CSR: Novartis warns India over drug patent
March 31, 2013 6:13 pm
Novartis warns India over drug patent
Paul Herrling, who is leading Novartiss handling of the affair, said that a refusal by Indias Supreme Court to grant patent protection for the medicine would have repercussions for multinational drug companies activities in the country.
The case is being closely watched by industry and also health advocates, who fear for its impact on Indias 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 Delhis 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 Novartiss 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 Glivecs patent applications were made before Indias 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 Indias pivotal role as the worlds 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.