Australia: Focus On Medicinal Marijuana: Obtaining Intellectual Property Rights For New Medicinal Cannabis Varieties

In jurisdictions where recreational cannabis use is legal, traditional selective breeding techniques have been used to develop thousands of new cannabis varieties or strains. With the recent enactment of legislation that permits the cultivation of medicinal cannabis in Australia, we are likely to see growth in the commercial development of new cannabis varieties with specific therapeutic traits, as opposed to recreational traits (e.g., euphoria or creativity).

In this first part of a three part series, we highlight the options available for protecting new cannabis plant varieties under Australia's intellectual property regimes. 
For Part 2 click here, for Part 3 click here.

Cannabis strain development for therapeutic use  

The legalisation of medicinal and recreational cannabis in several US states, Canada and some European countries has resulted in a new economic market from what was previously an illegal trade. New cannabis varieties with enhanced psychoactive and flavour characteristics that are designed to appeal to recreational users have been cultivated and aggressively marketed in the US. For example, Cookies Co, utilises a sophisticated marketing model to brand and market "luxury" cannabis varieties, such as "Cookies Kush" and "Birthday Cake". By partnering with celebrities and artists, these "luxury" cannabis products are associated with a specific lifestyle/brand identity that allows such products to be offered at premium prices.

Although it is likely that there will also be significant growth in the economic market associated with medicinal cannabis varieties, there are a number of key differences in the way that these varieties will be developed and marketed to consumers. In this context, it is important to recognise that recreational cannabis varieties are largely associated with high levels of psychoactive compounds. Tetrahydrocannabinol (THC) is currently understood to be the main psychoactive compound of cannabis, while cannabidiol (CBD) is associated with antipsychotic and anxiolytic effects. In the recreational context, traditional breeding programs aimed at developing new cannabis varieties with high levels of THC are generally favoured. This is to be contrasted with cannabis varieties that are bred specifically for medicinal use, where it is generally desirable to avoid or minimise the level of psychoactive compounds such as THC and CBD. Therefore, there is a clear distinction between cannabis varieties for medicinal use when compared with recreational use. 

Furthermore, medicinal cannabis varieties are also subject to more stringent quality control and regulation. The prescription of medicinal cannabis varieties and products must be supported by scientific evidence to establish the efficacy and safety of these products. In Australia, all medicinal cannabis products derived from seeds, extracts, resins, plants or plant parts must also conform to the Therapeutics Goods Order (Standard for Medicinal Cannabis), which requires consistency between batches, positive identification of the source plant and quality testing for the presence of contaminants, such as alflatoxins, foreign matter and heavy metals.

Obtaining intellectual property protection for new cannabis plant varieties

New cannabis plant varieties are eligible for Plant Breeder's Rights (PBR) protection, as well as patent protection, each of which offer differing scopes of protection.

Plant Breeder's Rights

PBR protection is available in Australia for new plant varieties that are created through traditional breeding programs and/or genetic engineering.  To be eligible for PBR protection, a plant variety must be new, distinct, uniform and stable. In order to be considered "new", a plant variety must not have been sold by or with the consent of the breeder in Australia more than 12 months before the filing date of the PBR application, or outside of Australia more than 4 years before the PBR application is filed (6 years for trees and vines). To be "distinct", a plant variety must have at least one key characteristic that distinguishes it from similar varieties known to exist at the time of filing the PBR application. A plant variety will be sufficiently "uniform" if any variations in key distinguishing characteristics are predictable. Finally, "stability" is satisfied where the key distinguishing characteristic(s) remain unchanged over successive generations.

Registered PBRs offer a period of protection of up to 20 years for most plant species (25 years for grapevines and trees). The exclusive rights afforded by a registered PBR include the production or reproduction of propagating material; conditioning the propagating material (i.e. cleaning, coating, sorting, packaging and grading); selling or offering the propagating material for sale; and importing or exporting the propagating material. In limited circumstances, the exclusive rights afforded by registered PBR protection also extend to material harvested from the variety and "essentially derived varieties" (i.e. varieties predominantly derived from the protected variety, retaining the essential features and not exhibiting any important features that differentiate it from the protected variety).

Unlike registered patent protection, as outlined below, there are currently no Australian laws that would exclude cannabis varieties from PBR protection, regardless of the purpose for which they are bred (i.e., recreational, industrial or medicinal)1.  Despite this, whilst several varieties of industrial hemp (Cannabis sativa) have been granted PBR protection in Australia, there are currently no other cannabis varieties on the Australian PBR Register. 

Similar plant variety protection is also available in other jurisdictions, including the US and Europe. US Plant Variety Protection is analogous to Australia's PBR regimen and can be used to protect new, sexually reproduced plants, including first generation (F1) hybrids and tuber propagated plants (e.g. potato varieties). The requirements and term of protection offered are largely identical to those of an Australian PBR.  The US Plant Variety Protection Act also requires that a deposit of seeds of the new variety be made at an authorised depositary, and in the case of F1 hybrids, seeds of the parents must also be deposited.  Similarly, European Community Plant Variety Rights provide unitary, EU-wide rights for the protection of new, distinct, stable and uniform plant varieties.

Patents

In Australia, patent protection is available for new plant varieties, as well as for plant parts (e.g., seeds, whole cuttings, cells, cell lines and protoplasts), plant products (e.g., fruit, flowers, oils, plant-derived compounds), bioprocessing (e.g., methods of extracting plant-derived compounds) and methods of producing plant or plant varieties (e.g., traditional breeding, genetic modification, marker assisted selection or embryo rescue).

To be eligible for patent protection, the plant or plant-related invention must be at least novel and non-obvious.  Care must also be taken to ensure that the patent specification provides sufficient written description that would allow others to reproduce the invention.  For instance, the patent specification should include a description of the parent strains, the method(s) by which the new plant variety was generated/selected and the phenotypic/genotypic characteristics of the new plant variety.  In many cases, it can be very difficult to adequately describe in writing an invention that is, or relies upon the use of, newly identified biological material such as a plant or plant part.  In those circumstances, the written description requirement can be satisfied by relying on a deposit of the plant material that has been made at an international depository under the Budapest Treaty, bearing in mind that the deposit should be made before the initial patent application has been filed.

It is important to note that, under current Australian law, a patent cannot be granted to an invention whose primary purpose would be "contrary to law". The position that has been taken by the Australian Patent Office is to refuse a patent where an unlawful use, but no lawful use, of the invention has been disclosed in the patent specification.  In the past, this has meant that patent protection was unavailable for new varieties of cannabis or cannabis-related inventions as their cultivation and use were generally prohibited by law. However, recent amendment to the Narcotic Drugs Act 1967 (Cth) has meant that it is now legal to produce and cultivate cannabis and cannabis resin for medicinal and scientific purposes.  Details of the amendments to the Narcotic Drugs Act 1967 (Cth) can be found here.  As a result of the amendments to the Narcotic Drugs Act, we are likely to see an increase in the number of Australian patent applications directed to new cannabis varieties and cannabis-related inventions.  To secure patent protection in Australia for new cannabis varieties it will be important to ensure the patent specification is appropriately drafted so as to not fall foul of the "contrary to law" provisions.

In other jurisdictions, patent protection for plants and plant-related inventions is much more limited. In Europe, for example, plants obtained by essential biological processes, such as traditional breeding techniques, are currently ineligible for patent protection, although patent protection may still be available where the plant was obtained using genetic engineering (e.g., genetically modified plants).  This is to be contrasted with Canada, where patent protection is not available for plants, whether obtained by traditional breeding techniques or by genetic engineering. 

In the US, new plants and plant varieties can be protected by Plant Patents and Utility Patents.  Plant Patents are only available for new and distinct plant varieties, as well as cultivated spores, mutants, hybrids and seedlings, that are stable and reproduce asexually (e.g., by grafting, bulbs, apomictic seeds, rhizomes and tissue culture). US Plant Patents are not available for tuber-propagated plants and plants found in an uncultivated state.  In contrast to US Plant Variety Protection, it is unnecessary to deposit the claimed plant of a Plant Patent at a recognised depositary.

Utility Patents are far less restrictive than US Plant Variety Protection and Plant Patents, as they are available for new and distinct plants produced by either sexual or asexual reproduction.  They can also be used to protect plant parts, including seeds and tissue cultures, and methods of generating or using plants or plant parts (e.g., methods of processing plants to extract useful compounds; methods of generating transgenic plants using genetic engineering). The criteria for the grant of a utility patent are substantially identical for non-plant-related inventions, where the plant or plant-related invention must be at least new and non-obviousness.

Similar to Australia, it is possible to secure concurrent protection for a new plant variety by both PBR and patents in the US, provided that the requirements for protection for each type of intellectual property right is fulfilled.

As noted above, up until now patent protection has typically not been available in Australia for cannabis varieties that have been bred or generated primarily for recreational use, as such use would be considered contrary to law.  This is to be contrasted with the US, where there is no such bar to patentability for illegal products and uses.  Indeed, the US Patent and Trademark Office has recently awarded a plant patent for a new recreational strain of cannabis called Equadorian Sativa (US Plant Patent No. PP27,475), which is said to exhibit "(a) medicinal properties that included hypotensive activity; and (b) psychoactive properties that motivated and energized, rather than creating lethargy, sleepiness, and increased food consumption".

The Open Cannabis Project

In response to the granting of patents for medicinal cannabis varieties and products, a movement has emerged in the US to prevent the grant of patents for known cannabis varieties. The Open Cannabis Project (opencannbisproject.org) seeks to limit the ability of companies and individuals obtaining patent protection for existing cannabis varieties by publishing the genomic sequences of cannabis varieties that have previously been developed for recreational and therapeutic use. According to the Open Cannabis Project website:

          "The only thing that can block a plant patent is proof that the plant is not new. Anything that has been public for more than a year cannot be patented. It's in the public domain, and it belongs to everyone."

Whilst the Open Cannabis Project was created as a way of limiting patent protection for cannabis varieties, it is nevertheless a useful tool that can be used to carry out a preliminary search to ensure that your variety is new.

Summary

The recent legalisation of medicinal cannabis in Australia represents a milestone in healthcare and medicine, but the full potential of the therapeutic benefits available will likely only be realised with effective intellectual property rights protection. Unlike recreational cannabis varieties, the development and breeding of new cannabis varieties specifically for therapeutic use will require significant financial investment to bring such products to the market.  It is well recognised that such financial investment is largely dependent on adequate intellectual property protection to ensure a return on that investment. Consideration should therefore be given to ensuring that the identification and development of new medicinal cannabis varieties is supported by adequate intellectual property protection.

Patents and registered plant variety protection are available in most jurisdictions to protect new cannabis varieties. However, as the laws governing eligibility vary significantly across major jurisdictions, including the US, Europe and Australia, it is important to ensure you have an appropriate filing strategy in place that will account for those differences and provide appropriate coverage for the important commercial embodiments of your innovation.

If you have any questions about intellectual property rights for medicinal cannabis, or for plant-related innovations in general, our experts at DCC and DCCL will be glad to assist.

Footnotes

1.Section 42 of the Australian Plant Breeder's Rights Act 1994 allows for regulations to be made to exclude a botanical group of plants from the operation of the Act (i.e., to render that group of plants unregistrable), although there are currently no such exclusions.

26 September, 2017

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