Key Victory for Generic Drugs: Indian Supreme Court Rejects Novartis Patent

Indian- made cancer drug displayed in Bhopal

India’s Supreme Court rejected a patent application by Novartis for a major cancer drug on Monday, in a landmark ruling that will permit poor patients continued access to many of the world’s best medicines, at least for a while.

The ruling allows Indian makers of generic drugs to continue making copycat versions of the Novartis drug Gleevec — also spelled Glivec in Europe and elsewhere — which provides such a miraculous cure for some forms of leukemia that the Food and Drug Administration approved the medicine in the United States in 2001 in record time.

But the ruling’s effect will be felt well beyond the limited number of leukemia patients in India who need Gleevec, made by the Swiss-based drug maker. On the one hand, it will help maintain India’s role as the world’s most important provider of cheap medicines, which is critical in the global fight against HIV/AIDS and other diseases. Gleevec can cost up $70,000 per year, while Indian generic versions cost about $2,500 a year.

“India, being the pharmacy capital of the world, can continue to produce affordable, high-quality medicines without the threat of patents for minor modifications of known medicines,” Dr. Yusuf K. Hamied, chairman of Cipla, an Indian generic drug giant, wrote in an e-mail.

On the other hand, the ruling could cost lives in the future. Drug company executives and others argue that India’s failure to grant patents for critical medicines – and Gleevec is widely recognized as one of the most important medical discoveries in decades – is a shortsighted strategy that undermines a vital system for funding new discoveries.

In a televised interview, Ranjit Shahani, vice chairman of Novartis’s Indian subsidiary, said that companies like Novartis will invest less money in research in India as a result of the ruling. “We hope that the ecosystem for intellectual property in the country improves,” he said.

The case grapples with the idea that rich nations that increasingly rely on the creation of idea-based products, like computer programs and medicines, require poorer countries to pay for their ideas. But some countries – particularly India, Brazil and China – have begun to challenge the price they must pay, particularly when the idea-based products are lifesaving medicines that their people desperately need.

The question is how to pay for ideas in ways that maximize their use while encouraging their creation, two sometimes contradictory goals. Poor countries have tended to focus on the immediate issue of access while tending to ignore the more uncertain and far-off issue of innovation, particularly since innovation tends to occur far from their shores.

India exports about $10 billion worth of generic medicine every year, more than any other country. India and China together produce more than 80 percent of the active ingredients of all drugs used in the United States.

In Monday’s decision, India’s Supreme Court ruled that the patent that Novartis sought for Gleevec did not represent a true invention. The ruling is something of a historic anomaly. Passed under international pressure, India’s 2005 patent law for the first time allowed for patents on medicines – but only for drugs discovered after 1995. In 1993, Novartis patented a version of Gleevec that it later abandoned in development, but the Indian judges ruled that the early and later versions were not different enough for the later one to merit a separate patent.

Leena Menghaney, a patient advocate at Doctors Without Borders, said that the ruling is a reprieve from more expensive medicines, but only for a while.

“The great thing about this ruling is that we don’t have to worry about the drugs we’re currently using,” Ms. Menghaney said. “But the million-dollar question is what is going to happen for new drugs that have not yet come out.”

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