The impact of Intellectual Property in the Medicinal Cannabis Industry
The positive results in the use of Cannabis for the treatment of various medical conditions have sparked discussions, openness, and legalization of this plant in new markets, creating greater opportunities for genetic improvement initiatives and the registration of new varieties.
By Paulo Peralta, Technical Expert at CIOPORA
Medicinal cannabis has shown promising results in the management of neurodegenerative diseases such as Alzheimer's and Parkinson's, as well as in the relief of symptoms of psychiatric disorders such as anxiety, depression, and post-traumatic stress disorder (Bridgeman and Abazia, 2017). Additionally, many patients have found in medicinal cannabis an effective complement in managing chronic illnesses, improving their quality of life and reducing reliance on conventional medications (Gülck and Møller, 2020). These benefits have generated a growing interest from the industry, consumers, and regulatory authorities, leading to increased legalization of medicinal cannabis use in various territories.
Likewise, the increasing interest in medicinal cannabis has resulted in a notable increase in plant breeding activity. Breeding programs in this crop focus on creating new varieties with specific profiles of cannabinoids and terpenes, as well as achieving disease resistance, increased biomass production, and other relevant traits. The main objective is to obtain plants that provide more precise and consistent therapeutic effects.
The increase in plant breeding activity in the field of medicinal cannabis has -therefore- fostered innovation and diversity of therapeutic options, making opportunities for intellectual property protection equally necessary. The current status of intellectual property for the protection of medicinal cannabis has sparked growing interest globally as this emerging industry continues to evolve. With the increasing recognition of the therapeutic benefits of cannabis, it is crucial to understand the various forms of protection available for cannabis varieties and how they have evolved over time.
Throughout this article, different ways of intellectual property protection will be analyzed, focusing on plant patents, utility patents, and plant breeders’ rights. The article will examine how these forms of protection have been applied and specifically adapted for cannabis varieties, considering the challenges and opportunities presented by the ever-changing legal and regulatory framework in this industry.
Intellectual Property Rights
Within the intellectual property tools for cannabis, we find plant breeder's rights, utility patents, and plant patents (exclusive to the United States).
Plant breeders’ rights recognize and protect the efforts and investments of plant breeders in developing new plant varieties with distinct, uniform, and stable characteristics, such as resistance to mildew or higher THC or CBD content. These rights grant the holder exclusivity in the commercialization, production, reproduction, and distribution of the protected variety for a specified period of 20 to 25 years. During this time, others cannot use commercially the protected variety without authorization from the holder. Plant breeder's rights are recognized at national and international levels, and there are international agreements to facilitate the protection of these varieties in different countries. Additionally, breeders can seek protection in multiple jurisdictions through a single procedure, simplifying the process of obtaining rights in various countries.
On the other hand, utility patents are granted for new and useful inventions, machines, manufacturing processes, or improvements thereof. These patents allow the owner to exclude others from manufacturing, using, or selling the invention for a period of up to 20 years from the date of the patent application.
Plant patents, on the other hand, are issued for asexually reproduced plants that are new and distinct, such as mutants, hybrids, and seedlings, excluding plants propagated by tubers or plants found in the wild. These patents, with a duration of 20 years, protect the holder's right to exclude others from asexual reproduction of the plant and from using, offering for sale, or selling the reproduced plant or any part thereof in the United States.
Global Trends in Cannabis Intellectual Property
Analyzing the global situation regarding intellectual property (IP) in cannabis, clear trends can be distinguished over the past 20 years. After the legalization of cannabis for recreational, medicinal, or personal use in pioneering countries such as the Netherlands (1970s), Uruguay (2013), and some states in the United States (2012), there was a transformation in the employed plant breeding methods.
From 2016, there was an exponential increase in the number of applications filed in various registration offices, such as the Community Plant Variety Office (CPVO). This is partly due to more countries legalizing the use of cannabis, including Australia (2016), Argentina (2017), Canada (2018), the United Kingdom (2018), Israel (2021), among others. With an established legal framework and in response to a growing market, the industry began investing in research programs across various areas of the cannabis production process, including the development of new varieties.
However, since 2022, and with a similar trend in 2023, a decrease of up to 50% in the number of registered varieties has been observed. This trend is also observed in other crops, such as ornamental and fruit plants, albeit to a lesser extent, with a 25% decrease (according to information provided by the CPVO). The reasons behind this decline in the development of new varieties have not yet been defined. However, in other sectors of the industry, there is a focus on developing fewer but more complex varieties, with the aim of balancing the costs of maintaining registration.
Fig. 1: Annual number of plant breeder's rights (PBR) granted for Cannabis sativa. Source: PLUTO databases (UPOV, 2023) and CPVO Variety Finder (CPVO, 2023).
When analyzing the global landscape, a predominance can be observed in the registration of plant breeder's rights for medicinal cannabis in the European Union, United Kingdom, Canada, Israel, Australia, Uruguay, Switzerland, and the United States. On the other hand, countries such as Ukraine and Russia have several registrations for industrial use, such as the production of fiber with non-psychoactive varieties.
Fig. 2: Worldwide Intellectual Property Rights Distribution (Patents and DOV). Source, data base PLUTO (UPOV,2023).
The cannabis industry has driven the development of different types of technologies with varying levels of complexity. At the first level, there is agrotechnological research for the improvement of new varieties, genetic modification, evaluation of plant materials, and harvest and post-harvest management technologies. At the second level, there is chemical/analytical research for extraction, purification, and separation methods. And at the third level, there is biological and medical research to combat diseases, develop medical devices, and formulations.
This level of complexity has led to intellectual property (IP) activity extending beyond the protection of plant varieties, resulting in the generation of more patents, particularly utility patents, to protect these inventions. A clear example of this is the United States, where the number of utility patents has grown not only to protect innovation in plant varieties but also for other types of creations. Traditionally, plant patents had been the most common form of protection in the United States, but they have been surpassed by a greater number of applications for plant breeder's rights (PBR).
Fig. 3: Comparacion de la PI de innovaciones de Cannabis en Estados Unidos entre 2018 y 2020. Fuente bases de datos PLUTO, (UPOV, 2023) y USPTO (USPTO, 2023).
In conclusion, intellectual property has gained increasing importance while the therapeutic potential of medicinal cannabis in managing various diseases and disorders is recognized. The demonstrated benefits of medicinal cannabis have led to greater legalization in various territories, resulting in an increase in plant breeding activities to create varieties with specific profiles of cannabinoids and terpenes.
In this context, plant breeder's rights, utility patents, and plant patents emerge as key tools to protect innovations in this field. Plant breeders’ rights acknowledge and protect the efforts of plant breeders, granting exclusivity in the commercialization and reproduction of new varieties. On the other hand, utility patents and plant patents provide protection for inventions and asexually reproduced plants, respectively. Globally, there is an observed increase in intellectual property activity related to cannabis, particularly in countries within the European Union, Canada, the United States, and Australia.
Despite the aforementioned trends, there has been a decrease in the number of registered varieties in recent years, which could be attributed to a shift toward creating more complex and specialized varieties. Overall, the protection of intellectual property plays a fundamental role in fostering innovation and therapeutic diversity in the field of medicinal cannabis, continuously adapting to the challenges and opportunities that arise in this evolving industry.
Bridgeman M.B., Abazia D.T. Medicinal cannabis: history, pharmacology, and implications for the acute care setting. P T. 2017; 4(2):180-88.
Gülck, T., & Møller, B.L. (2020). Phytocannabinoids: Origins and Biosynthesis. Trends in Plant Science. doi:10.1016/j.tplants. 2020.05.005.
U.S. Patent and Trademark Office [USPTO] (2023). Types of Patents. Available in: uspto.gov/web/offices/ac/ido/oeip/taf/data/patdesc.htm.
Oficina Comunitaria Variedades Vegetales [CPVO] (2023). CPVO Variety Finder. Available in: vf.plantvarieties.eu/varieties.
International Union for the Protection of New Varieties of Plants [UPOV] (2023). PLUTO Database. Available in: pluto.upov.int.