[Ip-health] TAC asks Supreme Court of Appeal to consider public health in patent dispute over cancer medicine
Riaz K Tayob
riaz.tayob at gmail.com
Fri Apr 20 02:09:13 PDT 2012
20 April 2012
TAC asks Supreme Court of Appeal to consider public health in patent
dispute over cancer medicine
The TAC National Council has resolved to seek admission in a legal
dispute between the brand name drug company Aventis Pharma and the
generic company Cipla, over a claim of patent infringement on a drug
that treats cancer called Docetaxel. SECTION27 will act as attorneys for
TAC. This briefing note sets out the background to the legal dispute and
explains why TAC is arguing that the Supreme Court of Appeal must
consider the right of access to health care services when it judges this
*Is cancer a problem in South Africa?*
Cancer is common in South Africa, particularly amongst poor people. This
is because poor people are vulnerable to exposure to other illnesses
that can lead to cancer, as well as exposure to environmental factors
such as pollutants in the air, water and soil.
According to the Medical Research Council, in 2000, 41 691 people died
from various forms of cancer. In women the most common cause of death
was cervical cancer, but this has now been overtaken by breast cancer.
In men the most common cause of death is lung cancer.
However, what is especially concerning is that experts say that cancer
is greatly underreported, especially amongst poor and black people. They
say that in fact the mortality rate could be twice as high as that
reported and that there could be as many as 120 000 new cancer cases per
year. Poor people present for and receive treatment for cancer late, if
at all. One of the reasons for this is the prohibitive cost of medicines
that treat cancer.
Is cancer a risk for people with HIV?
People with HIV have a higher incidence of cancer than people without
HIV. This is because of suppressed immune systems. The most common forms
of cancer in people living with HIV are Kaposi’s Sarcoma, cervical and
breast cancer. People with HIV need greater access to cancer medicines
and specialists, as well as better understanding and awareness of cancer
– treatment literacy.
*What is the name of the drug in the dispute and what does it do?*
Docetaxel is the active ingredient in a second line drug for cancer.
Docetaxel is registered in South Africa and other countries for the
treatment of non-AIDS-defining malignancies such as breast, prostate and
lung cancers. Docetaxel has also been proven to be – and is indeed
recognised as being – safe and effective as a treatment for
advanced-stage AIDS-related Kaposi's sarcoma.
The patent on Docetaxel is held by Aventis and was registered in South
African in 1993, which means that the patent has only one year to run.
It expires in November 2013.
In countries such as India, Docetaxel is not patented and is available
in various generic forms for cancer sufferers.*
What is the case before the Supreme Court of Appeal (SCA) about?*
Despite Aventis’ patent, Cipla, an Indian generic medicine company, has
registered and begun to manufacture and market a generic version of
Docetaxel in South Africa. It argues that the patent is ambiguous and
therefore invalid and that it has a right to make and distribute the drug.
In response, Aventis sought an interdict from the Commissioner of
Patents to stop Cipla from selling the drug in South Africa. However,
the Commissioner refused to grant the interdict, ruling that their
“prospects of success at a trial are so slender that interim relief must
be refused” (Judgment, para 26). This finding supports Cipla’s
arguments about the alleged ambiguity of the patent.
After the ruling, Cipla continued to infringe the patent and began to
make the medicine available in South Africa. Over 70 people with cancer
in South Africa are already using Docetaxel.
Aventis is now appealing against the Patent Commissioner’s decision to
the Supreme Court, meaning it is trying once again to stop the use of
this medicine in South Africa.
A major problem up to now is that the court has not considered the
constitutional right of “everyone to have access to health care
services” as a factor in the decision about whether to grant an
interdict or not. It has heard only technical arguments, such as whether
the patent is valid or not, that are to do with the interests of the
drug companies – not patients.
*Why is the case important for access to medicines in South Africa?*
Generally medicines in South Africa cost too much, particularly patented
medicines. Most medicines for cancer are extremely expensive.
• One of the problems we face is that patents are granted without an
examination of the substantive validity of the patent.
• Neither do we have a system such as exists in India where
individuals and organisations are allowed to register opposition to
patents, known as ‘pre-grant opposition’.
Generics are cheaper than the patented originals. This drug is 50% of
the price of the original drug. In addition once generics enter the
market there is more competition which further helps to bring prices down.
*What does TAC want to argue before the SCA?*
TAC is applying to be a ‘Friend of the Court’ (amicus curiae) in this
case. TAC’s Founding Affidavit is being signed by Nokhwezi Hoboyi, a TAC
leader living with HIV who has herself had cancer.
TAC is arguing that when the SCA hears this case it should take into
consideration arguments about the public interest and the constitutional
right to health.
TAC is not leading evidence or making any arguments about how effective
the drug is, or about the numbers of people who will benefit from the
drug, or the types of cancers it may be useful for. Our intervention
aims to establish as a principle something the Court has not considered
before, and that is that Constitutional rights must be factored into the
adjudication process when deciding patent infringements.
In this case TAC is arguing that it is in the interests of cancer
patients that the generic drugs be available, and that the harm to
patients will be greater than the harm to Aventis if they are granted
the interdict. This is especially so given the fact that the patent only
has one year left to run and the fact that there are questions about the
If TAC’s argument is accepted by the SCA it will be an important advance
for the rights of access to affordable medicines. It will mean that in
future in any dispute over patents on life saving drugs, the courts will
have to consider the public interest and the constitutional right of
access to health care services.
It will be a small but significant step forward for people who need
For further information contact:
Umunyana Rugege, SECTION27 Attorney – 011 356 4100
Mark Heywood, SECTION27 Executive Director – 011 356 4100
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