US co's AIDS drug: India refuses patent protection

In a victory for Indian drug companies, patent protection has been refused to Tenofovir, an anti-AIDS medicine of the US-based Gilead Sciences. The decision was taken by the patent office in New Delhi.

Domestic drug companies are now a step closer to manufacture the medicine for sale in India, as well as to export it to least developed countries.

Since Gilead had made several patent applications on the same medicine (for different claims), the companies will have to wait for the patent office's decisions on other pleas before they can launch the product.

Currently, the medicine is marketed by most Indian companies through a voluntary licence scheme negotiated with Gilead Sciences some years earlier. Cipla, which had challenged Gilead's patent claim, is the only firm that has launched the product at 'risk'. The patent office decision will see the medicine being freed of negotiated terms and conditions.

Tenofovir is an important anti-AIDS drug and has been recommended by World Health Organisation as the primary medicine for AIDS treatment.

The patent office decision was based on the pre-grant opposition filed against Gilead's application by civil society groups within the country and outside. The groups argued that the patent application lacked inventive steps and failed to satisfy the patentability criteria under Indian rules.

According to industry sources, Gilead is likely to appeal against the patent office decision. "Our stand has been vindicated, though the battle is far from over," domestic industry representatives said.

This is the first instance where a foreign advocacy group was seen joining hands with Indian NGOs to oppose a medicine patent application in the country.

Brazilian AIDS advocacy group Brazilian Interdisciplinary AIDS Association and a local NGO, Centre for Residential Care and Rehabilitation, while filing pre-grant oppositions, had said 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.

Last year, the Brazilian government had declared Tenofovir to be of 'public interest' in treating people living with HIV.

Brazil will not be able to procure generic versions from India if Tenofovir gets a patent in India. On the other hand, if the patent is rejected, Indian generic companies would be able to supply Tenofovir to Brazil and other middle-income countries.

This would also mean Brazil could purchase affordable generic versions of Tenofovir from multiple producers competing against each other.