The Hindu Business Line : Brazil AIDS group opposes Gilead patent

‘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.’

Our Bureau

Mumbai, June 27 A Brazilian AIDS advocacy group ABIA and the Indian non-government organisation Sahara have filed an application against the grant of a patent in India to Gilead Sciences on its 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,” a statement issued on their behalf said.

The opposition was on the ground that the drug consists of a previously known compound, and should not be considered an invention according to the Indian Patents Act, the note added.

Case review

The pre-grant opposition is a facility provided in the Indian Patent Act to allow anyone to oppose a patent application, before the Patent Office decided on whether to grant or reject the patent.

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 are expected to review the case in July, a health advocacy group representative said.

Explaining Brazil’s interest, a spokesperson for ABIA said that they needed to ensure that the option of importing affordable generic versions from India remains open to Brazil’s AIDS programme.

Tenofovir disoproxil fumarate (TDF) is used 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 end 2008, an estimated 31,000 people living with HIV will receive the drug through the national treatment programme. In April, the Brazilian Government declared Tenofovir to be of ‘public interest’ in treating people living with HIV, the note said.

Pre-grant patent oppositions had been filed in India in 2006 as well, but Gilead later offered voluntary licences to several Indian generic drug companies, though no patent on the drug had been granted.

High prices

“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,” the note claimed.

In Brazil, Gilead sells Tenofovir for $1,387 (Rs 59,571) per patient per year, and in comparison, the cheapest available generic version manufactured in India costs only $158 (Rs 6,770) per patient per year, it added. This, however, could not be independently verified with Gilead.

Brazil would not be able to procure generic versions from India if the patent is granted. If the patent were rejected, Indian generic companies that did not sign the voluntary licence 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 at competitive prices, the note said.

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