August 6: Today's verdict by an Indian court against the Swiss pharmaceutical giant Novartis is an important victory for global public health, according to aid agencies CARE International and Oxfam International, and the church-based advocacy network, the Ecumenical Advocacy Alliance.

The decision will protect India's special role as the world's leading provider of affordable medicines to the poor. The agencies welcome Novartis's response today that it is unlikely to appeal the ruling.

Novartis had challenged a law that allows India to refuse a patent for an existing medicine when it had been modified only slightly. The agencies said the case was a direct attack against India's right to protect public health.

Novartis and the pharmaceutical industry have been given a clear message to respect developing countries' legal right to use the World Trade Organisation TRIPS (trade-related intellectual property) safeguards to strike the right balance between protecting public health and intellectual property, the agencies said.

India - known as the 'pharmacy of the developing world' due to its massive generic drug production industry - supplies most of the world's affordable generic medicines to developing countries where patented medicines are priced out of most people's reach. More than two-thirds of the generic medicines produced in India are exported to developing countries at a fraction of the cost of patented brand medicines.

Novartis' legal challenge posed an enormous threat in developing countries to millions of people suffering from cancer, HIV and AIDS, diabetes and other diseases who are too poor to pay for expensive patented medicines.

Sandhya Venkateswaran, Head of Advocacy for CARE International in India said: "This ruling is a lifeline for the millions of people who cannot afford brand-name drugs, and ensures that essential medicines from India will reach those who rely on them. CARE and other agencies can breathe easily now and continue to deliver treatment programmes.

"More than 5 million people with HIV around the world still cannot afford anti-retroviral medicine, but this ruling reduces the number of people for whom HIV is a virtual death sentence. CARE has been able to buy more than twice the amount of anti-retrovirals to treat the HIV and AIDS patients we work with in Peru, thanks to the generic industry in India."

A global campaign by civil society has seen nearly half a million people around the world campaigning against Novartis to drop its case.

Celine Charveriat, head of Oxfam's Make Trade Fair campaign said: "This ruling is a vindication for India and a victory for campaigners. Developing countries should not be bullied by pharmaceutical companies and forced into having to defend themselves in court for correctly using the safeguards available to them to protect public health."

Linda Hartke, coordinator of the Ecumenical Advocacy Alliance, which mobilized church leaders to campaign against Novartis' case in India, said, "This is a victory for all those who believe people, not profits, must come first in public health."

CARE, Oxfam, and the EAA call on Novartis to continue to take positive steps to promote access to medicines in developing countries, to promote research and development for neglected diseases and to strike an appropriate balance between protecting public health safeguards in developing countries and intellectual property rights.

Ends/ Press contacts:

Sophie Kummer, CARE International, 020 7934 9347 Matt Grainger, Oxfam, 01865-339128 Sara Speicher, Ecumenical Advocacy Alliance, 01524 727 651

NOTES

o The provision in the Indian law - "section 3d" - states that patent monopolies will be awarded only for truly innovative medicines, rather than for minor modifications of existing medicines. Because monopolies will not be granted on medicines other than truly innovative ones, affordable generic versions will remain available. This will help protect India's role as the main supplier of affordable generics to other developing countries where patented medicines are priced out of reach of most people.

o This ruling comes at a time when patentability criteria are under examination in other countries as well, for instance the United States. Recognizing that patentability criteria which lead to the granting of frivolous patents can hinder innovation and access to new products rather than promote it, the US Supreme Court has recently ruled in favour of stricter criteria.

o The provision in Indian law under challenge by Novartis constitutes an important public health safeguard in TRIPS. Developing countries should be commended for using this and other safeguards to promote access to affordable medicines for their populations. Oxfam supports use of public health safeguards - recent examples include the issuance of compulsory licenses by Brazil and Thailand, and the introduction of a new, pro-health intellectual property law in the Philippines.

o The right of all WTO members to use the flexibilities and safeguards in the TRIPS Agreement to promote "access to medicines for all" was confirmed in 2001 (the Doha Declaration). Since then, however, rich countries and big pharmaceutical companies have sought to prevent or limit their use by developing countries, endangering the well-being of poor patients everywhere.