October 7, 2024

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The Legal System

Patenting Cannabis Genes: Three Ways To Protect New Cultivars

Many cannabis companies spend significant resources developing new cannabis cultivars or refining popular strain genetics. As they do so, more and more are looking for strategies to protect those investments. Plant patents for purportedly novel cannabis plants are increasingly common, but are plant patents really the best way to protect cannabis genes?

In addition to traditional security measures, there are 3 types of intellectual property available that may be used to protect new cannabis strains: (1) plant patents, (2) utility patents, and (3) the Plant Variety Protection Act. Each option has its own set of benefits and comes with its own particular registration requirements.

Plant patents for cannabis genes

Plant patents are one potential option to protect a newly invented cannabis cultivar. Plant patents can protect new plant varietals that are capable of asexual reproduction.

Cannabis is typically a sexually reproducing plant: both male and female versions can contribute genetic material to offspring (but only female plants produce the cannabinoid-rich flowers in which most people are interested).

Cannabis plants, however, are also relatively easy to reproduce asexually via cloning or cutting. Newly created cannabis strains, whether created accidentally or by intentional crossbreeding, may be therefore eligible for a plant patent once they have been reproduced asexually.

Drafting and prosecuting plant patent applications is relatively superficial compared to other patent types, making plant patents cheap and efficient to obtain. But the trade-off, and the reason why plant patents are not very popular for cannabis or other hybridized crops, is that the scope of protection that plant patents afford is extremely limited. Plant patents only cover genetically identical copies, reproduced asexually from the claimed plant.

“In the case of a plant patent, the grant shall include the right to exclude others from asexually reproducing the plant, and from using, offering for sale, or selling the plant so reproduced, or any of its parts….”  35 U.S.C. § 163.

That means to infringe a plant patent, one must directly clone the patented plant– a narrow base for an infringement claim. A plant patent does not prevent someone in possession of an authorized plant from crossbreeding or otherwise sexually reproducing it. Practically, absent direct evidence of theft or breach of a patent license, it is incredibly difficult to prove infringement of a plant patent.

Utility patents for cannabis genes

Utility patents are the most popular flavor of patent and they are the favorite tool of major agricultural genetic companies. They are more expensive to obtain than plant patents, but can provide a far broader scope of protection.

Utility patents are used to protect methods, devices, and chemical compounds. Because utility patents can protect novel chemical compounds, the inventor of a new cannabis strain can claim a plant, seed, or other plant part with a particular genetic sequence (i.e., chemical structure).

One major advantage of utility patents over plant patents is that they can prohibit cross breeding and sexual reproduction. This means that a utility patent owner can, if they wish, prevent a customer from replanting seeds harvested from a licensed plant.

Utility patents require that the inventor describe the claimed invention in sufficient detail to enable a person of ordinary skill in the art to make and use it as claimed (for after the patent expires). Thanks to gene editing technologies such as CRISPR, it may be possible to satisfy that enablement requirement for some genetically modified cannabis strains by describing the gene editing process and reproducing the gene sequence base pairs. In other cases where the gene sequences are more complex or unknown, as is typically the case with cannabis, the inventor must deposit samples with the Patent Office from which others could reproduce the invention.

Plant Variety Protection Act

The last vehicle that can protect the IP of a new cannabis strain is the Plant Variety Protection Act of 1970 (“PVPA”). The PVPA provides similar protections to a plant patent but was designed specifically to protect any new, distinct, uniform, and stable sexually reproducing plants, such as cannabis. The 2018 Farm Bill further extended this protection to asexually reproducing plants.

The PVPA, however, contains a strict requirement that at least 3,000 seeds of the claimed plant species be deposited with the U.S. Department of Agriculture. The deposit requirement adds an additional wrinkle for cannabis breeders. All seed deposits must be made to the USDA depository in Fort Collins, CO. The USDA will not accept any deposits for plants that are classified as controlled substances, including cannabis.

However, in January 2022, the DEA issued an opinion stating that cannabis seeds that with less than 0.3 % delta-9-THC (i.e. pretty much all of them) are not controlled substances. This decision should open the PVPA protection to cannabis cultivar, but it is not yet clear wither the USDA will follow the DEA’s position and accept cannabis seed deposits.

Conclusion

Each type of genetic protection comes with its own set of benefits and challenges. In addition to physical security, trusted employees, and well-drafted contracts, the best strategy for protecting proprietary cannabis genes is a woven network of patent and pseudo-patent rights.