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Indian pressure group challenges company's right to patent AIDS drug

BMJ 2006; 332 doi: (Published 18 May 2006) Cite this as: BMJ 2006;332:1176
  1. Ganapati Mudur
  1. New Delhi

    An Indian pressure group has challenged an application by a US drug company, Gilead Sciences, for a patent on tenofovir disoproxil fumarate, an antiretroviral drug that is generically produced in India.

    The Indian Network for People Living with AIDS/HIV and the Delhi Network of Positive People filed their opposition last week, saying that a patent would make the drug unaffordable to people in India and other developing countries.

    Tenofovir has emerged as an important antiretroviral in both first line and second line regimens. Representatives of the networks and humanitarian organisations have said that tenofovir is commonly prescribed in the US and Europe because it is associated with fewer side effects in adults than some other antiretrovirals.

    “We've been waiting impatiently to get tenofovir as a generic from India,” said Eric Goemaere, head of the Médicins Sans Frontières mission in South Africa. The agency currently provides antiretroviral treatment to more than 60 000 people in 30 countries, including India, Thailand, and South Africa.

    Médicins Sans Frontières officials said that the product from Gilead is available for about $5700 (£3000; €4450) a patient a year, but generic tenofovir made by an Indian drug company since last year costs about $830.

    “The entry of more generics is expected to reduce the price further,” said Hans van de Weerd, the head of the Médicins Sans Frontières mission in India.

    Although Gilead has offered a preferential price of $208 a patient a year for low income countries, this discounted price is not available to middle income countries such as Brazil, China, and India, Mr van de Weerd said.

    “India probably has some 500 000 people who need antiretroviral therapy now,” said Anand Grover, director of Lawyers Collective, an organisation that has been campaigning for the rights of HIV positive people. “Only 20 000 receive public funded therapy today,” he said.

    Lawyers who helped file the opposition said that they have challenged the patent application on the ground that tenofovir disoproxil fumarate is a salt of an existing compound—tenofovir disoproxil.

    “Tenofovir disoproxil fumarate is a prodrug [a precursor molecule] to facilitate absorption. Conversion of a drug into its prodrug form is an old procedure and has been done for many molecules in the past,” said Dr Chandra Gulhati, editor of India's drug information bulletin, the Monthly Index of Medical Specialities. “Neither tenofovir nor fumaric acid is a new molecule. I don't see any scientifically valid reason for this patent.”

    Earlier this year, India's patents office rejected an application by Novartis for imatinib mesylate, a drug for chronic myeloid leukaemia, on the grounds that it is a new form of a known substance. India's Cancer Patients Aid Association had opposed the application (BMJ 2004;329:419).

    “Generic producers in India are probably holding back on investing on tenofovir because of this patent application,” said Kappoori Gopakumar, a research officer with the Centre for Trade and Development in New Delhi, an agency studying the impact of trade laws on public health.

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