Indian court rejects
Novartis' drug patent suit By Gustavo
Capdevila
GENEVA - Non-governmental
organizations that advocate poor countries' access
to affordable medicines applauded an Indian
court's dismissal of a challenge brought by
Swiss-based drug-maker Novartis.
The
ruling handed down on Monday by the High Court of
Chennai is a basic condition for achieving access
to drugs, not only in India, but also in other
developing countries, said Julien Reinhard,
director of the health campaign at the Swiss
non-governmental
organization (NGO) Berne
Declaration.
Tido von Schoen-Angerer, head
of the Doctors Without Borders/Medecins Sans
Frontieres (MSF) Campaign for Access to Essential
Medicines, said the decision "is a huge relief for
millions of patients and doctors in developing
countries who depend on affordable medicines from
India".
Novartis, meanwhile, which is
based in the northern Swiss city of Basel, said in
a statement on Monday that the ruling would "have
long-term negative consequences for research and
development into better medicines for patients in
India and abroad".
"Medical progress
occurs through incremental innovation. If Indian
patent law does not recognize these important
advances, patients will be denied new and better
medicines," said Paul Herrling, head of research
at Novartis.
The court decision, which was
anxiously awaited by activists concerned about the
issue of drug patents and patients' rights,
rejected the challenge by Novartis that questioned
the constitutionality of Section 3d of the Indian
Patent Act of 2005. Section 3d basically permits
the manufacture of low-cost life-saving generic
drugs for the world's poor, by only allowing drug
patents on completely new compounds invented after
1995.
When Novartis filed for a patent on
its leukemia drug Glivec (also known as Gleevec),
India's patent office ruled that the drug was
simply a new form of an existing treatment that
had been developed before 1995. It was India's
first ever drug-patent rejection. The company then
decided to challenge Section 3d as
unconstitutional.
The stakes in the case
were high. When the Swiss drug giant brought the
case in January, the MSF's von Schoen-Angerer
said, "If Novartis wins, it could mean the end of
India's generic drug industry." As he said at the
time, India has become the pharmacy for the
world's poor. More than half of all the developing
world's HIV (human immunodeficiency virus) and
AIDS patients rely on low-cost generic drugs from
India.
Reinhard said Berne Declaration,
one of Switzerland's oldest NGOs, has urged
Novartis and Swiss authorities to respect the
ruling.
He said he is worried that
Switzerland or some other country could bring a
complaint against India in the World Trade
Organization's dispute-settlement mechanism, under
pressure from Novartis, based on the argument that
Section 3d is not compatible with TRIPS (the WTO
Agreement on Trade-Related Aspects of Intellectual
Property Rights). Novartis said the Indian court
"deferred to the WTO forum to resolve the TRIPS
compliance question."
If Monday's ruling
is weakened or overturned, access to affordable
drugs in India and other developing countries will
be put in jeopardy, Reinhard warned.
Von
Schoen-Angerer also urged transnational drug
corporations and rich countries "to leave the
Indian Patents Act alone and stop pushing for
ever-stricter patent regimes in developing
countries".
Reinhard said that by
challenging Section 3d, Novartis was attempting to
undermine the Indian government's ability to adopt
provisions aimed at protecting public health and
to maintain a patent system in keeping with the
country's social and economic reality.
Novartis was selling Glivec in India at a
cost of US$26,000 a year per patient, similar to
the prices it charges in other developing
countries, according to Berne Declaration, which
noted, "This price is well above the financial
capacity of most of the patients." By contrast,
generic versions of the drug in India cost about
$2,100 per patient per year.
However,
Brandi Robinson, a Novartis spokesperson in New
York, said early this year that the company
actually gave the drug away, under the Gleevec
donation program, to "99% of the people who need
it" because they could not afford it.
In a
communique issued on Monday, the MSF observed, "A
ruling in favor of the company would have
drastically restricted the production of
affordable medicines in India that are crucial for
the treatment of diseases throughout the
developing world.
"Developing-country
governments and international agencies like UNICEF
[United Nations Children's Fund] and the Clinton
Foundation rely heavily on importing affordable
drugs from India, and 84% of the antiretrovirals
[anti-AIDS drugs] that MSF prescribes to its
patients worldwide come from Indian generic
companies. India must be allowed to remain the
'pharmacy of the developing world'."
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