Meet the Experts is a series of interviews conducted by experts from the field of Cannabis to world leaders in research and clinical practice of Cannabis as medicine.
Dr. Dale Hunt is a plant scientist, a Cannabis lawyer and registered U.S. patent attorney with over 20 years of experience protecting plant varieties in the United States and throughout the world.
Dale is the founder of Plant & Planet Law Firm, an Intellectual Property Law practice, where he provides guidance and expertise on patents and IP matters, and aids clients in establishing IP protection for their legal marijuana cultivars, products and businesses. Before he began working in the legal Cannabis industry, Dale worked with other clients in Agriculture, Water Purification, Alternative Energies, Biotechnology, and Medicine, and he helped many of his clients commercialize their IP, products and plant varieties internationally.
Through Plant & Planet Law Firm he and his team continue to service these clients in addition to their Cannabis clients. Dale has degrees in botany (BS), plant genetics (MS) molecular & cellular biology (PhD), and law (JD). Dale has spoken on Cannabis-related topics at several gatherings including the Marijuana Business Convention, Emerald Cup, National Meeting of the Association of University Technology Managers, Meadowlands Leadership Summit, Perrin Conference on Emerging Legal Trends in the Cannabis Industry, and San Diego chapters of the MIT Enterprise Forum and the Licensing Executives Society.
He has also been interviewed for and quoted in numerous news articles and by national media outlets on the topic of marijuana and patenting. Dale maintains a blog for plant breeders and others interested in the plant law at www.plantlaw.com.
Dale Hunt: I was an undergrad bouncing around between majors. I took a botany class because it fit my schedule. And after the third session I was so fascinated I changed my major to botany, and I've never looked back.
After finishing my undergrad studies, I got a master's degree in plant genetics. I knew I wanted to keep going with science so I came to San Diego to do a PhD in molecular and cellular biology. But I knew after grad school that I didn't want to be a professor.
I looked at law school because I heard about a program, known as patent law, that used a heavy dose of science and law. I attended Berkeley and took all their IP (intellectual property) classes. I got a job with an IP law firm. Much to my delight, they had a client who was doing plant genetics. We protected and commercialized their IP all over the world.
About 18 years into my career as a lawyer, I was invited to get involved in the cannabis industry in order to give IP advice. By then I was well suited to do that. And getting into this industry has been the most fun I've ever had.
SR: Can you describe the Breeder's Best project and why it's currently important?
DH: One of the trends with legalization is that Big Business rushes in. And the true veterans of this industry get left behind. I kept seeing committed, passionate plant breeders who didn't have a good outlet for getting their life's work to the markets or to individual consumers. They aren't necessarily inclined or favorable to big business. In many cases, they didn't have the means to pay for their IP protection or legal advice. Even if you get protection, it doesn't guarantee money will come in.
Many cannabis breeders are phenomenally talented, and most of them are self taught. I realized we needed something that would let them focus on what they were good at without having to be business people. The closest analogy is that of a record company. If someone is a songwriter or singer, they can be great at one thing. The record company ensures their success and gets their art into the world.
Breeder's Best is fashioned after that model. The breeders don't have to focus their efforts on anything except what they love,. We identify valuable cultivars and do legal protection. Then we work with growers to assist them in getting products into the market.
The team we've assembled is well versed in this. I've got 20 years of experience protecting plant IP. Dr. Ethan Russo, our Medical Director, definitely knows how to identify a good chemotype. That's a crucial part of evaluating which cultivars we can work with. We also have members of our team who know how to interact with farmers, growers, extractors, and distributors. We've assembled a kind of expertise that completes the pathway from great plant genetics to people wanting to enjoy those products.
SR: Many people are apprehensive about patenting of any kind. What is your response to this in the cannabis space
DH: I think a lot of that comes from well documented abuses or power grabs within the patent system. This leads people to think that all patents are the same. The main kind of intellectual property for plants that we embrace at Breeder's Best and my law firm is a narrow form of protection focused on one genetic cultivar. A patent on a cultivar is more like a copyright. Copyrights are harder to abuse because there is a very direct correlation between what someone created and the scope of their rights.
In the US a plant patent is very close to a copyright. The only way you infringe it is to make an actual copy. It's a narrow type of patent and isn't prone to misuse. It protects the breeder against third party abuses. Plants are easily copied by nature. Someone could grow thousands of acres of it if they wanted to. If there isn't any recourse against that, it can interfere with doing business. That's one end of the spectrum.
On the other side, there are some patents that try to cover an entire chemotype (chemical profile). That makes it so that any plant that has a certain ratio of CBD to THC, or terpenes, is going to infringe this patent regardless of the underlying genetics. But someone cannot get a patent to make cultivators stop growing what they have been for decades. It might look like they can, but that wouldn't be a valid patent. I don't blame anyone for not liking those types of patents.
SR: Is there a difference in patenting seed vs. clones?
DH: In most of the world it is the same system for seeds and clones. These "plant breeders rights" are administered under an international convention. If you have seeds, it has to be a stable seed line. This is challenging with cannabis because people have to do a lot of backcrossing and other selections to stabilize the seeds.
For something to be protected, it has to be distinct and uniform across one generation and stable across multiple generations. If a seed line is stable and you have plant breeders rights, people can still purchase those seeds, plant them, and reap the harvest. You can also replant the seeds from that harvest. But it is an infringement to replicate the seeds and compete with the owner of the rights.
The United States is the only country in the world that has a separate plant patent statute that grants plant patents in an actual patent office. The US also has a system that is directly analogous to the plant breeders rights in the rest of the world, which is administered by the USDA (United States Department of Agriculture). That was only for seed propagation until December 2018. Once the Farm Bill passed, it authorized the USDA to accept applications for seed plants and clones. So now the system is very much like the rest of the world, but then there is also a way of protecting through the patent office.
In some cases, people might choose to have three types of protection. They could get a plant patent to cover their clone propagation, plant breeder's rights to cover it through a different agency, and also get a utility patent. A utility patent treats their plant variety as an invention and lets them control its use by others in a breeding program. The only way to have rights of exclusion for breeding is through a utility patent.
SR: How does your work positively influence the independent breeder community?
DH: When we agree to work with a breeder, we create the IP protection through my law firm. But the IP protection belongs to the breeder, not us. Breeder's Best is the licensee of those rights. We give the breeder a royalty on the income from their cultivar. This directly benefits breeders because it creates an income stream that might otherwise be difficult to access.
The other less direct benefit is the opportunity for the breeder community to not get squashed by Big Ag. They have an outlet that hopefully provides a sense of optimism. It lets them be very independent. We're also involved in the organic and regenerative cannabis movement to benefit small farmers. Our vision is an alternative to conventional Big Business models.
SR: It is a common fear that Monsanto and other big interest companies will patent cannabis. Is that inevitable or is there hope?
DH: I get this question many times. The short answer is that you're not going to be sued successfully for patent infringement for growing your own plants. So that's the good news. The bad news is that these Big Ag companies are excellent at finding efficient ways to grow commodities. If you are a commodity farmer, you are competing with very powerful high tech ways of producing on a large scale. And they sell their high tech seeds to all of your competitors. Your competitor can grow a crop at a sale price that's less than your cost of production. That's how Monsanto and others have driven commodity farmers to play by their rules and adopt their technologies.
Farmers can differentiate themselves from a commodity market by growing something organically or having an appellation of origin. They can create a special product that will never be interchangeable with the mass produced, low cost stuff from Big Ag. We can also avoid getting squashed by Big Ag by staying out of commodity markets. The certified regenerative agriculture farmers are differentiating themselves from massive industrial farming. The regenerative agricultural piece is extremely important.
As the cannabis market grows worldwide, it's going to be a mass production crop. When extracting API (active pharmaceutical ingredients) like CBD and THC for wide consumption, it is a commodity. But another part of the market will be craft cannabis for unique medicines. There's no way to keep Big Ag out of commodity cannabis. But there will definitely be a craft market too.
The other fear that people have in the cannabis space is that broad patents cover things that they really shouldn't cover. But just because someone has a patent doesn't mean it's valid. There is a fight involved, but it is definitely possible to make that defense.
When you apply for a patent, the patent examiner looks at whatever has been published to see if what you are claiming is new. In the US, if they find a publication, such as a prior patent or an academic paper, that predates your application by more than a year, then they can reject you for lacking novelty. The problem in the cannabis industry is that much of what happened commercially wasn't ever published or was intentionally hidden. So there's cloudy validity over any broad patent in the cannabis space because the examiners don't have the tools to fully examine such a claim. We stand up to Big Ag by bringing our own evidence as a cohesive community to the defense of anyone who gets sued.
SR: What are some ways that folks in the cannabis industry can best protect their intellectual property?
DH: If someone doesn't have the money or doesn't want to file for formal IP protection, they can be cautious about access to their genetic material. Anytime they grant access, they need to make a written agreement that governs what the other party can do with it. That way, there is some recourse to not lose all the value.
One of the beautiful things about this community is the ethic about sharing and not reducing cannabis down to legalities. But in this era it's essential to be realistic about the problems around that. Even if you don't want formal IP protection, you've got to be careful.
If a cultivator wants more, they can look at IP protection. Navigating the system requires a level of experience to understand the complexities. That's why it's important to do it with someone knowledgeable because it's an esoteric field.
SR: What special cannabis chemovars is your team especially interested in?
DH: We are interested in a few categories. Dr. Ethan Russo has a wish list about what he thinks would make great medicines. We are watching our breeder submissions to see if any of them align with that. Another is that there are certain APIs that have a lot of value. THC and CBD are well known as the major cannabinoids. The plant makes at least another 150 other cannabinoids. Each one has the potential to be as useful, or more, than THC and CBD.
We're on the lookout for anything with a high concentration of minor cannabinoids, such as CBG, CBN, CBC, THCV, CBDV, and others. These are already known, and have early indications of great medical or recreational benefits. Because they haven't been mass produced like CBD and THC, they still have a lot of value.
Another is anything with an unusual ratio of minor cannabinoids and terpenes because there's often a significant interaction. That's not only in terms of the aromas and appeal, but also what's happening inside the body. We're looking for unusual terpene profiles that seem to be notable for pain relief, inflammation, mood stabilization, depression, and more.
The last is harder to judge, but we are interested in any cultivar that would be especially appealing to people. Either it has a great psychoactive signature or some medical effects beyond what certificate of analysis says. We have a team to help us evaluate submissions apart from the lab analysis.
SR: What parts of the plant can be patented? What about specific formulations- how far can someone go to claim ownership?
DH: You can't patent a product of nature. But you can patent something that was altered by the hand of human activity. A utility patent on a cannabis cultivar can claim the flowers, other parts of the plant, its extracts, and breeding with it. We are protecting the whole plant because it all stems from an original genetic selection.
But if you find a cannabis flower that is an unusual color, you'd first have to show that it had never occurred in nature before. It wouldn't be enough to find one plant that makes a bright blue flower. If you want to patent the bright blue flower, first you'd have to describe how to replicate it with different genetic backgrounds. If it happens only once, then you should patent that particular cultivar.
No one is ever going to be able to patent CBD, even though people think that has been done. With Epidiolex, the particular use of CBD in specific dosage ranges and purity levels to achieve a certain medical effect is what has been patented. Let's suppose we find a new cannabinoid that no one has patented before. We can't patent that cannabinoid. It's a product of nature. We might be able to patent how to purify it if that process was a breakthrough. Or if someone finds that a combination of cannabinoids in a specific ratio with other ingredients gets an amazing effect, then that could be patented.