A recent court victory that allows a South African company to produce a cheaper cancer drug will reduce prices significantly only if such medicines were more widely available.
Cancer researcher Prof Paul Ruff says significant price reductions would happen if the wider public were included. “Only 15% of the population have health insurance, and of that only 5% have access to comprehensive insurance,” he says.
But those who can afford it could benefit from local company Eurolab’s victory in the patents court. It took on Japanese multinational Astellas, which holds the patent for enzalutamide, sold in South Africa as Xtandi, a drug to treat prostate cancer, and the University of California, which developed the drug. Eurolab sells the drug as Enzutix and CEO Lynne du Toit says it may save patients about R50,000 a year.
The Xtandi patent was registered by the university and is licensed to Astellas. When Astellas became aware of Eurolab’s registration of Enzutix with the South African Health Products Regulatory Authority, Astellas and the university threatened Eurolab with legal action, claiming the two drugs were identical.
Eurolab said it had identified the potential of enzalutamide, an androgen receptor inhibitor, used in the treatment of prostate cancer patients. Androgen receptor inhibitors are medicines that stop prostate cancer cells from growing by blocking their ability to use male hormones such as testosterone.
The company undertook an analysis of patents and through its attorneys established that the compound patent directed to this inhibitor was invalid.
Ruff says the court’s decision is important because “in cancer in general, the treatment is usually expensive because of long-term patents, with the vast majority of patients in the country being denied access to many cancer treatments”.
Ruff says many medical aids exclude treatments such as enzalutamide because it is not a prescribed minimum benefit.
Du Toit says the court ruling has implications for the pharmaceutical industry and intellectual property law, particularly in patent enforcement.
Ruff says the ruling is an important step. However, enzalutamide is not “front-line treatment” for prostate cancer and is usually used in patients who have undergone other treatments.
He says significant price reductions are unlikely unless there is competition between several generics companies. “We would need commitment from a number of companies like this to come in at prices that are affordable to the state to provide broad access to treatments such as this.”
Ruff says that in a previous case a South African laboratory had a product that was a generic version of an originator product from Bayer, a blood thinner called Xarelto (rivaroxaban). Bayer went to court citing patent infringement and won, which appears to be the opposite of what happened with Eurolab.
“One judge ruling in one direction and another judge in another direction makes it hard to tell what will happen,” says Ruff.
Multinational pharmaceuticals keep patents for many years, which ensures profits after significant investment. Sometimes companies tweak formulas in a process known as “evergreening”.
On Eurolab’s court victory, Ruff says: “We need to see more of this. I’ve always been of the opinion that patents have been maintained too long and indeed extended by some pharma companies to prevent competition. As a result, people are denied access to the best treatments.”
He says medications require a price reduction of about 80% to make them affordable for the majority of the population.
“Eurolab has always been a bit brazen when it comes to this sort of thing. They tend to take on everybody no matter how big, being a small independent local company. Some of the bigger generics companies may be a bit scared to take on multinational pharmaceuticals, as I’m not sure if they’d want to take on the risks. I’m sure it will influence Eurolab to do more with other products, but whether other generics companies will take the same sort of stance, I’m not sure.”
Prostate cancer is the second leading cause of cancer deaths in men worldwide. “We felt this was an important fight,” says Du Toit.
Patent court judge Andre le Grange said some of the inventors of the compound had not signed over their rights to the university, which meant the intellectual property did not belong to it. The university had not correctly acquired the rights to the molecule when it filed the patent.
Inez Naidu, head of Discovery Health’s medicines unit, says it provides cover for Enzutix and Xtandi on its plans except for the Keycare series, which provides access to prescribed minimum benefits only. Naidu says the Eurolab price since the patents court ruling is 31% lower than that of Astellas.
She says enzalutamide’s cost remains high, but the addition of a generic version is expected to bring this down.
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