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March 31, 2013 6:13 pm
Novartis, the Swiss pharmaceuticals group, has threatened to stop supplies of new medicines to India if the country’s top court refuses on Monday to grant a patent for Glivec, its cancer drug.
Paul Herrling, who is leading Novartis’s handling of the affair, said that a refusal by India’s Supreme Court to grant patent protection for the medicine would have repercussions for multinational drug companies’ activities in the country.
India’s Supreme Court is expected on Monday to hand down its final verdict in a closely watched, seven-year legal battle about whether Glivec, a drug for leukaemia and other cancers, meets the standards laid down in India’s 2005 patent law to enjoy patent protection.
The case is being closely watched by industry and also health advocates, who fear for its impact on India’s ability to produce low-cost generic versions of medicines for the developing world including its own 1.2bn people, who pay for 70 per cent of healthcare costs from their own pockets.
India – which for years did not offer patent protection to drugs, allowing a generics drugs industry to flourish – adopted tougher new patent laws as part of the process of joining the World Trade Organisation.
However, New Delhi’s law included the requirement that newly modified versions of existing drugs had to show additional efficacy in order to be eligible for a patent – a provision intended to prevent companies from extending exclusivity and obtaining new patents on old drugs by making slight changes; a process known as “ever-greening”.
Successive Indian courts have ruled that Glivec, also known as imatinib, was ineligible for a patent because it was a so-called salt – a subtly modified version of a related compound that had been previously patented. Novartis has challenged the interpretation.
Mr Herrling – formerly Novartis’s head of research and development – said that the original form of the drug was too unstable and unsafe ever to be tested in humans, and it was the “salt” version that was ultimately approved for human use worldwide.
“If the situation stays as now, all improvements on an original compound are not protectable and such drugs would probably not be rolled out in India,” he told the Financial Times. “Why would we?”
Analysts have pointed out that Glivec’s patent applications were made before India’s current legislation went into force, so any precedent set by the case would not necessarily apply to more recent applications.
Mr Herrling said most Glivec currently used in India is donated by Novartis under its access programme, with rival versions made by Indian generic companies still too expensive to be affordable.
Groups including Médecins Sans Frontières fear a ruling in favour of Novartis would undermine India’s pivotal role as the world’s leading supplier of low-cost life-saving medicines for the poor, and would reduce the competition that has made high-tech medicines available at much lower prices.
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