Roche, the Swiss drugmaker, has decided to relinquish its patent on the breast cancer drug Herceptin in the Indian market, paving the way for other companies to make lower-cost versions without protracted legal battles.
The company said it had decided “not to pursue” the patent, taking into account “the strength of the particular rights, and the [intellectual property] environment in India in general”.
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Herceptin, a biological drug that is used for treating a particularly aggressive form of breast cancer, has been in the sights of drug access campaigners, who said the medicine’s high prices had put it out of reach for most.
Roche declined to detail how much of the medicine it has sold in India, although it said in a statement it had developed “a local pricing strategy”.
Kalyani Menon-Sen, a campaigner for affordable medicines, said Roche had told the authorities it had sold about 1,500 courses of Herceptin in the past year. At least 25,000 Indian women a year are diagnosed with the type of breast cancer the drug can treat.
Global sales of Herceptin hit SFr5.9bn ($6.3bn) last year, mainly in industrialised countries. India accounted for only 0.2 per cent of Roche’s total pharma sales of SFr35.2bn last year.
Herceptin’s active protein was discovered before India’s 1995 deal with the World Trade Organisation to begin protecting drug patents. Roche applied for, and received, a patent in India for a different composition of the medicine.
India’s Supreme Court, in a ruling on Novartis’s blockbuster cancer drug Glivec this year, made clear it would not grant new patents for improvements to old medicines unless change led to much improved therapeutic efficacy.
India’s government has been considering issuing a compulsory licence that would have overridden Roche’s patent and allowed other local companies to produce cheaper versions.
“It’s a completely face-saving thing,” said Ms Menon-Sen. “They know the patent is on wobbly grounds, and they know the compulsory licence is coming through. They are just backing off before the compulsory licence comes through.”
Roche said there were “currently no approved bio-similars of Herceptin in India”, but Ms Menon-Sen said at least two Indian companies were developing equivalents.
“If the government gives it a push and agrees to fast-track approvals and clinical trials, by the end of 2014 we should have more than one in the market,” she said.
The skirmishing over Herceptin is the latest legal battle between Western pharmaceutical companies and Indian activist groups upset about the high prices of innovative drugs for diseases such as cancer.