GENETICALLY MODIFIED PLANTS: MAKING DUAL PROTECTION A PRIORITY
Providing Protection for Plant Varieties
The Agreement on the Trade Related Aspects of Intellectual Property Rights (TRIPS), to which South Africa together with all other World Trade Organization member countries are signatories, mandates in Article 27(3)(b), that members may exclude plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes from patentability.
TRIPS goes on to state that members shall provide for the protection of plant varieties either by patents or an effective sui generis system or by a combination thereof.
In South Africa the exclusion of plant varieties from patentability is qualified in that only plant varieties which are produced by non-microbiological processes or by essentially biological processes (i.e. conventional breeding techniques) are excluded, as is evidenced by Section 25(4)(b) of the Patents Act 57 of 1978. This section provides that: “A patent shall not be granted for any variety of animal or plant or any essentially biological process for the production of animals or plants not being a micro-biological process or the product of such a process.”
Where a variety has been bred by conventional means such variety is protectable by way of Plant Breeders’ Rights, which are dealt with in the Plant Breeders’ Rights Act 15 of 1976.
The International Convention for the Protection of New Varieties of Plants (UPOV Convention), of which South Africa is a member, recognizes that both conventionally produced varieties and genetically engineered varieties can be protected by means of plant breeders’ rights protection. Therefore, it is possible that dual protection by way of a patent and a plant breeders’ right may well be possible where the Patents Act does not specifically exclude plant varieties from protection.
The qualified exclusion relating to the patentability of plant varieties
This exclusion, as discussed above, has not as yet been litigated upon in South Africa therefore when interpreting this section recourse must be had to foreign law more particularly recourse is had to litigation that has dealt with the interpretation of Article 53(b) of the European Patent Convention. Article 53(b), which is nearly identical to Section 25 (4) (b), reads as follows:
“European Patents shall not be granted in respect of plant or animal varieties or essentially biological processes for the production of plants or animals; this provision does not apply to microbiological processes or the products thereof.”
In Novartis Transgenic Plant v EPO Enlarged Board of Appeal the court held that “variety” includes a variety produced by genetic engineering techniques as well as a variety produced by conventional breeding techniques.
The meaning of “essentially biological” was litigated upon in Lubrizol Hybrid Plants v EPO Technical Board of Appeal , where the court held that it has never been in dispute that classical breeder’s methods involving selection and crossing and propagation to breed new and different varieties of plants are essentially biological in nature notwithstanding that human intervention brings the crossing about. The court held further that whether or not a non-microbiological process amounts to an essentially biological process as per Article 53(b) depends on what the essence of the invention is taking into account, the totality of human intervention and its impact on the result achieved. This was confirmed in Novartis Transgenic Plant v EPO Enlarged Board of Appeal.
The decision in Plant Genetic Systems v EPO Technical Board of Appeal held that where at least one technical step, which cannot be carried out without human intervention, is employed in the production of such a plant the plant can not be excluded from patentability as this step is not essentially biological in nature. In general terms the introduction of a specific gene into the genetic make-up of a plant by human intervention is not considered essentially biological as the resultant plant would not be produced without such human intervention.
The meaning of “microbiological” was interpreted in Plant Genetic Systems v EPO Technical Board of Appeal where the court held that a microorganism is deemed to include all generally unicellular organisms with dimensions beneath the limits of vision. Microbiological in this section is deemed to refer to technical activities in which direct use is made of micro-organisms.
The upshot of these cases is that plants, which are produced either by processes which are not essentially biological in nature or by microbiological processes (the plant being the product of such process), as well as processes for the production of plants which are not essentially biological in nature, are not necessarily excluded from patentability and hence it is possible that in some instances protection under both the Patents Act and the Plant Breeders’ Rights Act may be sought.
Genetic Engineering and Genetically modified plants
Genetic Engineering is the process by which an organism’s genetic information is deliberately modified by directly changing its nucleic acid genome. Genetic Engineering has been used extensively to modify the genomes of a variety of different plants. Genetically modified plants are not produced by essentially biological processes. This is confirmed in the Genetically Modified Organisms Act 15 of 1997, which states that “a genetically modified organism means an organism the genes or genetic material of which has been modified in a way that does not occur naturally through mating or natural recombination or both.”
In order to understand how such plants may be protectable under the Patents Act it is fundamental that the processes by which such plants are produced is understood. In general terms there are two manners in which plants are genetically engineered, the first being transfection with a micro-organism (Agrobacterium tumefaciens), and the second being microprojectile introduction using a gene gun.
In the first method the gene which is to be incorporated into the plant is incorporated into the genetic make-up the micro-organism which is then used to infect the plant. During the infection process the gene to be transferred is transferred into the plant’s genome. Once the required gene has been correctly incorporated the plant will begin expressing such gene and will effectively show the desirable characteristics associated with such gene. These characteristics can make a plant more drought resistance, frost resistance or more resistant to various pests, to name a few examples. This process is a microbiological process and the genetically engineered plant produced by this process is the product of such microbiological process.
In the second method a microprojectile is coated with the gene to be incorporated and shot into the plant cell to be transformed. Once the relevant gene is incorporated in the plant genome the plant will begin expressing such gene and display the relevant traits associated with that gene. This process is a human mediated process containing at least one technical step which could not be carried out without human intervention and therefore such process is not an essentially biological process.
Dual Protection: Requirements, Term and Rights Acquired
As stated dual intellectual property protection for genetically modified plants is possible under the Patents Act and the Plant Breeders’ Rights Act.
To obtain protection under the Patents Act the invention must be new, it must involve an inventive step and it must be capable of being applied in trade or industry or agriculture. In terms of the Patent Act an invention is deemed to be new if it does not form part of the state of the art immediately before the priority date (first filing date) of that invention. This means in order to obtain patent protection there must be absolute worldwide novelty.
The term of protection for a patent is 20 years from the date of application subject to the payment of the prescribed renewal fees.
Once the patent has been granted the patentee will obtain the right to exclude others from making, using, exercising, disposing of or offering to dispose or importing the invention so that he or she shall have and enjoy the whole profit and advantage accruing by reason of the invention.
To obtain protection under the Plant Breeders’ Rights Act the variety must be a prescribed variety of plant that is new, distinct, uniform and stable. In terms of the Plant Breeders’ Rights Act a variety is deemed to be new if propagating material or harvested material thereof has not been sold or otherwise disposed of by, or with the consent of, the breeder for purposes of exploitation of the variety in the Republic, not more than one year; and in a convention country or an agreement country, in the case of varieties of vines and trees, not more than six years; or other varieties, not more than four years, prior to the date of filing of the application for a plant breeder’s right. Therefore in terms of plant breeders’ rights protection absolute worldwide novelty is not required.
The term of protection for a plant breeders’ right is 25 years in the case of trees and vines and 20 years in all other cases from the date of grant subject to the payment of the prescribed renewal fees.
Upon grant the holder of the right shall be entitled to exclude others from undertaking the following acts in respect of such variety without obtaining prior written authority and license from the proprietor of the right to do so: producing or reproducing (multiplication) the variety; conditioning the variety for the purpose of propagation; sale of or any other form of marketing of the variety; exporting or importing the variety; stocking propagating material or harvested material of the variety, including plants, which were obtained through the unauthorized use of propagating material of for any of the above mentioned purposes.
Dual Protection: Playing with priorities
As can be seen above the novelty requirements for patents and plant breeders’ rights are different, a patent requiring absolute worldwide novelty and a plant breeders’ right having a novelty grace period of between 1 and 6 years depending on the type of plant and where it has been commercially exploited.
Therefore it is possible to file a plant breeders’ rights application after the application for the patent has taken place and provided that such filing in within the novelty grace period the patent will not have an adverse impact on the novelty of the plant breeders’ rights application and accordingly different priority dates for each application can be obtained.
The difference in how the terms and the required novelty standards of these rights work means that, if for instance, you file a patent in South Africa, in respect of a genetically engineered vine, and only begin exploiting the plant commercially within South Africa 5 years after filing the patent, at the beginning of year 6 you could file a plant breeders’ rights application in respect of the same variety, as such variety has only been disposed of in the Republic by or with the consent of the breeder for one year. The plant breeders’ rights application could take up to 7 years to grant whereafter the term of protection would being to run. This would mean that you would have patent protection for 14 years before obtaining plant breeders’ right protection. Once the plant breeders’ right is granted at year 14 you would then get an additional 25 years of protection for the variety in respect of the plant breeders’ right.
The result would therefore be 14 years of patent protection, 6 years of dual protection and 19 years of plant breeders’ rights protection which would mean the same variety of plant could be protected for a total of 39 years before all intellectual property protection relating to such variety would expire.