Geneva/New Delhi, September 3, 2012 – German pharmaceutical company Bayer today heads to India’s Intellectual Property Appellate Board in Chennai in a bid to overturn a compulsory licence that has allowed more affordable generic versions of sorafenib tosylate, a cancer drug patented by Bayer, to be produced in the interests of public health. International humanitarian health organization Doctors Without Borders/Médecins Sans Frontières (MSF) has criticized Bayer for the move.
“Bayer's appeal against this landmark ruling in India is predictable; they're using litigation rather than addressing the reality that their prices are too high," said Leena Menghaney, campaign manager in India for MSF’s Access Campaign. “It is not the use of a compulsory license that should be challenged, but the continued pursuit of excessively high profits over public health needs."
India's Patent Controller made the landmark decision in March this year to allow generic competition and production – by issuing a "compulsory license" – of a more affordable version of Bayer's liver and kidney cancer drug, sorafenib tosylate, which is unaffordable to most patients. The move brought the price of the patented drug down from over $5,500 per month to $175 per month; a price reduction of 97 percent. Bayer is being paid a 6 percent royalty on sales by Natco, the generic manufacturer who received the license.
The issue of India’s first compulsory license is a potential watershed for affordable access to patented medicines. Compulsory licensing could open the way for other lifesaving drugs now patented in India and priced out of reach to be produced by generic companies for use across the developing world at a fraction of the price. New medicines which are patented in India – which include medicines to treat HIV, for example – are too expensive for those who need them most.
“With the newest drugs now patented in India, there is no price-busting generic competition to reduce their sky-high prices," said Ms Menghaney. “A compulsory license is one solution to overcome this, but by appealing this decision, Bayer is trying to prevent the use of a key public safeguard that can in the future act as a lifeline, allowing people, governments and treatment providers like MSF access to the newest drugs from India.”
HIV drugs are one area in which MSF hopes to see the benefits of future compulsory licenses in India.
“We have started to switch people we treat for HIV who develop drug resistance on to newer medicines, which are expensive," said Luke Arend, Head of Mission for MSF in India. “For example, to treat people living with HIV in our Mumbai clinic who need a third-line drug like raltegravir costs MSF as much as $1,775 per person per year.”
“That’s unsustainable in the long run – and if Bayer succeeds in overturning one of the legal options we have to receive the newer drugs we need at an affordable price, it will be a set back for our medical projects," Mr. Arend added.
India is currently in the middle of several patent disputes with multinational pharmaceutical companies. Swiss multinational Novartis, for instance, is currently embroiled in a legal attack on India’s public health-friendly patent laws, having challenged the Indian government over the interpretation of a provision that restricts the grants of secondary patents. That case is due to be heard in the Supreme Court this month.