Info Service on Health Issues (February 07/03)
Groups urge Novartis to drop patent case against India
a quarter of a million people from more than 150 countries, global health
organisations and The Lancet have all asked Novartis to drop
the case against India’s patent law. This was in response to an international
petition launched by Medicins Sans Frontieres to put pressure on the
drug company to drop its legal action against India.
article below has the story which is reproduced with the permission
of South-North Development Monitor (SUNS) #6180, 31 January 2007.
Health: Groups urge Novartis
to drop patent case against India
By Kanaga Raja, Geneva, 30 January 2007
Nearly a quarter of
a million persons from more than 150 countries have voiced concerns
over the negative impact that a legal challenge brought by the multinational
pharmaceutical company Novartis against India's patent law could have
on access to medicines in developing countries.
The legal challenge brought by the Swiss-based Novartis against the
government of India began to be heard in the Chennai High Court on Monday
- despite an international petition launched by the international medical
humanitarian organization Medicins Sans Frontieres (MSF) last December
to put pressure on the company to drop its patent case against India.
According to MSF, nearly a quarter of a million people from 150 countries
had signed its petition.
Novartis is seeking to overturn India's refusal to grant a patent on
the cancer drug that the company markets as Gleevec/Glivec, and is also
challenging the provision in the Indian Patents Act of 2005 which formed
the basis for rejecting the Novartis patent.
On Monday, the Indian Network for People with HIV/AIDS (INP+), the People's
Health Movement, the Centre for Trade and Development (Centad), and
MSF, again called on Novartis to immediately cease its legal action
According to the groups, many developing countries rely on affordable
medicines produced in India, and such medicines constitute over half
the AIDS drugs used in the developing world. India has been able to
produce affordable versions of medicines patented elsewhere because
until 2005, the country did not grant pharmaceutical patents.
"Novartis is trying to shut down the pharmacy of the developing
world," said Dr. Unni Karunakara, Medical Director of MSF's Campaign
for Access to Essential Medicines, in New Delhi.
"Indian drugs account for at least a quarter of all medicines we
buy, and form the backbone of our AIDS programmes, in which 80,000 people
in over 30 countries receive treatment. Over 80% of the medicines we
use to treat AIDS come from India. We cannot stand by and let Novartis
turn off the tap," added Dr. Karunakara.
Novartis is challenging a specific provision in India's patent law that
restricts patenting of medicines to innovations only. If the provision
were overturned, patents would be granted far more widely in India,
heavily restricting the production of affordable medicines that has
become crucial to the treatment of diseases across the developing world,
the groups argued.
"Here in India, the People's Health Movement fought hard to make
sure our government implemented a law that put people's health before
patents and profits," said Dr. Amit Sengupta. "But now, Novartis
is trying to force a change in our patent law, which could deprive people
suffering from life-threatening diseases and conditions."
The World Trade Organization's Agreement on Trade-Related Aspects of
Intellectual Property Rights (TRIPS) obliged India to begin reviewing
pharmaceutical patents in 2005. The TRIPS agreement, however, includes
pro-public health safeguards that countries can implement, and India
has included some of these in its patent law. The Doha Declaration on
TRIPS and Public Health, signed by governments in 2001, reinforced the
right of countries to use these safeguards.
"The TRIPS Agreement already makes it difficult for India to produce
the affordable drugs that people need," said Gopakumar of Centad.
"By challenging the pro-public health safeguards in the Indian
law, Novartis is going even further and is trying to undo the Doha Declaration,
restricting access to medicines."
According to the groups, one provision of the Indian law states that
any interested party can oppose a patent before it is granted in a "pre-grant
opposition" process. Such oppositions have been filed against numerous
patent applications on essential medicines that do not warrant patents
under Indian law.
"We have opposed patent applications for crucial AIDS drugs that
we need to be able to access at affordable prices," said Elango
Ramchandar, President of INP+. "Our survival depends greatly on
winning these patent oppositions. We need everyone, everywhere to join
us in our effort to get Novartis to back off here in India."
A joint NGO statement on Novartis' challenge to the Indian Patents Act
said that the stakes of the case reach far beyond India, and are global.
Today, Indian generic manufacturers supply over 50% of all antiretroviral
drugs given to patients in the developing world. But if Novartis wins
and succeeds in getting the provision of the Indian law changed to resemble
patent laws in wealthy countries, patents may be granted in India far
Over 6,000 drug patents including for AIDS drugs are awaiting examination
by the Indian patent offices. Whether patents on these medicines are
granted may depend on the outcome of this case. If Novartis prevails,
India will cease to be the pharmacy of the developing world, and access
to medicines will be further threatened, the NGOs warned.
The statement, released on Monday, urged Novartis to immediately cease
its legal action in India.
The NGOs that signed the statement included MSF, Oxfam, Knowledge Ecology
International, Health Action International, Third World Network, Delhi
Network of Positive People, India, Centre for Trade and Development,
India, Instituto Brasileiro de Defesa do Consumidor, Brazil, Associacao
Brasileira Interdisciplinar de Aids, Brazil, Grupo de Trabalho da REPRIB
sobre Propriedade Intelectual (GTPI), Brazil, and Berne Declaration,
IPS adds from Brooklin, Canada: India did not allow the patenting of
pharmaceuticals until 2005, when it was forced to as a condition of
its entry into the World Trade Organisation (WTO), said Ellen't Hoen,
director of policy advocacy for MSF.
However, the WTO's 2001 Doha Declaration allows developing countries
to manufacture generic drugs and override patents in times of public
health crises and to export these to others that don't have the ability
to make them.
"Big pharmaceutical corporations have been pushing to ignore Doha
and obtain higher levels of IP (intellectual property) protection through
free trade agreements and lawsuits," Hoen said in an interview.
India's 2005 patent law only allows drug patents on completely new compounds
invented after 1995. When Novartis filed for a patent on its leukaemia
drug Glivec (Gleevec in some countries), the Indian patent office ruled
that the drug was simply a new form of an existing treatment that was
developed before 1995. This was India's first-ever drug patent rejection.
Novartis acknowledges that Glivec is an improved version of an older
drug. And despite the fact that the company gives the drug away free
to anyone in India who can't afford to buy it, it wants the courts to
overturn the patent decision and is challenging Section 3d of the Indian
Patent Act of 2005.
"The Indian Patent office is creating hurdles to pharmaceutical
innovation," says Brandi Robinson, a Novartis spokesperson in New
Since the company gives away the drug to "99% of the people who
need it", the court case is about patent rights and not access
to life-saving drugs, Robinson said in an interview.
Hundreds of thousands of AIDS patients are living today because of India's
generic drugs, said Loon Gangte of the Delhi Network of Positive People,
an AIDS activist organisation. "If Novartis wins, it will affect
the lives of AIDS patients," Gangte told IPS.
Leading medical journals such as The Lancet, global health organisations
and officials in many countries have all asked Novartis to drop the
case. MSF launched a petition that now has nearly a quarter of a million
people from over 150 countries who expressed their concern about the
impact of the Novartis case on access to medicines in developing countries.
"It feels like we're back in South Africa in 2001," said von
Novartis was one of the 39 companies that took the South African government
to court five years ago in an effort to overturn the country's medicines
act that was designed to bring drug prices down.
"The current economic model of drug R&D doesn't work for the
developing world," said Hoen.
Under this model, high levels of patent protection for at least 20 years
and often longer means that companies with proprietary products have
monopolies and can charge whatever price they want, guaranteeing money
for research and plenty of profits.
"In some cases, this works, boosting R&D investment but in
many cases, the money doesn't go into research," Hoen noted.
Pharmaceuticals are a $600 billion a year industry and there are "lots
of opportunities to make money", she said.
Free handouts from drug companies aren't the answer either. These benefit
a few thousand people, but by no means do all drug companies have such
donation programmes and they are often short term or one time only offers,
"We need a new and affordable system for drug research and manufacturing,"
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