Indians march on parliament over Aids drug patent

[Guest guest]

Indians march on parliament over Aids drug patent

By Jack and Jo in New Delhi

Published: May 10 2006 17:45 | Last updated: May 10 2006 17:45

Hundreds of people affected by HIV/Aids on Wednesday marched on the

Indian parliament to support a legal challenge to a patent

application on a key anti- retroviral drug made by US pharmaceutical

group Gilead Sciences.

The Indian Network for People Living with HIV/AIDS and the Delhi

Network of Positive People this week registered a pre-grant

opposition to the patenting of tenofovir disoproxil fumarate

(Viread), an important second-generation treatment.

The challenge will test the Indian patent regime put in place last

year, and comes after Roche announced in March that it had become

the first drugs company since 1972 to receive a product patent in

India.

India's importance goes far beyond drug access for its own

population since it is a high-volume, low-cost centre for the

production and export of drugs for much of the developing world,

undercutting western branded medicines it has copied.

India, dealing with a backlog of 7,000-9,000 applications in the

patent " mailbox " , faces the prospect of years of intellectual

property litigation pitting multinational drugs groups against

Indian generic manufacturers and NGOs.

" We have reached a critical stage because many patent applications

are now under review or about to be granted, a process which will

have a massive impact on people's lives, " said Johannes van de

Weerd, a director of Médecins Sans Frontières.

Chanting " We want tenofovir " and wearing t-shirts blazoned with the

words " HIV positive " , the New Delhi protesters drew stares from

passersby. NGOs say India is still largely in denial about an

epidemic affecting more than 5m people.

Lawyers advising the NGOs say the patent office should reject

Gilead's application on the grounds that the Californian group is

trying to patent a new form of a pre-existing drug without evidence

of enhanced therapeutic efficacy.

Indian pharmaceutical companies, such as Cipla, have developed a low-

cost generic version of tenofovir, priced in India at a seventh of

international levels, and would be likely to have to cease

production or pay steep royalties if a patent was granted.

Yusuf Hamied, chairman of Cipla, said the company had also filed a

pre-grant opposition to the patent application, arguing that

tenofovir was " known " prior to 1995, the cut-off date for patent

protection under the new law.

" At least 5,000 of the 7,000-9,000 applications filed in the mailbox

over the years do not conform with the Indian patent law as passed

in 2005, " he said in an interview. " I urge big pharma to withdraw

them to avoid frivolous litigation. "

In January the Indian patent office rejected a patent application

filed by Novartis for its anti-cancer drug Gleevac in response to a

pre-grant opposition filed by the Cancer Patient Aid Association.

In a move designed to foster self-sufficiency in drug production,

India in 1972 repealed colonial-era patent laws and only allowed

patents on the manufacturing process used to produce

pharmaceuticals, not on the products themselves. The NGOs claim a

tenofovir patent would push up the cost of the treatment beyond the

reach of national AIDS budgets and further delay the achievement of

the World Health Organisation's goal of bringing antiretroviral

drugs to 3m people.

In March, the WHO announced the programme had fallen short of its

end-2005 target, with the number on HIV antiretroviral treatment in

low- and middle-income countries reaching 1.3m, compared with

400,000 in December 2003.

" It's a matter of life and death, " said Loon Gangte, president of

the Delhi Network of Positive People. " At any moment I'll be

developing resistance to my existing treatment and will be needing

the next line of treatment in the form of tenofovir. "

Gilead has been criticised for the slow implementation of its 2002

pledge to make the drug available cheaply in 97 least developed

countries through its " access " programme. The drug has so far been

approved for use in only 11 of the countries.

MSF claims Gilead has not offered to sell tenofovir at the

discounted price of $208 (€162, £111) per patient each year in fast-

growing developing countries such as China, Brazil, Thailand and

India. In developed countries, MSF says Gilead charges $5,718.

Amy Flood, Gilead spokeswoman, said the group was studying ways to

make tenofovir available in countries other than those classified as

least developed and that the decision to supply at cost would be

based on income level and disease incidence.

Gilead had filed for registration in a further 50 countries and

hoped to have filed in all 97 by the end of this year. It estimated

cut-price tenofovir through its access programmes was treating about

20,000 patients worldwide at the end of 2005.

http://news.ft.com/cms/s/694ee44a-e043-11da-9e82-0000779e2340.html