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Novartis defeated in drug patent application case

Indian companies can produce generic leukemia treatment

Indian drug makers can keep producing copycat versions of leukemia drug Gleevec, made by Novartis.
Divyakant Solanki/EPA
Indian drug makers can keep producing copycat versions of leukemia drug Gleevec, made by Novartis.

NEW DELHI — India’s Supreme Court rejected a patent application by Novartis for a major cancer drug 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 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 Switzerland-based Novartis.

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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.

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Gleevec can cost up to $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. Drug company executives and others argue that India’s failure to grant patents for critical medicines is a shortsighted strategy that undermines a vital system for funding discoveries.

In a televised interview, Ranjit Shahani, vice chairman of Novartis’s Indian subsidiary, said companies like Novartis would invest less money in research in India as a result of the ruling.

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“We hope that the ecosystem for intellectual property in the country improves,’’ he said.