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Patients' groups and health organisations proclaimed victory this week after an Indian court dismissed a petition by the drug company Novartis challenging a section of the Indian law on patents.
Novartis had questioned section 3(d) of the law, which prohibits patents on new forms or new uses of known substances, arguing that it was in violation of the Indian constitution and that it did not meet international trade rules.
The Madras High Court dismissed the petition, ruling that the clause was not unconstitutional and that the issue of whether it complies with international law should be determined by the World Trade Organization.
Health agencies say the verdict is a victory for global public health. “This is a huge relief to millions of patients and doctors in developing countries who depend on affordable medicines from India,” said Tido von Schoen-Angerer, director of the campaign for access to essential medicines at Medécins Sans Frontières (MSF). Nearly 85% of the antiretrovirals that MSF procures for some 100000 people infected with HIV across 30 countries come from Indian manufacturers of generic drugs.
“This ruling will allow the Indian generic industry to continue providing inexpensive drugs to the world's poor,” said Anand Grover, director of Lawyers Collective HIV Unit, who had represented India's Cancer Patients Aid Association against Novartis. The association had opposed a patent on Novartis's drug imatinib (Glivec), used to treat chronic myeloid leukaemia.
Novartis challenged section 3(d) after India's patent office had rejected the company's application for a patent on imatinib on the grounds that the drug involved minor modifications of an old molecule.
Novartis has said that the verdict will have long term negative consequences for research into new drugs and that effective patent systems ensure that incentives are in place to stimulate the long term research efforts needed for medical progress.
“Medical progress occurs through incremental innovation,” said Paul Herrling, head of corporate research at Novartis. “If Indian patent law does not recognise these important advances, patients will be denied new and better medicines.”
The company said it disagrees with the High Court's ruling but is unlikely to appeal in the Indian Supreme Court. Its appeal against the decision on imatinib is still pending. “We expect the appellate board to conduct an impartial review of our appeal,” said Ranjit Shahani, managing director of Novartis India. Mr Shahani said the case has helped to advance the debate over what he said were the “inadequacies of section 3(d).”
But health activists believe that the case goes beyond imatinib. “This victory will help poor people with other illnesses too,” said Yogendra Sapru, chairman of the Cancer Patients Aid Association, which had opposed the patent on Glivec (BMJ 2004;329:419 doi: 10.1136/bmj.329.7463.419).