October 9, 2012
A "Stop Novartis" rally in Mumbai, India, December 2011. © Claudio Tommasini.
India's Intellectual Property Appellate Board (IPAB) has dismissed Bayer's request for a stay order against the compulsory licence granted by the Patent Controller to a generic manufacturer earlier this year.
In its appeal before the IPAB, Bayer alleged that the CL decision of the Indian Patent Controller is illegal and unsustainable, and had filed for an immediate stay until the appeal could be heard. This has now been rejected by IPAB.
"This decision once again affirms that courts can and should act in the interest of public health in the case of pharmaceutical products," said Leena Menghaney, of Médecins Sans Frontières/Doctors Without Borders (MSF)'s Access Campaign.
"The high prices caused by patents in India are a growing problem that needs to be grappled with: one year's treatment costs over US$1,700 for one of the newer HIV medicines we use in our project in Mumbai, and will be needed across the developing world. This price needs to come down, and we hope that the routine use of compulsory licensing may be one way of making this happen."
India's first compulsory licence is seen as a prospective watershed for affordable access to patented medicines, by potentially opening the way for other life-saving drugs - such as the newest drugs used to treat HIV -- 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.
The CL brought the price of the patented anti cancer drug, sorafenib tosylate, down from over US$5,500 per month to $175 per month; a price reduction of 97 percent.
MSF had welcomed the grant of a compulsory licence issued in March this year to allow a more affordable version of liver and kidney cancer drug, sorafenib tosylate, to be produced. Bayer is being paid a six per cent royalty on sales by Natco, the generic manufacturer who received the licence.
German pharmaceutical company Bayer today heads to India's Intellectual Property Appellate Board in Chennai in a bid to overturn a compulsory licence which 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 organisation Médecins Sans Frontières/Doctors Without Borders (MSF) has criticised 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 licence 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 licence' -- of a more affordable version of an unaffordable Bayer liver and kidney cancer drug, sorafenib tosylate.
The move brought the price of the patented drug down from over US$5,500 per month to $175 per month; a price reduction of 97 percent. Bayer is being paid a six percent royalty on sales by Natco, the generic manufacturer who received the licence.
The issue of India's first compulsory licence is a potential watershed for affordable access to patented medicines. Compulsory licensing could open the way for other life saving 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 licence 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 which MSF hopes will see the benefits of future compulsory licences 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 US$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 currently finds herself in the middle of several patent disputes by multinational pharmaceutical companies; Swiss multinational Novartis 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.