[Ip-health] IHT: AIDS drug provokes patent battle in India

[Sheila.SHETTLE@geneva.msf.org]

AIDS drug provokes patent battle in India
By Amelia Gentleman and Hari Kumar International Herald Tribune

THURSDAY, MAY 11, 2006

NEW DELHI A legal challenge to a patent application in India on a crucial
AIDS drug was filed this week in Delhi by two patients' rights groups, who
claim that thousands of lives could be put at risk if the patent is
approved.

If the drug, tenofovir, is granted a patent, the manufacture of cheaper
versions in India will become illegal, making the drug too expensive for
patients in developing countries.

The suit is one of the first major challenges to an Indian patent
legislation introduced last year that was designed to control the country's
large pharmaceutical industry, which for decades has specialized in making
cheaper copies of Western manufactured medicines.

The Indian patent office is processing about 9,000 patent applications,
most of them filed by international pharmaceutical companies. Patient
advocates warn that the supply of a wide range of vital drugs to people in
the developing world may be jeopardized. Hundreds of thousands of AIDS
patients in developing countries are treated with generic Indian drugs.

Those backing the legal challenge are hopeful that this case, if
successful, could help set a legal precedent, thereby making it easier to
block other pending patent applications. They say the recent rejection of a
patent application by Novartis for a cancer drug, on the grounds of similar
legal arguments, gives some cause for optimism.

The Delhi Network of Positive People and the Indian Network for People
Living with HIV/AIDS registered a formal opposition Tuesday to a patent
application by the U.S.-based Gilead Sciences for the drug tenofovir
disoproxil fumarate, commonly known just as tenofovir.

Their lawyers make the case on a scientific technicality, arguing that
tenofovir is not a new drug, but just a modified version of an earlier
drug, and therefore not eligible for a new patent under India's act.

The successful challenge to a patent for the cancer drug, Gleevac, was also
made on this basis - that the application claims "a new form of a known
substance."

The World Health Organization recently recommended the drug for patients
who are just starting treatment for AIDS and for those who have been
receiving anti-retroviral treatment therapy for some time, but who have
become resistant to other treatments. The drug has relatively few known
side effects and is in wide use in the United States and Europe, although
less so in the rest of the world.

"These generic drugs are not only consumed in India," said Leena Menghaney
of M=E9decins Sans Fronti=E8res, or Doctors Without Borders, in Delhi, whic=
h is
working with the Indian groups on the issue. "People in Africa and the
Caribbean are relying on India to produce these drugs.

"The quality matches that of U.S.- manufactured drugs, but the prices are
affordable. These drugs are very important, which is why we are opposing
this patent application.

"People who suffer extreme side effects from other drugs, and people who
have developed resistance to other drugs, have been waiting for an
effective substitute such as tenofovir. If they don't get it, then probably
their lives will be at risk, and certainly their quality of life will be
worse."

Eric Goermaere, of M=E9decins Sans Fronti=E8res in South Africa, said in a
written statement: "We have all been waiting impatiently to get tenofovir
as a generic from India. It's clear that the world desperately needs more
sources of tenofovir. If Gilead is granted the patent, our patients will
face a potentially deadly delay."

In developed countries, Gilead's tenofovir costs $5,718 per patient per
year. According to company's Web site, it has been offering the drug at
cost to treatment programs in eligible developing countries. But officials
with M=E9decins Sans Fronti=E8res said the company has not yet made the dru=
g
available in many low-income regions. A spokeswoman for Gilead, Erin
Edgley, said in an e-mail message that the company declined to comment.

Cipla, one of the largest generics companies in India, is already marketing
a generic version of tenofovir, called tenvir, at a cost of $700 per person
per year in India.

Yusuf Hamied, chairman of Cipla, said the drug would in time be made
available in Africa for about half the price in India. Tenvir will have to
be withdrawn if the Gilead patent, which would last for 12 years, were
granted.

About 150 protesters, many of them HIV-positive, demonstrated outside the
Indian Parliament on Wednesday in support of the legal action, carrying
banners declaring "Patients before patents" and "Lives before profit." A
number of campaigners were detained when they crossed the police barriers.

Among the protesters was Loon Gangte, president of the Delhi Network of
Positive People, who like more than 5.1 million people in India is
HIV-positive.

"If this patent is granted, it will chop off a lifeline for me," he said,
adding that he has been taking anti-retroviral treatment for the past 3=BD
years. "Any time now I am going to become resistant to the first line
treatment and I will need new drugs. For many of us living with HIV/AIDS,
newer drugs like tenofovir offer new hope of continuing treatment.

"If the government grants the patent the price of these drugs will go up,
and I won't be able to afford them. It is a life- and-death issue for me
and many more people like me around the world. We do not want to die when
our lives can be easily saved."

The Indian patent law, introduced last March, was designed to regulate the
copying of Western medicines by the Indian pharmaceutical industry and to
bring the country into line with World Trade Organization rules.

International aid organizations warned that the legislation could mark the
beginning of the end of affordable generic drugs.

Supporters of the legislation counter that patents ensures that
pharmaceutical companies have the security to invest in further research
allowing them to develop vital drugs. They argue the patent law also
creates benefits for the Indian pharmaceutical industry as it begins to
develop world-class drugs. Those innovators will want protection from
generic copies.

The AIDS patients rights' groups issued the formal opposition to the patent
on a scientific technicality, arguing that tenofovir is not a new drug, but
just a modified version of an earlier drug.

Cipla plans to start a parallel legal opposition to the patent application.

"We have never been against intellectual property and patents," Hamied said
by telephone from Mumbai. "We are against monopoly. I believe that life-
saving, essential drugs should be freely available and the innovator should
be paid a suitable royalty payment for his invention."

He said he believed that a large number of the 9,000 patents currently
pending will ultimately prove to have no basis in law and will be rejected.
Most of them were filed speculatively before the Indian legislation was
passed in 2005 and before the precise details of the new legislation were
announced.

Hamied called on those multinational corporations with patents are pending
which do not comply with the current Indian law, "to withdraw them
voluntarily, instead of entering into litigation after litigation after
litigation."


+++++++++++++++++++++
Sheila Shettle
Communications Officer
M=E9decins Sans Fronti=E8res
Campaign for Access to Essential Medicines
Rue de Lausanne 78
1211 Geneva
Switzerland
+ 41.22.849.8403
sheila.shettle@geneva.msf.org
www.accessmed-msf.org