the Applicant will further be required to:

  1. Make the same two § 97.7(d)(2)(i)-(ii) declarations noted above; and
  2. Submit a deposit within three months of notice that the technical infeasibility has been resolved.

Overall, Applicants should be prepared to submit deposits of propagating material for asexually reproduced plants, although such deposits will not be formally required until January 6, 2023. During the intervening time, as noted above, the PVPO is reviewing the technical feasibility of making deposits for asexually reproduced plants. Following this review period, the PVPO may modify the deposit requirements outlined above.

PVP Certificates vs. Plant Patents

Prior to the PVPA amendment, intellectual property protection on asexually reproduced plants in the United States was already available in the form of plant patents under 35 U.S.C. § 161. Plant patents continue to be available, but PVP certificates offer broader protection in terms of so-called “essentially derived varieties” (EDVs). That is, in addition to covering the variety owned by the titleholder, PVP certificates also require the titleholder’s permission before commercialization of any variety that has been “essentially derived” from the titleholder’s variety (7 U.S.C. § 2541). In contrast, plant patents cover only the exact plant set forth in the issued patent and clones thereof. Thus, the option to obtain PVP rights expands the scope of protection available for breeders of asexually reproduced plants in the United States. Furthermore, with the addition of asexually reproduced plants, the U.S. PVP system is now more aligned with analogous systems in other UPOV countries, allowing breeders to streamline their international portfolios.

While PVP certificates provide broader protection for breeders than do plant patents, they do present some drawbacks. Specifically, the PVPA contains exemptions to infringement for seed-saving, research, and breeding (7 U.S.C. §§ 2543-44), while plant patents do not. Furthermore, unlike PVP applications, plant patent applications do not formally require a deposit. Finally, plant patents are more economical than PVPs. Indeed, PVP certificates require both a $3,000 deposit fee and a $5,150 application fee, while the official fees for a plant patent are likely to total less than half of that amount.

Moving Forward

In addition to incorporating the inclusion of asexually reproduced plants, the PVPO’s revised Regulations updated the fee schedule and modernized administrative procedures. The full text of the new rule is available at the PVPO’s website. Given the cost and the potential technical complications of the deposit requirement, it remains to be seen how popular PVPs for asexually reproduced plants will be. However, the opportunity to obtain PVPs for asexually reproduced plants—particularly considering the EDV protection provided—is a significant step forward for plant intellectual property in the United States.