Claiming biotechnological inventions
Under Section 25(4) of the Patents Act (57/1978), a patent will not be granted for:
- inventions whose publication or exploitation would generally be expected to encourage offensive or immoral behaviour (eg, a patent for an apple tree containing a gene which expresses a protein in apples that acts as an aphrodisiac in humans); or
- any animal or plant variety or any essentially biological process for the production of animals or plants, which is not a microbiological process or the product of such a process.
To understand what an 'essentially biological process' for the production of animals or plants and a 'microbiological process' (or the products of such a process) means in the absence of South African court cases dealing with these definitions, guidance can be obtained from the EU Directive on the Legal Protection of Biotechnological Inventions (98/44/EC), which entered into force on 30 July 1998.
The definitions set out in the directive are as follows:
- 'Biotechnological inventions' are inventions that concern a product consisting of or containing biological material or a process by means of which biological matter is produced, processed or used.
- 'Biological material' is any material containing genetic information and capable of reproducing itself or being reproduced in a biological system.
- A process for the production of plants or animals is 'essentially biological' if it consists entirely of natural phenomena (eg, crossing or selection).
- A 'microbiological process' is any process involving or performed on or resulting in microbiological material.
- A 'plant variety' is any plant grouping within a single botanical taxon of the lowest known rank, which, irrespective of whether the conditions for the grant of a plant variety are fully met, can be:
- defined by the expression of characteristics that result from a given genotype or combination of genotypes;
- distinguished from any other plant grouping by the expression of at least one of the said characteristics; and
- considered as a unit with regard to its suitability for being propagated unchanged.
Biotechnological inventions will also be patentable if they concern:
- biological material which is isolated from its natural environment or produced by means of a technical process, even if it previously occurred in nature;
- plants or animals if the technical feasibility of the invention is not confined to a particular plant or animal variety; and
- a microbiological or other technical process or a product obtained by means of such a process other than a plant or animal variety.
Patents will not be granted in respect of biotechnological inventions which, in particular, concern:
- processes for cloning human beings;
- processes for modifying the germ line genetic identity of humans;
- the use of human embryos for industrial or commercial purposes; and
- processes for modifying the genetic identity of animals that are likely to cause them suffering without any substantial medical benefit to humans or animals, as well as animals resulting from such processes.
The human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions. However, an element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element.
Proposed test of patentability of life sciences invention
When considering the patenting of a life sciences invention in South Africa, the following questions should be considered:
1. Is the invention novel?
If YES – see next question
If NO – end of enquiry.
2. Is the invention inventive?
If YES – see next question
If NO – end of enquiry.
3. Is the invention useful? i.e. Is the invention capable of being used or applied in trade/industry/agriculture?
If YES – see next question
If NO – end of enquiry.
4. Is the invention excluded by section 25(2) as being patentable?
If YES – end of enquiry
If NO – see next question.
5. Would the publication or exploitation of the invention encourage offensive or immoral behaviour?
If YES – end of enquiry
If NO – see next question.
6. Does the invention pertain to a variety of animal/plant or an essentially biological process for the production of animals/plants not being a microbiological process/product of such a process?
If YES – end of enquiry
If NO – see next question.
7. Does the invention pertain to the cloning of a human being?
If YES – end of enquiry
If NO – see next question.
8. Does the invention pertain to the modification of human germ line genetic ID?
If YES – end of enquiry
If NO – see next question.
9. Does the invention pertain to the use of human embryos for industrial/commercial purposes?
If YES – end of enquiry
If NO – see next question.
10. Does the invention relate to the modification of the genetic identity of animals causing "unjustifiable" suffering?
If YES – end of enquiry
If NO – see next question.
11. Does the invention pertain to the human body at the various stages of its formation and development and not to the simple discovery of one of its elements including the sequence or partial sequence of a gene?
If YES – end of enquiry
IF NO – THEN IT IS PATENTABLE.
Section 25(11) of the Patents Act (57/1978) states that inventions which constitute a method of treatment of humans or animals by surgery or therapy or of diagnosis practised on humans or animals will not be patentable.
However, this will not prevent a product consisting of a substance or composition from being patentable merely because it is invented for use in any such method. Such a product is therefore patentable, provided that all of the other criteria for patentability are met.
The Concise Oxford English Dictionary sets out the following definitions:
- 'Surgery' is the treatment of bodily injuries or disorders by incision or manipulation, especially with instruments.
- 'Therapy' is treatment intended to relieve or heal a disorder or treatment of mental or psychological disorders by psychological means.
- 'Diagnoses' means the identification of the nature of an illness or other problem by examining of the symptoms.
It is generally accepted that the term 'therapy' should be construed in its wider sense as meaning the medical treatment of disease, including both preventative and curative treatments. Notably, the treatment referred to herein as being unpatentable must be practiced on the human body (in vivo). In such cases, the diagnosis practised in vitro would be patentable.
Method of treatment claims – for example, "a method of treating [condition Y] comprising administering [compound X]" – are not permitted in South Africa.
Section 25(9) of the Patents Act states that in the case of an invention consisting of a substance or composition for use in a method of treatment of humans or animals by surgery or therapy, or of diagnoses practised on humans or animals, the fact that the substance or composition forms part of the state of the art immediately before the invention's priority date, will not prevent a patent being granted for the invention if the use of the substance or composition in any such method does not form part of the state of the art at that date. Thus, the novel and inventive use of a known substance is patentable.
Under the European Patent Convention 2000 claim form, second medical uses – for example "[Compound X]* for use in the treatment of [condition Y] (*where compound X is a known compound" – are permitted.
Strictly speaking, South Africa does not permit patents covering new uses of known pharmaceutical compounds (ie, second medical use claims). Following the European provision, the Patents Act provides that a known substance can be claimed for use in a method of medical treatment only the first time that it is disclosed as being useful in a medical treatment. The South African courts have confirmed this.
Once the use of the compound in a method of medical treatment has formed part of the state of the art, it cannot then be claimed a second time in respect of a new medical use.
In order to overcome this prohibition, South Africa has adopted Swiss-type claims to provide protection in instances where a second medical use is sought to be protected. This serves as a mechanism by which second medical uses are protectable in South Africa, albeit through the Swiss form and not via direct protection of the second medical use.
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