Gilead's patents on key HIV drug rejected in US

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Gilead patent case to help Indian firms

25 Jan 2008, 0027 hrs IST,Rupali Mukherjee,TNN

NEW DELHI: The US Patent & Trademark Office's rejection of four patents held by

Gilead Sciences on a key HIV drug Tenofovir, paves the way for a more affordable

treatment for millions of patients suffering from AIDS.

The US patent office decision strengthens the pre-grant opposition filed in 2006

by Indian Network for People Living with HIV/AIDS (INP+) to several patent

applications filed by Gilead on tenofovir disoproxil fumarate (TDF) in India, on

the ground that they did not meet the country's patentability standards.

For the domestic generic industry, the development encourages production of the

drug in the country, and gives them opportunities to export to developing

countries.

US public interest organization, Public Patent Foundation (PUBPAT) challenged

the patents in the US patent office, saying that Gilead's patent on TDF did not

fulfil the criteria of novelty.

With this rejection, Gilead Sciences faces an uphill task to get a patent in

India, and other developing countries. Legal experts say, Gilead will now have

to share this information with the Indian patent office, which is in the process

of examining patent applications on TDF by Gilead.

TDF is important for people suffering with AIDS as a first line treatment, and

also for those who have developed resistance to first-line antiretroviral

therapy. WHO treatment guidelines include TDF in first and second-line

antiretroviral regimens.

INP+, which filed a pre-grant opposition in India is concerned that if patents

on TDF are granted access to affordable generic versions of the drug will be

affected. Patents granted on TDF by other countries denied people living with

HIV/AIDS access to this important anti-retroviral. In fact, Brazil who has

granted the patents on TDF has not been able to produce the generic version and

has been forced to pay high prices to Gilead to provide the drug to its

patients.

The lowest price that Gilead offers TDF (300 mg) in Brazil is $2766 per patient

per year, which was nearly halved at $1400 after it threatened invoking a

compulsory licence.

The cost of treatment would be one-seventh of that price, if an Indian generic

such as Hetero Drugs, Cipla and Matrix offers the drug — at $195 per patient per

year.

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