India's role as a "pharmacy for developing countries" is at risk.
New Delhi/Rome, 11 September 2012 – The Swiss pharmaceutical company Novartis appears today before the Indian Supreme Court in New Delhi, in a final attempt to undermine a key provision of Indian patent law, designed to prevent any abuse by pharmaceutical companies to keep drug prices high. According to the medical humanitarian organization Médecins Sans Frontières (MSF) - which relies on low-cost Indian-made generics to carry out its work in 68 countries - if Novartis comes out on top, the impact on access to life-saving medicines in all developing countries they could be devastating.
"For six years, Novartis has been trying to get India to change parts of its patent law, which protects patients' access to affordable medicines instead of corporate profits," said Leena Menghaney, head of the Campaign of MSF for Access to Medicines in India. "India's current system is designed to prevent drug companies from extending their drug monopoly by obtaining new patents on slightly modified forms of pending drugs."
Novartis has in fact engaged in a legal battle against a specific provision of the Indian patent law (known as Section 3d), which establishes that a new form of a known drug can only be patented if its increased therapeutic efficacy compared to the drug is demonstrated already existing. It is a measure to stop the industry's usual practice of extending or perpetuating its monopolies indefinitely, through routine modifications of existing drugs.
Through the application of Section 3d, which is in line with international trade laws, Novartis was denied a patent for the anti-cancer drug Imatinib Mesylate (trade name Gleevec) in 2006. Novartis had applied for a patent for a new form of the imatinib molecule, already described several years earlier in patents granted in the United States and other developed countries.
“We have had the opportunity to directly verify the concrete benefits brought to the protection of public health by the Indian patent law”, continues Leena Menghaney. “Due to the strictness of this law, patents on pediatric versions and fixed-dose combinations of medicines for the treatment of HIV have been rejected, formulations for which it is more necessary than ever to have low-priced generic equivalents”.
The consequences of a Novartis victory would be worldwide, because India would be cost
