Brazilian patient group files opposition in India

This is the first time a foreign patient group is deciding to oppose an Indian patent application on that ground that a patent in India would have a direct impact on the ability of Brazil to produce and access affordable generic versions of the drug.

The NGOs said that the drug consists of a previously known compound, and should not be considered an invention according to India's Patents Act.

Civil society groups have also filed an opposition to Gilead's patent application on tenofovir in Brazil. The patent offices in both India and Brazil will be reviewing the case in July.

"Although we are confident the tenofovir patent will not be granted in
Brazil, we must ensure that the option of importing affordable generic
versions from India remains open to our AIDS program," stated Veriano
Terto, ABIA's general coordinator.

"This will contribute to the sustainability of our national AIDS program's universal access policy, upon which 180,000 Brazilians depend on for their lives."

The WHO recommends tenofovir disoproxil fumarate (TDF) for use in first and second-line drug regimens for people living with HIV who suffer side effects from other drugs and those who have developed drug resistance.

Access to affordable tenofovir is particularly important for Brazil, as by the end of 2008, an estimated 31,000 people living with HIV will receive the drug through the national treatment program. In April, the Brazilian government declared tenofovir to be of 'public interest' in treating people living with HIV.

As a result of patent oppositions filed in India previously in 2006,
Gilead had offered voluntary licenses to several Indian generic
manufacturers, even though no patent on the drug had been granted.

These agreements are restrictive and do not permit export of the drug or raw material (active pharmaceutical ingredient) to certain middle-income countries, including Brazil. This allows Gilead to continue to charge high prices in these countries.