April 2013 SciDev.net; The Swiss pharmaceutical company Novartis has lost its seven-year court battle to patent the cancer drug Glivec in India, where generic versions of the medicine provide life-saving drugs to thousands of people.
Novartis wanted exclusive rights to manufacture the drug on the grounds that a new substance had been used in its production. But the Indian Supreme Court in Delhi ruled yesterday (1 April) that the small changes to the drug were not worthy of a patent: the drug had “failed in both the tests of invention and patentability”, it said.
The ruling is a victory for Indian generic drug companies and will enable some 300,000 patients in the country and many more in other developing countries to access cheaper generic versions of Glivec.
India is widely known as the ‘world’s pharmacy’, because it supplies cheap, generic versions of medicines to many countries across the developing world.
Prices of Indian generic versions of Glivec, which is mainly used to treat leukaemia, are many times lower than those of the branded drug.
Novartis was contesting the rejection of its 2005 patent application by the Indian Patent Office and the Intellectual Property Appellate Board to patent imatinib, a salt form of imatinib mesylate, the drug marketed as Glivec.
The court ruled that as imatinib is only a modification of a known molecule, and since it does not offer improved therapeutic efficacy, it is not patentable, according to the 2005 Indian Patents Act.
Section 3(d) of the 2005 act stipulates that an innovation constituting “the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance” cannot be patented.
Generic versions of Glivec are currently marketed by Indian companies like Ranbaxy, Natco Pharma and Cipla.
Natco Pharma, one of the appellants in the Novartis case, says the judgment is a victory for both cancer patients and the Indian government.
Madineedi Adinarayana, Natco’s general manager, tells SciDev.Net that the judgment is a victory for the entire generic pharmaceutical industry and for section 3(d) of the patents act.
“It is a feature unique to Indian law, and many countries like China and South Korea plan to amend their laws to incorporate this provision,” he says. “We are offering Glivec to Indian patients for 9,600 Indian rupees [US$177] a month while Novartis charges 110,000 rupees [US$2,270] a month.”
Adinarayana says the Glivec judgement will ensure that drugs are accessible to the poor.
Leena Menghaney, India manager for Médecins Sans Frontières’ Access Campaign, tells SciDev.Net that the ruling “appears to be the best outcome for patients in developing countries as fewer patents will be granted on existing medicines”.
“Novartis’s attacks on the elements of India’s patent law that protect public health have failed,” she says.
“The Supreme Court’s decision prevents companies from abusing the patent system … [and] confirms that all patent offices in India have to use this interpretation and the law is now clear and must be strictly applied,” she adds.
But Novartis has said the judgement will hinder research on new drugs and discourage innovation.
“We strongly believe that original innovation should be recognised in patents to encourage investment in medical innovation especially for unmet medical needs,” Ranjit Shahani, vice chairman and managing director of Novartis India, said in a press statement yesterday.