[Ip-health] Patents case a bitter pill to swallow

[Ira Glazer]

http://www.atimes.com/atimes/South_Asia/HK04Df03.html

By Ann De Ron

BRUSSELS - Medecins Sans Frontieres (MSF) and other groups campaigning
for access to affordable medicines in developing countries are closely
following a patent-challenge case filed by the Swiss pharmaceuticals
giant Novartis in India. A decision in this case could establish an
important precedent, with consequences that go far beyond India.

"If the Novartis challenge against Indian patent law is successful,
patients worldwide who depend on India for affordable medicines risk
becoming victims," said Ellen 't Hoen, policy director with the MSF
Campaign for Access to Essential Medicines.

"Eighty-four percent of AIDS medicines we currently use for patients in
more than 40 countries come from India," 't Hoen said. "Because of the
lower prices, we can treat 60,000 people. If we would use only patented
medicines, this would be a lot less. And this is only one example."

As of 2005, India is bound by World Trade Organization rules in the
agreement on Trade-Related Aspects of Intellectual Property (TRIPS). But
India remains one of the largest producers of generic medicines. Until
last year, it only recognized patents for a production process, not for
a product, and this was good for Indian producers of generic medicines
that develop their own process to produce a known medicine.

"India simply does not obey TRIPS, and our company has the right to make
a profit from its investment in research there, too," Novartis spokesman
in Belgium Xavier Thiriar said. "India will be one of the largest
markets in the world in terms of population, and they export a lot too."

Thiriar acknowledged that access to basic medicines can be a problem,
but said Novartis cooperates with MSF and gives free medicines worth
large amounts of money.

But discounts and free medicines from companies are not a structural
solution for the pressing lack of available medicines, said Sigrid
Sterckx, professor of ethics and an expert on patents at the University
of Ghent in Belgium.

And India does adhere to TRIPS, argued 't Hoen. "India refuses patent
applications for medicines for trivial improvements of known molecules.
That is allowed under TRIPS."

Such "trivial improvements" can, for instance, involve removing a limey
taste, said Sterckx. "I find it morally evident that this should not be
patentable. But in Europe and the US, this sort of change is sufficient
to get a new patent. The medicine is then sold more expensively, and
people are made to think it is a real improvement."

The challenge to India's patent law arose when an Indian patent bureau
rejected an application for the Novartis cancer drug Gleevec on the
grounds that the company wanted to patent a "trivial improvement".

Thiriar denies that Novartis has ever patented trivial improvements, in
India or elsewhere.

But more is at stake here than the question of whether the Gleevec
version Novartis wanted to patent in India is innovative or not.
Novartis not only went to court to fight the Gleevec case, but
challenged the entire Indian patent law. The company has sued the Indian
government, Indian producers of generic medicines and an Indian group of
cancer patients before the Chennai High Court in southern India.

The case came up first on September 26. A new hearing is expected this
month.

"This is a very dangerous precedent for India and other countries," said
Leena Menghaney of MSF India. "Now it's about Gleevec, but later on it
will be about all other medicines."

The patent law cannot be allowed to weaken, Menghaney insisted. "We
cannot follow the Western system - people here have no health insurance,
and when they get ill they may have to sell their house, their jewelry."

MSF and 16 other organizations are asking Novartis to withdraw the case.
One of the signatories to an open letter the groups have written to
Novartis is former Swiss president Ruth Dreifuss, who also chairs the
World Health Organization Commission on Intellectual Property Rights,
Innovation and Public Health.

Sterckx compares the current court case to the case that major
pharmaceutical companies filed in 1998 against the government of Nelson
Mandela in South Africa. They demanded that South Africa abolish a law
that made it possible to produce or import affordable versions of
patented AIDS medicines. They finally withdrew the case in 2001.

"It was a total PR [public relations] disaster for the pharmaceutical
industry," Sterckx said. "Have they learned nothing from the debacle of
those days?"

(Inter Press Service)