The Brazilian Interdisciplinary AIDS Association (ABIA), a non-governmental organization (NGO) has joined Indian patient groups in opposing a patent application for Tenofovir (commonly known as Viread), a key AIDS drug marketed by Gilead Sciences in India.
This is the first time a foreign patient group has decided to oppose an Indian patent application on the grounds that an India patent would have a direct impact on Brazil's chances to produce and access affordable generic versions of the drug.
The Indian patent office will hear the oppositions filed by ABIA and an Indian NGO, Centre for Residential Care & Rehabilitation, next month. The NGOs said the drug consists of a previously-known compound, and should not be considered as an invention as per India's Patents Act.
Civil society groups have also filed an opposition to Gilead's patent application in Brazil.
"Though we are confident that patent will not be granted for tenofovir in Brazil, we must ensure the option of importing affordable generic versions from India remains open to our AIDS programme," stated Veriano Terto, ABIA's general coordinator. "This will contribute to the sustainability of our national AIDS programme's universal access policy, on which 180,000 Brazilians depend for their lives."
The WHO recommends tenofovir disoproxil fumarate (TDF) for use in first and second line drug regimens for people 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 HIV people will receive the drug through the national treatment program. In April, the Brazilian government declared tenofovir to be of ‘public interest' in treating people 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.
In Brazil, Gilead sells tenofovir for $1,387 (Rs 59,571) per patient a year, and in comparison, the cheapest available generic version manufactured in India costs only $158 (Rs 6770) per patient a year, the NGOs said.
Brazil will not be able to procure generic versions from India if tenovofir gets a patent in India. On the other hand, if the patent is 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 them bring prices down.
The Indian Network for People Living with HIV/AIDS (INP+) and the Delhi Network of Positive People (DNP+) had filed oppositions to the patent applications on tenofovir at the Delhi Patent Office in 2006.
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