Brazilian AIDS advocacy group ABIA (Brazilian Interdisciplinary AIDS Association) and the Indian NGO SAHARA (Centre for Residential Care & Rehabilitation) submitted an opposition against the grant of a patent in India to Gilead Sciences for the key AIDS drug tenofovir. A patent in India would not only restrict generic competition in India, but would also have a direct impact on the ability of Brazil to produce and access affordable generic versions of the drug.

The opposition has been filed on the ground that the drug consists of a previously known compound, and should not be considered an invention according to India's Patents Act. India's patent law is pro-public health, with strict patentability criteria. A major public-health safeguard in the law is the provision against patenting of minor improvements of known medicines (section 3(d)). The law also allows any party to oppose patent applications that do not deserve patents under Indian law.

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 programme," said 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 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. In Brazil, Gilead sells tenofovir for US $1,387 (Rs 59,571) per patient per year, and in comparison, the cheapest available generic version manufactured in India costs only US $158 (Rs 6770) per patient per year.

Brazil would not be able to procure generic versions from India if the patent were granted. If the patent were rejected, Indian generic companies that did not sign the voluntary license agreement with Gilead would be able to supply tenofovir to Brazil and other middle-income countries. This would mean Brazil could purchase affordable generic versions of tenofovir from multiple producers competing against each other, helping bring prices down.

The Indian Network for People Living with HIV/AIDS (INP+) and the Delhi Network of Positive People (DNP+) filed oppositions to the patent applications on tenofovir at the Delhi Patent Office in 2006.

"There's a global momentum building against the granting of a patent in India on tenofovir," said Loon Gangte, president of the Delhi Network of Positive People (DNP).