Back to the Future with Cannabis Patents

Yes you can patent cannabis related inventions! The United States Patent and Trademark Office (USPTO) granted the first one in 1942, but the majority of cannabis-related applications have been made in the last 25 years [1]. Patent law can be deeply complicated, perhaps more so for a product class that is simultaneously a Schedule 1, federally-controlled substance, and sanctioned by 36 states for medical or adult recreational use [2]. This article will explore the cannabis patent landscape and what it means for the future of cannabis.

Can you patent cannabis?

The first cannabis patent was issued to Roger Adams for the “Isolation of Cannabidiol” on December 8, 1942. Adams was head of the chemistry department at University of Illinois from 1926 – 1954 [3], and he had published an article on the structure of cannabidiol (CBD) in 1940 with co-authors, Madison Hunt and J.H. Clark [4]. His patent documentation described the methods the group used for the isolation of the cannabinoid from hemp, which is defined in the patent as “cannabis sativa or cannabis indica.” Adams began with a red viscous hemp extract known as red oil, and obtained an isolated pure crystalline compound of cannabidiol (CBD) [5].

What is patentable? 

When the U.S. government passed the Patent Statute of 1790, the first of its kind, it said a patent could be for “any useful art, manufacture, engine, machine, or device, or any improvement there on not before known or used [6].” Patent protection of this sort is a creation of the mind is intellectual property, and as such, is protectable. The Statute granted the inventor the “sole and exclusive right and liberty” of making, using and selling their invention [6].

Changes have been made to U.S. patent law over the years and U.S Code Title 35, Section 101 currently states, “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title [7].” Utility patents give the right to exclude others, for a limited time (usually 20 years) from profiting from a patented technology without the consent of the patent-holder. Specifically, it is the right to exclude others from: making, using, selling, offering for sale, importing, inducing others to infringe, applying for an FDA approval, the patented work [7].

According to legal experts, there are three main categories of cannabis patents that are generally seen in federal courts in the U.S., and these often overlap. First, cannabis compositions, drug formulations, and methods of preparation may be patented. Second, people may patent a characterization of how cannabis compounds engage with the human endocannabinoid receptors. And third, methods of treating diseases with cannabinoids may be patented [1].

Patenting plants

Patenting cannabis plants themselves has also attracted attention as an intellectual property opportunity. There are three avenues for patenting plants. The first is the Plant Patent Act of 1930. Before this, plants were largely beyond the reach of patent protection mainly because they were thought of as products of nature and hence unpatentable. The Plant Act declared asexually-reproduced plants (reproduced in a way other than from seeds) as eligible for patents [8]. Plant patents offer limited protection as infringement is difficult to prove. This may be why less than 1% of cannabis patents are plant patents [8].

A second method is through the Plant Variety Protection Act of 1970 (PVPA), also known as plant breeder’s rights, employed “to protect commercialization of new plant varieties and of cannabis plants developed by traditional breeding [9].” The PVPA has protection for sexually-reproduced plants similar to what a plant patent offers, for example, but the Act requires applicants to submit at least 3,000 seeds to a depository at Fort Collins, Colorado. This high bar is probably why there have been no cannabis plant patents under the PVPA, given that the plant is still on the Drug Enforcement Agency’s list of Schedule I controlled substances [8].

Products are generating revenue in the billions of dollars.

Thirdly, utility patents offer protection for both sexually and asexually reproduced cannabis plants, plus any formulations and other products made from the plant. Utility patents provide broader protection than the above methods but also come with challenges. A utility patent has a more rigorous written description requirement and must enable those skilled in the art to make and use the invention. This “enablement requirement” can be difficult to satisfy for plant parts, tissues, cells, and clones of cannabis varieties. In lieu of it, a patent applicant can deposit biological material like seeds at a depository that is recognized by the USPTO [8]. The number of required seeds is 2,500 though so it is still a high bar.

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Finally, for a plant to be eligible for a utility patent it must not simply be a product of nature. According to the USPTO, a patentable substance derived from a natural product must have “markedly different characteristics” from that found in nature [8]. For instance, a species of naturally-occurring cannabis may not be eligible for patenting, but a product consisting of cannabinoids isolated from it, mixed with preservatives, may be eligible [8]. Despite the challenges, almost all cannabis plant patents are utility patents [1].

Why patent an invention for a controlled substance?

While there is a trend to legalize cannabis on a state-by-state basis, marijuana and its derivatives are still illegal as a Schedule 1 controlled substance under federal jurisdiction. It might seem illogical that another federal agency would allow patents connected to the same plant. In fact, rules do vary by agency and to receive a trademark approval, a product must be shown to be lawful for use in interstate commerce [8]. Not the case for patents, and the US Patent Office is not deterred from issuing patents for cannabis innovations. According to the Cohen IP Law Group, “the only things that are not patentable are human beings and inventions that can only be used in association with atomic weapons [10].” A search of the USPTO Patent Database for abstracts containing the words “cannabis” or “marijuana” or “hemp” returns 23,579 results so it doesn’t seem like the USPTO is sweating the federally controlled status.

Meanwhile, advances in cannabis legalization and decriminalization on a state level have opened up massive markets for new cannabis products and the related intellectual properties. When the 2018 Farm Bill defined cannabis containing less than .3% Delta-9 THC per dry weight as hemp, another huge and adjacent market for cannabidiol (CBD) was created. The hemp derived opportunities continue to grow with Delta-8, Delta-10, and even Delta-9 THC cannabinoids becoming routinely available—regardless of state medical or adult use marijuana laws.

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Profit motive

These products are generating revenue in the billions of dollars so there is an obvious incentive to enter the market, create innovation, and protect that intellectual property. And there is space. Counterintuitively, the main generators of new patents have recently been small to mid-size companies [1].

Historically, larger players like big pharma and academia were pushing research. There were peaks in cannabis research (and patent applications) first in the 1970s when there was interest in hormone and neurotransmitter receptors in the mechanism of drug action. And again in the 1990s with the discovery that cannabinoid compounds interacted with the endocannabinoid receptors in human cells [1]. These research surges established much essential knowledge about cannabis so a cool-down in activity from the big entities was a natural occurrence.

Legalization and decriminalization on a state level have opened up massive markets.

Some smaller producers feel that creating a custom blend of cannabinoids and terpenes at particular ratios creates a “designer high” that warrants patenting of a product. Offering distinct and repeatable experiences will make cannabis use more mainstream they say, lessening consumers’ perceived risks [11]. Patenting plant genetics for a new plant strain that does not occur in nature has a similar allure. Going beyond a novel cannabinoid – terpene blend, growers can genetically edit the plant so that it produces more or less of specific compounds [11].

In either case, with proprietary blends or genetic editing technology, the patent gains the patent holder a limited monopoly on their invention, again generally for 20 years [11]. By mid-2021, 26 patents had been issued for cannabis plants. The first was granted in 2016 for Ecuadorian Sativa, but 22 of the 26 were granted just recently in 2020 and 2021 [12] so the pattern seems to be expanding.

Despite being a logical option for patenting cannabis, plant patents may actually offer limited protection in practice [8]. Forbes reported that the real reason for cannabis patents may be the market. This theory says that a patent’s value may be to gain status that will generate interest in a company and attract or retain investors [13]. Showing there is intellectual property to protect could then be valuable by itself.

Uncle Sam’s own cannabis patent?

No, it’s not for G13 or Obama Kush. It’s patent number 6,630,507 and it’s for “Cannabinoids as antioxidants and neuroprotectants [14].”  It was applied for in 1999 and granted in 2003. The applicants were three scientists from the National Institute of Mental Health (NIMH). This patent granted the government exclusive right to make, sell, license, etc. cannabidiol. It also comes with the right to license the patented technology, which it did exclusively to Kannalife Sciences Inc. in 2012, for research and option to create drugs for neurological diseases [15]. GW Pharmaceuticals gained license as well in 2017 and produces the sole cannabis derived drug that the FDA has approved for prescription by a licensed healthcare provider [16]. Even though patent number 6,630,507 expired in 2019, the FDA still has the exclusive right to approve or deny any cannabis drugs.

The cannabis-derived drug product is called Epidiolex, which contains a purified form of cannabidiol (CBD). It has been approved for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome. The FDA has concluded that this particular drug product is safe and effective for its intended use [16].

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Controversy

Is it right for the  government to receive royalty payments on sales of Epidiolex or other drugs based on the patented technology, or even to control access to the ability to research and create goods? How can cannabis derived and related drugs be approved by the FDA and in use by doctors and patients, and have “no currently accepted medical use?”

Some think that it smells of insider trading, especially since the DEA controls the federal legality of cannabis and has kept it classified as a Schedule 1 drug. With this classification in place, only those approved by the government can use and profit from it. This leaves room for big money for the insiders that don’t actually help individual citizens or patients.

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If cannabis receives federal approval, it will lessen the advantage for the likes of Kannalife and GW Pharmaceuticals, and open the industry for massive growth near future. [15]. It will level the field to allow for more participation, increased innovation, and a potential surge in patent applications. This will only occur if small cannabis brands and cannabis businesses are allowed to compete within the structures of expensive license holders that currently exist in “green” states.

Cannabis businesses that are just emerging may have a hard time affording expensive licenses, and larger pharmaceutical companies that have investments in cannabis patent applications are looking to take up cannabis ip as quickly as possible. Cannabis ip, or cannabis intellectual property, involves patent rights around cannabis products, giving patent owners a significant competitive advantage in fully legal markets. This competitive advantage give patent owners a significant head start in the emerging cannabis industry – both medical and adult use. As we see the cannabis industry continue to evolve through changes in federal law and state law, the patent and trademark office will be busy with applications from cannabis companies. While patent application is a controversial subject, federal legalization will hopefully help smaller businesses across the country have a shot at getting a piece of the cannabis industry.

What’s next?  

It remains to be seen whether or not anything significant will change on the federal cannabis landscape that will cause a rush of patents. Some think that changes are on the way. The DEA ordered around 7 times more cannabis for research in 2020 than in 2019 and has majorly increased its number of research personnel [16]. These could in fact indicate improvements are coming, or just mean that more publicly-funded information will be immediately siloed, available only to the privileged. Those who care about free access to information and cannabis should stay aware and vigilant to promote the truth.

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Medical Disclaimer / Legal Disclaimer – Information is provided for educational purposes. It does not and is not intended to constitute legal advice or medical advice. We attempt to be accurate and up-to-date, but the legality of cannabinoids and the science of cannabis are evolving. The author is neither a legal professional nor a medical expert. Before buying or using any products, you should check with your local authorities and medical providers.

References

1. Deconstructed US Cannabis Patent Landscape
2. Wikipedia: Legality of Cannabis by US Jurisdiction
3. Wikipedia: Roger Adams
4. Structure of Cannabidol
5. US Patent Office 1942
6. Wikipedia: United States Patent Law
7. Conditions of Patentability
8. Possible Pitfalls of Cannabis Patenting
9. Trends in Intellectual Patenting for Medical and Recreational Cannabis
10. Basics Marijuana Patent Law
11. Rolling Stone: future Weed Formulation Patents and Where Cannabis Is Going Next
12. Industry Snapshot Cannabis Plant Patents
13. Why Patent Cannabis? For Markets, Mostly
14. USPTO.gov
15. The Big Secret Surrounding Patent No. 6630507
16. FDA and Cannabis Research and Drug Approval Process

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