Precedent-setting move likely to increase access to important AIDS drug.

Rio de Janeiro/New York - The Brazilian Patent Office has rejected a patent application by Gilead on the drug tenofovir disoproxil fumarate (TDF), in a move that could increase access to a key HIV/AIDS medicine across the developing world, says the international medical humanitarian organisation Médecins Sans Frontières (MSF).

"Securing wider access to TDF is absolutely crucial," said Dr. Tido von Schoen-Angerer, Executive Director of MSF's Access Campaign. "TDF is a cornerstone drug, recommended by the World Health Organization (WHO) both for patients starting treatment and for those whose medications aren't working anymore. In the past Brazil's production of ARV drugs has helped to bring down prices of ARVs globally. We hope this will happen again."

The decision now means that the medicine can be produced by Brazilian generic companies or imported from other generic sources from abroad. With around 31,000 people currently receiving the drug through Brazil's universal AIDS treatment programme, and an estimated 37,000 by the end of 2008, the consequences on the sustainability of Brazil's efforts to provide AIDS treatment for all will be considerable. Companies in India for example produce WHO-approved TDF at a tenth of the price: US$158 for one patient's yearly treatment, compared to the US$1,387 charged by Gilead in Brazil.

The patent application filed by the US pharmaceutical company Gilead Sciences was opposed by a coalition of Brazilian NGOs and a government pharmaceutical laboratory. The patent office in Brazil rejected it on the grounds that it lacks inventiveness - one of the key requirements for a patent in Brazilian and international patent law.

This is the first time that a patent related to an antiretroviral (ARV) medicine has been rejected as a result of a pre-grant opposition in Brazil. But the consequences extend far beyond Brazil's borders.

"This sets an important precedent for people living with HIV/AIDS in all developing countries whose lives depend on these treatments," said Leena Menghaney, MSF's Access Campaigner in India. "In India, where MSF purchases most of our ARVs, civil society organisations have filed a similar opposition to Gilead's patent application, and we hope that the Indian patent office will be taking note of the Brazilian decision."