SOUTH AFRICA: Activists protest as Novartis ruling approaches
80 percent of all antiretrovirals used in Africa are Indian generics
CAPE TOWN, 12 July 2012 (IRIN) - At least a hundred protesters arrived at South Africa's parliament on 11 July to demonstrate their disapproval of the ongoing court case by Swiss pharmaceutical company Novartis against the Indian government over its patent laws. As the case draws to a close, health organizations say a win for the pharmaceutical company will be a loss to the developing world, which sources the bulk of its generic medicines from India.
Novartis approached the Indian government six years ago, seeking to register a cancer drug already commonly marketed under the name Gleevec. The patent was denied and a long-running court battle ensued, but at each step Indian courts have ruled against Novartis and the company has appealed.
India has laws against “evergreening”, a term used to describe instances where drug companies maintain artificially high prices on medicines for longer by continually extending patent protection for minor modifications to existing drugs.
India's Supreme Court is expected to hand down the judgment that will draw the legal saga to a close on 22 August. This could not only limit the country's ability to produce generics, but also set a precedent in other countries - like South Africa - looking to revamp patent laws.
"A win for Novartis will restrict generic access to medicines both within my country and across the world," Leena Menghaney, manager of the Access Campaign in India at Médecins Sans Frontières (MSF), an international NGO, said in a statement. "The threat to the developing world is real - millions of people rely on affordable drugs from India. If patents are granted more easily in India, patients across the world will see their supply of life-saving drugs dry up."
India, described as the "pharmacy of the developing world”, is the world's leading producer of generic drugs. The country has achieved this status in part because the stringent Patent Act prevents evergreening by requiring new drugs to show improved therapeutic efficacy over existing ones to deserve a patent.
The Patent Act has been used to block previous patent applications on fixed-dose antiretrovirals (ARVS) and paediatric formulations of the ARV medication, nevirapine.
"As a person living with HIV, and reliant on generic medicines, I call on Novartis to drop the case against the Indian government," Sydney Makgai of the Treatment Action Campaign (TAC), a South African AIDS lobby, said in a statement. "This may be about profits for them, but it is about life and death for me." More than 80 percent of Africa's ARVs are sourced from generic producers in India.
South African patent laws need fixing
South African law has no provision against evergreening and has issued patents for a number of previously registered medicines, including Gleevec. MSF's Access Campaign said the patent-protected Gleevec sells for about US$117 in the South African private sector, but the generic equivalent from Cipla, an Indian drug manufacturer, costs just one-tenth of the price.
Civil society organizations such as MSF, TAC and the human rights NGO, SECTION27, are putting pressure on the government to revise existing legislation to include a provision preventing evergreening.
TAC senior researcher Catherine Tomlinson said the organizations have spoken to South Africa's Department of Trade and Industry, which has assured them that a policy document on the patent laws will be released in June or July, with a three-month public comment period.
Tomlinson told IRIN/PlusNews the organizations have now written to the department calling for the document to be released.