As medicinal cannabis (MC) becomes more established in the medicinal sector due to regulatory and attitudinal changes, there has been a corresponding worldwide increase in applications for intellectual property rights in the field. Australia is no exception, there being a steady increase in patent application filings before the Australian Patent Office for inventions related to MC in recent years[1]. However, a closer inspection of these patent filings since 2016 reveals that less than half originated in Australia, and of these, a large portion were from a single entity, Ag Victoria. A similar analysis of the pending PCT patent applications filed recently shows that of the approximately 230 MC PCT applications that have published since May 2021[2], only 4 were filed by Australian entities, with this pipeline being dominated by companies originating in the US, Europe, Canada, Britain and Israel.
This begs the question: Given Australia is emerging as a major force in MC products and research, why are so few patent filings from Australian innovators?
We believe Australian innovators may be missing out on opportunities to secure valuable IP rights for their innovations. In part 3 of this blog series, we consider a few of the potentially hidden areas that patentable inventions may be lurking.
Plants and the production of cannabinoids
Medicinal cannabis is typically derived from Cannabis sativa plants, so when contemplating IP rights associated with MC, many stop at Plant Breeders Rights (PBRs). However, in view of the considerable limitations associated with PBRs as discussed in our next piece, PBRs should not be considered the end game of protection for MC plants and their production.
PBRs protect new plant varieties, but even if a plant is not new, there may be patentable IP in various aspects of the product, and the associated production processes.
For example, the new and inventive processes of cultivation or propagation of a plant may be patentable for an old product. Novel cultivation methods based on growth conditions that result in the improved yields of cannabinoids or important secondary metabolites such as terpenes and phenolic compounds in the plants may be patentable, as may be novel methods that enhance growth in difficult conditions, such as indoors or in arid/salinated environments. New vegetative propagation or micropropagation methods developed to maintain the supply chain of the MC biomass, along with precision harvesting and crop protection innovations can also be the source of patentable subject matter.
Another area that is expected to be patentable is the development of genetically engineered plants, expression hosts and synthetic methods for the production of cannabinoids (native, modified or new) in a range of scalable systems, such as microbes or disease resistant plants.
Processing technologies, formulations and delivery methods
There is a wealth of intellectual property to be found in the production of administrable MC, which generally starts with the extraction of the active compounds from the plant or expression host. Patent applications to extraction and purification methods for MC products are common, as novelty can be found in methods that produce more stable or pure extracts, extracts with desirable ratios of cannabinoids to secondary metabolites, or separate cannabinoids with different chemical modification patterns.
Administering bioavailable cannabis products to a patient via appropriate delivery methods (such as a tablet or oil, injection or a topical composition) has only been made possible by the development of novel bioprocess engineering operations and formulation chemistry, and will only be expanded by continued innovation in the space. In traditional Pharma domains, these mid-downstream technologies are one of the main sources of IP rights, as specific therapeutics generally require specific bioprocesses to be developed around them when scaling-up, and these bioprocesses are often novel and inventive by necessity.
This is an area that should not be ignored by MC innovators, as it represents a major part of the product development pipeline, and novel formulations with advantageous properties that have been painstakingly optimised can generally be easily reverse engineered by a competitor with enough motivation.
Methods of treatment and dosage regimes
Last but not least, methods of treatment (or equivalent type inventions) are patentable in most major jurisdictions. In view of there being a long history of prior art that suggests the usefulness of MC for the treatment of a range of ailments, standard method of treatment inventions for known indications may be difficult to secure. However, there is still a considerable amount of free IP space for novel dosage regimes (i.e. use of 50mg of specific cannabinoid, administered once every 2 weeks, for the treatment of pain), new indications, or methods of treatment that require the co-administration of a cannabinoid with another compound.
Closing comments
We emphasise the value of patent rights to MC innovators in Australia, not just as an exclusive right to protect your commercial assets and “shore up” your revenue stream, but also as an asset that can be traded, licenced, used as a marketing tool, or as an incentive to secure further investment.
[1] Search of Australian Patent Office database, based on effective filing date of published patent specification with the terms “cannabis” or cannabinoid” in the claims, with the term “medicinal cannabis” in the description.
[2] PCT application are only published 6 months after filing; PCT applications published in the last 12 months would correspond to applications filed November 2020 – November 2021