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Patent’s Defeat in India Is Key Victory for Generic Drugs Patent’s Defeat in India Is Key Victory for Generic Drugs
(about 3 hours later)
NEW DELHI — The Indian Supreme Court rejected a Swiss drug maker’s patent application for a major cancer drug Monday in a landmark ruling that will allow poor patients continued access to many of the world’s best drugs, at least for a while. NEW DELHI — 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 — spelled Glivec in some markets, like Europe — which can have a seemingly miraculous effect on some forms of leukemia. 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 patients in India who need Gleevec, because it will help maintain India’s role as the world’s most important provider of inexpensive medicines, which is critical in the global fight against HIV/AIDS and other diseases. Gleevec can cost as much as $70,000 per year, while Indian generic versions cost about $2,500 year. 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.
“The judgment in the Novartis case is a victory for patients both in India and around the world,” Dr. Yusuf K. Hamied, chairman of Cipla, an Indian generic drug giant, wrote in an e-mail. “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.” “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.
In a televised interview, Ranjit Shahani, vice chairman of Novartis’s Indian subsidiary, said that India would suffer as a result of the ruling because companies like Novartis would invest less money in research there. “We will continue with our investments in India, even though cautiously,” he said. “We hope that the ecosystem for intellectual property in the country improves.” 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.
The ruling is a landmark in one of the most important economic battles of the 21st century, in which rich nations that increasingly rely on the creation of idea-based products like computer programs and medicines try to compel mostly poor countries that make physical things like clothing and toys to pay for their ideas. 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.
While the goods made by poor countries cannot easily be shared or stolen, the ideas that power the economies of rich countries can be. So rich countries have insisted that poor countries give some of the world’s most profitable companies government-sanctioned monopolies for what the rich nations see as innovative ideas. But a few of these poorer countries particularly India, Brazil and China have begun to question the price they must pay for these idea-based products and whether paying such prices does them any good. 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.
India exports about $10 billion worth of generic medicine every year, more than any other country. Its home drug market is dominated almost entirely by generics. 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.
On Monday, the Indian Supreme Court ruled that the patent that Novartis sought for Gleevec did not represent a novel invention. In many ways, this ruling is something of a historic anomaly. India’s 2005 patent law allowed for drug patents on medicines 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. 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.
Leena Menghaney, a patient advocate at Médecins Sans Frontières, said the ruling Monday was a reprieve from more expensive medicines, but only for a while. 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.”“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.”
But Anand Grover, a lawyer who argued the case on behalf of the Cancer Patients Aid Association of India, said that the ruling confirmed that the country had a very high bar for approving patents on medicines. He noted that the majority of patented drugs in the United States won patents for fairly minimal discoveries like a new form of drug delivery or for certain manufacturing techniques. Anand Grover, a lawyer who argued the case on behalf of Cancer Patients Aid Association in India, said the ruling had a sweeping effect since it confirmed that India has a very high bar for approving patents on medicines.
In a classic example, Nexium, a heartburn pill by AstraZeneca that was long one of the world’s biggest selling drugs, is almost identical to Prilosec. But both medicines managed to win patent protection in the United States, something that would not happen in India under the new ruling, Mr. Grover said. “What is happening in the United States is that a lot of money is being wasted on new forms of old drugs,” Mr. Grover said. Because of Monday’s ruling, “that will not happen in India.”
“What is happening in the United States is that a lot of money is being wasted on new forms of old drugs,” Mr. Grover said. “That will not happen in India.” Indeed, the vast majority of drug patents given in the United States are for tiny changes that often provide patients few meaningful benefits but allow drug companies to continue charging high prices for years beyond the original patent life.
While advocates for the pharmaceutical industry argue that fairly liberal rules on patent-granting lead to innovation, academics are far from united in sharing that view. Indeed, there is increasing evidence that widespread patenting in the biotechnology industry particularly on research tools and gene-based discoveries may be impeding the search for new drugs. In a classic example, AstraZeneca extended for years its franchise around the huge-selling heartburn pill, Prilosec, by performing a bit of chemical wizardry and renaming the medicine as Nexium. Amgen has won such a blizzard of patents on its hugely expensive erythropoietin-stimulating drugs that the company has maintained exclusive sales rights for 24 years, double the usual period.
Nonetheless, the United States has become increasingly insistent in recent years that countries wishing to do business there adopt far more stringent patent protection rules, with the result that poorer patients often lose access to inexpensive generic copies of medicines when their governments undertake trade agreements with the United States. One result is that the United States pays the highest drug prices in the world, prices that only a tiny fraction could afford in India, where more than two-thirds of the population lives on less than $2 a day. While advocates for the pharmaceutical industry argue that fairly liberal rules on patents spur innovation, academics are far from united in sharing that view.
The ruling Monday is bound to be seen with some concern by the United States and the international pharmaceutical industry, and may be yet another blow to India’s standing among major multinational companies, many of whom view protection of their intellectual property as vital to their business interests. But as the economies of emerging markets grow, their refusal to pay higher premiums for newer drugs could significantly reduce the money needed for innovation. The drug industry makes nearly two-thirds of its profits in the United States, a dependence that many in the industry fear is unsustainable. And even minor improvements in medicines making a pill once-a-day instead of twice-a-day can have significant impacts on patient wellness, industry executives say.
The United States government has become increasingly insistent in recent years that other countries adopt far more stringent patent protection rules, with the result that poorer patients often lose access to cheap generic copies of medicines when their governments undertake trade agreements with the United States.
Drug companies have relied on the American government to lobby on the issue because they have few tools to punish India and other countries. If the companies decide not to introduce high-priced drugs in India, the country could legalize generic copies under international law. And with major drug makers cutting back on research budgets anyway, large investments in research infrastructure may be unlikely even if countries adopt patent laws more amenable to the industry.