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Indian drug ruling hailed by health campaigners

Generic version of cancer drug Glivec will be available at a tenth of the cost of the original

Mark Gould

Tuesday, 02 April 2013

A drug which is used to treat leukaemia and other cancers will continue to be available in its generic guise costing a tenth of the original, thanks to a decision by the Indian supreme court. Health campaigners say the decision will mean that thousands of cancer patients across the world will now have access to affordable medication.

Glivec, which is used to treat chronic myeloid leukaemia and other cancers, costs about $2,600 (£1,710) a month. The generic equivalent is currently on sale in India for just $175. Manufacturers Novartis' application for a patent for a new version of the drug was rejected by the court on Monday on the grounds that it was only slightly different from the original. The decision means generic drugmakers can continue to sell cheaper copies of Glivec in India, one of the fastest growing pharmaceutical markets.

Novartis applied for a patent in 2006 for its new version of the drug, arguing that it was easier to absorb and therefore qualified as an innovation.

However, the Indian patent authority rejected the application based on a law aimed at preventing companies from getting fresh patents by making only minor changes to existing drugs, a practice known as "evergreening". Officials also turned down a subsequent appeal by the company three years later.

Yesterday the AFP news agency quoted the court as saying that the updated drug "did not satisfy the test of novelty or inventiveness" as required by the law. The previous version of Glivec did not have a patent, as it preceded India's 2005 patent law.

Novartis said the Supreme Court's ruling "discourages future innovation". "This ruling is a setback for patients that will hinder medical progress for diseases without effective treatment options," said Ranjit Shahani, vice-chairman and managing director of Novartis India.

On the other hand, MSF lawyer Leena Menghaney said the ruling had come as a “big relief” as there were concerns that, if granted, a patent could threaten access to cheap generic versions of life-saving drugs in poorer countries.

"The ruling doesn't mean no patents will be granted in India, but the abusive practice of seeking many patents for one drug will be curbed," she said.

Anand Grover, a lawyer representing India's Cancer Patients Aid Association, said he was "ecstatic with the ruling". "This will go a long way in providing affordable medicine for the poor," he said.

Patents usually protect the companies for 20 years of exclusive sales. After that, it is open to other firms who can make cheaper copies of the original drug. Once the protection expires, the first company to challenge the patent gets an exclusive right to sell the copy for 180 days. After 180 days, more companies can sell the generic versions, potentially resulting in a further price drop.

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