India refuses patent protection for AIDS drug of US company

[Guest guest]

India refuses patent protection for AIDS drug of US company

Joe C Mathew / New Delhi September 2, 2009, 0:49 IST

More appeals pending, domestic manufacturing some way off.

http://www.business-standard.com/india/news/india-refuses-patent-protection-for-\

aids-drugus-company/368821/

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 here.

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

(ABIA) and a local NGO, Centre for Residential Care and Rehabilitation (SAHARA),

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.