Money in the Pot The impact of deregulation on cannabinoids innovation - By Mark Markley and Ed White - Clarivate Analytics
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2 Clarivate Analytics The shifting innovation landscape. In this paper we explore the patent landscape surrounding cannabinoids, the active ingredients extracted from cannabis, their innovative use, and commercialization in the context of progressive global deregulation and the impact of regulation on cannabinoid innovation. Recognizing that cannabis is still deemed a controlled substance in most legal jurisdictions, we see a clear trend towards the exploration of cannabis and cannabis compounds for both therapeutic and recreational applications.
Money in the Pot 3 The first innovation sition 215, setting a precedent and a viable pathway – through the ballot – to decriminalization in the US. In Human ingestion of strange tasting, fermented fruit 2018, Vermont became the first state to legalize through with a pleasant mind-altering effect was an early legislation. As of November 2018, cannabis usage has indulgence. Imbibing other plants with similar results been approved for recreational use in 10 states and the seems a natural extension. These early experiments in District of Columbia, and for medicinal use in an addi- psychoactive substances likely represent some of the tional 23 states, although still illegal at the federal level. earliest experiments in our history with cannabis. The trend towards decriminalization and legalization Cannabis use has been documented by archeologists is not limited to the US. Four countries have now legal- in prehistoric societies throughout the world, and agri- ized recreational use of cannabis, and another 11 have cultural advancements have supported its recreation- legalized medicinal use. al, medicinal and textile use for thousands of years. In June 2018, the UK Home Secretary announced a review of the medicinal use of cannabis,3 prompted The trend towards deregulation by the case of Billy Caldwell, a 12-year-old boy treated Cannabis use in the United States was largely unre- with cannabis oil for epileptic seizures. As a result of stricted prior to the 1930s, when it became regulated this review, on July 26, the Home Office announced as a drug in every US state. In 1937, the Marijuana Tax that medical cannabis would be made available by Act effectively made possession or transfer illegal1 prescription.4 On September 18, South Africa became unless a tax stamp, a costly and legally complicated the first African nation to decriminalize via a ruling in process, was obtained. its Constitutional Court. Most recently, on October 17, 2018, recreational use of cannabis was legalized in The American Medical Association (AMA) opposed this Canada. Clearly, there is a trend. act due to its impact on cannabis prescriptions by physi- cians, retail pharmaceutical sales, and medical cannabis cultivation or manufacturing. The AMA proposed instead that cannabis be added to the Harrison Narcotics Tax As of November 2018, cannabis Act; however, the bill was passed despite objections. has been approved for Dr. William Creighton Woodward, legislative counsel for the AMA, appealed the decision, claiming that the recreational use in 10 states and the bill had been prepared in secret without proper time District of Columbia, and for medicinal to prepare an opposition. He also expressed doubts regarding allegations of marijuana addiction, violence, use in an additional 23 states, although and overdosage, and asserted that the use of the word “marijuana” itself was misleading, as the medical still illegal at the federal level. profession did not realize they were losing the more commonly termed “cannabis.” “Marijuana is not the correct term,” Woodward argued, Old is new “yet the burden of this bill is placed heavily on the In June 2018, the FDA approved the first canna- doctors and pharmacists of this country.” bis-based drug for sale in the US. GW Pharmaceuticals’ Fast-forward 33 years to 1970, when cannabis was epilepsy treatment Epidolex makes use of one of officially outlawed by the Controlled Substances Act hundreds of molecules found in the marijuana plant, and regulated as a Schedule 1 drug. This classified it cannabidiol (CBD). While Epidolex may be considered as a substance with “a high potential for abuse and no first-to-market today, the history of cannabis in US accepted medical use.”2 pharmaceutical innovation dates back centuries. In the decades since, there have been many efforts to Prior to cannabis regulation in the US, it represented a roll back this regulation. In 1998, medicinal cannabis tremendously innovative field. The earliest example of was approved in California by the passage of Propo- a US patent describing cannabis was US patent 82,541, 1. https://definitions.uslegal.com/m/marijuana-tax-act%20/ 2. https://www.dea.gov/controlled-substances-act 3. https://www.gov.uk/government/news/home-office-launches-review-into-medical-use-of-cannabis 4. https://www.independent.co.uk/news/health/medical-cannabis-uk-prescription-legal-epilepsy-pain-relief-home-office-moj-nhs-a8464766.html
4 Clarivate Analytics “Patent rights are a trade. Inventors gain ownership over the technology, but in return they must tell the world what it is and how others can use it.” issued September 29, 1868 to George Mohler of Illinois. Tracking the ideas Mr Mohler’s somewhat alarming mixture of cannabis, In this paper, we explore the patent landscape sur- licorice, peppers, quassia and sarsaparilla plants, and rounding active ingredients extracted from cannabis, potassium carbonate was aimed at treating a variety of their innovative use, and commercialization in the nineteenth century ailments. context of progressive global deregulation. We were interested in seeing if changes in regulation would Similar inspiration led to John Pemberton’s “French have an impact on innovation in this space. Wine Coca” in 1886, which after 132 years, significant recipe change and removal of its cocaine content is Recognizing that cannabis is still deemed a controlled now better known as Coca-Cola®. substance in most legal jurisdictions, we see a clear trend towards exploration of cannabis and cannabis The lack of early legal restriction in the US provided a compounds for both therapeutic and recreational creative forum for invention. To bring this story full circle, applications. on September 17, 2018, Coca-Cola (now a $35 billion cor- poration) announced plans to introduce drinks infused We wanted to see what we could uncover using the Der- with cannabidiol as part of a collaboration with Canada’s went World Patents Index6 from Clarivate Analytics and Aurora Cannabis Inc. Like Mr Pemberton’s “French Wine the frameworks developed and used by our Patent Ana- Coca” more than a century before, the new drinks are lytics team. We created search queries on terms around intended to ease inflammation, pain and cramping.5 cannabinoids and cannabinoid receptors, focused on 5. https://www.reuters.com/article/us-coca-cola-jointventure-aurora-cannabi/coke-aurora-in-talks-to-make-cannabis-infused-drinks-bnn-bloomberg- idUSKCN1LX17K 6. https://clarivate.com/products/derwent-world-patents-index/
Money in the Pot 5 inventions from 2005 onwards and aimed our models at the inventions and ideas identified. Tracking patent activity, or more specifically, patented ideas, gives a detailed picture. This is because the patent right is a trade. Inventors (and their employers) get ownership and exclusivity of the technology, but in return they must tell the world what the invention was and how others can use it. This provides a unique data source that links the worlds of commerce and innovation together. Our experts track trends for our clientele every day. Generally, interest in patent data goes hand in hand with emerging or growing innovation sectors. It is not often that we see a patent timeline like the one in cannabinoids, with a sharp downturn followed by an equally sharp recovery (Figure 1). Figure 1. Cannabinoids patent landscape timeline. In the timeline of global cannabis innovation, 2012 is a pivot point. What occurred around that time that could explain such a turnaround in activity? Simple – the electorates of US states Colorado and Washington Global patent activity, regardless of technical content, voted in favor of the legalization of cannabis. Seven generally increases year on year (depicted by the green US states and the District of Columbia followed with line in Figure 1) due to increases in: similar measures over the next four years. • emerging country innovation, particularly in China; Notable is the lack of patents • economic activity globally; and of territories in which cannabis • STEM-educated professionals, who naturally pro- duce more patentable ideas. remains illegal. Instead, we see US deregulation has allowed the cannabinoids market Canada and Israel, where regulation to join this global, all-tech trend. A major question for this study surrounds the nature of invention pre- and is becoming less tight. post-2012. Does it differ? We explore this question later in the paper.
6 Clarivate Analytics Another question concerns the location of inventions. This question can be answered by reviewing the addresses of patent inventors (Figure 1). Inventor address information is used as a proxy measurement for the physical, geographic location of the innovating entity. As inventors tend to reside in the same coun- try as their place of business, it is a good indicator of company location. At a simple level, the number of residents of a country listed as inventors on patents or patent applications can provide a useful assessment of the “inventiveness” of that country. Confirming our thesis that US deregulation is driving cannabinoid research, we find that 50% of inventors list the US as their place of residence (Figure 2). The UK and Germany also show activity, but not to the scale of the US. Figure 3. Protection locations. Figure 2. Sources of innovation. Equally notable are low patent numbers in regions where cannabis or its derivatives remain illegal, includ- ing for therapeutic use – for example China (usually Figure 4. Sources of innovation timeline. a high-volume source of patents), Japan and South Korea. In place of these innovation giants, we see Canada, Spain, Israel and Switzerland – all countries in When reviewing innovation source trends (Figure 4), which regulation is becoming less tight. the US leads again, followed by Israel and Canada – lo- We arrive at similar findings when we look at where cations where a similarly easing regulatory framework inventions are registered for protection. Figure 3 has empowered innovation to thrive. contrasts the typical distribution of protection loca- As shown in Figure 5, the cannabinoids sector is dom- tions with our cannabinoids dataset (in white). The inated by corporate entities with small patent portfo- filing comparison again reflects unusual activity, with lios, illustrating an early “wild west” market – highly under-representation in China, Japan and Korea, and competitive and not yet settled. This model may also significant over-representation in Canada and Australia. suggest that cannabinoid innovation is resulting in the While the US is currently the most prominent market development of new companies, as new markets in for this technology, other above-average levels of this space are opened and explored. filing suggest markets where entities are planning for commercialization.
Money in the Pot 7 Figure 5. Entity dynamics. Figure 6. Entity dynamics timeline. Strength is important In addition, the Derwent Strength Index also models the value of inventions over time. The DSI is scored Growth in cannabinoids innovation is coming from across individual inventions, then aggregated across smaller entities and corporations (Figure 6). This may entities and technologies. be a result of the decline in larger, traditional pharma companies in recent years, as the traditional combina- The strongest cannabinoids portfolios (Figure 7) are torial chemistry approach of developing new synthetic held by pharmaceutical majors Roche, Boehringer, compounds is supplanted by new start-up companies and Abbvie. relying on endogenous cannabinoid compounds. Measuring the number of patented inventions is useful but it does not tell the whole story. The quality and strength of intellectual assets that the patenting process produces are equally important and can provide us with useful information on where the sector is headed next. The Derwent Strength Index is a metric that assesses several desirable characteristics a single invention has gathered to date. It is aggregated across technologies and entities to identify trends and direction. The DSI assesses: • The frequency of downstream citation to an inven- tion – a well known metric of impact and impor- tance • The breadth of geographic filing, which correlates very closely to the level of cost and investment in patent protection Figure 7. Competitive dynamics model. • Existence and location of granted, issued patent rights, a proxy for validity as well as commitment by the patent applicant This trend can be better understood by examining in- dividual entities. Most entities, including big pharmas • The invention’s technical breadth, correlating to the like Sanofi, Merck, Abbott, Astra Zeneca and Boehring- range of industry which the invention maps on – er Ingelheim, displayed higher distribution of filing essentially, how “big” the invention is prior to 2009, and less activity in more recent years.
8 Clarivate Analytics “Measuring the number of inventions is useful but does not tell the whole story. Measuring the quality and strength of the patents is equally important.” GW Pharma, Roche, Pfizer, Otsuka, Yissum and Almirall show more recent activity, suggesting renewed inter- est in this space. Large entities such as Merck Sharp & Dohm show a strong decline and likely, a sharp drop- off in research and investment. We need to go a little deeper to understand the before and after of the US deregulation phenomenon. From medicinal to recreational use? Table 1 shows a detailed breakdown of what has been patented in the cannabinoids space, exploring individ- ual inventions by therapeutic target and type of active cannabinoid. Grouping innovation approaches together by therapy, compounds, and delivery devices (Figure 8) provides additional information and a useful summary. Through this analysis, we find that pre-2012 cannabi- noid patent activity is therapy-centered, while post- 2012 research is all about the active ingredient and how to make it ingestible. An eyebrow-raising conclu- Table 1. Timeline of technical categories, as % per year. sion could be that pre-2012 patenting was medicinal, and post-2012 is recreational. Certainly, the data points in that direction.
Money in the Pot 9 Pre-2012 activity looks medicinal while post-2012 looks recreational. Certainly, the data points in that direction. Figure 8. Timeline of major innovation directions. Landscaping cannabinoid innovation Patent analysis techniques deploy data mining software and domain expertise to structure the millions of tech- Patent data is a major, if often overlooked or misunder- nical solutions mentioned in public patent data, making stood, data source for assessing future market trends. it ready for interpretation and indeed exploitation. Patents are typically 20+ page documents full of text One such technique is to mine the data for technical describing what the invention is, how it works and how it themes, industrial uses or, in this case, compounds can be used. Indeed, for a patent to be valid it must pro- and therapies. Figure 9 shows the results of this data vide this detail. This is because providing a state-spon- mining exercise. sored monopoly comes with the “cost” of full disclosure. This taxonomy was developed by extracting terms That personal or corporate cost is every other innova- from the Derwent World Patents Index abstract, vari- tor’s gain, as it contributes to an intelligence source on ous patent classification and indexing schemes as well the world’s best solutions to technical problems large as the original text of the patent documents them- and small. selves. The result is a data structure that reflects the broad uses and concepts employed by cannabinoid innovators. Individual innovations often fall into more than one category. For example, it is common in pharmaceuti- cal patents to list several possible conditions a com- pound may be used to treat. We see that several compounds are experiencing growth, particularly CBD and THC. CBD shows the highest growth rate in the categorization, demonstrat- ing a high degree of recent interest. Our taxonomy breaks the cannabinoid space into 22 technical approaches. In Figure 10, green represents cannabinoid compounds; grey, devices; and white, dis- ease or condition indications. The classifcaiton “other cannabinoids” represents a mix of phytocannabinoids, endocannabinoids and synthetic cannabinoids. Figure 9. Technical categorization distribution.
10 Clarivate Analytics “Tetrahydrocannabinol (THC), the main psychoactive compound derived from cannabis, is the most common derivative explored in the patent landscape, followed by cannabinadiol (CBD).” Figure 10. Technical approach in recent 3-year trends. Figure 11. Technical dynamics. Tetrahydrocannabinol (THC), the main psychoactive those recent trends in context – applying a degree of compound derived from cannabis, is the most com- commercial importance to the research alongside mon cannabinoid compound mentioned, followed by volumetric trends. cannabinadiol (CBD). Using our dynamic measurement of where innovation The strength verses recency model we earlier ap- is strongest right now – depicted in the top right quad- plied to organizations to understand the competitive rant – we see focus on Cannabidiol (CBD), Cannabi- dynamic in the field can also be applied to measure noid devices and long-standing therapeutic areas of technical dynamics (Figure 11). The model puts pain and inflammation treatment.
Money in the Pot 11 “The commercial heart of cannabis innovation today is cannabidiol and delivery devices, alongside pain and inflammation therapy.” This model reveals the focus areas of cannabinoid in- Conclusions: From patent data to real-world novation and the commercial heart of the cannabinoid implication industry: CBD and devices, and pain and inflammation Innovation in the cannabinoid sector is undergoing treatment. significant change. Early ideation in the mid-2000s The relatively low level of device activity, despite its came from large, established pharmaceutical entities location in the model, strongly identifies it as the key predominantly developing synthetic compounds emerging technology in the sector. There is more to intended to modulate cannabinoid receptors. Howev- come from this technology, and it appears likely that er, this early activity experienced a significant downward CBD will be the compound delivered by these future trend and declining commercial opportunity. devices to patients and recreational users. All that changed when individual states in the US This model also provides more information on the piv- began deregulating cannabis for recreational use, kick- ot described earlier in the paper from therapy centered ing off a flurry of research and innovation. That new innovation to compound and delivery. research has mostly concerned novel synthesis and delivery of cannabinoids, leaving behind most medic- Most of the therapeutic targets (asthma, anxiety, inal uses with the exception of pain and inflammation neurological or psychological conditions etc.) are treatment. The impetus for new ideas in cannabinoids clustered in the older, weaker quadrant at lower left. has largely stemmed from changes in the US, evi- This placement implies that these applications are denced both by the timing of renewed innovation as no longer pursued to the same degree as in previous well as by the field’s dominance by US innovators, who years, and even when they were pursued, they did not represent more than half of all innovators in the sector. produce strong intellectual property assets.
12 Clarivate Analytics governments.7 The regulatory environment is struggling to keep up with black market synthesis of ever-more powerful, abuse-centered and harmful variants of Everything changed cannabinoids – mirroring the trend seen in the 19th and early 20th centuries that ended in legislative bans. when individual states Research, development, testing and regulation pro- in the US began deregulating. In vide a sensible approach to addressing this detrimen- tal trend – encouraging a safer environment for users doing so, they kicked off a flurry of of these compounds, and reducing or eliminating the need for a black market. innovation. In most of the world, cannabinoids remain illegal. Our research into patented innovation shows that deregulation has the effect of stimulating research and However, patent data also highlights recent dereg- commercialization. ulation trends in Canada, Australia and other coun- Filing for patents is expensive; the research that goes tries, providing a direct link between regulatory and into patented ideas even more so. The world’s bio- research environments. chemists can only make that investment in locations We can’t say with certainty how regulations around where legal, safe market opportunities are available cannabis and cannabinoids will change and further ef- for them to explore safer usage and the easing of fect the innovation landscape. As governments around suffering. the world continue to re-assess cannabis and can- Analyzing the unique data source that is public patent nabinoids for therapeutic use and global acceptance data provides a powerful viewpoint into innovation similarly grows for recreational use, we can predict trends. We predict much more to come, so let’s see that any further deregulation will act as a catalyst for what happens next. research and new ideas, new applications and new commercial activity. Conversely, synthetic cannabinoid compounds devel- 7. https://www.economist.com/britain/2018/09/29/spice-is-throwing-up- oped and sold illegally are growing concerns for many problems-not-seen-with-other-drugs
Money in the Pot 13 About Clarivate Analytics Clarivate Analytics accelerates the pace of innovation by providing trusted insights and analytics to customers around the world, enabling them to discover, protect and commercialize new ideas faster. We own and operate a collection of leading subscription-based services focused on scientific and academic research, patent analytics and regulatory standards, pharmaceutical and biotech intelligence, trademark protection, domain brand protec- tion and intellectual property management. Clarivate Analytics is now an independent company with over 4,000 employees, operating in more than 100 countries and owns well-known brands that include Web of Science, Cortellis, Derwent, CompuMark, MarkMonitor and Techstreet, among others. About Derwent Derwent powers the innovation lifecycle from idea to commercialization – with trusted patent data, applications and services including Derwent Innovation, Derwent World Patent Index, Derwent Patent Citation Index and Derwent Data Analyzer. We build solutions for inventors, patent attorneys and licensing specialists at start-ups and the largest global innovators, legal professionals at the leading intellectual property practices, and patent examiners at more than 40 patent offices. Our solutions are used to monitor technology trends and competitive landscapes, inform FTO opinions, prosecute patents, monetize and license assets and support litigation activities. To learn more, visit: clarivate.com/derwent North America Asia Pacific Europe, Middle East and Africa Alexandria: + 1 800 987 9376 Tokyo: +81 3 5218 6500 London: +44 207 433 4000 Beijing: +86 10 6267 4111 Seoul: +82 2 2076 8011 analytics_support@clarivate.com © 2018 Clarivate Analytics
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