The effort comes a year after India awarded a compulsory license to a generic drugmaker to produce a lower-cost version of a Bayer drug called Nexavar that is used to treat kidney and liver cancer, a step that was regarded as a landmark decision at the time and was predicted to usher in still more licenses. After the license was issued, the monthly treatment cost dropped by about 95 percent, according to the paper (back story).
The latest decision - which pertains to the Herceptin breast cancer treatment sold by Roche (RHBBY), as well as two Bristol-Myers Squibb (BMY) medicines, Ixabepilone, which is used for chemotherapy, and Dasatinib, which treats leukemia - was hailed by physicians and patient advocates who maintain that existing prices are too high.
“Even after the recent cut in the prices of Trastuzumab and Dasatinib, they are still way too expensive for the common man," Shyam Aggarwalk, a consultant oncologist at Sir Ganga Ram Hospital, tells the paper. "It is a very good move and will not just benefit Indians but possibly also bring down cancer drug prices in countries where the pharma market is not controlled by the US and western European nations.”
The cost per dose for Herceptin is roughly $1,400 per month, according to Knowledge Ecology International Trastuzumab, a non-profit advocacy group that focuses on intellectual property issues that affect access to medications. The monthly cost-per-dose for Ixabepilone is similar, while Dasatinib costs about $300, according to the paper.
"This move will come as a huge relief to the thousands of women with HER2+ breast cancer whose lives can be saved by Trastuzumab, but who are unable to access this drug because of predatory pricing by Roche, which currently controls the drug," says the Campaign for Affordable Trastuzumab, a patient advocacy group that has protested the cost (see here), in a statement. Trastuzumab is the generic name for Herceptin.
“Drug companies are holding our health hostage to their greed for profits," says Kalyani Menon-Sen, the campaign coordinator. “Roche should not be allowed to get away with such a predatory pricing policy. Courts and other authorities like the Competition Commission must take (its own) action against Roche for abusing its dominant position in the market.”
In March, Roche had given manufacturing and marketing licence for Herceptin to Pune-based Emcure Pharma. Herceptin, for breast cancer. We asked Roche and Bristol-Myers for comment and will update you accordingly.
What is not clear about the government move is the specific provision under the Indian Patents Act that will be cited to allow licenses to be issued. One section permits an applicant to establish that the patent holder is not making available its drug at a reasonable cost. The other section allows a licensed to be issued under a public health emergency. Other countries, notably Thailand, have cited emergencies when issuing licenses.
"The news could serve as a very rude wake up call for some constituents of big pharma, which have refused to take into consideration the realities of the Indian market," writes Prashant Reddy on the SpicyIP blog. "Companies like Roche have cut the prices of Herceptin in the past but the price cut has been a joke."
[UPDATE: On Tuesday, January 15, a Roche spokeswoman wrote us to say: "We are aware of the articles in the Indian press, but cannot confirm or comment on their content. Roche has taken steps to increase access to a number of our drugs in India, including Herceptin. This includes a local price structure and involvement in manufacturing with a local partner."]
We should also note that, two months ago, India's Intellectual Property Appellate Board in India revoked the patent on the Pegasys hepatitis C treatment marketed by Roche, which will make it possible for generic drugmakers to introduce lower-cost copycat versions. Roche can appeal (back story).
Meanwhile, as noted previously, the Supreme Court in India is reviewing whether the government had the right to deny a patent to Novartis for Gleevec, which is marketed as Glivec in India. Novartis (NVS) wants a patent based on a new form of its drug, which would offer a 20-year extension. An earlier government ruling denied this after deciding the new form did not meet a standard for enhanced efficacy (see this and this).