United States: IP Protections For Novel Cannabis Plant Varieties: Which Options Are Right For You?

For nearly a century, the United States has offered some form of intellectual property (IP) protection for novel plant varieties. Companies operating within the agriculture and horticulture space have had multiple options available to them for protecting novel plant varieties for several decades. The same is now true for companies operating within the cannabis industry, with some caveats.

Though federal illegality has created some limits on IP options for novel cannabis varieties, patent protection has always been an option in one form or another. The Agriculture Improvement Act of 2018, commonly referred to as the 2018 Farm Bill, made two key changes to federal cannabis and IP law that opened further options for cannabis breeders, as well. See Public Law 115-334, at Sects. 10113 and at Sect. 10108 (Dec. 20, 2018), available at. Thus, under current U.S. law, there are three primary options that cannabis breeders can use to secure protection for their novel varieties. Which options are available and useful depends on several factors.

Primary considerations when selecting IP protection for cannabis varieties

Though there are countless factors that should be considered when deciding which types of IP rights should be obtained to protect a new cannabis variety, there are two factors that are of primary concern: (1) whether the new cannabis variety is marijuana (i.e., high-THC) or hemp (i.e., low-THC), and (2) whether the new cannabis variety will be reproduced asexually/clonally or sexually/seed.

Marijuana vs. hemp

When selecting appropriate IP protection for a novel cannabis variety, one of the primary considerations is whether the variety is marijuana or hemp under current law. Cannabis plants predominantly produce two distinct cannabinoids: cannabidiol (CBD) and delta-9 tetrahydrocannabinol (THC). THC is the primary psychoactive compound found in cannabis plants, while CBD does not produce psychoactive effects. Under the 2018 Farm Bill, a variety that produces 0.3% THC or less is defined as "hemp," while a variety that produces )0.3% THC is "marijuana." See Public Law 115-334, at Sect. 10113 (Dec. 20, 2018). Moreover, the 2018 Farm Bill made hemp a legal plant in the U.S., while marijuana remains federally illegal. Whether a variety qualifies as federally legal "hemp" can impact the available IP options.

Asexual vs. sexual reproduction

Another primary consideration is whether the variety can be, and will be, reproduced sexually, meaning via seed, or asexually, meaning clonal reproduction via, e.g., cuttings or tissue culture. Certain cannabis varieties have been bred such that they can be reproduced in a true-to-type manner via seed. While both marijuana and hemp varieties can fall into this group, this is especially common for commercially produced hemp varieties. On the other hand, certain varieties are not able to be reproduced in a true-to-type manner via seed and therefore these varieties must be reproduced asexually. Depending on whether a variety can be successfully reproduced asexually, sexually, or both can impact the available IP options.

Three Primary Options for Protecting Novel Cannabis Varieties

The ongoing federal illegality of marijuana complicates the issue of certain IP protections for novel cannabis varieties. In general, there are three primary avenues available for protecting novel cannabis varieties: Plant Patents, Utility Patents, and Plant Variety Protection (PVP) Certificates. The answers to the above inquiries largely will guide, or even dictate, the selection of the most appropriate and useful IP rights for a particular novel cannabis variety.

Plant Patents

Plant Patent protection is available only to plant varieties that are reproduced asexually, not to seed-reproduced varieties. See 35 U.S.C. § 161. However, there is nothing in either the Plant Patent Act that limits the types of asexually reproduced plants that can be protected using Plant Patents or that excludes plants that have illicit purposes from the protections of the Plant Patent Act. As such, cannabis plants, whether hemp or marijuana, can be (and have been) protected using Plant Patents, so long as the variety can be reproduced asexually. On the other hand, if it is a cannabis variety that cannot or will not be reproduced asexually, then Plant Patent protection is likely not appropriate.

One advantage that Plant Patent protection holds over the other options is that there is no requirement to make a deposit of biological material. As discussed below for Utility Patents, a biological deposit requirement can present a hurdle to marijuana breeders because of difficulties in finding an approved laboratory willing to accept a deposit of material that is federally illegal. So the lack of this requirement for Plant Patents can be a real advantage to this form of protection, especially in regard to marijuana.

Utility Patents

Utility Patents can also be used to protect novel plant varieties, whether they are produced sexually or asexually. This is a clear distinction between the Plant and Utility Patent route for cannabis variety protection.

Moreover, as discussed above for Plant Patents, there is nothing in the law that precludes the granting of a patent for a plant variety that is federally illegal (see, e.g., 35 U.S.C. § 101), so Utility Patent protection can be (and has been) obtained for novel varieties of hemp and marijuana.

However, it should be noted that protection of novel marijuana varieties using a Utility Patent can be somewhat challenging because of the requirement of submitting a deposit of biological material sufficient to allow the variety to be reproduced. To satisfy the enablement requirement of U.S. Patent Law, an applicant of a patent application that claims a particular plant variety will often be required to make such a biological deposit. See, e.g., 35 U.S.C. § 112; Manual of Patent Examining Procedure (MPEP) §§ 2402, 2164.06(a)II. Given that hemp is now federally legal, this requirement is easily satisfied for hemp varieties. However, for marijuana varieties, approved repositories within the U.S. may refuse to take such deposits and attempting to export marijuana material to another country to utilize a depository outside the U.S. can run afoul of laws controlling such activities. Because of this, obtaining a Utility Patent for novel marijuana varieties is possible, but can pose some challenges.

PVP Certificates

In contrast to patents, which are issued by the U.S. Patent and Trademark Office, PVP certificates are issued by the Plant Variety Protection Office (PVPO) of the USDA pursuant to the Plant Variety Protection Act ("PVPA"). See 7 U.S.C., Ch. 57, §§ 2321-2583. Though PVP certificates were originally only available for sexually reproduced varieties, the 2018 Farm Bill included provisions that opened the PVP route for asexually reproduced varieties. See Public Law 115-334, at Sect. 10108.

Thus, in theory, PVP protection could be available for any type of cannabis plant, regardless of its manner of reproduction. However, in practice, this option is only available to hemp varieties, and not to marijuana varieties. In April of 2019, following the enactment of the 2018 Farm Bill, the USDA announced that it will begin accepting PVP applications for novel hemp varieties since hemp is now federally legal.. Though the USDA did not directly state that it will not be accepting applications for marijuana varieties, this was clearly implied and that is how the industry has generally viewed the USDA's position. This is bolstered by the fact that the USDA typically asks cannabis applicants to certify that the variety produces less 0.3% THC or less, thus qualifying it as federally legal hemp. So PVP protection is now available for asexually- and sexually reproduced hemp, but not marijuana.

Summary of Protection Options

As this all demonstrates, by analyzing just two key factors, one can start to determine which IP options are available, and which IP options may be most beneficial, for a particular novel cannabis variety. A summary chart of this initial analysis is presented below:

Two other points worth noting that are not addressed above relate to the use of trademarks and trade secrets. First, depending on how a novel cannabis variety will be utilized commercially, one should consider whether trade secret protection should be utilized instead of the other protections discussed herein. This may be appropriate, for example, for novel varieties that will be used as parental lines in producing F1 hybrid seed varieties.

Second, cannabis breeders should always consider whether trademark protection may also be appropriate and useful for a new variety that is developed (though trademarks for cannabis also come with their own set of caveats).

These are just a few of the further considerations that should be made when formulating an IP strategy around novel cannabis varieties. By making such a fulsome evaluation of the numerous factors involved in the decision-making process, cannabis breeders can formulate an IP strategy that maximizes the benefit they receive from their innovations.

Reprinted with permission from the January 25, 2022 issue of The Legal Intelligencer © 2022 ALM Media Properties, LLC. Further duplication without permission is prohibited. All rights reserved.

Read the article on law.com here: https://www.law.com/thelegalintelligencer/2022/01/25/ip-protections-for-novel-cannabis-plant-varieties-which-options-are-right-for-you/

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.