Inter Press Service - November 2, 2006
Ann De Ron

A decision in this case can create an important precedent, with consequences that go far beyond India. "If the Novartis challenge against the Indian patent law is successful, patients worldwide who depend on India for affordable medicines risk becoming victims," Ellen 't Hoen, policy director with the Medecins Sans Frontieres (MSF) Campaign for Access to Essential Medicines told IPS.

"Eighty-four percent of AIDS medicines we currently use for patients in more than 40 countries come from India," Ellen '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 Organisation (WTO) rules in the agreement on Trade-Related Aspects of Intellectual Property (TRIPS). But India remains one of the largest producers of generic medicines. Until 2005 it only recognised 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 profit from its investment in research there too," Novartis spokesman in Belgium Xavier Thiriar told IPS. "India will be one of the largest markets in the world in terms of population, and they export a lot too."

Thiriar acknowledges that access to basic medicines can be a problem, but says that 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, Sigrid Sterckx, professor of ethics, and expert on patents at the University of Ghent in Belgium told IPS.

And India does obey TRIPS, argues Ellen 't Hoen of MSF. "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 limy taste, says Sterckx. "I find it morally evident that this should not be patentable. But in Europe and the U.S. 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 a patent application for the Novartis cancer drug Gleevec on the argument that the company wanted to patent a 'trivial improvement'.

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

But more is at stake here than the question 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 Sep. 26. A new hearing is expected later in November.

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

The patent law cannot be allowed to weaken, Menghaney insists. "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 jewellery."

MSF and 16 other organisations 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 Organisation Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH).

Sterckx compares the current court case with 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?"

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