A technical case going through the Supreme Court in India is being carefully watched by aid agencies and other human rights organisations, who claim it could have severe consequences for the supply of lifesaving drugs to the developing world.
More than 90% of drugs used to treat children with AIDS in Africa come from Indian generic manufacturers, according to the medical NGO Medicins Sans Frontieres. And if the Swiss pharmaceutical giant Novartis wins a case it has brought against the Indian government, MSF fears that supply could dry up.
Novartis is seeking patent protection for its leukaemia drug Glivec, whose patent has expired in India. It is challenging India’s interpretation of a section of the nation’s patent law — Section 3(d) — which prevents ‘evergreening’.
Leena Menghaney, MSF
Turning old into new
Evergreening is a common method used by drug companies to extend the life of their patents. They make slight alterations to the basis molecule every few years and apply for fresh patents for the amended versions, which then prevents generic copies of the drugs being made.
But in India, applications to patent many new forms of old drugs, including HIV/AIDS and tuberculosis treatments have failed. Under Indian law a new patent will not be granted unless the company can prove the changes make the drug significantly more effective.
The Novartis challenge, currently being heard in the Supreme Court, could effectively water down Section 3(d). MSF believes the cost of drugs to the developing world would spiral as other pharmaceutical companies sought to extend the patents for drugs used to treat diseases such as HIV/AIDS and TB.
It is an argument that Novartis wholeheartedly rejects. ‘Currently available generic drugs launched in India before 2005–including HIV/AIDS medicines and generic versions of Glivec – will continue to be available under the transition clause in the Indian patent law regardless of the legal outcome of our case,’ it says.
Leena Menghaney of MSF says: ‘India is literally the lifeline of patients in the developing world, especially in the poorest parts of Africa…If Sec. 3(d) is overturned, it means any meaningful effort to make these vital medicines available will be put in jeopardy.’
Novartis has argued that it provides thousands of patients in developing countries with free Glivec through the Glivec International Patient Assistant Programme (GIPAP). In 2008 CEO Daniel Vasella pointed out that 8,400 patients in India had received the drug through this programme – by 2011 this had risen to more than 13,000.
But the New York Times‘ 2003 investigation into GIPAP criticised the programme’s operation in India. ‘Novartis began its donations of Glivec with a warning that it would halt the program if the government let local companies eat into its profits by selling generic versions of the drug,’ the paper reported.
‘Hundreds of Indian cancer patients got Glivec free, and commercial sales soared, as well. But after India cleared generic Glivec for sale, Novartis made good on its threat last month, saying it would leave it to Indian companies to meet the needs of the indigent.’
In wealthier countries, the paper said Novartis had encouraged people who received the drug for free to become Glivec advocates, pressuring their government to pay for it.
GIPAP was restored in India but as Amit Sen Gupta of the People’s Health Movement points out, there are some 100,000 patients in India with chronic myeloid lukaemia, with 20,000 new cases diagnosed every year. Philanthropy, he suggests, is no substitute for generic medicines.
Too much at stake
‘What Novartis is challenging in the Supreme Court of India is not just the order denying the company a patent for Glivec. Novartis is challenging the very heart of the Indian Patent Act and its attempt to balance the rights of patent holders with the needs of the Indian people for access to treatment that is affordable,’ he says. It is a case, he adds, that Novartis ‘must not win’.
Novartis, meanwhile, insists that generics alone aren’t the solution to the problems faced by the poorest in access medicines. ‘Even our critics recognise that generic versions of Glivec are not affordable for the poor in India.
In India, the cost of a year of treatment with generic Glivec is four to five times the average annual income,’ it said. ‘Poor people in developing countries will suffer needlessly until a wide variety of issues such as lack of diagnosis, infrastructure and distribution are solved.’
‘As the second largest manufacturer of generics in the world, Novartis fully understands and recognises the contribution of generics once drug patents expire; our concern is with the non-recognition of intellectual property rights.’
With so much at stake on both sides, it is no wonder the case is being carefully watched around the world.
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October 3rd, 2011 at 9:15 pm (#)
Just need to understand some basic points.
What Novartis fighting for? As per my understanding, Novartis is neither fighting for imatinib (free base) nor imatinib mesylate, they are fighting rejection order made against the beta-crystalline variant of imatinib mesylate.
What if Novartis wins the case? As per my understanding, even if Novartis wins protecting beta-crystalline variant of imatinib mesylate this will nowhere prevent generic manufacturers from producing and selling imatinib mesylate. Generics will only be barred from using beta-crystalline form not imatinib mesylate per se. In other words, generic manufacturers can produce generic Glivec tablets using any form other than beta-crystalline. What’s the big deal in that?
Will patenting of beta-crystalline seriously impact drug pricing? I serious doubt this! Just mere patenting of specific crystalline variant does not stop generic manufacturers from using and selling various other possible forms of imatinib mesylate. And when generics can easily manufacture and sell crystalline variant other than beta-crystalline variant then where the issue of excessive pricing arises.