The Delicate Web of the Pot-tent Gap — An Overview of the First Hemp Plant Patent

In the patent world, it is common knowledge that products of nature are not eligible for patent protection. Yet, patents for natural things do exist. In an ever-changing field to protect ingenuity and “inventor-ship,” the rules have changed. Combined with the questionable legality of cannabis, it was laughable for any cannabis-related plant matter to be considered for patent protection… until now. Using a combination of the 2018 Farm Bill and a judicious breeding process, the Stanley brothers of CWB Holdings, Inc., have secured the first hemp plant patent in the United States.

 

Patent Basics for Plants

Natural vs. ingenious has always been a debate in the patent community, especially in the microbial world known for its rapid reproduction and ease of genomic modification. One of the most notable decisions in the past ten years is the Myriad matter where isolated segments of DNA were determined to be outside the scope of a product of nature.[1] However, the applicability to plant matter has always been more linear as there are specific characteristics and guidelines to obtain a plant patent.

Generally speaking, the U.S. Plant Patent Act of 1930 established protective rights for asexually propagated plants. The most common example given in this category is plants derived from cutting pieces of the stem and re-planting to populate — think apple trees, figs, and rose bushes. Some of the most common methods considered are: root cuttings, grafting, budding, bulbs, slips, rhizomes, runners, layering, tissue culture, and division. However, despite these options there is a limitation placed on wild-occurring (feral) plants and tuber-plants — potatoes, yams, peanuts. The former qualifies as a strict product of nature, while the latter qualifies as a food, and is exempt.

Asexual reproduction in this case is key since absent a mutation, it would assure an exact genetic copy of the plant reproduced, further protecting a specific strain or genetic subset. Any known method of asexual reproduction which produces a true genetic copy of the original subject can be used.

While plant patents are certainly unique, it is also possible to apply for a utility patent, which would cover the creation of a new or improved (and useful) product, process, or machine. This type of patent is most common with genetically modified organisms. While a utility patent offers broader protection, a plant patent only covers the specific varietal denomination of the plant and its genetic clones.

What is Charlotte’s Web?

The more appropriate question is, “Who is Charlotte Figi?” Charlotte Figi is a child who was born with Dravet’s Syndrome, a rare condition associated with mutation of the SCN1A gene —a family of genes that provides instructions for making sodium channels, which play a key role in a cell’s ability to generate and transmit electronic signals.[2] Dravet’s Syndrome is particularly challenging because it is a severe form of intractable epilepsy and is unable to be controlled by medication. At around three months, Charlotte began to have seizures, which progressed as she grew older to the point where she was having up to 300 grand-mal seizures a week. Charlotte’s physicians attempted a myriad of medicines and combinations, and attempted to change her diet and lifestyle to alleviate her epileptic symptoms, all with minimal results. To truly appreciate the severity of her illness, consider that Charlotte’s cognitive development slowed by the age of two and her heart had stopped a number of times before the age of five due to the stress and strain on her body.

After exhausting other options, the Figi parents turned to a treatment of cannabis oil, seeking out solutions with low THC content. After finding positive results, the Figis reached out to the Stanley brothers, who at the time were medical marijuana growers and dispensers in Colorado. The Stanley brothers created a hybrid strain of cannabis that featured an industrial strain of hemp and a low THC strain to create what was originally known as the “Hippie’s Disappointment.” When applied orally, this particular strain helped Charlotte reduce the number of seizures she was having drastically. Soon, “Hippie’s Disappointment” became “Charlotte’s Web.”

 

The Patent

Fast forward to July 2, 2019, Joel Stanley of CWB Holdings, Inc., located in Larkspur, Colorado, filed for, and received, a United States Plant Patent—U.S. Patent No. US PP30,639 P2. Specifically, the plant patent represents that it is a:

…new and distinct hemp cultivar designated as CW2A. Whole plant hemp extracts from CW2A contain an assortment of phytocannabinoids (e.g. CBD), terpenes, flavonoids and other minor but valuable hemp compounds that work synergistically to heighten effects of products produced from ‘CW2A’. This synergistic effect is sometimes referred to as the “entourage effect”. ‘CW2A’ extracts can be used to produce a variety of products, including liquid and capsule forms for oral administration, topical products, cosmetic products, infused beverages, sport products and hemp-infused pet treats. … The primary goal of the breeding program [for CW2A] was to develop a new hemp variety with high cannabidiolic acid (CBDA) concentrations and low tetrahydrocannabinolic acid (THCA) concentrations in its mature female flowers.[3]

Most notable though, the patent indicates that the total THC and CBD content at harvest maturity are 0.13 percent to 0.27 percent and 4.50 percent to 6.24 percent respectively. This firmly places CW2A under the ambit of the 2018 Farm Bill.

While the generation of this patent is surely impressive on its own, it is most significant because it provides a model for future development and patent of cannabis products. Specifically, the interaction of cannabinoids, terpenes, and flavonoids described as the entourage effect by the ‘639 Patent, alleged to be medically beneficial in different combinations and concentrations, now has a path to patent.

Under the limited scope of the 2018 Farm Bill, only hemp-designated plants could qualify for patent protection, which will exclude protection for plants that may benefit from potential THC synergy. However, with some ingenious breeding, this could open the door for the creation and protection of cannabinoids as a whole. The permissive protection of different strains without the THC components will potentially spark growers and researchers to further explore such applications.

 


 

 

[1] See Molecular Pathology v. Myriad Genetics Inc., 133 S. Ct. 2107 (2013).

[2] https://ghr.nlm.nih.gov/gene/SCN1A

[3] See US Patent No. US PP30,639 P2 at page 1-2.

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