[Ip-health] MSF press release: Bayer attempts block on affordable patented drugs in India

Joanna Keenan-Siciliano joanna.l.keenan at gmail.com
Mon Sep 3 06:48:09 PDT 2012

*Bayer attempts block on affordable patented drugs in India *

*German company appeals against life-saving compulsory licence decision in

*Geneva/New Delhi, 3 September, 2012* – 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 (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 per cent. Bayer is being paid a six per cent 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.

– ends –

*Notes for editors*

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

*The compulsory licence has been granted by India’s Controller of Patents
(the highest authority of the Indian Patent Office) to the generic company
Natco for the eight years sorafenib tosylate will remain patented in India
(until 2020), and against the payment of a  royalty rate fixed at 6%. *

* *

*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
treatment.  *

* *

*The order of the compulsory licence can be found here:*


* *

*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




*Joanna Keenan*
Press Officer
Médecins Sans Frontières - Access Campaign
E: joanna.keenan[at]geneva.msf.org
T: twitter.com/joanna_keenan


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