This year, many issues have gotten put on a shelf as the world has dealt with the COVID-19 pandemic. The legalization of cannabis in many states has been one of those issues. But this time on pause has given the industry a chance to identify how it would like to move forward as an emerging market that has many benefits across medicine, from mental health to the economy.
For many of these reasons, cannabis use is coming out of the shadows and there has clearly been a shift in recent years from cannabis being an illicit item to becoming a boutique product in many circles. The transition of cannabis’ image from that of the stoner in his parent’s basement to the “it” consumable for the jet set has as much to do about science as it does sophisticated branding.
Approximately 24 million Americans in 2019 have used cannabis, about 10% say they consume it for medical purposes based upon a growing body of evidence supporting the use of medical cannabis for a number of conditions. There are also economic reasons why legalizing cannabis makes sense including increased revenue for the government, job creation and more.
As cannabis becomes legal across America—11 states have adopted laws allowing for recreational use, while 22 others permit only medical cannabis—it’s finally becoming the sprawling business its proponents have long envisioned.
And this has moved the mainstreaming of cannabis in today’s society from a taboo illicit drug to now being openly discussed at dinner tables.
First of all, our hats need to be taken off to the cannabis advocates who over the last 20 years have shaped an emerging industry, educating society and the government on the benefits cannabis can offer based on science.
The global cannabis community has collaborated with regulatory bodies to establish compliance and regulations as a starting point to help the general public understand sourcing products from legal entities is a safer way to get quality product to consume that is not compromised from unregulated producers.
In addition, technology advancements within the cannabis space have led to sophisticated track and trace solutions of raw materials and products through the supply chain. The data captured within these systems allows cannabis brands to tell a compelling authentication story to end consumers based on scientific facts.
This all leads to an emerging market that has open transparency, full traceability and establishing trust with consumers. The early master growers now work hand in hand with designer laboratories, perfecting and protecting their IP. A sophisticated supply chain has been put in place so consumers know where their cannabis was grown and by whom. Consumers understand which strains have been harvested and what hybrid models have been created. This is certainly no longer a bag of weed you purchased from a neighborhood friend, but a complex, innovative industry with established brands that have celebrities, ex-politicians and well know business executives involved now and the advocates that has been leading the charge for over 30 years are still the backbone to educate the masses on the benefits cannabis and hemp will bring to mankind over time.
Project Yosemite, a cannabis product innovation and brand development company, announced earlier this month the appointment of Jennifer Raeder-Devens as their new Chief Scientific Officer. Raeder-Devens is a veteran of the MedTech industry, working for companies like Becton Dickinson, Cardinal Health, Medtronic and 3M.
Prior to joining Yosemite, she was the Vice President of Research & Development at Becton, Dickinson, where she oversaw product development and technology strategies to launch infection prevention products including the ChloraPrep first-in-the-US sterile solution patient preoperative topical antiseptic. She was previously the Vice President of R&D, Strategy and Innovation at Cardinal Health. She’s also held roles at Medtronic, 3M Drug Delivery Systems and 3M Skin Health Division and she has a number of patents in drug delivery and medical devices.
In November of 2018, Project Yosemite launched their first product, OLO, which is an infused, controlled-release sublingual strip. Part of Raeder-Devens’ new role at the company is the continued development and expansion of the OLO sublingual strip technology platform. Andrew Mack, CEO and founder of Project Yosemite, says he’s thrilled to have Raeder-Devens on the team. “Jennifer is an extremely accomplished scientist and engineer with extensive experience driving innovation and R&D in the pharmaceutical and medical device industries,” says Mack.
We caught up with Jennifer over the phone to talk about her background in the MedTech space, why she decided to jump ship to join the cannabis industry and what she’s excited to work on now.
Cannabis Industry Journal: Can you tell us about your background, including your work with 3M and Medtronic?
Jennifer Raeder-Devens: I’m coming directly from Becton Dickinson, a global med tech company, where I supervised the development of drug-device combination products for topical antiseptics. I spent about 10 years there, mostly in topical drug and combination product development. Prior to that, I was at 3M and Medtronic working in drug-device combination products. At 3M, I was supervising a team of technology developers for the 3M Drug Delivery Systems business. I had experience working with designing and manufacturing transdermal, nasal, buccal and inhalation drug delivery mechanisms for pharmaceutical partners.
I worked on implantable drug delivery systems at Medtronic, which included working on the biocompatibility of things like pacemakers and drug infusion pumps and optimizing them to reduce infection and enhance healing after the implantation procedure.
CIJ: What made you consider joining the cannabis industry?
Jennifer: With my work in topicals, transdermal and inhalation drug delivery, I had an easy understanding of the different routes of administration we see today in the cannabis industry. And so, from the technology standpoint, I thought this was a place I could contribute to immediately. And then what got me really excited about it was thinking about cannabis, and just like any other drug, with oral drug delivery, you’ve got first class metabolism and side effects from the 11-Hydroxy-THC that are undesirable and you’d rather not have delivered through the gut.
I got excited when I saw the development of things like sublingual strips that were focusing on alternatives to smoking that would preserve that relatively fast onset and mitigate some of the side effects of edibles.
The other thing I really like about the cannabis industry: Previously I have been very focused on known drugs that are already approved and repurposing them into a new delivery system. What really interests me about the cannabis industry is the active cannabinoids and terpenes are somewhat known and somewhat unknown, so there is this really interesting challenge there of trying to separate the wheat from the chaff in terms of producing therapeutic effects.
It is a really interesting space where the indications of certain molecules are evolving along with the delivery technology. So, it is a really exciting and eye-opening way to take the next step in my career and have this wide-open space in front of me, both in terms of the different cannabinoids, their effects and the delivery systems we can use.
CIJ: How might you be prepared, given your background, for some of the challenges in the cannabis space?
Jennifer: I think the challenges in cannabis delivery are not different from the challenges in pharmaceutical drug delivery. It’s just that we have this additional complexity of the entourage effect. We can be engineering not just the main ingredient of THC, but also all the other cannabinoids and terpenes. So, for example, with my background in infection prevention, we build a product that we know reduces the risk of infection, but we are really challenged to actually prove it reduces the risk of infection. We have a similar situation in the cannabis industry, where we can get the THC, or CBG or CBN where we want it to go, but then we are really challenged to figure out how we can find, what we call in the pharmaceutical industry, a surrogate end point for efficacy, so that we can test that product and really believe that when we put the product on the market, even though we haven’t tested thousands of users or conducted large randomized clinical trials, that the effect will be shown. We are networking and partnering with a good scientific community to build the right product and do some testing at a small scale that really demonstrates the product achieves the effect that we are really looking for.
CIJ: Can you tell us a little about your new role with Project Yosemite?
Jennifer: My job description falls into three buckets: The first part is that we are forming a scientific advisory board and we are working with some of the leading cannabinoid researchers around the country and around the world. These are the people identifying whether or not certain cannabinoids could reduce cancer cell metabolism or whether cannabinoids contribute to weight loss or diabetes control and other things of that nature. We are trying to reach as far upstream as we can to grasp the emerging understanding of the performance of cannabinoids and terpenes in the endocannabinoid system. So, part of my job is to chair that scientific advisory board, get the thought leaders together in the room and have them bring their knowledge and explore with our own knowledge what cannabis can really do.
I have worked in topical, transdermal, buccal, nasal, inhalation drug delivery. In the second bucket of my job, we are trying to understand a given indication or experience that our users want to have, what would be the right route for them. We are challenging our sublingual delivery mechanism to see how fast of an onset we can really get. Right now, we are at 10 minutes for drug delivery in sublingual and we are still trying to get an even faster onset time for the sublingual strip.
For other indications, like chronic pain, we may want to think about a sustained release, so sort of aligning the different indications with which different cannabinoids and terpenes will work for it and see which delivery platform will work for what we are trying to accomplish in each indication. So, we do not plan to remain solely a sublingual strip company, but will build out additional delivery platforms as we develop new indications.
Right now, we are working upstream with the growers and the processors to get cannabis oil and extracts. Some of the growers are working on different genetics in their cultivars to grow plants that have different ratios of different cannabinoids that we know from the emerging research will have an impact on people’s experience. Now we are working with growers to really get ahead of the curve on how to formulate products with various cannabinoids.
We have an R&D team in house that I supervise. We are always working with our production team to make small improvements such as the faster onset and the dissolution rate and things like flavors, which covers a downstream focus as well.
In today’s innovation marketplace, everybody wants to be the first. Tech and non-tech companies alike are racing to raise capital for crypto, blockchain and AI, yet these sectors and technologies are still not even close to mass adoption.
Today’s entrepreneurs are obsessed with disruption. While this is obvious in the world of tech, it may soon be overshadowed by the nascent cannabis industry in the United States. Every time a new state opens an application submission period for a new cannabis dispensary, hundreds of companies apply. Each new market and state have pre-existing demand. Until recently, obtaining cannabis was difficult for many and illegal.
Most of these companies apply in good faith, only to run into unforeseen problems as the regulatory landscape changes. This is part of the risk inherent to pioneering and disrupting industries. Often, the latecomers who learn from pioneers’ mistakes are the ones who earn the greatest successes.
The Difference Between Pioneering and Innovating
In the world of commerce, paving the way for a new product to hit the market is usually a thankless, time-consuming task. It exposes the weaknesses of the market’s operators and invites newcomers to disrupt the already unstable status quo.
Although household names like Levi’s and Wells Fargo owe their success to the California Gold Rush, historians pay relatively little attention to the hundreds of thousands of casualties the Gold Rush caused. Pioneers paved the way, and innovators – like Levi Strauss – profited from the result.
Similarly, when it comes to cars, Peugeot and Tatra are not household names like Ford and Honda. Henry Ford’s assembly line innovations and Honda’s unbeatable factory flexibility led to those younger companies becoming far more successful than their older counterparts.
Pioneers change the way an industry operates. Airbnb did not succeed because it offered superior service compared to the powerful and deep-pocketed hotel industry. It succeeded because it improved the model that HomeAway and VRBO launched years prior – and did so in a way that undermined the hotel’s typical strengths while capitalizing on their weaknesses.
Although pioneering the creation of new business models is an admirable thing to do, it’s not for everyone. Airbnb has been fighting regulators since the very beginning. The company has been forced to pay fines and taxes that simply didn’t exist until Airbnb’s business model came into being.
Uber’s regulatory troubles regularly make headlines around the world. Although it successfully disrupts every market it enters, established taxi companies and newcomers like Taxify often get the last laugh when they implement Uber-like functionality into existing business models. Uber found it too difficult to compete in China and sold its business to local newcomer Didi Chuxing.
All of these cases demonstrate that being the first or early to introduce a business concept comes with many challenges. Pioneering disruption is not equal to innovation, and the cannabis industry will follow the same course.
Cannabis Industry Pioneers vs. Innovators
In the cannabis industry, being the first often meant living in constant fear of being arrested. During the early years of medical cannabis legislation, it was unclear whether federal authorities would raid and prosecute cannabis cultivators and dispensaries.
Every new cannabis market offers important, expensive lessons to future cannabis entrepreneurs:
California changed its cannabis product packaging laws several times before its market went live.
Oregon’s lack of state inspectors led to a laboratory testing bottleneck and an upsurge in black market cannabis diversion that the state’s last audit called “currently unstoppable.”
The two largest medical marijuana cultivation facilities in Illinois cost about $40 million to build, yet they compete over a market of less than $10 million.
Major pioneers like Medmen have paid enormous sums of money to gain entrance into regulatory environments they can’t accurately predict profits from.
Newer cannabis industry entrepreneurs are taking notice of all these obstacles and implementing plans to overcome them. It’s likely that the next generation of medical and recreational dispensaries will have far greater success than today’s biggest names, primarily due to this fact.
Consider the fact that all three of the S&P’s biggest cannabis industry companies have valuations far in excess of their actual sales. It is possible that these large, deep-pocketed organizations will generate enough revenue to justify their valuations, but in the meantime, newer players will enter the picture with greater responsiveness and startup efficiency.
Newcomers to the cannabis industry are setting themselves up for success with highly targeted business objectives, strong executive teams and high-impact advisors. They are navigating the regulatory landscape with more agility than early cannabis pioneers can muster, obtaining lower price-to-sales ratios in the process.
This is the hallmark of innovation. While disruptions and inventions typically take the form of new products or services, innovations expand marketplaces and lay the groundwork for new interactions between economic actors in those marketplaces.
What Tomorrow’s Cannabis Innovators Can Do Now
States like Pennsylvania, New York, and New Jersey are currently leaning towards recreational marijuana legislation like those currently in place in Colorado and California. Cannabis entrepreneurs need to be creative in their assessment of the opportunities these new environments create.
Opening a cannabis company is no small task. As regulators gradually come to agree on the requirements each state will ask its business owners to meet, the next generation of pioneering cannabis entrepreneurs will have to adapt. At the same time, a relatively small contingent of innovators – the new generation of Levi Strauss’s – will coincide to provide much-needed products and services to the incoming rush.
These innovators will not be limited to one side of the industry. Innovation thrives on integration, and tomorrow’s cannabis entrepreneurs are going to develop streamlined solutions for tackling today’s inefficiencies in ways that simply are not possible right now. These lean, sophisticated startups will use that path paved by the first generation of cannabis industry incumbents.
Cannabis innovators will need to develop solutions for minimizing the costs and complications of setting up companies in highly regulated environments. This can mean anything from developing superior seed-to-sale tracking POS integrations to building a more efficient supply chain and a path to the consumer.
With luck, the next generation of cannabis entrepreneurs will look to the past when informing their strategic decisions for the future.
The projected growth of the legal cannabis market is astounding. According to a report from BDS Analytics, the industry is expected to grow from $9.2B to $47.3B in 2027 in North America, with medical cannabis contributing 33% of that overall growth. While this number is impressive for an industry still in its infancy, I have reason to believe it can be much higher.
In the pharmaceutical industry, treatment of pain and insomnia represent an annual revenue exceeding $140B; concurrently, studies have shown cannabis to be an effective treatment for both conditions. If medical cannabis can capture 10% of that revenue over the next ten years, it essentially doubles the current estimates mentioned above.
So, what stands in our way? Education.
To gain acceptance from the medical community, physicians need to better understand the plant and its therapeutic benefits. To do so, they need more substantial data to prove cannabis’ efficacy before prescribing it to their patients. However, federal illegalities have prevented government-mandated clinical studies, but I believe there’s another way.
By adopting a collaborative health care model, patients and caregivers can work together to track the effectiveness of their cannabis treatments and share their learnings with the larger medical community. With the right tools in place, we can fast-track the research process and provide physicians and politicians with the information they need to make this medicine more approachable and accessible to those who could benefit from it.
By harnessing the power of the community, we can apply learnings from one patient’s cannabis use to help countless others.The Spine Patient Outcomes Research Trial (SPORT)was a five-year study consisting of approximately 2500 patients with back and spine conditions. Participants entered qualitative data into an online portal, including post-surgical results and patient outcomes, to provide a comprehensive insight into treatment methods and their efficacy. Today, others suffering with those same conditions can enter their personal information into an online calculator and receive a prospective treatment plan. Together, patients and their doctors can view results and build a customized plan using more informed decisions about the available treatment options.
Another example comes from OpenNotes– an exploratory study that provides patients with full access to their medical files and the opportunity to input comments about their doctor visits and prognosis and make corrections related to the care they received. Results showed that this process helped patients retain a better understanding of their condition which improved their decision making and resulted in increased adherence to treatment plan protocols because they had greater trust with their doctors.Not only will this improve the patient experience by providing a safer, more sustainable treatment option, it also provides a very significant financial opportunity.
I believe the cannabis industry can take a leadership role in empowering patients to become active participants in their own treatment, while also sharing knowledge with the larger patient and physician communities. In fact, this core belief was the reason I founded Resolve Digital Health. Data-empowered patients not only make better decisions but also enjoy a greater feeling of control over their treatment. The power of collaborative healthcare grows exponentially when the data is shared to educate a broader group. By harnessing the power of the community, we can apply learnings from one patient’s cannabis use to help countless others.
Businesses within the cannabis industry can also leverage this data to create new products and services. For example, insights as to what products work best for certain conditions can help LP’s improve their product offerings and guide recommendations from dispensaries. Through product innovation, companies can make cannabis more accessible to a larger group of patients, who may be currently taking pharmaceuticals. Not only will this improve the patient experience by providing a safer, more sustainable treatment option, it also provides a very significant financial opportunity.
Ultimately, knowledge is power. When patients are empowered to make educated decisions about their health care and doctors are more tuned into the patient-tested cannabis treatment options, it’s a win-win for everyone.
Disclaimer: Marguerite Arnold has just raised the first funds for her blockchain-based company, MedPayRx in Germany (and via traditional investment funding, not an ICO). She will also be speaking about the impact of blockchain on the cannabis industry in Berlin in April at the International Cannabis Business Conference.
You have probably heard of cryptocurrencies, tokens and smart contracts. You might have also heard, even if you did not understand the significance, that IBM recently suggested that the Canadian government use their form of blockchain, called Hyperledger, to track the recreational cannabusiness. Or that a large LP called Aurora is also looking at this space (as are other licensed producers large and small). Or maybe you have seen an item in the mainstream news about an ICO for a cannabis company that is now also going terribly wrong.
What on earth is going on?
These are all related issues, even if highly confusing and disjointed. Blockchain technology and cryptocurrency are hot right now and getting hotter – both in the mainstream world and in the cannabis industry globally. But for all its fans, the drumbeat for caution is also growing louder the more mainstream this technology (and the legitimate cannabis industry) becomes.
The many problems the entire cannabis vertical has with banking has make this current development almost inevitableOn the technology and finance side, that is why so many big names right now are urging caution. Nouriel Roubini, professor at NYU’s Stern School of Business, is just the latest to do so – and for reasons that everything to do with history. Including recent history ten years ago, when the world stood on the brink of a financial disaster thanks to unchained derivatives. The biggest worry in fact, right now, is about the financial implications of widespread adoption of the technology, beyond the tech itself and how it may (and may not) be legitimately used. Which itself is a huge question.
So why all the fuss?
This is revolutionary technology which is also being introduced into the market at a time when decentralized processing for automation is on the horizon. But also because blockchain can be used to create tokens or digital coins that act like financial instruments. And once created, such tokens can be issued much like money or even stock, to raise additional funds – for both start-ups and ongoing enterprises. The best thing though? This technology was invented to create a decentralized form of value exchange and trust-less, anonymized auditing and verification. No traditional financial institutions or even governments needed, wanted or should apply (at least in theory).
The many problems the entire cannabis vertical has with banking has make this current development almost inevitable. Not to mention accessing investment cash (although this is certainly changing outside the United States). Compliance issues in every direction are another wrinkle this tech will help solve. Starting with tracking product but also rapidly expanding to uses including protecting users’ privacy and facilitating access to high-quality, inspected product for qualified users and buyers. Not to mention other areas that are literally space-age but coming fast. Look for cool stuff coming soon involving both AI (artificial intelligence) and IoT (internet of things).
It is a fascinating, complex space. However, one aspect of this world, in particular, Initial Coin Offerings – or ICOs are getting attention right now. Why? They can be an incredibly efficient way to raise money for companies – both ones currently in business and start-ups with little more than a whitepaper or business plan and perhaps a working prototype. More and more of the successful ICOs are, however, for an existing company or are even attached to an asset, including a license, a prototype or a fund of money (or other combinations). They also rely on blockchain and alternative currency or tokens (sometimes also referred to as smart contracts) to work.
From a technology perspective, you can “mint” new coins relatively easily these days, sourced from a variety of different kinds of blockchain. Or even combinations thereof. You also can issue tokens or altcoins without an ICO.
In a world where there is vastly expanding cannabis opportunity, and many of these hopeful entrepreneurs are both digitally astute but without access to traditional capital, what could be better?
From a financial and investor perspective, ICOs are a hybrid form of an IPO meets social media. “Coins,” “tokens” and “smart contracts” –or cyber currency collectively– are digital forms of cash, contracts, membership cards, discounts or even authorizations for identity. There are many ways tokens can be used, in other words. This by way of saying there are also important differences too. Not all tokens are the same. Not all are used as “money.” Some are but have assets assigned to them (like real estate). Others, particularly smart contract tokens, are strictly functional (pay funds when product is delivered and verified). The one caveat here is that the exchange of any token or altcoin will also cost money. Why? It is the electricity cost of computer processing the request for transfer. Plus access and service fees. There is no such thing as a “free” token. How tokens are priced, sold, bought, maintain value and for what purposes, is a debate if not process function that will not be solved anytime soon. Starting with the fact that some blockchains are more energy efficient (and sourced from green energy) than others.
To add to all of this confusion, not all ICOs function the same way. Some do give investors ownership in the company or specific portfolios that even include real-world assets. Others offer to use pooled funds to buy assets (like real estate or an expensive license). Many rely on the “coin” issued as a kind of discount scheme, reward mechanism and in many cases, direct discounted payment for future goods and services, of both the digital and real world kind. Many offer banking services directly, including in the very near future, the ability to exchange cyber cash for the fiat variety at even remote ATMs. Sound futuristic? It is coming and soon.
Most ICOs in the market now, however, rely on the following supposition: Issue a token with a unique name. Put up an ICO website. Encourage investors from anyplace on the planet with an internet connection, to use either crypto or fiat currency to buy tokens in the issuing startup as an investment that will give the new company funds to operate and build out services or the application (whatever that is). Also, plan to use the tokens for an exchange of some kind in the future (either for other coins or a good or service). Watch the value of the coin increase (for whatever reason) while informing investors (or contributors) that this is not really a security but a “utility” token that is expected but not guaranteed to become more valuable. Retire early with the prospect of having brokers of expensive real estate in places like London and Dubai come calling.The public tide of opinion, even if regulations are slow to move, is on the side of reform if not outright advocacy.
That will not be the case for the vast majority of ICOs, however, no matter what returns, goods or services they offer. Even if they also have vibrant communities already using their services (whatever those are). It will not be the case for most of the cryptocurrencies upon which such ICOs are based (most at the moment are based on Ethereum, NEO, Hyperledger or combinations of the three). There will be more of those too. And not every blockchain will make it (cryptocurrencies and tokens are based on an origin protocol or blockchain much like computer operating systems are either PC or Mac or mobile phones are Android or Apple). Some speak to one another well. Most do not “exchange” easily – even between themselves – let alone back into good old cash. And while nobody wants to be the Betamax of blockchain, there will, inevitably, be quite a few of them. When that happens, any economic value of the coins and even contractual relationships created with them disappear as well. Add in extreme price volatility in the current market pricing of these tokens, and you begin to get a sense of the risk profile involved in all of this.
The real hurdle, not to mention expense, comes when transferring back from the world of crypto to the one of fiat (regular money). Being a Bitcoin billionaire (there are about 1,000 individuals who own about 40% of the entire global Bitcoin issuance) is no fun if you have no place to spend it.
A Rapidly Changing Marketplace
In the past 18 months, cryptocurrency and ICOs have gotten increasing attention because of the increasing value of all kinds of cyber currency (far beyond Bitcoin). The total market cap for all forms of cryptocurrency itself zoomed past $700 billion at the turn of the year. That is impossible to ignore. You might have heard of some of these currencies too. There is ETH, Litecoin, Bitcoin Cash, Dash, even Dogecoin (created originally as a joke on an internet dog meme). Right now, in fact, at some of the most expansive exchanges, there are literally hundreds of these coins which are constantly bought and sold if not exchanged and used.
And then there are the sums ICOs are bringing in some cases, flagrantly flaunting regulatory agencies and doing end runs on the global banking system that cannot keep up with them. The top ICO of 2017, a company called Block.one and registered in the Cayman Islands, so far holds the record at $700 million and counting. Filecoin, the second largest ICO last year, raised $262 million in one month from August to September. And then, of course, there is the cannabis industry-specific case of Paragon – now headed for class-action lawsuit litigation over their $70 million pre-and ICO sale intentions.
It would be logical to assume, given the eye-watering sums potentially involved not to mention the large role a smart digital media footprint has to do with an ICO’s success, beyond its service or technology offerings, that this would be a perfect place for cannapreneurs to turn for funding. The global market is opening for cannabis reform at the same time the crypto craze meets Fintech Upheaval is occurring – in fact, these two things are happening almost simultaneously.
Thanks to regulatory realities and an ongoing stigma, there is still no institutional investment in the industry in the United States (that is rapidly changing other places). These are two new industries and dreams are large.
In the legit cannabis space, so are the expenses.
The price of opening a dispensary in most U.S. states tops a million dollars right now. In Europe, the price of entry is even more expensive. A GMP compliant grow facility in Western Europe, plus the money for lawyer’s fees and negotiations for the license itself will set you back anywhere from $20 million and up, depending on the location. Even staying afloat in the industry once the doors are opened is a challenge. And loans, even for outstanding invoices, are still tough to come by in an industry where banking services of the simple business account kind are a challenge. Particularly in the United States.
The public tide of opinion, even if regulations are slow to move, is on the side of reform if not outright advocacy. Why shouldn’t a reform-group-rooted ICO aspire to own or provide ongoing business financing to a community-minded canna farm in California, Canada, Germany, Israel or Australia? Or even Greece?
However, right now, with some noted exceptions, the cannabis business remains at minimum, a dangerous place to consider issuing altcoins that act like financial instruments or raise money with them. Why and how?
By Alison J. Baldwin, Brittany R. Butler, Ph.D., Nicole E. Grimm 1 Comment
With legalization of cannabis for medicinal and adult use occurring rapidly at the state level, the industry is seeing a sharp increase in innovative technologies, particularly in the area of cannabis extraction. Companies are developing novel extraction methods that are capable of not only separating and recovering high yields of specific cannabinoids, but also removing harmful chemicals (such as pesticides) from the concentrate. While some extraction methods utilize solvents, such as hydrocarbons, the industry is starting to see a shift to completely non-solvent based techniques or environmentally friendly solvents that rely on, for example, CO2, heat and pressure to create a concentrate. The resulting cannabis concentrate can then be consumed directly, or infused in edibles, vape pens, topicals and other non-plant based consumption products. With companies continually seeking to improve existing extraction equipment, methods and products, it is critical for companies working in this area to secure their niche in the industry by protecting their intellectual property (IP).
Comprehensive IP protection for a business can include obtaining patents for innovations, trademarks to establish brand protection of goods and services, copyrights to protect logos and original works, trade dress to protect product packaging, as well as a combination of trade secret and confidentiality agreements to protect proprietary information and company “know-how” from leaking into the hands of competitors. IP protection in the cannabis space presents unique challenges due to conflicting state and federal law, but for the most part is available to cannabis companies like any other company.
Federal trademark protection is currently one of the biggest challenges facing cannabis companies in the United States. A trademark or service mark is a word, phrase, symbol or design that distinguishes the source of goods or services of one company from another company. Registering a mark with the U.S. Patent and Trademark Office (USPTO) provides companies with nationwide protection against another company operating in the same space from also using the mark.
As many in the industry have come to discover, the USPTO currently will not grant a trademark or service mark on cannabis goods or services. According to the USPTO, since cannabis is illegal federally, marks on cannabis goods and services cannot satisfy the lawful use in commerce requirement of the Lanham Act, the statute governing federal trademark rights. Extraction companies that only manufacture cannabis-specific equipment or use cannabis-exclusive processes will likely be unable to obtain a federal trademark registration and will need to rely on state trademark registration, which provides protection only at the state-level. However, extractors may be able to obtain a federal trademark on their extraction machines and processes that can legitimately be applied to non-cannabis plants. Likewise, companies that sell cannabis-infused edibles may be able to obtain a federal trademark on a mark for non-cannabis containing edibles if that company has such a product line.
Some extraction companies may benefit from keeping their innovations a trade secretSince the USPTO will not grant marks on cannabis goods and services, a common misconception in the industry is that the USPTO will also not grant patents on cannabis inventions. But, in fact, the USPTO will grant patents on a seemingly endless range of new and nonobvious cannabis inventions, including the plant itself. (For more information on how breeders can patent their strains, see Alison J. Baldwin et al., Protecting Cannabis – Are Plant Patents Cool Now? Snippets, Vol. 15, Issue 4, Fall 2017, at 6). Unlike the Lanham Act, the patent statute does not prohibit illegal activity and states at 35 U.S.C. § 101 that a patent may be obtained for “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.”
For inventions related to extraction equipment, extraction processes, infused products and even methods of treatment with concentrated formulations, utility patents are available to companies. Utility patents offer broad protection because all aspects related to cannabis extraction could potentially be described and claimed in the same patent. Indeed, there are already a number of granted patents and published patent applications related to cannabis extraction. Recently, U.S. Patent No. 9,730,911 (the ‘911 patent), entitled “Cannabis extracts and methods of preparing and using same” that granted to United Cannabis Corp. covers various liquid cannabinoid formulations containing very high concentrations of tetrahydrocannabinolic acid (THCa), tetrahydrocannabinol (THC), cannabidiol (CBD), THCa and cannabidiolic acid, THC and CBD, and CBD, cannabinol (CBN), and THC. For example, claim 1 of the ‘911 patent recites:
A liquid cannabinoid formulation, wherein at least 95% of the total cannabinoids is tetrahydrocannabinolic acid (THCa).Properly crafted non-disclosure agreements can help further ensure that trade secrets remain a secret indefinitely.
Although the ‘911 patent only covers the formulations, United Cannabis Corp. has filed a continuation application that published as US2017/0360745 on methods for relieving symptoms associated with a variety of illnesses by administering one or more of the cannabinoid formulations claimed in the ‘911 patent. This continuation application contains the exact same information as the ‘911 patent and is an example of how the same information can be used to seek complete protection of an invention via multiple patents.
An example of a patent application directed to solvent-based extraction methods and equipment is found in US20130079531, entitled “Process for the Rapid Extraction of Active Ingredients from Herbal Materials.” Claim 1 of the originally filed application recites:
A method for the extraction of active ingredients from herbal material comprising: (i) introducing the herbal material to a non-polar or mildly polar solvent at or below a temperature of 10 degrees centigrade and (ii) rapidly separating the herbal material from the solvent after a latency period not to exceed 15 minutes.
Claim 12, covered any equipment designed to utilize the process defined in claim 1.
Although now abandoned, the claims of this application were not necessarily limited to cannabis, as the claims were directed to extracting active ingredients from “herbal materials.”
Other patents involve non-toxic extraction methods utilizing CO2, such as Bionorica Ethics GMBH’s U.S. Patent No. 8,895,078, entitled “Method for producing an extract from cannabis plant matter, containing a tetrahydrocannabinol and a cannabidiol and cannabis extracts.” This patent covers processes for producing cannabidiol from a primary extract from industrial hemp plant material.
There have also been patents granted to cannabis-infused products, such as U.S. Patent No. 9,888,703, entitled “Method for making coffee products containing cannabis ingredients.” Claim 1 of this patent recites:
A coffee pod consisting essentially of carbon dioxide extracted THC oil from cannabis, coffee beans and maltodextrin.
Despite the USPTO’s willingness to grant cannabis patents, there is an open question currently regarding whether they can be enforced in a federal court (the only courts that have jurisdiction to hear patent cases). However, since utility patents have a 20-year term, extractors are still wise to seek patent protection of the innovations now.
Another consideration in seeking patent protection for novel extraction methods and formulations is that the information becomes public knowledge once the patent application publishes. As this space becomes increasingly crowded, the ability to obtain broader patents will decline. Therefore, some extraction companies may benefit from keeping their innovations a trade secret, which means that the secret is not known to the public, properly maintained and creates economic value by way of being a secret. Properly crafted non-disclosure agreements can help further ensure that trade secrets remain a secret indefinitely.
Regardless of the IP strategy extractors choose, IP protection should be a primary consideration for companies in the cannabis industry to ensure the strongest protection possible both now and in the future.
Last week, the 4th annual Emerald Conference brought attendees from around the world to San Diego for two days of education, networking and collaboration. Leading experts from across the industry shared some of the latest research in sessions and posters with over 600 attendees. The foremost companies in cannabis testing, research and extraction brought their teams to exhibit and share cutting edge technology solutions.
The diversity in research topics was immense. Speakers touched on all of the latest research trends, including tissue culture as a micropropagation technique, phenotype hunting, pharmaceutical product formulation, chromatography methods and manufacturing standards, to name a few.
On the first day of the event, Ken Snoke, president of Emerald Scientific, gave his opening remarks, highlighting the importance of data-driven decisions in our industry, and how those decisions provide the framework and foundation for sound progress. “But data also fuels discovery,” says Snoke, discussing his remarks from the event. “I told a story of my own experience in San Diego almost 30 years ago while working in biotech, and how data analysis in a relatively mundane and routine screening program led to discovery. And how we (the folks at Emerald) believe that when we get our attendees together, that the networking and science/data that comes from this conference will not only support data-driven decisions for the foundation of the industry, but it will also lead to discovery. And that’s why we do this,” Snoke added.
Snoke says the quality of the content at the poster session was phenomenal and engaging. “We had over 500 attendees so we continue to grow, but it’s not just about growth for us,” says Snoke. “It’s about the quality of the content, and providing a forum for networking around that content. I met a scientist that said this conference renewed his faith in our industry. So I firmly believe that the event has and will continue to have a profound and immensely positive impact on our industry.”
Introducing speakers as one of the chairs for first session focused on production, Dr. Markus Roggen says he found a number of speakers delivered fascinating talks. “This year’s lineup of presentations and posters really showcase how far the cannabis industry has come along,” says Dr. Roggen. “The presentations by Roger Little, PhD and Monica Vialpando, PhD, both showed how basic research and the transfer of knowledge from other industries can push cannabis science forward. Dr. Brian Rohrback’s presentation on the use of chemometrics in the production of pharmaceutical cannabis formulations was particular inspiring.”
Shortly after Snoke gave his opening remarks, Dr. Roggen introduced the first speaker, Roger Little, Ph.D., owner of CTA, LLC. He presented his research findings on phenotype hunting and breeding with the help of a cannabis-testing laboratory. He discussed his experience working with local breeders and growers in Northern California to identify high-potency plants early in their growth. “You can effectively screen juvenile plants to predict THC potency at harvest,” says Dr. Little. The other research he discussed included some interesting findings on the role of Methyl jasmonate as an immune-response trigger. “I was looking at terpenes in other plants and there is this chemical called methyl jasmonate,” says Dr. Little. “It is produced in large numbers of other plants and is an immune response stimulator. This is produced from anything trying to harm the plant such as a yeast infection or mites biting the stem.” Dr. Little says that the terpene has been used on strawberries to increase vitamin C content and on tobacco plants to increase nicotine content, among other uses. “It is a very potent and ubiquitous molecule,” says Dr. Little. “Cannabis plants’ immune-response is protecting the seeds with cannabinoid production. We can trick plants to think they are infected and thus produce more cannabinoids, stimulating them to produce their own jasmonate.”
Dr. Hope Jones, chief scientific officer of C4 Laboratories, spoke about tissue culture as an effective micropropagation technique, providing attendees with a basic understanding of the science behind it, and giving some estimates for how it could effectively replace cloning and the use of mother plants. You could overhear attendees discussing her talk throughout the remainder of the show.
Dr. Jones has worked with CIJ on a series of articles to help explain cannabis tissue culture, which you can find here. “In this example, we started with one vessel with 4 explants,” says Dr. Jones. “Which when subcultured 4-6 weeks later, we now have 4 vessels with 16 plants.” She says this is instrumental in understanding how tissue culture micropropagation can help growers scale without the need for a ton of space and maintenance. From a single explant, you can potentially generate 70,000 plants after 48 weeks, according to Dr. Jones.
Those topics were just the first two of many presentations at Emerald Conference. You can take a look at some of the other presentation abstracts in the agenda here. The 5th Annual Emerald Conference in 2019 will be held February 28th through March 1st in San Diego next year.
Philly Tech Week held its first cannabis industry conference this past weekend, hosted by Greenhouse Ventures, a cannabis startup accelerator based in the Northeast. The Innovation in the Cannabis Industry conference brought leaders in cannabis technology, investing and medical research to discuss the changing landscape of the cannabis marketplace in the Northeast.
Kicking off the event, Tyler Dautrich, co-founder of Greenhouse Ventures, welcomed attendees to the first ever Philadelphia cannabis conference. The initial panel of the day reviewed investment trends and included Scott Greiper, president & founding partner of Viridian Capital Advisors, Marc J. Ross, Esq., founding partner of Sichenzia Ross Friedman Ference LLP, Jim Fitzpatrick, advisory board member at Kodiak Capital Group and John Kagia, director of industry analytics at New Frontier Data Analytics. The panel, moderated by Kevin Provost, co-founder of Greenhouse Ventures, examined various financial trends in the marketplace, roadblocks to raising capital for startups and emerging markets.
John Kagia of New Frontier provided useful tools in comparing cultivation models as well as industry projections. “It [the legal cannabis market] has largely been dominated by the West Coast,” said Kagia. “The East Coast is very well poised for success.” Scott Greiper, president of Viridian Capital, discussed his top performing markets. “Biotech is definitely the top performing category and a close second is cultivation and retail –production and sale is at the root of every industry,” said Greiper. “At its core, cannabis is an agricultural commodity.” He went on to list infused products as the third top performing market, noting that edibles account for over half of retail sales.
In looking at emerging markets, Leslie Bocksor, president and founder of Electrum Partners, echoed Scott Greiper’s advice for new businesses to stay grounded in the numbers and operations. “Stay focused on solid, tangible data,” Bocksor said. The two also shared a similar view in opportunities in hemp. “Hemp is a very underserved niche and there are ample opportunities for new businesses,” said Bocksor.
State Senator Daylin Leach (D- Montgomery/Delaware), co-sponsor of the bill for Pennsylvania’s medical cannabis legalization, delivered the keynote address. He lauded the bill, mentioning that patient advocates were instrumental in swaying the legislature. “This is the most important piece of legislation for PA in thirty years,” said Leach. “I have always believed in moving this bill forward and very recently, we passed it with a huge bipartisan majority.” Attendees gave Senator Leach a standing ovation in response to his positive outlook on Pennsylvania’s future with cannabis. “This will be a huge new industry and medical technology is vital to moving it forward.”
In the afternoon, a panel on medical technology discussed the need for more comprehensive diagnostic tools and crowd-sourced data for treatment with cannabis. David Goldstein, chief executive officer and founder of PotBotics, expressed concerns over bringing consistency to patients. “We need to understand how cannabinoids are affecting patients,” said Goldstein. “We want patients to feel confident in their medication.”
The conference closed with a panel of physicians discussing their clinical experience with recommending cannabis and the gaps in medical research. Among them, Dr. Scott Gottlieb, board-certified anesthesiologist and pain management specialist from Pearl River, New York, discussed some of his experience in recommending cannabis in treating neuropathic pain. The closing panel emphasized the need to educate more physicians and some of the obstacles to physicians recommending cannabis. The conference highlighted the Northeast as a quickly emerging cannabis market ripe with business opportunity.
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