Reggie Gaudino: Patenting Strains & the Future of Cannabis Intellectual Property

Reggie Gaudino is Vice President of Scientific Operations and the Director of Intellectual Property at Steep Hill, a national leader in cannabis science and technology.

Reggie recently joined our host Shango Los for a conversation about the genetic patenting of specific cannabis strains, the future of cannabis breeding, and how the involvement of big agriculture is going to shift the landscape of the entire marijuana industry.

Listen to the podcast below, or scroll down for the full transcript!

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Shango Los: Hi there and welcome to the Gangapreneur.com podcast, I’m your host Shango Los. The Gangapreneur.com podcast gives us an opportunity to speak directly to entrepreneurs, cannabis growers, product developers and cannabis medicine researchers, all focused on making the most of cannabis normalization. As your host I do my best to bring you original cannabis industry ideas that will ignite your own entrepreneurial spark and give you actionable information to improve your business strategy and improve your health and the health of cannabis patients everywhere.

Today my guest is Dr. Reggie Gaudino, Vice President for Scientific Operations and Director of Intellectual Property at Steep Hill. Reggie is building their genetic analysis division and is also working with his teams to further the science behind cannabis testing. Dr. Gaudino is a published genetic researcher with 18 years of intellectual property experience in writing, prosecuting, and managing patents and patent portfolios in fields as diverse as software and telecom to biotechnology and molecular genetics. Welcome Reggie, glad you could join us.

Reggie Gaudino: Thank you, glad to be here.

Shango Los: So Reggie, let’s start with the burning question that’s on everybody’s mind as I speak to them as far as cannabis and intellectual property goes. People all over the country have got their favorite strains that they have developed themselves and they want to patent them, they want to own them forever, they want to license them to other people. I’ve seen it in so many different business plans whether or not it seems to be reasonable science-wise. What are you seeing as this is evolving as your … Seeing the new technologies that can track the cannabis genetics. Is this something that is on the horizon for these entrepreneurs or is it just something they’re going to be hoping for?

Reggie Gaudino: No, not only is it on the horizon, but it’s actually a lot closer than most people think. This is actually a really intense area of focus for not only myself but the program that I’m building here at Steep Hill. I’ve been trying to get the message across for the last couple of years that the industry is changing. At some point, big agriculture, Monsanto, Dow Agrosciences, the pharmaceutical industry, they’re all going to jump on the bandwagon once everything goes from schedule I to schedule II. That’s a reality, it’s not when is it going to happen or maybe it will happen. It’s going to happen and it’s going to come pretty soon. There’s a lot of movement in the government right now. A savvy observer of the industry will see that the movement is gaining momentum and is moving towards that direction. Why is that important?

That’s important because every strain that is publicly available for sale right now basically becomes open source. Patent law states that you can’t apply for a patent of any kind anything that’s been being sold for a year or more. The message that Steep Hill is trying to get out is, you know, if you’re a breeder, the best thing that you can be doing right now is breeding your butt off. Finding those nuances, going after those new unique strains, trying to develop better phenotypes, so that you can have some relevance, you know, a few years down the line. There’s not a single grower who seriously has the power to compete with the likes of the Monsanto or Dow Agrosciences.

The only thing left then is to put your stake in the ground and to really protect your strains so that when everything that’s on the shelves now becomes open source, you have something better to offer the community. That’s exactly the message we’re trying to do. How do we go about doing that?

That can be done in a number of ways. Here, at Steep Hill, we try to not only have the best science and the best testing, but we’re actually trying to build something right now, a breeder services program, that will allow us to help breeders not only do those things like find the better traits, breed the better strains, but also have a concerted package of tools they can use, that they can do those things better and faster and hopefully that will help them put that stick in the sand and allow them to really get to the point where they have IP. They have something to license. They have something that they can build a bigger business around. That’s exactly the message that we’re trying to give and we really believe that that is the way the industry will change and it will change soon.

Shango Los: Reggie, there are so many bombs in that answer that you just dropped it’s amazing. You dropped that, get ready because big-Ag is really coming, get ready because licensing your strains is coming, and also you better hurry up and get your breeding stuff out on the market so you can actually own it. You just probably got a lot of people shaking in their boots just right there.

Reggie Gaudino: I was hoping not to be doom-and-gloom. You know there are certain realities. Right now, because it’s counted as schedule I, you have a lot of people in a sense looking in. They’re looking in, waiting for that opportunity. Right? I think you see the success that some people that have really taken that cutting-edge approach have. Granted it’s outside the United States. You look at GW Pharmaceuticals, well GW Pharmaceuticals is doing some great stuff. The fact that they went that route, you know that other pharmaceutical companies are chomping at the bit, but the bigger pharmaceutical companies, those with the most to lose, don’t want to get there too soon and/or be the test case for someone saying, “Eh, you know this is not right yet.”

We know that it’s coming in the industry and because of that it would be better to have a good plan in place then to be caught with your pants down. That’s the reality. While doom-and-gloom, nobody wants to hear that negative message, I mean, these are realities. These are realities. The realities are because of the way the cannabis industry is actually coming in to mainstream business. It’s not like we’re going to come in to mainstream business and suddenly things are going to change for us. The patent law is the patent law. Because of the way patents work and I know that in my bio lead-up you said intellectual property. Well, from an intellectual property stand point, everything that has been done in the cannabis industry through the altruism and the kind of camaraderie that has typically been associated with the industry, when you get to big business, that goes away. It’s unfortunate, but the industry is going to change. It has to change.

One of the things that we have to make do, we have to look more like a pharmaceutical industry, we have to make it look more like some of these other industries if we want people to take it seriously and use this wonderful plant for medicine. That’s what we’re about. That’s why we did the testing. That’s why we want to ensure the safety of the product. To the point where we actually, we as Ynsight, Ynsight is our arm for genetic research, what we would like to be able to do is help, actually, doctors embrace the product better because we can give them a more systematic naming convention that is tied to chemical profiles, that is tied to genetics. These things are all very important for the industry to make the industry advance as a powerhouse unto itself and not because it was absorbed by big Ag or big farming.

To do that, we as an industry have to start looking at the other industries that we will touch and we have to play by those rules. The rule in patent law is, if you have been selling something for a year or more, commercially, or if it has been offered for sale, then it cannot be patented. That means everything on the shelves in a dispensary right now, Monsanto and Dow Agrosciences and all those other big Ag companies, can come in, buy clones, but not pay a penny to the original breeder, and grow them and outsell you because they will be able to do it faster, better, and at a lower price point. If all those things go away, what’s left for the people that have worked so hard for this industry?

That’s the message. If you make new breeds, and you don’t sell those breeds before you apply for a plant patent and assuming that you can get that plant patent because you have a unique strain, which has unique characteristics. There are a number of plant patents that are in the plant patent queue that the government is kind of dragging their feet on them. But they’re there, you can go and you can look at all the plant patent applications, there’s dozens if not hundreds of plant patent applications already out there. That is where breeders have to go to be able to maintain being relevant, to maintain not only their revenue stream, but the rights to what they want to do or who they want to give their product to.

Shango Los: Wow, that’s some shiver-me-timbers kind of talk right there. I’m sure that a lot of people’s minds have just been blown. You know, I want to talk a bit more about how breeders can defend their plant lines, but we need to take a quick break first. We’re going to take a short break and be right back, you are listening to the Gangapreneur.com podcast.

Shango Los: Our guest this week is Reggie Gaudino of Steep Hill. Before the break we were talking about how big Agribusiness is going to be moving in and sweep up the strains that are presently on the market. Some pretty scary stuff for heritage growers. Reggie, what can heritage growers do to defend themselves? You were pretty clear that strains that are presently on the market for more than a year are not patent-able and therefore indefensible from big Ag. But at the same time, a lot of the strains that are presently on the market have not have the genetic testing done on them yet, and so really, what is and what is not a strain is kind of hard to probably argue in court. If a strain has been on the market locally, but has never had it’s genes identified and so it’s just kind of an anonymous source, and heritage growers who are developing things right now, what can they do to either protect the strains that they already have out there? Maybe the answer is nothing. Then, when should they wait to put out the strains in the future that they want to be able to cash in on?

Reggie Gaudino: Those are both great questions. The best thing that they can be doing right now is developing strains and getting to stable phenotypes. That can be done a number of ways. That’s a whole other section that we can possibly, if you would like, have another podcast on, but the reality is, you want to be looking at phenotypes that you have been breeding for awhile that you’re in to your F8, your F9, your F10, right? It’s about at that level of back-crossing and end-crossing that you’ll start to see stability in the cannabis genome. Stability in terms of breeding is based on a genome size. Cannabis genome is about three times smaller than the human genome so it’s actually a fairly large genome. It actually takes closer to 10-12 generations to ensure that you’re really at stable phenotypes. Why do I bring that up?

Plant patents require that you are at a stable phenotype and, depending on the type of patent applied for, that it’s an asexually propagated plant (cuttings), or it’s actually something that comes from/produces seed. In the plant patent statutes, which is what I’ve been kind of trying to cull the information and develop a check-list for growers and breeders. We have that … If it’s not already up on the website it will be on the Steep Hill website pretty soon. You know, the important thing there is that there are regular plant patent features that have to be met. You have to know times to flower, inter-node length, flower colors, there’s just a bunch of stuff that has been accumulated over the years that are required for a plant patent. One of those things is a genetic component.

The genetic component is what really, I think, is the most important thing in the cannabis industry because there are so many different strains as you mentioned, and there’s probably a lot of strain similarities. How do you ensure that the stuff you’re breeding now can be distinguished from the stuff that’s already out there? Then what can you do with your stuff that’s already out there? That’s the second part of the question. Girl Scout Cookies are phenomenally popular, right? It’s going to be a shame when these guys (Big Ag) come in and take Girl Scout Cookies and grow it out the wazoo. What I would recommend is if you have stuff on the market, take that stuff, bring it to somebody who does genetic analysis, there are not a lot of companies out there that can do it right now, and spend the money if your product is a big bread winner for your business, spend the money and get some genetic analysis done.

The analysis is going to be anything from Deep Sequencing, which is fairly expensive, to more like qualitative trait analysis. Those terms are on different sides of the spectrum in terms of the involvement of genetic analysis. We at Steep Hill, have been building tools that we are trying to put out on the market for the breeders so they can follow these things. We’re working on molecular diagnostics for various traits, we’re working on methods to be able to identify similarities between strains or differences between strains. A lot of this stuff is actually fairly high-tech. We have a lot of really cutting-edge molecular biology equipment in our lab that allows us to do a lot of this research. What this allows us and possibly some other more advanced labs to do is to actually give you kind of a genetic profile that you can kind of layer on top of a chemical profile, right?

Chemical testing is important because that gives you the terpene profiles, it gives you the cannabinoid profiles, right? Here’s the kicker, sometimes profiles are not the be all and end all. The reason for that is that you can get similar profiles from crosses that give you convergent phenotypes. Let’s say you take two different strains, the F1 of strains that have been crossed are very rarely the real final phenotype that you get at F10, right? As you breed an F1 and interbreed an F1, you’ll get a lot of pheno’s out and then those pheno’s will sometimes look like other strains. It’s a transient kind of thing. If you were to continue to breed that particular strain, you would possibly lose the thing that made it look like something else. That’s why, getting back to stable phenotypes. You want something that’s going to breed true (or at least stably) and you want to be able to follow those traits.

People who have been breeding for a long time are actually their own best laboratory. The reason I say that is if you’ve got strains that you’ve been looking at for 8-10 generations you’ve been inter-breeding yourself, you already have what we call in genetics, a mapping population. At that point, you can find any trait that you’re interested in and you can measure it. In one or two experiments, a good genetic analysis team can take the parents and the offspring and tell you what gene is responsible for that trait. The reason for that is because the background between the parents and the offspring at F8 if not F10 are so similar that when you find one difference, it’s fairly easy to locate in the DNA. Based on that power, we have the ability to start helping breeders identify the genes and the DNA sequences that are responsible for those traits that they find unique. That is why not doom-and-gloom, right? They’ve been doing it so long. They’re already so good at what they do that they’ve already created the tools that they need to be able to help them move forward and they don’t even realize it.

Shango Los: Reggie, getting it to be stable, you know, F8, F9, F10, so that you would be able to get a patent, for heritage growers, that can take a long time. One of the things I dig when I learned about GenKit from Steep Hill, was that it’s ability to let growers sex the plants way earlier in the process while they’re still in veg instead of the traditional looking at it with a magnifying glass to figure out the sex as it’s starting to head towards bloom. Tell us a little about the GenKit and how it’s being adopted by growers.

Reggie Gaudino: I’m glad you asked. We built GenKit as a vehicle for this service. I’m not sure how it got out there, but GenKit for whatever reason people thing that means gender kit, right, but it’s actually not, it’s genetics kid. What it allows us to do is with the same work flow, test for a whole bunch of different things. The first product we put out on the market was the male-not-male discriminator. The whole idea was to have this be a piece of a bigger plan. That bigger plan is to allow breeders to get to stable phenotype much faster. The sex-test is actually the first part, but now as we develop these new traits and we actually keep an eye out on our website because in probably less than a month, two months max, we have two or three trait markers that we’re adding to GenKit that we’re going to announce.

What that allows us to do is, you know, as soon as you crack a seed, at the second true leaf, you send us a little piece of leaf in and we can test, you know, we can tell you, male, not male, I say not male for a reason and we can talk about that in a little while, and we can tell you what some of the other traits might be. The reason that’s important is because then if you combine that with some early leaf-testing services, so you have a genetic profile now, and then you run an early chemical test to see, of the seeds you’ve cracked, which are the males, which are not males, if you’re interested in males do you want to keep some of these males because they have the highest CBD-THC ratio, or what the genetics tells you. Then what that allows you to do is once you figure out what are the best in that, say, 50-100 seeds you’ve cracked, you throw away everything that’s not going to give you what you want, reducing your resource load, and then you force flower between like 4-6 weeks. You don’t have to grow to full maturity.

If you can do that, you don’t need a lot of seeds, you just need a couple hundred seeds. You don’t need a full plant worth of seeds, right? You force flower early, you do the breeding with a male pollen you want, you get some seeds, you crack those seeds, you keep doing it. Now if you look at it, you’re mating, seeding, you know, at the 6, maybe latest, 8 week mark. 52 weeks divided by 6 weeks is 8 with a few weeks left over, that means you’re at 8 generations per season now, using these tools. If you’re an indoor grower, that’s great. Obviously, that doesn’t always translate for an outdoor grower, but if you combine your process where you do some indoor and some outdoor, then you’re at 8 generations in one year.

Shango Los: I can totally see how the GenKit is going to excite so many breeders who want to be able to get to that stable F8 and F9 really fast. Also our time is going really fast, so we’re going to have to take another short break now, Reggie, hold on just a second. You are listening to the Gangapreneur.com podcast.

Shango Los: Welcome back, you are listening to the Gangapreneur.com podcast. I am your host Shango Los and our guest this week is Reggie Gaudino of Steep Hill. Reggie, we’ve been talking a lot today about protecting your phenos and getting them to stable at F8 and F9 for an eventual patent. The other thing that we talk a lot about on this show is the reliability of analytics labs and we’ve talked to a couple pros that have said, “You know, it’s one thing to want labs to give you the same answers.” Because we know that growers are shopping around for labs to give them the results that they want and sometimes it’s also the way that they’ve chosen their sample, but the one thing we keep coming back to on the show is this common opinion by professionals that it’s the standards themselves that are used in the HPLC machines that have not been developed enough because they haven’t been developed long enough for cannabis specifically and therefore since the standards themselves, they’re quick to degrade and folks may not be buying the same standard from different companies, that just at it’s very basis, it’s going to be impossible to have consistent testing. With your deep background on this, what are your thoughts?

Reggie Gaudino: We’ve been experiencing that same thing here. We work really hard to ensure that we have good calibration on all of our machines. The way we do that is by, we order our standards from multiple sources. We have seen that on any given batch of material that we get from the standard vendors, that on some day some will have great standards and those same companies on other days will have not so good standards. What we do to minimize that is whenever we want our calibrations, we measure them on standards that we source from multiple places. It’s expensive because the standards are not cheap. That’s the kind of lab that customers should be looking for. They should not be afraid to say, “Hey, can I see your calibration curves? Can I see how often you run your standards? How often to do you run your blanks?” That kind of stuff. Because that’s how we ensure that we are doing the best job and giving the best quality results to the clients, right?

The other thing that is very, very important and we take pride on is joining those Emerald Cup Competitions, because now, you have a third party that is now certifying your level of accuracy because they send out complete unknowns, you have to send the test results back to them, they do the analysis. Labs that are not competing in those, everybody should take a second look at those and say, “Hey, why are you not competing in a national standards competition?” It’s there for us to be able to say, “Hey, you know what? We meet at least a minimal level of certification that means that we’re doing the job the right way.” Clients should be adamant that the labs that they test with compete and meet at least those minimal certifications standards. It’s very important that they the labs have that level of certification to offer their clients.

Shango Los: That’s really good insight. You know, I’m surprised/not surprised, to hear you run it home again. What we’ve heard a couple times is that, you know, with these standards being different from the different companies, there is no doubt then that the different cannabis analytics labs are putting out different results. I mean, so many people, they want to hate the lab and think that maybe it’s their team that’s bad, but actually it’s just the state of the science. That’s something pretty severe to have to deal with.

Reggie Gaudino: Certainly that’s true, right? But by doing what I said, if every lab does not take it on gospel that once the standard maker is doing the job the right way all the time, you minimize that. That’s the extra step a good lab will take to make sure they’re giving out the right answers.

Shango Los: Right on, good, that’s a good book-end on that. Before we finish up here, I want to address, you know because our show is for entrepreneurs and certainly the cannabis breeders that are listening have really greatly appreciative of the stuff we’ve been talking about so far, let’s talk about the people that want to be you, Reggie. For a lot of those breeders, they want to step it up and get the education to become geneticists themselves so that they can work in the lab instead of necessarily in the grow room. What do you recommend for folks that are in states that have not normalized yet who want to prepare themselves for a career doing what you are doing? I mean it’s pretty exotic and there are not a lot of mentors yet for people to follow in their footsteps. What are your words of advice for somebody that wants to come up behind you in the future?

Reggie Gaudino: A good strong plant biology and molecular biology background will help them get almost all the way there. If they want they want to do the intellectual properties stock kind of stuff that I do, that’s above and beyond, but to be a good cannabis geneticist, to be able to do the kind of research that I do and my team does, to be able to ask those kind of questions, it’s really just basic science. All we’ve done is taken good people from regular science and brought them to the cannabis industry.

What’s so wonderful and what I love about this and why I’m here is because it gave me the opportunity to do stuff that was being done in other commercially important agricultural crops. Think about that, right? Cannabis is a commercially important agricultural crop that we know nothing about. We know so much more about wheat, about rice, about all these other things and so, it was basically a blank slate here. There’s a lot of room, there’s so much to be done in the cannabis industry in terms of understanding the genetics and understanding the biology of the plant that I would say anybody who’s in college, who’s studying biology, this field is just waiting with open arms.

A good education, not even the PhD. Bachelors or Masters, if you have good science skills, you can do what we do here and advance this industry. That’s what we really need right now. We and other labs that do this kind of work are more than happy to bring people in, to teach them, mentor-ships. I can’t stress enough how … Look for good programs. If you’re going to college, look for good programs. University of Colorado in Boulder, they have the Cannabis Research Genome Initiative, right? Rather the Cannabis Genome Research Initiative, CGRI, you know. There are programs out there that will help bring the level of cannabis science up to everybody else’s and at that point all I can say is watch out, because there is a lot to come.

Shango Los: Right on, well that sounds like a really inspiring place for us to end today because we are out of time. Reggie, thanks so much for being on the show.

Reggie Gaudino: Thanks for having me, this was great and I hope I provided some helpful information.

Shango Los: Yeah, absolutely, well I’m already planning on having you on again because I still have a lot of questions left. Dr. Reggie Gaudino is Vice President for Scientific Operations and Director of Intellectual Property at Steep Hill. You can find more episodes of the Gangapreneur podcast at the podcast section at Gangapreneur.com. You can also find us on the Cannabis Radio Network website and in the Apple iTunes store. On the Gangapreneur.com website, you will find the latest cannabis news, product reviews, and cannabis jobs updated daily along with transcriptions of this podcast. You can also download the Gangapreneur.com app in iTunes and GooglePlay. We’re also thrilled to announce that you can now find this show on the iHeartRadio Network app, bringing Gangapreneur to 60 million mobile devices. Thanks to Brasco for producing our show as always, I am your host Shango Los.