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South Africa

Patentability of Cannabis Varieties

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Cannabis breeding involves the direct manipulation of cannabis species to create desired phenotypes, for example to increase or decrease cannabinoid or tetrahydrocannabinol (THC) levels.  Traditionally, cannabis breeders employed techniques of selective pollination followed by artificial selection of progeny and/or vegetative propagation (cloning).  However, genetic engineering of cannabis is emerging as a rapid method of optimising cannabis strains, particularly for large-scale production of cannabinoids in the pharmaceutical industry.

Under the Patents Act, any invention which is new, involves an inventive step and which can be used or applied in trade, industry or agriculture, may be eligible for a patent in South Africa.  Certain inventions are excluded from patent eligibility, including any variety of plant or any essentially biological process for the production of plants, provided same is not a micro-biological process or the product of such a process.  Although to date, South African case law has not elucidated what constitutes “essentially biological”, the European patent law interpretation can be loosely followed.  Specifically, the G3/19 (“Pepper”) decision of the Enlarged Board of Appeal (EBA) found that unless there is an additional step of a technical nature which modifies a genomic trait of a plant, the process/product is “essentially biological”.  Therefore, cannabis varieties produced by traditional selective pollination, also known as sexual reproduction, and vegetative propagation, will likely not be considered eligible subject matter for a patent in South Africa.  However, where a technical step has been used in addition to such techniques, or where genetic engineering has been utilised, to modify a genomic trait of the cannabis plant, this may be eligible subject matter for a patent in South Africa.  Patent protection may be considered for the process, the product and the use of the product.

Importantly, this creates a distinction between that which can be protected by patents and that which can be protected by plant breeders’ rights.  In the case of varieties produced by essentially biological processes, plant breeders’ should consider plant breeders’ rights as a strong alternative to patents.  Contact us for assistance in patents and plant breeders’ rights applications in South Africa.

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