The international aid organisation Médicins Sans Frontières has called on the Swiss pharmaceutical company Novartis to withdraw its challenge to the Indian government, which has refused to give the company a patent on its leukaemia drug imatinib (Glivec).
In a case scheduled to be heard in an Indian court next week, Novartis has challenged sections of the Indian patent laws that are seen as an important public health tool by Médicins Sans Frontières, doctors, lawyers, and health activists, because they ensure cheap access to medicines. The sections do not allow patents for new applications for old drugs, or for products that are simply a new combination of old drugs.
Novartis started legal action after its patent application for the cancer drug imatinib was rejected by Indian patent examiners, who described it as a new form of a known substance. Indian manufacturers produce generic versions of imatinib mesylate that cost a fraction of the cost of the drug marketed by Novartis.
Médicins Sans Frontières has warned that if Novartis wins the case, fewer generic versions will be available for production in India. “This will have a devastating impact on people around the world who rely on affordable medicines from India,” the organisation said.
Indian generic manufacturers have been producing inexpensive versions of drugs that are then sold in developing countries. “India has emerged as the pharmacy of the world's poor,” said Ellen t'Hoen, director of policy advocacy with Médicins Sans Frontières.
About 50% of AIDS drugs in the developing world are Indian generics, she said.
A Médicins Sans Frontières official briefed the European Parliament in Brussels earlier this week at a special hearing on implications of the challenge by Novartis. “We're calling on parliament members to join others in asking Novartis to drop the case,” said Ms t'Hoen.
Novartis has said it does not agree with the contention that its legal action in India will adversely impact access to affordable medicines in the developing world. The company said generics would not solve the challenge of improving access to imatinib mesylate.
A year's treatment with a generic version of imatinib mesylate in India would be four times a person's annual average income, the company said. Novartis currently provides the drug free to more than 6500 patients in India. Neither generic companies nor the government are providing access programmes to this medicine, the company said.
“While patent protection has increased over the past decade, the innovation rate has dropped,” said Kapoori Gopakuma, a researcher with the Centre for Trade and Development in New Delhi.