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.
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.
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