Appellate board's order upholding Natco's CL for sorafenib tosylate may pave way for manufacture of generic version of other patented drugs
Encouraged by the recent decision of India's Intellectual Property Appellate Board (IPAB) to uphold the compulsory licence granted to generic drug manufacturer Natco for a cancer-drug, an advocacy group has demanded grant of licence for another cancer drug on occasion of International Woemn's Day on Friday. Members of the Campaign for Affordable Trastuzumab called on the commerce minister to grant similar licence to Trastuzumab, a life-saving drug for women with HER2+ breast cancer.
Trastuzumab, the patent for which is held by Swiss pharma giant Roche, is currently priced at Rs 6-8 lakh for a full course of 12 injections, and is out of reach for most. An estimated 25,000 new cases of HER2+ breast cancer are reported in India every year, with younger women being in majority among them.
IPAB at Chennai has upheld the compulsory licence (CL) granted for the manufacture of the generic version of cancer drug Nexavar. This means that the life-saving drug for cancer of kidneys will be available to consumers at a price three per cent the rate of the patented version. Activists hope this will pave the way for compulsory licensing of many more drugs, including those prescribed for people living with HIV.
The patent of cancer drug for kidneys, sorafenib tosylate, was held by German pharmaceutical giant Bayer Healthcare, which sells it under the brand name Nexavar. The drug costs Rs 2,80,000 for a month's dosage. As it was not affordable for most Indian patients, India’s Controller of Patents (the highest authority in the Indian Patent Office) granted compulsory licence to Indian generic company Natco in March, 2012. It was the first time that such a licence was granted in India. Natco was required to make the generic version of the drug available within India at not more than Rs 8,800 a month. The licence was granted for eight years.
Bayer appealed against it in September 2012. The appellate board held hearings in January this year. On March 5, IPAB rejected Bayer's appeal.
The order is important not only for people suffering from cancer of the kidneys but also other diseases. Its opens the possibility of more compulsory licences being granted for other costly drugs as well.
“The decision means that the way has been paved for compulsory licences to be issued for other drugs, now patented in India and priced out of affordable reach, to be produced by generic companies and sold at a fraction of the price,” said a statement by advocacy group Médecins Sans Frontières (MSF). “We hope that, in the near future, compulsory licences will be issued for the newest drugs to treat HIV and affordable generic versions will be available not only in India, but in the rest of the developing world,” it adds.
MSF's HIV projects in 23 countries rely heavily on generic medicines produced in India.
“MSF has started to switch people we treat for HIV who develop drug resistance on to newer medicines, which are expensive. For example, to treat people living with HIV and who need a third-line drug like Raltegravir, our Mumbai clinic has to spend as much as US $1,775 per person per year,” says Leena Menghaney, India manager for MSF Access Campaign. If compulsory licences are granted for such medicines, too, then nearly 80 per cent of the 220,000 people in 23 countries will benefit, she adds.
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