The Swiss drug company Novartis is under growing pressure from all sides as its long awaited High Court case against the Indian government began last month in Chennai.
Novartis is challenging the government's refusal of a patent for the leukaemia treatment imatinib (Glivec) and also section 3(d) of the Indian Patent Act, which restricts drug patents to innovative drugs. The law was designed to make it easier for poor patients to get cheaper generic drugs. If Novartis succeeds in the case, it would signal the start of more stringent patent laws in India and an end to the current trend of lower prices.
“People living with HIV from Lesotho to Laos depend on India for generic equivalents of antiretrovirals,” said Sarah Renn, from the US Student Global AIDS Campaign, which staged protests this week outside the Novartis offices in Cambridge, Massachusetts. “Novartis's court case in India could jeopardise sustainable access to medicines for countless numbers of poor people throughout the world.”
Ellen t'Hoen, coordinator of the globalisation project of Médecins Sans Frontières' campaign for access to essential medicines, said, “The hearing has now started, and there has been a real increase in global mobilisation on this issue.
“Novartis was one of the 39 companies that took the South African government to court over five years ago in an effort to prevent the government from importing cheaper AIDS medicines. It feels like we're back in South Africa in 2001. I think Novartis is genuinely surprised at the strength of feeling. It will be very difficult for Novartis to maintain this challenge.”
About 300 000 people from more than 150 countries have now signed the international petition against Novartis's actions organised by Médecins Sans Frontières. Crowds have also gathered outside Novartis's offices in Belgium demanding that Novartis drop the case.
At a meeting of South African church leaders and healthcare workers Archbishop Desmond Tutu said, “People, not profits, must be at the centre of patent law for medicines.” The former UN special envoy for HIV and AIDS in Africa, Stephen Lewis, and the new head of the Global Fund to Fight AIDS, Tuberculosis and Malaria, Michel Kazatchkine, have also denounced the company's actions.
Most experts believe that India is not in breach of any international laws. The World Trade Organization's 2001 Doha agreement on trade related aspects of intellectual property rights (TRIPS) and public health incorporated a degree of flexibility to protect public health and promote access to drugs.
“The Doha declaration tries to find a balance between intellectual property rights and public health,” said Ruth Dreifuss, a former member of the Swiss Federal Council. “This balance can be achieved only if countries make use of the flexibilities contained in the TRIPS agreement, and this is what the Indian law does. By challenging it Novartis is sacrificing public health objectives and weakening the whole system.”
In a statement Novartis said that its legal challenge sought to make clear the status of India's laws regarding the protection of intellectual property and the granting of patents.
“Lost in this debate is that patents help patients by stimulating the long term research and development efforts needed to develop breakthrough therapies like Glivec,” said Ranjit Shahani, of Novartis, India. “Only if patents are respected can research based organisations continue making long term, risky investments in new medicines for patients.”
Novartis remains adamant that its actions will not hinder the supply of essential drugs produced in India and exported elsewhere.