IP rights for genetically modified plants and other GMOs
Genetically modified (GM) plants enjoy intellectual property protection under patent and plant breeders’ rights (PBR), as well as other statutory provisions, and are additionally affected by legislation in cases where the plants are associated with an indigenous source or traditional knowledge. The interrelationships between the respective statutory and IP rights and obligations are investigated below, with specific reference to GM plants and other organisms (GMOs).
Plant Breeders’ Rights Act 1976
New plant varieties produced through biological processes are protected exclusively in terms of the PBR Act. However, GM plants of unspecified varieties could additionally be subject to patent protection, as they are not strictly new varieties of plants that are produced through biological processes.
To qualify for PBR protection, a variety must be new, distinct, uniform and stable.
The holder of the right shall be entitled to exclude others from undertaking acts such as producing or reproducing the variety or conditioning the variety for the purpose of propagation; sale, or any other form of marketing.
Under the act, any person has the right to use varieties that are protected under PBR for the development of new varieties, known as “breeders’ privilege”. Should a trait present in the variety in question be protected additionally by a patent, the breeders’ privilege could be curtailed by the patent, so that a party which exercises its rights in terms of the PBR Act, could thereby infringe the patent.
Sections 45 and 65 of the Patents Act dealing with the exhaustion of patent rights and so-called Bolar provisions, respectively, provide some reprieve. However, the ever-increasing conflicting rights granted in terms of the Patents and PBR acts are a cause of concern for breeders.
For example, the PBR in respect of a GM tree would endure for 25 years, whereas a patent in respect thereof would lapse after 20 years. This clearly illustrates the advantage of obtaining protection under both forms of IP rights.
Genetically Modified Organisms Act 1997
The GMO Act governs the responsible development, production, use and application of GMOs. Its aim is to ensure that all related activities are carried out in a way that limits any harm to the environment.
A GMO is an organism in which the genetic material has been changed in a way that does not occur naturally through the usual reproductive process. Genetic engineering has been used extensively to modify the genomes of a variety of different plants.
"The Plant Breeders' Rights in respect of a GM tree would endure for 25 years, whereas a patent in respect thereof would lapse after 20 years. This clearly illustrates the advantage of obtaining protection under both forms of IP rights."
A permit is required to conduct any such activity in South Africa. Permit number 17/3(5/01/177) was granted to Monsanto SA (Pty) Ltd for the conditional release of the MON810 trait, or ‘event’, and exclusive rights to allow planting of seed containing the event. Monsanto has commercialised maize varieties transformed with the MON810 gene sequence under the YieldGard trademark since 1998 and licensed the technology to other seed companies. South African patent ZA90/1417 to Monsanto in respect of GMPs containing the MON810 trait lapsed in 2010 and other seed companies are now free to apply for a permit. Until a permit is issued to another seed company, Monsanto SA retains its exclusive right granted in respect of the permit, including the right to license the technology to other entities.
Bolar provision
Section 69A was inserted into the SA Patents Act in 2002, detailing certain acts of non-infringement.
This section provides that it shall not be an act of infringement of a patent to make, use, exercise, offer to dispose of, dispose of, or import a patented invention on a non-commercial scale and solely for the purposes reasonably related to obtaining, development and submission of information required under any law that regulates the manufacture, production, distribution, use or sale of any product.
However, the act has no express provision excluding experimental activity from the ambit of patent infringement. Prior to the amendment, the legal position was that experimental ‘use’ of an invention, ie, experimental work for purposes of market registration, did amount to infringement.
The GMO Act similarly provides for an exemption from the requirement of a permit in Regulation 2(2), for organisms that are used under conditions of contained use in academic and research facilities, and for those organisms specified as GMO events that have obtained general release or commodity clearance authorisations.
Interaction between the Patents and PBR acts
IP protection for GMPs is possible under both the Patents and the PBR acts. The novelty requirements are different, a patent requiring absolute worldwide novelty and a PBR having a novelty grace period of between one and six years.
It is possible, therefore, to file a PBR application after the application for the patent has taken place and, provided that such filing is within the novelty grace period, the patent will not have an adverse impact on the novelty of the PBR application.
Although the right granted in terms of a patent could be regarded as a negative right, certain positive rights are granted in terms of the Patents Act such as the Bolar and exhaustion of rights provisions. However, the rights granted under certain other IP acts, such as those granted in terms of the PBR Act, could be curtailed by the negative rights granted by a patent.
At van Rooy is a patent attorney and director at DM Kisch Inc. He can be contacted at: atv@dmkisch.com
