Similarly to the British Patents Act and the European Patent Convention, the South African Patents Act excludes from patentability a method of treatment by therapy of the animal or human body.
A question that can arise is whether any method implemented outside of a patient's body could ever be construed as relating to a method of treatment by therapy of an animal or human body.
Initially, one might think that surely, in order for any method to count as a therapeutic method of treatment, it must have some therapeutic effect in a patient's body, and that accordingly any method practised outside of the patient's body that does not in itself have a therapeutic effect on the patient's body could never count as a therapeutic treatment when assessing whether the exclusion from patentability applies.
However, an example worth considering is an extracorporeal method of treating unhealthy cells or tissue obtained from a patient so that the treated cells or tissue can be returned to the patient, as in for example when a patient's blood is treated by a blood dialysis and returned to the patient.
Would the legislative exclusion of therapeutic methods from patentability be avoided if the invention were to be defined as only being the part of the procedure in which the patient's tissue is treated outside of the patient's body? After all, it is up to the patentee to formulate a definition of the invention for which a patent monopoly is sought. In particular, the invention must be defined in one or more claims in a patent specification, which is a document which must be provided when a person applies for a patent.
If a patentee were to define an invention for which protection is claimed in terms of extracorporeally treating unhealthy tissue obtained from a patient and then returning the treated tissue to the patient in a continuous, closed loop system such as in a blood dialysis, it is hard to see why this should not be regarded a method of therapeutically treating an animal or human body, and thus be unpatentable because of the exclusion in the Patents Act.
However, would the situation be different if a patentee were to define an invention for which protection is claimed as an exclusively extracorporeal method of treating unhealthy tissue obtained from a patient? In other words, what would be the situation if protection is only claimed for the part of the procedure that takes place outside of a patient's body?
A first issue to consider is the history and purpose of the exclusion from patentability of a method of treatment by therapy of the animal or human body.
The European Patent Convention came into force prior to the present South African Patents Patent, as did the British Patents Act. One can reasonably infer that the purpose of the exclusion of therapeutic methods from patentability in the South African Patents Act will be the same as for the same exclusion to be found in the European Patent Convention and the British Patents Act. It can also be noted that the United Kingdom is a member of the European Patent Convention, it in fact being amongst the first group of countries for which European Patent Convention came into force. It is thus unsurprising that the exclusion of therapeutic methods in the British Patents Act is aligned with the exclusion to be found in the European Patent Convention.
It is generally accepted that the reason for the exclusion from patentability of therapeutic treatments in the European Patent Convention was to avoid an undue interference in the doctor-patient relationship if therapeutic treatment methods were generally to be patent-eligible subject matter, albeit that an exception was made to this to provide for the patent eligibility of substances and compositions intended for use in such a treatment (exceptions are also made in the British and South African patent legislation). The exclusion of therapeutic methods from patentability in the South African Patents Act can thus reasonably be taken to be the avoidance of undue interference by patents in doctor-patient relationships.
Returning to the dialysis example, it would seem that whether or not a patent claim for treating blood obtained from a patient connected to a dialysis machine includes or omits the step of returning the treated blood to the patient would make little difference on the potential impact of such a patent claim on doctor-patient relationships, i.e. as a result of concern by the medical profession about the possibility of liability for patent infringement. Thus, it would seem that a patentee should not avoid the exclusion from patentability by limiting the definition of the invention in the patent claims to the extracorporeal part of the process.
It is interesting to note that the UK Guidelines for the Examination acknowledge that treatments that take place outside the body can in some circumstances be regarded therapeutic treatments of the human or animal body, and hence be unpatentable, such as if treated blood is returned to the same body in a continuous or "closed loop" process, even if a patent claim does not explicitly include the re-infusion step.
However, the legal situation could vary according to the details of such inventions. According to a decision of a Technical Board of Appeal of the European Patent Office, an invention can be patentable where the purpose of the invention is to treat a blood fraction spatially and temporally separate from the extraction of blood from the patient and the reinfusion of the treated blood fraction into the patient (T 144/04 ARUBA INTERNATIONAL). In another decision of a Technical Board of Appeal of the European Patent Office, it was found that a method of preparing a dialysis solution which was carried out while the patient was connected to a dialysis system can be patentable, since the solution in question, which was merely a component of the dialysis solution, never came into contact with the patient's blood (T 794/06 GAMBRO LUNDIA).
There have been no South African court decisions to date in relation to the patentability of extracorporeal methods that relate to therapeutic treatments, so it remains to be seen how our courts will approach this issue.
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