Indian Court Begins Hearing Patent Dispute Over Popular Cancer Drug

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Indian Court Begins Hearing Patent Dispute Over Popular Cancer Drug

Associated Press WorldStream - Sep. 26, 2006

NEW DELHI--A southern Indian court began hearing a case Tuesday in which

Swiss pharmaceutical giant Novartis seeks a patent for its popular

cancer drug Gleevec.

The trial is seen as a test for India's new patent law, which has been

criticized by public health activists for favoring multinational

companies.

Earlier this year, Novartis filed multiple writs at the Chennai High

Court after Indian patent authorities rejected its application for a

patent on the anti-leukemia drug Gleevec.

Several Indian pharmaceutical companies make generic copies of the drug

and sell it at almost a tenth of the price charged by the Swiss drug

maker. A month's dose of Gleevec costs about US$2,500 (euro2,000).

Aid groups say tens of thousands of cancer patients in India will suffer

if Novartis wins its case and Indian firms are banned from making

generic copies of Gleevec.

It will also set a precedent for other pharmaceutical companies seeking

patent protection for essential medicines, especially those making

antiretroviral drugs used in the treatment of AIDS, said Leena Menghaney

at Medecins Sans Frontieres, or Doctors Without Borders.

MSF and other aid groups have since come in support of Cancer Patients

Aid Association, which offers treatment to some 40,000 patients in

different parts of India and has challenged Novartis' claim for a patent

on Gleevec.

India's new patent law, which came into force Jan. 1, 2005, allows

patents for products that represent new inventions after 1995--the year

India joined the World Trade Organization, which regulates patent rules

for member countries.

Indian drug companies and aid groups say Gleevec is a new form of an old

drug--imatinib mesylate--that was invented before 1995.

India's earlier patent regime allowed domestic drug companies to make

low-cost copies of expensive Western medicines and helped create an

affordable market for medicines in this South Asian country with an

annual per capita of income of about US$700.

When patent laws were changed, the Indian parliament agreed to include

several safeguards into the new legislation to protect public health and

redress concerns raised by aid groups and the domestic industry.

Under the new law, patents must be only for basic molecular structures.

That gives a company just 20 years to make its profits before the

initial drug--and any spinoff--could be legally copied and thus prevents

what is called " evergreening " of a patent.

This safeguard is being tested for the first time since India's new

patent regime came into force.

" The issue is people should have access to the medicines they need, "

said Loon Gangte, who heads a New Delhi-based group of HIV-infected

people.

Gangte said his group challenged patent applications for 13

anti-retroviral drugs, including Combivir from GlaxoKline Plc and

Tenofovir made by Gilead Sciences. Some applications have since been

withdrawn, he said.

If Novartis gets away with a patent for Gleevec, it will boost the

morale of such multinational companies that plan to enter the Indian

market with their patented drugs for AIDS, he said.

Not many people in India can afford buy those drugs, said Gangte, who

has AIDS and spends about 1,000 rupees (US$220) a month on generic drugs

used in his treatment.