[Ip-health] MSF responds to India upholding compulsory licence on cancer drug in Bayer case appeal

Joanna Keenan-Siciliano joanna.l.keenan at gmail.com
Mon Mar 4 06:39:49 PST 2013

India upholds compulsory licence on cancer drug in Bayer case appeal


New Delhi/Geneva, 4 March 2013 – The verdict into German pharmaceutical
company Bayer’s appeal against the grant of a compulsory licence has been
issued by India’s Intellectual Property Appellate Board (IPAB) in Chennai.
Médecins Sans Frontières (MSF) has learnt that the IPAB has upheld the
first compulsory licence granted to a generic manufacturer issued in March
2012 for the kidney and liver cancer drug sorafenib tosylate.

Médecins Sans Frontières’ reaction to the decision

“We’re relieved with the decision by the IPAB to uphold India’s first
compulsory licence. We are yet to read the decision and analyse it fully,
as it has not been published.

The decision confirms that the Indian patent office is able to use all the
means legally at its disposal to check the abuse of patents and open up
access to affordable versions of patented medicines.

Most importantly, the decision means that the way has been paved for
compulsory licences to be issued on 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.

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.

As with more people living with HIV, tuberculosis or hepatitis need to be
switched to more expensive, effective treatments, the need for affordable
generic versions of these medicines will be critical to maintain the
numbers of people with these diseases staying alive and healthy.

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 in our Mumbai clinic who need a third-line
drug like raltegravir, costs MSF as much as US$1,775 per person per year.

We urge Bayer to address the reality that their prices are too high and not
to appeal this decision. 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.”

-      Leena Menghaney, India Campaign Manager, Médecins Sans Frontières
Access Campaign


The compulsory licence was granted in March 2012 by India’s Controller of
Patents (the highest authority of the Indian Patent Office) to the generic
company Natco for the eight years the cancer drug sorafenib tosylate will
remain patented in India (until 2020), and against the payment of a royalty
rate now fixed at seven percent, up from the original order of six per

The reasoning behind the decision: Bayer had made the drug available to a
small percentage of eligible patients (approximately slightly above 2
percent), which did not meet the requirements of the public. The price of
Rs 280,000 per month (approximately US$5,500) was not "reasonably
affordable." Natco was required to make the drug available within India at
a price of not more than Rs 8,800 (approximately US$175) for one month's

The order of the compulsory licence can be found here:

Bayer appealed the decision in September 2012, and hearings were held in
front of the IPAB in January this year.

Compulsory licences are a legally recognised means to overcome barriers in
accessing affordable medicines under international trade rules.

MSF relies on quality, affordable generic medicines made in India, often
called the ‘pharmacy of the developing world’, to treat more than 80% of
the 220,000 people in its HIV projects across 23 countries.  Competition
among generic manufacturers in India is what has brought HIV medicine
prices down by nearly 99% since 2000, from US$10,000 per person per year to
roughly $150 today. But after a new patent law was introduced in 2005,
newer medicines are increasingly being patented in India, keeping prices

Kind regards


Joanna Keenan
Press Officer
Médecins Sans Frontières - Access Campaign
P: +41 22 849 87 45
M: +41 79 203 13 02
E: joanna.keenan[at]geneva.msf.org
T: twitter.com/joanna_keenan


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