India’s Supreme Court on Monday rejected drug maker Novartis AG’s attempt to patent an updated version of a cancer drug in a landmark decision that health activists say ensures poor patients around the world will get continued access to cheap versions of lifesaving medicines.
Novartis had argued that it needed a patent to protect its investment in the cancer drug Glivec, while activists said the drug did not merit intellectual property protection in India because it was not a new medicine. In response to the ruling, Novartis said it would not invest in drug research in India.
The court’s decision has global significance since India’s $26 billion generic drug industry, which supplies much of the cheap medicine used in the developing world, could be stunted if Indian law allowed global drug companies to extend the lifespan of patents by making minor changes to medicines.
Once a drug’s patent expires, generic manufacturers can legally produce it. They are able to make drugs at a fraction of the original manufacturer’s cost because they don’t carry out the expensive research and development.
Pratibha Singh, a lawyer for the Indian generic drug manufacturer Cipla, which makes a version of Glivec for less than a tenth of the original drug’s selling price, said the court ruled that a patent could only be given to a new drug, and not to those which are only slightly different from the original.
"Patents will be given only for genuine inventions, and repetitive patents will not be given for minor tweaks to an existing drug," Singh told reporters outside the court.
Novartis called the ruling a "setback for patients," and said patent protection is crucial to fostering investment in research to develop new and better drugs.
Ranjit Shahani, the vice chairman and managing director of Novartis India, said the ruling "will hinder medical progress for diseases without effective treatment options."
He said the court’s decision made India an even less attractive country for major investments by international pharmaceutical companies.
"Novartis will not invest in drug research in India. Not only Novartis, I don’t think any global company is planning to research in India," he said.
The Swiss pharmaceutical giant has fought a legal battle in India since 2006 to patent a new version of Glivec, which is mainly used to treat leukemia and is known as Gleevec outside India and Europe. The earlier version of Glivec did not have an Indian patent because its development far pre-dated the country’s 2005 patent law. Novartis said Glivec is patented in nearly 40 other countries.
India’s patent office rejected the company’s patent application, arguing the drug was not a new medicine but an amended version of its earlier product. The patent authority cited a provision in the 2005 patent law aimed at preventing companies from getting fresh patents for making only minor changes to existing medicines — a practice known as "evergreening."
Novartis appealed, arguing the drug was a more easily absorbed version of Glivec and that it qualified for a patent because it was "a revolutionary treatment," not an incremental improvement.
Anand Grover, a lawyer for the Cancer Patients Aid Association, which led the legal fight against Novartis, said the ruling Monday prevented the watering down of India’s patent laws.
"This is a very good day for cancer patients. It’s the news we have been waiting for for seven long years," he said.
Aid groups, including Medicins Sans Frontieres, have opposed Novartis’ case, fearing that a victory for the Swiss drug maker would limit access to important medicines for millions of poor people around the world.
Glivec, used in treating chronic myeloid leukemia and some other cancers, costs about $2,600 a month. Its generic version was available in India for around $175 per month.
"The difference in price was huge. The generic version makes it affordable to so many more poor people, not just in India, but across the world," said Y.K. Sapru, of the Mumbai-based cancer patients association.
"For cancer sufferers, this ruling will mean the difference between life and death. Because the price at which it was available, and considering it’s the only lifesaving drug for chronic myeloid cancer patients, this decision will make a huge difference," Sapru said.
Leena Menghaney of Medicins Sans Frontieres said India would continue to grant patents on new medicines.
"This doesn’t mean that no patents will be granted. Patents will continue to be granted by India, but definitely the abusive practice of getting many patents on one drug will be stopped," Menghaney said.
The judgment would ensure that the prices of lifesaving drugs would come down as many more companies would produce generic versions.
"We’ve seen this happening with HIV medicines, where the cost of HIV treatment has come down from $10,000 to $150 per year. Cancer treatment costs have come down by 97 percent in the case of many cancer drugs," she said.
"This decision is incredibly important. The Supreme Court decision will save a lot of lives in the coming decades," Menghaney said.
AP writer Kay Johnson contributed to this story from Mumbai, India.
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