Drugs for needy nations hang on India ruling

 In a case that could affect India's role as drug provider to the developing world, the country's top court began hearing arguments Tuesday over whether the Indian government had the right to deny a patent to Swiss drugmaker Novartis AG for its lifesaving cancer treatment Gleevec.

A victory for the company, world health groups warn, could open the door to patenting dozens of other generic medicines made by India's $20 billion drug industry and sold to needy nations at far lower costs than those charged by Western drug manufacturers.

"There will be nothing left to defend, if we lose," said Leena Menghaney of Medecins Sans Frontieres. "The generic industry is just going to pack up and leave."

The case, launched soon after India passed its Patent Act in 2005, revolves around a legal provision aimed at preventing companies from seeking patents or extensions based on minor changes to existing treatments -- a practice known as "evergreening" that is common in Europe and the United States.

The provision has allowed India to reject patents for a range of older drugs for cancer, AIDS, tuberculosis, malaria and other illnesses that are made by India's generics industry.

It also led to the rejection of Novartis' application for Gleevec, in which it argued a newer, more easily absorbed version qualified for a patent because it was demonstrably more effective. The blockbuster drug keeps chronic myeloid leukemia and some other cancers in remission. Its earlier version was ineligible for an Indian patent because the country gives no protection to drugs invented before 1995.

Novartis insisted the revamped Gleevec, marketed outside the United States as Glivec, represents a unique breakthrough rather than just a tweak to the old formula, and that the Indian law "intended as a hurdle for 'evergreening' is not applicable at all," the company said in a statement.

But Indian patent officers and an appellate court said the change only amounted to an obvious development on an existing treatment. It's not known when the Supreme Court might rule.