Novartis Ruling Reverberates Past India's Borders

India's Supreme Court says drug maker Novartis can't hold onto its patent for the pricey cancer drug Gleevec simply by tweaking its chemical formula. That means generic drug makers can keep making a form of the drug at a tenth of Novartis's price. Consumer advocates call it a major advance for access to generic drugs. The drug industry says it will chill companies' willingness to produce innovative products.

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Let's report now on a landmark moment in the debate over the soaring price of prescription drugs. The landmark is a court ruling in India. To understand why that ruling has global implications, remember that there's a global market for pharmaceuticals; India is a growing part of it. Big drug companies have patents on drugs worth billions of dollars. They try to maintain those patents and avoid competition from cheap generic drugs for as long as they can.

The global drug maker Novartis tried to do that by slightly changing a cancer drug and patenting it all over again. The Indian High Court said no. The Court says a drug has to be truly new and different to justify patent protection.

NPR's Richard Knox reports on the implications.

RICHARD KNOX, BYLINE: Arnand Grover argued the case on behalf of Indian cancer patients. He says he's very, very happy indeed about the high court's ruling.

ARNAND GROVER: It's very important for India and for developing countries.

KNOX: He says the victory means that India's generic drug makers can continue to sell the leukemia drug Glivec at less than a tenth of the sticker price; that's $2,000 a month.

Grover is something of a folk hero in the movement for cut-rate pharmaceuticals. In the early 2000s, he helped lead the campaign for generic HIV drugs that have saved the lives of millions.

For its part, Swiss drug maker Novartis says the ruling discourages companies from doing research on tomorrow's wonder drugs. Ranjit Shahani, Novartis's chief in India, says the decision wasn't necessary to ensure that patients there get access to Glivec.

RANJIT SHAHANI: Novartis has actually provided Glivec free of charge to 95 percent of patients prescribed the drug in India. More than 16,000 patients today have it at zero cost.

KNOX: But Dr. Jennifer Cohn, of Doctors Without Borders, says drug company giveaway programs aren't good enough.

DR. JENNIFER COHN: We don't want access to medications to be dependent on the drug companies' whim or voluntary program. What does work on the long term to bring down prices and ensure sustainable access to medicines is generic competition.

KNOX: Cohn says the India court's ruling assures that groups like hers can afford to buy generic medications for its far-flung patients around the world.

COHN: It's an incredibly important decision for us. Over 80 percent of these generic medications actually come from India. So India has been called the pharmacy to the developing world.

KNOX: But defenders of patent rights aren't so happy. Mark Elliot heads the Global Intellectual Property Center of the U.S. Chamber of Commerce.

MARK ELLIOT: This decision is significant because this patent for the drug Glivec is recognized right around the world except for India. It's recognized in both China and Russia and 38 major countries specifically. And India in this case is the odd man out.

KNOX: He says the decision is a symptom of India's cavalier attitude about patent rights.

ELLIOT: This is not the first incident of this kind in India. There's a pattern of behavior over many years that is of concern to the business community.

KNOX: Elliot doesn't think the Indian attitude will go viral and infect other countries' approach to pharmaceutical patents. But others aren't so sure.

AMY KAPCZYNSKI: There's a global fight going on about what the appropriate standards for patents are. And that fight is going on in India but it's also going on in the United States.

KNOX: That's Amy Kapczynski, a law professor at Yale.

KAPCZYNSKI: Some of the kinds of arguments that people are making that patents are being granted too easily and that we have issues with having too much patent protection. Those arguments that are getting traction in India also have had some traction in the United States.

KNOX: By this school of thought, the current system gives drug companies strong incentives to keep profitable patents ever-green, as the insider term goes. Companies spend a lot of their research dollars on minor chemical changes that don't really make any difference to patients.

Arnand Grover, the Indian attorney who's leading the charge against ever-greening patents, says companies don't have enough incentives to invest in truly new kinds of drugs when they can make so much by tweaking old ones.

GROVER: They can just tweak. They can just tweak and make as much money.

KNOX: He rejects drug companies' traditional argument that tightening patent law will stifle innovation. Grover says if they could only get patents for truly new drugs, we'd see more of them.

Richard Knox, NPR News

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