Novartis Indian patent battle nears conclusion
pharmafile | March 7, 2012 | News story | Sales and Marketing | Glivec, HIV, India, Novartis, patents
A long-running battle over the patent of cancer treatment Glivec in India is about to reach its dramatic climax.
India’s Supreme Court will shortly make a ruling which could end a six-year legal battle between Novartis and the Indian government, and could be decisive for the future of patents in the country.
The Swiss pharma company began its legal action after its patent application for leukaemia drug Glivec was rejected in 2006.
Novartis maintains that Section 3(d) of Indian patent law does not comply with international patent law, but it has twice had its case rejected by Indian courts.
Non-governmental organisations such as Medecins Sans Frontieres have opposed Novartis throughout the period, saying a victory for the company would affect India’s entire generic industry.
MSF says poorer countries rely on India’s generics firms to product low-cost medicines, and without them, the health of millions could suffer.
The company said in a statement that it believed that using India’s legal system was a ‘legitimate and appropriate approach’ to gaining clarity on India’s patent law.
“We need to know if we can rely on patents in India and whether as a research-based organisation we can continue to invest in the development of better medicines for India”.
Novartis also says it disagrees with MSF and other activist groups that the challenge threatens availability of all generics. “The basis of this argument is false and very misleading,” it said.
The company notes that generic drugs launched in India before 2005 – including HIV/AIDS medicines and generic versions of Glivec will still be available in the country regardless of the Supreme Court’s ruling.
India updated its patent laws in 2005 to bring them into line with international standards, but has allowed generics already on the market to remain.
Novartis insists that it supports ‘flexibilities’ in the international trade agreements that allow countries like India to make exceptions to patent rights, such as when a national public health crisis requires supplies of cheap medicines.
The company says it runs various projects to ensure access for its drugs in poorer countries. Its Glivec International Patient Assistance Programme has helped more than 31,000 patients in 2011, and Novartis currently provides the drug free of charge to around 15,000 patients in India – more than 95% of those receiving the medicine.
India’s generic firms are a powerful lobby in the country, and a leading industry which politicians want to nurture. This means that whatever the outcome, the Indian government is likely to ensure that the generics sector will continue operating.
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