South Africa has the largest pharmaceutical products market in Africa, with the pharmaceutical industry playing a very important role in the South African economy. Patentability is the economic driver for research and innovation. Furthermore, contrary to the fear that patentability may curtail access to medicines by making them more expensive, it is patentability itself that serves as the economic incentive with respect to the manufacture and distribution of various drugs within an economy.
Applicants are often unfamiliar with the position of second medical uses (new uses of known pharmaceutical compounds), of method of treatment claims and Swiss-type claims in South Africa due to the significant differences in legislation compared to other jurisdictions such as Europe and the USA.
Method of Treatment Claims
Method of treatment claims “A method of treating [condition Y] comprising administering [compound X]” are not allowable in South Africa.
Second Medical Use Claims
In Europe, under the EPC 2000 claim form, second medical uses “[Compound X]* for use in the treatment of [condition Y]” are allowable. *where compound X is a known compound
Strictly speaking, South Africa does not permit patents covering any new uses of known pharmaceutical compounds (second medical use claims). Following the original European provision, the Patents Act provides that a known substance can only be claimed for use in a method of medical treatment the first time that it is disclosed as being useful in a medical treatment. This has been confirmed by the South African courts.
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 the Swiss form of claiming to provide protection in instances where a second medical use is sought to be protected, and hence serves as a mechanism by which second medical uses are protectable in South Africa albeit through the Swiss from and not via direct protection of the second medical use.
Swiss-type claims follow the form “Use of [compound X] in the manufacture of a medicament for the treatment of [condition Y]”.
The Swiss claim focuses on the method of manufacture. Hence, once disclosed this method will then form part of the prior art and, for this reason, any subsequent Swiss-type claims that vary the dosage regimes may not be patentable.
However, this aspect of Swiss claiming has not been tested in the South African courts and therefore we do not have an unequivocal answer with respect to the South African position. It may well be that a Swiss claim characterised by a certain dosage regime may be considered to be patentable.
The effect of the different claim formulations on patentability in South Africa may be summarised as follows:
- Method of treatment claims are not patentable in South Africa.
- Second medical use claims are not patentable in South Africa.
- Swiss-type claims are patentable in South Africa.
In terms of a policy that is currently in draft form, South Africa is considering implementing a substantive patent examination system (the current examination system being a depository system) and pre- and post grant opposition procedures as a means to prevent patent ever-greening.
The policy also suggests that the government systems with respect to patents and with respect to the registration of medicines should be aligned. The purpose of this alignment would be to prevent the granting of patents to medicines that may be expiring and to thereby prevent access to public health being undermined. The policy also specifically states that South African legislation must allow strict rules to apply and should exclude new uses of known products.
In an effort to promote such access, including access to medicines at lower prices, South Africa is currently considering utilizing the mechanism of compulsory licensing to urge patent holders to license the manufacturing rights to third parties and to thereby allow for a reduction in price.
Although the issue of compulsory licensing does not speak directly to the issue of the allowability of second medical use claims, it does speak directly towards the South African position as regards access to medicines and the tendency to want to move towards a patent system which, it would appear, is not intended to favour second medical use claims.
As regards generic medications, the so-called Bolar provision applies in South Africa. This provision allows the generic companies to have completed the requisite regulatory approval processes prior to the expiration of the patent so that upon expiration of the patent they are entitled to enter into the market. The law does not, however, allow for stockpiling.
Swiss claims are allowable in South Africa and hence the pharmaceutical industry may still obtain protection in respect of second medical uses using this type of claim format.
We recommend against the inclusion of both method of treatment claims and EPC 2000 claim forms as these are not permissible in South Africa.
Our chemical and life sciences patent specialists are at your disposal should you require any further assistance on these issues.