[Ip-health] BMJ on Novartis vs India: MSF challenges Novartis's action over Indian patent for imatinib

[thiru@cptech.org]

MSF challenges Novartis's action over Indian patent for imatinib

Ganapati Mudur

1 New Delhi

The international aid organisation M=E9dicins Sans Fronti=E8res has called =
on
the Swiss pharmaceutical company Novartis to withdraw its challenge to the
Indian government, which has refused to give the company a patent on its
leukaemia drug imatinib (Glivec).

In a case scheduled to be heard in an Indian court next week, Novartis has
challenged sections of the Indian patent laws that are seen as an important
public health tool by M=E9dicins Sans Fronti=E8res, doctors, lawyers, and
health activists, because they ensure cheap access to medicines. The
sections do not allow patents for new applications for old drugs, or for
products that are simply a new combination of old drugs.

Novartis started legal action after its patent application for the cancer
drug imatinib was rejected by Indian patent examiners, who described it as
a new form of a known substance. Indian manufacturers produce generic
versions of imatinib mesylate that cost a fraction of the cost of the drug
marketed by Novartis.

M=E9dicins Sans Fronti=E8res has warned that if Novartis wins the case, few=
er
generic versions will be available for production in India. "This will have
a devastating impact on people around the world who rely on affordable
medicines from India," the organisation said.
Indian generic manufacturers have been producing inexpensive versions of
drugs that are then sold in developing countries. "India has emerged as the
pharmacy of the world's poor," said Ellen t'Hoen, director of policy
advocacy with M=E9dicins Sans Fronti=E8res.
About 50% of AIDS drugs in the developing world are Indian generics, she
said.
A M=E9dicins Sans Fronti=E8res official briefed the European Parliament in
Brussels earlier this week at a special hearing on implications of the
challenge by Novartis. "We're calling on parliament members to join others
in asking Novartis to drop the case," said Ms t'Hoen.

Novartis has said it does not agree with the contention that its legal
action in India will adversely impact access to affordable medicines in the
developing world. The company said generics would not solve the challenge
of improving access to imatinib mesylate.

A year's treatment with a generic version of imatinib mesylate in India
would be four times a person's annual average income, the company said.
Novartis currently provides the drug free to more than 6500 patients in
India. Neither generic companies nor the government are providing access
programmes to this medicine, the company said.

"While patent protection has increased over the past decade, the innovation
rate has dropped," said Kapoori Gopakuma, a researcher with the Centre for
Trade and Development in New Delhi.