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The giant Swiss drug multinational Novartis’
challenge to India’s patent laws could seriously reduce, if not
cut the supply of affordable medicines to treat AIDS and other
epidemics in poor countries.
India changed its patent laws in
2005 to comply with a global agreement on intellectual property.
Subsequently, Novartis applied for a patent. It is one of the
first under the new rules. It is for its leukemia anticancer drug
Glivec.
In January 2006 India’s patent
office rejected the application. Novartis protested and sued in
court. It is also challenging India’s patent laws, claiming that
they do not comply with the international agreement.
The trial opened in Madras. The
main issue is the question of innovation. India’s patent law
requires that drugs be “new and involve an inventive step” in
order to win patent protection.
NGOs including Medécins Sans
Frontiéres (MSF) and Oxfam say that if Novartis succeeds,
pharmaceutical firms will be able to put newer AIDS treatments based
on existing drugs under patent protection in India, preventing cheap
generic versions being exported to Africa and elsewhere.
India became the “pharmacy of
the world’s poor” in 1970 when it stopped issuing drug patents,
allowing its many drug producers to create generic copies of
medicines still patent-protected in other countries—at a fraction
of the price charged by multinational drug behemoths. In 1994,
however, New Delhi became signatory to the Agreement on Trade
Related Aspects of Intellectual Property Rights (Trips), a deal
which required all WTO member countries to grant patents on
technological products, including pharmaceuticals, by 2005.
This prompted drug firms to queue
up to patent their brands in India. Up to 9,000 patents await
examination. Glivec was one of the first to go to court.
Novartis’ bid was rejected
because it was judged to be merely a new version of an older
medicine. The Swiss company argues that India’s requirement for
drugs to be new and innovative is not in line with the TRIPS.
It is not clear whether the
Glivec case would set a precedent allowing other modified drugs to
be patented in India. “There are an estimated 9,000 patent
applications waiting to be reviewed, of which some 7,000 are said to
be modifications of old drugs,” says Richard English, manager of
Oxfam’s Make Trade Fair campaign. “If Novartis wins, countless
medicines previously available cheaply to poor people could then be
patented and priced out of reach.”
While the company sells the drug
at a price of Rs 1,200,000, Indian companies retail it at Rs 8,000.
NGOs say the outcome of the case could have a profound effect on the
accessibility to generic medicines in the developing world.
Glivec is considered a
breakthrough therapy for treating Chronic Myeloid Leukemia.
In challenging the Indian patent
law, Novartis in effect is saying any variation of an existing drug
is patentable. Also patentable will be new uses of existing drugs or
even new combinations or delivery systems of existing drugs might be
patentable.
Meanwhile, Medécins Sans Frontiéres
is said to have collected some 300,000 signatures worldwide to
pressure Novartis to drop its case.
MSF says generic manufacturers
have helped bring the cost of AIDS treatment down from $10,000 per
patient per year in 2000, to just $130 now.
“The Glivec case is a litmus
test,” said US Chamber of Commerce’s senior vice president
Daniel Christman.
“If India chooses to protect
the intellectual property of Novartis, it will help open a floodgate
of investment into India’s pharmaceutical industry, propelling
India onto center stage as a destination for innovation, R & D,
and breakthrough medicine,” he said.
The Berne Declaration, Oxfarm
International and the international medical humanitarian
organization Medécins Sans Frontiéres have emphasized that
Novartis is challenging countries’ rights to have patent laws that
put the interest of people first.
“The Doha Declaration tries to
find a balance between intellectual property rights and public
health,” said Ruth Dreifuss, who chaired the 2004-06 WHO
Commission on Intellectual Property Rights, Innovation and Public
Health (CIPIH). “The balance can be achieved only of countries
make use of the flexibilities contained in the TRIPS Agreement, and
this is what the Indian law does. By challenging it, Novartis is
sacrificing public health objectives and weakening the whole
system.”
Many developing countries rely on
affordable medicines. Over half the AIDS drugs used in the
developing world are generics. India has been able to produce
affordable versions of medicines patented elsewhere because until
2005, the country did not grant pharmaceutical patents.
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