National Policy on Intellectual Property

One of the forms of IP which the National Policy on Intellectual Property ("the Policy") aims to address is PATENTS, and in particular with regard to technoloy transfer, patents relating to public health and the substantive search and examination of new patent applications.

1. Technology

The Policy identifies an outcry by users of the patent system for South Africa to have strong patents that can survive the test of competitiveness throughout the world.  This can be achieved if South Africa impliments a substantive search and examination system.  Licensing approval for technology-transfer contracts are subjected to rules that are not so strong, even if some are heavily regulated technologies.  Certain technologies may be subject to export controls and a maximum cap for precentages (e.g. not more than 5%).  The Policy recommends standardising technology transfer contracts to regulate restricted technologies subjected to export controls and maximum precentages.

2. Patents and Access to Public Health

A patent is an important, economical tool to protect medicines where huge costs are often incurred in respect of research, development and clinical trials.  But patents for medicines need to be valid.  It is contended that if "weak" patents are granted for medicines, even if there is no real innovation over the original patent, it stifles the public's access to proper and affordable health care.  This is one of the problems of South Africa's current depository system for patents, where the possibility exits that inherently weak patents are nevertheless granted.  The Policy recommends amending the South African Patents Act to provide for both pre- and post-grant opposition to effectively foster a spirit of granting stronger patents.  Obviously, implementing a substantive search and examination system in South Africa will result in a significant increase in costs for filing and prosecuting patent applications to grant. The Policy recommends that a cost and benefit analysis should be conducted through the Regulatory Impact Assessment (RIA) process and benchmarks should be based on similar economies, such as India, Brazil and Egypt.  Benefits should, however, not only be calibrated in monetary terms, as access to public health does not necessarily translate into monetary value.

3. Patent Extensions

There is no harmonised approach, internationally, in relation to the registration or approval of medicines.  However, from the users' point of view, registration of a patented medicine may take a long period of time.  For this reason, owners of patented medicines often argue in favour of providing for an opportunity to extend the duration of a pharmaceutical patent beyond its normal 20-year lifespan, in order to compensate for time lost resulting from regulatory delays at the MCC.  (Both innovators and generics aver that there are regulatory delays.)  However, the extension of patents by its nature is not good as it extends the lifespan of a patent and delays market entry for generics.  The Policy recommends that the MCC should encourage transparency in its registration system as allegations of regulatory failures are putting strenous pressure on the DTI to amend the Patents Act to accommodate patent extensions, which in turn may prejudice access to public health.

4. Generic Medicines

In patent law, there exists what is called the "Bolar provision".  In terms of the Bolar provision, despite the existence of valid patent rights, performing research and tests for preparing regulatory approval (e.g. MCC or FDA in the USA), does not constitute infringement for a limited term before the end of the patent term.  Generic medicines are manufactured based on patents that are no longer in force.  Due to a public policy option that is available to the state, the state may allow the working of a patent before its expiry for the purposes of allowing the development of generic medicines.  (Generic medicines should not be confused with counterfeit medicines, which are unlawful.)  The Policy encourages generic companies to optimally utilise the Bolar provision without resorting to stockpiling or commercialisation before expiry of the patent term.  

     

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