Why IP rights are essential for the growth of cannabinoid R&D
Zack Bellman argues that addressing key legal questions and improving the management of IP rights will lead to a more robust and innovative landscape for cannabinoid medicine
The Medical Cannabis Journal has become the Cannabinoid R&D Journal to reflect a new focus on research and development in the sector. This first post under the new name reflects these priorities. For more information visit the Cannabinoid Research & Development Group website.
Scientific research into cannabinoids is increasing around the world, with the majority of the research being conducted in the medical sector by governments, universities and businesses1. But this growth has to be accompanied by a sharper focus on intellectual property (IP) rights, which are part of the wider legal framework that is essential for encouraging investment, promoting scientific innovation, and developing safe, effective medical technologies.
While cannabinoid researchers are conducting experiments and clinical trials in an ever more permissive regulatory environment, IP rights such as patents are necessary to ensure medical and commercial viability. In fact, as the regulatory and practical barriers in this field lift, we can only expect IP rights to become more important.
Types of IP protection for cannabinoids
For cannabinoids, IP rights come in various forms, the main classes being patents, trademarks, and copyrights, sitting alongside supplementary protections focusing on plant breeding and variety rights, which are still relevant to pharmaceutical and medical developments2. These protections are granted by designated regulatory bodies in relevant jurisdictions such as the UK, the US and the EU.
The national protections are complemented by an effort to coordinate and harmonise international patent processes by groups such as the World International Patent Office, which sits under the United Nations. This would be welcome given the many different types of patents and the variability of individual countries’ patent laws and processes, as well as the confounding role of applicable case law.
Those applying for patents can focus on different uses for cannabis and cannabinoids, with some researchers suggesting there are seven main categories:
Plant breeder rights (or similar plant variety rights)
Analysis methods
Extractions and methods
Formulation compositions
Devices for medicines delivery and consumption
Specific therapeutic treatments
Auxiliary methods around cultivation or processing
Alternatively, Wyse and Luria (2021) categorise inventions into ‘upstream’ agritech, ‘midstream’ chemistry and analytics, and ‘downstream’ medical and biological innovations.
Patent information from Espacenet that uses the international patent classification system shows that the main class of patents related to cannabinoids fall under the ‘medical or veterinary science’ category. However, patents related to cannabinoid R&D cover a wide range of non-medical topics including agricultural, industrial, forensic and other applications.
Total number of cannabinoid patents
The complexity makes it difficult to assign an exact number of valid patents related to cannabinoid R&D. Some estimates put it between 10,000 and 17,500, while other sources such as Google Patents3, Scopus and Espacenet put the number at 20,000 or more, depending on how the patents are classified.
These figures do not consider the validity and relationships between interrelated patents, and not everything included will be relevant to medicine nor specific to cannabinoids – for example, some items may be technologies that possess a labelled potential application related to cannabinoids, or a patent may be in a non-medical application.
Yet even with these caveats, there is clearly a growing number of patents related to cannabis and cannabinoids worldwide, and it is predicted that this will continue to increase, with positive ramifications for the sector.
Validity of cannabinoid patents
Patent protection for cannabinoids follows various IP pathways pursued by the pharmaceutical industry – especially for organisations working with novel derivatives or formulations that qualify for patent protection. This means that biotech investors can engage with the cannabinoid industry through a value creation model that they are already familiar with.
While patent validity can be challenged on the grounds of lack of novelty, inventive step, insufficiency and so on, there’s nothing unusual about how this area of law applies to cannabinoids when compared to other areas of pharmaceutical R&D. And there are also other ways to protect cannabinoid R&D when patent protection is not available or where disputes are subject to court proceedings.
There are ongoing patent trials and appeals involving companies like GW Pharmaceuticals and its parent Jazz Pharmaceuticals. Meanwhile, many large pharmaceutical companies including Roche, AstraZeneca, Merck, GlaxoSmithKline, Janssen and Pfizer possess patents relevant to cannabinoid medicine. (Espacenet provides further details on cannabinoid patents broken down by applicant4.)
Currently there is no harmonised way of talking about cannabis extracts, or other related terms. Many national pharmacopoeias are inconsistent, as explored in detail by Riboulet-Zemouli (2020)5. For companies seeking to establish IP rights, it is necessary to carefully word documents to align with the relevant legislation for their jurisdictions.
There are also some complications due to the role of ‘prior art’ in cannabinoid science and cannabis plant breeding – the result of decades of restrictive drug control laws, grey area science, and the exploitation of legal loopholes.
Nonetheless, there is a huge opportunity for innovative scientific R&D supported by robust legal protections.
Access and benefit sharing for cannabinoids
Outside of patent law, another important consideration for cannabinoid researchers is the UN Convention on Biological Diversity, implemented in 1993 and later augmented by the Nagoya Protocol that came into effect in 2010. This requires that companies demonstrate fair processes to ensure that biological resources are not exploited, with the UK being an active member67.
In the UK adherence to the Nagoya Protocol is the responsibility of the Department for Environment, Food & Rural Affairs (Defra). Companies using genetic material from other countries are required to follow relevant guidance around benefit sharing activities over any genetic resources related to their innovations, especially if the biological resources are being used commercially.
The extent and nature of the role of the Nagoya Protocol and its legal implications as it relates to cannabis and cannabinoid IP are not entirely clear, and depend on the jurisdiction. But its relevance is only likely to increase given the wider focus on sustainability, fairness, benefit sharing, and safeguards against ‘biological piracy’ with regard to plant resources8 9101112.
Robust framework and growing potential
Ultimately the law is emerging in this area in terms of application, and the situation will be further clarified as legislation is refined and the relevant case law grows. By addressing key legal questions and improving the management of IP rights, an even more robust legal framework for innovative cannabinoid medicine can be developed.
Overall this highlights that cannabinoid science and R&D will continue to be an important area for healthcare, with positive ramifications for patients, and that it is an area the research community will continue to explore for its medical and scientific potential.
Zack Bellman’s academic background is in biological neuroscience from the University of Sussex, MRes in Drug Sciences from University College London School of Pharmacy, researching the use and quality of hemp and CBD products using NMR spectroscopy, and other methods. As a PhD candidate in Pharmacognosy at the UCL School of Pharmacy, current topics of research include medicinal natural products chemistry (analysis using NMR, NIR and Raman spectroscopy), supply chains, medical cannabis, cannabinoids and science communication. He recently joined the CRDG as a researcher looking into cannabinoid R&D.
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