In the United States, the intellectual property rights system for plants is multifaceted, encompassing utility patents, plant patents, trademarks, and Plant Variety Protection (PVP) Certificates. These mechanisms offer different types of protection and are not mutually exclusive.
Utility patents protect both sexually and asexually propagated plants for 20 years from filing. Protection can cover genetically modified plants, algae, bacteria, and fungi, genes, proteins and products, a class of varieties with specific traits, and methods of making or using the plants. Naturally occurring plants, however, are ineligible for protection.
Plant patents protect a single plant for 20 years from filing and provide the owner with the right to exclude others from asexually reproducing the plant, and from using, offering for sale, selling or importing into the United States the plant, or any of its parts.
The Plant Variety Protection Office (PVPO) of the U.S. Department of Agriculture provides protection to breeders of new plant varieties through PVP Certificates. Anyone who is the breeder of a unique variety of a sexually reproduced, asexually reproduced, or tuber-propagated plant may apply for plant variety protection. Fungi, bacteria, and controlled species are ineligible for protection. To obtain a PVP certificate, the application must show that the varieties are new, distinct, uniform and stable. PVP Certificate owners have the right to exclude others from selling, marketing, reproducing, importing or exporting the protected variety for 20 years (25 years for trees and vines) from the date that the certificate issues. PVP certificates are recognized worldwide and facilitate filing for plant variety protection in other countries.
Current Landscape and Limitations for Marijuana Plant Varieties
Historically, intellectual property rights for marijuana plant varieties have been restricted essentially to utility and plant patents due to marijuana’s classification as a Schedule I controlled substance, which rendered it ineligible for PVP certificates and made registering trademarks on a federal level problematic (see accompanying article for more information about trademarks.)
The 2018 Farm Bill marked a pivotal shift in the intellectual property landscape for certain cannabis-related plants. Among other things, the Bill changed certain federal authorities relating to the production and marketing of hemp, defined as “the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.” [1] These changes include removing hemp from the Controlled Substance Act (CSA), which means that cannabis plants and derivatives that contain no more than 0.3 percent THC on a dry weight basis are no longer controlled substances under federal law.
Since that law was enacted, the PVP Office has issued 19 PVP Certificates of Protection for hemp varieties.[2] Those Certificates have, as expected, been limited to low-THC hemp varieties, in line with the Farm Bill’s requirements. Higher-THC plant varieties, however, have remained ineligible for PVP Certificate protection. A recent development could change that.
Recent Developments and Potential Implications for High-THC Marijuana Plant Varieties
The Department of Justice recently proposed rulemaking to reclassify marijuana from Schedule I to Schedule III of the CSA.[3] If enacted, this reclassification presents a potentially exciting opportunity for breeders and innovators in the cannabis industry because it could broaden the scope of intellectual property protections available for high-THC marijuana varieties to also include PVP Certificates.
Expanding these protections for higher-THC marijuana plants could drive industry growth by encouraging new plant breeding research and development, attracting investment, and opening new market opportunities.
Breeders often find it easier and more cost-effective to secure plant variety protection through a PVP Certificate than through plant or utility patents, as it is typically easier to meet the PVP Certificate qualification criteria—new, distinct, uniform, and stable—than the utility, novelty, and non-obviousness requirements for patents. Additionally, breeders do not need to demonstrate a specific level of human intervention to qualify for PVP Certificate protection.
The International Convention for the Protection of New Varieties of Plants (UPOV) sets an international standard for Plant Variety Protection. With 72 nations as UPOV members, this agreement streamlines international protection for new plant varieties through PVP Certificates. Globally, this is crucial because many countries do not have a legal framework for “plant” patents, though some countries permit patents for plants if they meet the legal criteria for patentability.
It is important, however, to understand the limitations associated with PVP Certificates. For example, individuals can propagate protected varieties for private, non-commercial use despite the existence of a PVP Certificate, and protected varieties may also be used for research, experimentation, and plant breeding to develop new varieties. Additionally, under the farmers’ privilege, farmers can save and replant seeds from their own land, on an acre-for-acre basis.
Future Outlook
As marijuana’s legal status continues to evolve, the intellectual property landscape for cannabis-related plants will evolve too. The proposed reclassification of marijuana to Schedule III likely will pave the way for new developments in plant variety protection, including PVP certificates, for high-THC plants, much like the Farm Bill did for low-THC hemp plants.
Understanding the availability of and interplay between the various intellectual property rights available for plants is essential for breeders, researchers, and industry stakeholders. As regulatory changes unfold, staying informed about the implications for plant protection will be crucial for navigating this dynamic field.
[1] H.R.2, 115th Cong. (2018) (later enacted).
[2] USDA, Agricultural Marketing Service Certificate Management System: https://apps.ams.usda.gov/CMS/CropSearch.aspx
[3] Schedules of Controlled Substances: Rescheduling of Marijuana (May 16, 2024), 89 FR 44597 available at https://www.federalregister.gov/documents/2024/05/21/2024-11137/schedules-of-controlled-substances-rescheduling-of-marijuana (receiving 43,564 comments at Regulations.gov by the July 22, 2024 deadline).
