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HIV Generic Drugs-Patent Battles in India
  Drug firms seek to stop generic HIV treatment
Randeep Ramesh in New Delhi
Thursday May 11, 2006
The Guardian
Multinational drug firms have begun to seek patents for Aids drugs in India, a main source of cheap treatments, provoking protests from campaigners and patients who say this will stifle supplies of affordable therapies.
Until last year India permitted the copying of patented drugs, which allowed the country's pharmaceutical industry to sell cheap versions of Aids drug cocktails, known as antiretrovirals. Legislation enacted in March 2005 curtails the ability of firms to make copycat treatments and allows foreign pharmaceutical companies to claim ownership of drugs.
The California- based Gilead and Britain's GlaxoSmithKline, have now applied for patents on two HIV treatments. Campaigners, lawyers and Indian drug makers have opposed the applications, and more than 100 people were arrested in protests yesterday in Delhi.
Activists say patents would drive up prices as Indian manufacturers would have to pay royalties and rival generic versions would be blocked for 20 years.
Gilead has sought a patent on a key Aids treatment called tenofovir (Viread), while Glaxo has sought one for a widely used drug called Combivir. Lawyers say 8,000 patent applications are in the pipeline.
Exports by Indian companies helped to cut the price of antiretroviral treatment from $15,000 (L8,000) per patient per year a decade ago to $200. Indian companies now provide two- thirds of the world's cheap Aids therapies.
Campaigners say that as Aids patients develop a resistance to "first- line" drugs, there will be no scope for a reduction in prices of second- generation medicines without the Indian generic drugs. The second- generation drugs are already 10 times more expensive than older treatments.
"Granting [these patents] would set a dangerous precedent," said Ellen 't Hoen, director of policy at Medecins sans Frontieres. "We will be back to the days when multinationals controlled the price."
Drug companies say they sell to poor countries at cheap rates and that problems with public health systems, rather than patents, curtails accessibility.
Indians march on parliament over Aids drug patent
By Andrew Jack and Jo Johnson in New Delhi
Published: May 10 2006 17:45 | Last updated: May 10 2006 17:45
aids pharmaceutical newsHundreds 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 Medecins Sans Frontieres.
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, L111) 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.
Press Release
Source: Global AIDS Alliance
Protestors at Gilead Shareholders' Meeting May 10
Tuesday May 9, 12:57 pm ET
Company's AIDS Drugs Unavailable Where Most Needed, Says GAA
SAN FRANCISCO, May 9 /PRNewswire/ - - On May 10, AIDS activists will stage a vigil outside the shareholders' meeting of Gilead Sciences, a company based in Foster City. The vigil is sponsored by the American Medical Student Association, ACT UP East Bay, Global AIDS Alliance, Global Exchange, Peninsula Peace and Justice, Priority Africa Network, Student Global AIDS Campaign, and Survive AIDS.
When: 9:00 - 10:00am, Wednesday, May 10th
Where: Hyatt Regency, San Francisco Airport, 1333 Bayshore Highway,
Burlingam, CA
The protest, led by people living with AIDS from the San Francisco area,will call attention to the company's appalling slowness at making sure itsAIDS drugs are available and affordable in poor and middle income countries.About 8,000 people die of AIDS each day, 1500 of them children. In Africa,only 17% of people needing AIDS treatment is receiving it.
Inside the meeting, shareholders will raise the urgency. Faith- basedinvestors will offer a resolution which asks for a report from the board ofdirectors on the impact of the HIV/AIDS pandemic on the business of thecompany.
A letter to the company which urges that it change its policies has beensent by numerous Bay Area groups, as well as national and internationalorganizations, including Network of African People living with HIV/AIDS,Global AIDS Alliance, Doctors Without Borders and American Jewish WorldService. The letter was also signed by the Ecumenical Advocacy Alliance, aglobal action network of sixty- three churches and church- relatedorganizations.
The letter is available online at:
Also on May 10, members of the Student Global AIDS Campaign will alsostage a protest at a Gilead facility in Durham, North Carolina.
Gilead's AIDS drugs Emtriva, Viread, and Truvada are life- saving medicinesthat could save the lives of millions of people around the world.Unfortunately, Gilead has yet to:
1) Price Emtriva, Viread and Truvada affordably in middle- income countries,
2) Sell the drugs in all countries where the price discount is offered
3) Offer a voluntary, open license to generic producers,
4) Register the drugs in all countries, and
5) Expedite development of pediatric formulations
Millions are dying while Gilead waits to act.
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