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
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.

Conclusion
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.

Written by Ursula Baravalle, Director, KISCH IP