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Cut-price cancer drugs face court battle for survival
Sydney Morning Herald - August 23, 2012
The long-running legal tussle, which was set to resume in Delhi yesterday, has been brought by the Swiss pharmaceutical company Novartis. It wants an Indian patent for its leukaemia drug imatinib mesylate, which has been patented as Glivec in nearly 40 countries including China, Russia, Mexico, Taiwan, Germany and Britain, and Gleevec in the US.
Novartis says the legal bid is "about protecting intellectual property to advance the practice of medicine, not about changing access to medicines", according to Ranjit Shahani, the vice-chairman and managing director of Novartis India. But campaigners argue that a victory for Novartis could result in the deaths of thousands of people who will no longer be able to afford the drugs they need.
"It would quite simply be a death sentence for us," said Vikas Ahuja, who was diagnosed with HIV in 1993 and is now the president of the Delhi Network of Positive People. "I am quite sure that if Novartis wins, other multinationals will follow suit and other drugs will become prohibitively expensive."
Medecins Sans Frontieres believes the ramifications of a Novartis win would be felt beyond India's borders. "If Novartis won the case, patents would be granted in India as broadly as they are in wealthy countries and on new formulations of known medicines already in use," it says in a Q&A on its website. "India would no longer be able to supply much of the developing world with quality affordable medicines."
Indian generic medicines are among the cheapest in the world, largely because India did not issue patents on drugs until 2005. Its size also means it has the production capacity to manufacture reliable and safe copies of branded medicines.
As a result, India now makes one-fifth of the world's generics, such as antiretrovial medicines used to treat HIV and AIDS. About half are sent abroad, mostly to other developing countries.
Even if Novartis wins, generic versions of Glivec will still be available in India because it came on the market before 2005 and is protected under a so-called "grandfather clause" in Indian patent law, Mr Shahani said.
This week's Supreme Court case is the final chapter in a legal spat that has rumbled since 2006, when Novartis first tried and failed to patent Glivec. At that time, the drug was sold at #1650 per patient per month in countries where Novartis had obtained a patent. In India, generic versions of Glivec in 2006 were available for less than #127.
The patent office in Chennai rejected the claim on the grounds that the drug was not sufficiently new, but a slightly modified update of an older medicine. When India finally introduced a patent law seven years ago, it included a clause which decreed that "patentability" shall be granted only if pharmaceutical companies can prove "enhanced efficacy".
Given India's own poverty, 30 per cent of people earn less than a dollar a day, many argue the limits still make sense domestically – Indian patients bear at least 80 per cent of their own medical costs. Branded and patented drugs are often 10 to 40 times more costly than generics. (Guardian News & Media)
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