By Kassandra Officer and Lauren Robinson
The cannabis industry may be on the brink of a significant shift in intellectual property protection for new marijuana varieties. With the recent announcement by the U.S. Attorney General to initiate proceedings to transfer cannabis from a Schedule I to Schedule III [1] substance, cannabis breeders may be able to obtain protection under the Plant Variety Protection Act (PVPA) for their high-tetrahydrocannabinol (THC) varieties. This development, coupled with the U.S. Department of Agriculture’s (USDA) evolving stance on hemp, [2] has potentially far-reaching implications for cannabis industry executives as they navigate the changing landscape of intellectual property rights in this sector.
Since the 2018 Farm Bill, [3] hemp breeders have been able to secure 20-year exclusivity for new varieties containing less than 0.3% Delta-9-THC under the PVPA. [4] However, the protection has been limited to low-THC hemp varieties, leaving high-THC marijuana varieties ineligible for protection. The proposed rescheduling of marijuana from a Schedule I to Schedule III substance may open the door for the USDA to grant PVPA certificates for eligible cannabis varieties, regardless of their THC content. Schedule III substances have accepted medical uses and a lower potential for abuse compared to Schedule I substances, [5] but the notice of proposed rule-making reiterates that the manufacture, distribution, dispensing, and possession of marijuana would remain subject to the applicable criminal prohibitions of the Controlled Substances Act (CSA) under Schedule III, and that any drugs containing a substance within the CSA’s definition of “marijuana” would also remain subject to the applicable prohibitions in the Federal Food, Drug, and Cosmetic Act. [6] Accordingly, greater federal guidance following the proposed rescheduling, including in any updated Farm Bill addressing marijuana, should be closely monitored. [7]
This development is particularly significant for cannabis industry executives as they strategically plan for the coming months. The ability to protect high-THC marijuana strains under the PVPA would provide breeders with a previously unavailable method to safeguard their intellectual property and to maintain a competitive edge in the marketplace. With exclusive rights to produce, market, and sell their protected varieties for 20 years, [8] breeders may be more incentivized to invest in research and development that may be increasingly possible with the proposed rescheduling.
Whether the USDA will accept applications for protection of high-THC marijuana varieties, even with the proposed rescheduling, remains a question. As of now, the USDA does not explicitly allow for protection of Schedule III substances, and PVPA protection has been historically limited to non-controlled substances. [9] The USDA’s stance on this matter may become clearer once the rescheduling process is completed and new regulations are put in place, but uncertainty remains even towards treatment of low-THC varieties. This uncertainty underscores the need for cannabis industry executives to stay informed about the evolving regulatory landscape and to carefully consider all available options for protecting their intellectual property.
As the cannabis industry continues to mature and legalization efforts gain momentum, [10] the importance of a comprehensive IP protection strategy cannot be overstated. In addition to the potential availability of PVPA protection for high-THC marijuana varieties, executives should also consider other forms of IP protection, such as utility patents, [11] plant patents, and trademarks. [12] Each of these tools offers unique advantages and can be leveraged to create a robust, multi-layered IP protection strategy.
Utility patents, for example, can provide broad protection for novel and non-obvious inventions related to cannabis, such as new methods of extraction, formulations, or delivery systems. Plant patents, on the other hand, can protect asexually reproduced plant varieties, such as those propagated through cuttings or tissue culture. [13] Trademarks can be used to protect brand names, logos, and other distinctive elements that help differentiate a company’s products in the marketplace—which may be increasingly valuable as rescheduling to Schedule III may allow.
As cannabis industry executives develop their IP protection strategies, it is essential to work closely with experienced legal counsel who can provide guidance on the most appropriate forms of protection for their specific needs. By staying informed about the changing regulatory landscape and proactively seeking IP protection, companies can position themselves for long-
term success in this rapidly evolving industry.
In short, the proposed rescheduling of marijuana and the potential availability of PVPA protection for high-THC cannabis varieties could present a significant opportunity for cannabis breeders and industry executives. By considering all available options for IP protection and developing a comprehensive strategy, companies can safeguard their investments, develop and
maintain a competitive edge, and capitalize on the growing demand for innovative cannabis products. As the industry continues to evolve, those who prioritize IP protection will be well-positioned to thrive in the years ahead.
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1 U.S. Dep’t of Justice, Justice Department Submits Proposed Regulation to Reschedule Marijuana (May 16, 2024), https://www.justice.gov/opa/pr/justice-department-submits-proposed-regulation-reschedule-marijuana; see 89 FR 44597 available at https://www.federalregister.gov/d/2024-11137 (receiving 43,564 comments at Regulations.gov by the July 22, 2024 deadline).
2 Establishment of a Domestic Hemp Production Program, 86 Fed. Reg. 5,596 (Jan. 19, 2021) (to be codified at 7 C.F.R. part 990), available at https://www.federalregister.gov/documents/2021/01/19/2021-00967/establishment-of-a-domestic-hemp-production-program.
3 H.R.2, 115th Cong. (2018) (later enacted).
4 USDA, Plant Variety Protection https://www.ams.usda.gov/services/plant-variety-protection (last visited July 16, 2024); USDA AMS, USDA Plant Variety Protection Office, YOUTUBE (Sept. 12, 2022) https://www.youtube.com/watch?v=H_iU5UKz6fE
5 DEA Diversion Control Div., Controlled Substances Schedules (April 2024), https://www.deadiversion.usdoj.gov/schedules/schedules.html. 6 89 FR 44597 available at https://www.federalregister.gov/d/2024-11137.
7 The 2018 Farm Bill was last extended through September 30, 2024.
https://www.fsa.usda.gov/programs-and-services/farm-bill/index.
8 USDA, Plant Variety Protection: Marketing New Plant Varieties by Protecting Plant Breeders’ Innovations (Mar. 15, 2021), https://www.ams.usda.gov/publications/content/plant-variety-protection-marketing-new-plant-varieties-protecting-plant.
9 USDA, PVPO Program Requirements https://www.ams.usda.gov/services/plant-variety-protection/pvpo-requirements (last visited July 16, 2024); Joseph Dylan Summer, Patenting Marijuana Strains: Baking up Patent Protection for Growers in the Legal Fog of This Budding Industry, 23 J. INTELL. PROP. L. 169 (2015).
10 Ted Van Green, Americans Overwhelmingly Say Marijuana Should Be Legal for Medical or
Recreational Use, PEW RES. CTR. (Nov. 22, 2022), https://www.pewresearch.org/short-reads/2022/11/22/americans-overwhelmingly-say-marijuana-should-be-legal-for-medical-or-recreational-use/.
11 USPTO, Patents, https://www.uspto.gov/ip-policy/patent-policy/patents (last visited July 16,
2024).
12 USPTO, Trademark Policy, https://www.uspto.gov/ip-policy/trademark-policy (last visited July
16, 2024).
13 USPTO, General Information About 35 U.S.C. 161 Plant Patents,
https://www.uspto.gov/patents/basics/apply/plant-patent (last visited July 16, 2024). traditional advertising for cannabis and cannabis products that is currently prohibited under 21U.S.C. § 843(C). 14
14 USPTO, What is a Trademark?, https://www.uspto.gov/trademarks/basics/what-trademark (last
visited July 16, 2024).
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Kassandra Officer is a partner at Finnegan, where she focuses on patent and trade secret litigation before U.S. district courts as well as on post-grant proceedings before the Patent Trial and Appeal Board of the U.S. Patent and Trademark Office. Her practice encompasses a range of technologies, with an emphasis on chemicals, pharmaceuticals, and agricultural technologies. [email protected]
Lauren Robinson is a partner at Finnegan and is experienced in intellectual property litigation and transactional matters in a variety of technologies, including the life sciences and chemical fields. In particular, she helps clients develop robust IP strategies involving pharmaceutical technologies, agricultural technologies, catalytic processes, and energy technologies. [email protected]
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