Chemical Technology May 2015

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Chemical Technology • May 2015
COVER STORY
do so, to say the least, and would be very difficult for most
small companies or lone innovators to do so.
However, this permit, the Discovery Phase permit, only per-
mits the search for and indexing of the indigenous biological
resource but not any further research or commercialisation
thereof. In order to conduct further research or to com-
mercialise any indigenous biological resource or a product
thereof, a Commercialisation Phase permit must be obtained
by each link in the chain of research and development and
commercialisation thereof. This means that it is not simply a
matter of obtaining a Commercialisation Phase permit by the
party that discovered it under a Discovery Phase permit, but
each research organisation, manufacturing entity, wholesaler,
and so on, must have its own permit for the commercialisation
of the indigenous biological resource.
To complicate matters further, the requirements for the
obtaining of these permits are very onerous and, for example,
require the identification of the indigenous people who may
have been using said indigenous biological resource, entering
into a benefit-sharing agreement with them, and the applica-
tion to the Department of Environmental Affairs for a permit
– all before any research or commercialisation can take place.
The result of the above regulatory environment on
bioprospecting is that many small businesses are simply
ignoring it and continuing illegally which puts them at risk of
prosecution, but also prevents them from obtaining patent
protection for their innovation, since the Patents Act requires
that permits and benefit-sharing agreements be in place be-
fore a patent can be applied for. These smaller businesses,
and some large ones, either are not aware of the onerous
regulatory requirements or are simply unable to comply due
to a lack of skills in dealing with such complexity which falls
outside their core field of business.
Another example of how innovation is being stifled by
regulation, is the Foodstuffs, Cosmetics, and Disinfectants
Act which has numerous regulations associated with it, many
of which are based on existing technology and entrench
that which has already been approved, thereby making it
very difficult to introduce new and innovative ingredients
in food manufacture. The path to innovation is made more
tortuous not only by the existing regulations but also by the
slow process of change in the regulations, for example, the
Colourant regulations which prescribe which colourants may
be used in foodstuffs in South Africa have not been updated
comprehensively for about 20 years with the result that the
table of permitted colourants does not include any natural
colourants, with the absurd result that artificial colourants are
permitted in your food but natural colourants, such as those
produced by physical concentration processes of fruit and
vegetables are not permitted. Thus, innovators who see a gap
in the market and spend their time and effort to satisfy the
demand are prevented fromcommercialising their innovative
ideas, such as processes for producing natural colourants for
foodstuffs, until the long and winding road of amending the
Colourant regulations is finally completed.
Even in research the long red tape is there to trip up the
unwary, for example, the Intellectual Property from Publicly
Funded Research determines who owns any intellectual prop-
erty which arises from co-operation with a publicly funded
institution and thus the unwary innovator co-operating with
a university may find at the end that he does not own the
intellectual property in respect of his own innovation as under
this law the university does!
It is a sad fact of our system that patent attorneys, al-
though highly qualified by being required to hold both a degree
in science or engineering and a law degree and to pass many
qualifying examinations before being admitted to practice,
are not trained in understanding and assisting their clients
in overcoming the regulatory hurdles which stifle innovation
and which to the writer is just as important as protecting the
invention if the innovator is to be able to commercialise and
monetise the innovation.
Having identified this gap of the approaching regulatory
tsunami and its effect on innovation, the author has set up
a team at Hahn & Hahn which is able to assist its clients in
understanding and overcoming the regulatory hurdles. If you
are an innovator who is experiencing these frustrations, then
remember to contact the writer (on or
). to help you navigate the regulatory maze
and to protect your innovations and inventions.
Janusz F Luterek, PrEng
Tel: +27 (12) 342 1774
Email: