Prophylactic medicines, such as vaccines, are administered to healthy people to prime their immune systems against infection, thus preventing or minimising the chances or effect of infection.
On April 25, World Malaria Day, the World Health Organisation announced a vaccine against malaria had been developed by Glaxo Smith Kline.
The vaccine, RTS,S, is the culmination of nearly two decades of research.
Malaria is an illness of particular concern in sub-Saharan Africa, which has 88% of cases and contributes to 90% of global malaria deaths.
It is caused by the plasmodium parasite, which is transmitted to people through the bite of a mosquito.
Current malaria therapy includes the use of antimalarial drugs, but the treatment can be complicated due to drug-resistant malaria strains.
The best method available in the fight against malaria has always been prevention, which includes bed nets, insecticides and preventative medication.
RTS,S has the potential to fill an enormous gap and such a remedy is eagerly awaited by people living in malaria-affected areas across the globe. The WHO recommends that RTS,S pilot implementations be focused on areas in Africa experiencing moderate to high risk of parasite transmission. It could commence in early 2018.
The WHO’s goal would be virtually to eradicate malaria, similarly to smallpox, proving the effectiveness of vaccine use.
Patents for medicinal inventions are usually granted years before the patented medication is approved and released for consumer use, limiting the window of opportunity for the patentee to regain researching, patenting and clinical trial costs
It is generally accepted in medicine that the side effects of prophylactic medicine are less than that of the disease. The cost of prophylaxis is a fraction of the cost of treating a sick patient.
In the same way as prophylactic medicine is used to combat the onset of disease, taking the correct steps in protecting the intellectual property (IP) of a business limits the extent of the harmful effect of infringers and competitors trying to impinge on its domain.
By taking the appropriate steps to protect the IP, the business can inhibit others from infringing and copying its work, by enforcing the exclusive right vested in its IP. Without the exclusivity afforded by the prophylactic effect of IP protection, the business’ domain will soon be overrun by the competition benefiting from its efforts.
The ability to protect IP drives research and development incentives as businesses have the opportunity to regain the expenses spent during the research and development process and beyond that. Part of that profit can be reinvested into subsequent research projects.
But patented medication is much more expensive than generic counterparts, so how does IP protection support the availability of crucial medicines to the poorest populations?
Maintain Balance
A fine balance is struck between IP property protection and the availability of patented medications at affordable prices. Many countries are members of the World Trade Organisation’s (WTO’s) agreement on Trade-Related Aspects of Intellectual Property (Trips) and have to enforce patents for pharmaceuticals and other medical inventions. The purpose of Trips is to maintain the balance between the reward for innovators and businesses and the affordability of patented medicine. Patents are granted for 20 years only and are not extendible.
Patents for medicinal inventions are usually granted years before the patented medication is approved and released for consumer use, limiting the window of opportunity for the patentee to regain researching, patenting and clinical trial costs.
The patentee has to disclose its invention in the patent specification in such a way that anyone skilled in the art is able to recreate the patented invention, creating a platform for sharing knowledge and information.
Most governments have the power to make pharmaceutical products available to their people by granting compulsory licences. Section 56 of the Patents Act No 57 of 1978, allows the government to license patents to other companies if the patent holder refuses to do so on reasonable commercial terms and provided the patent holder is sufficiently compensated.
Similarly to prophylactic treatment benefiting persons exposed to risk of malaria, it is also beneficial for a business to apply proper prophylactic law and to ensure that the IP generated is properly protected by patents and other forms of IP protection before publication and commercialisation.
If multinational pharmaceutical companies are not sufficiently compensated for their research and development through patent protection, they may be discouraged to conduct research and development in fields in which there is a dire need for remedies.
After the patents for these remedies have been granted, these companies may decide to make the remedies available by funding nonprofit organisations or under favourable licence terms to the poorest of the poor, thus removing the conflict between prophylactic law and prophylactic medicine.
• Van Rooy is a director and head of Kisch IP’s patent department and Moraal is a candidate attorney at Kisch IP
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