Money in the Pot The impact of deregulation on cannabinoids innovation - By Mark Markley and Ed White - Clarivate Analytics

Page created by Bertha Payne
 
CONTINUE READING
Money in the Pot The impact of deregulation on cannabinoids innovation - By Mark Markley and Ed White - Clarivate Analytics
Money in the Pot
The impact of deregulation
on cannabinoids innovation

By Mark Markley and Ed White
Money in the Pot The impact of deregulation on cannabinoids innovation - By Mark Markley and Ed White - Clarivate Analytics
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 The impact of deregulation on cannabinoids innovation - By Mark Markley and Ed White - Clarivate Analytics
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
Money in the Pot The impact of deregulation on cannabinoids innovation - By Mark Markley and Ed White - Clarivate Analytics
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 The impact of deregulation on cannabinoids innovation - By Mark Markley and Ed White - Clarivate Analytics
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.
Money in the Pot The impact of deregulation on cannabinoids innovation - By Mark Markley and Ed White - Clarivate Analytics
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 The impact of deregulation on cannabinoids innovation - By Mark Markley and Ed White - Clarivate Analytics
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.
Money in the Pot The impact of deregulation on cannabinoids innovation - By Mark Markley and Ed White - Clarivate Analytics
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 The impact of deregulation on cannabinoids innovation - By Mark Markley and Ed White - Clarivate Analytics
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.
Money in the Pot The impact of deregulation on cannabinoids innovation - By Mark Markley and Ed White - Clarivate Analytics
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
You can also read