E-DRUG: MSF PR on Indian CL: Groundbreaking move sets precedent for overcoming drug price barriers
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Médecins Sans Frontières has issued the below press release in response to
the India Controller General Controller General of Patents, Designs & Trade
Marks' decision to issue a compulsory licence on cancer drug sorafenib
tosylate:
INDIA ISSUES FIRST COMPULSORY LICENCE
Groundbreaking Move Sets Precedent for Overcoming Drug Price Barriers
Delhi/Geneva – 12 March 2012 – In a landmark case, the Indian Patent Office has issued the first-ever compulsory licence in India to a generic drug manufacturer. This effectively ends German pharmaceutical company Bayer’s monopoly in India on the drug sorafenib tosylate used to treat kidney and liver cancer. The Patent Office acted on the basis that not only had Bayer failed to price the drug at a level that made it accessible and affordable, it also was unable to ensure that the medicine was available in sufficient and sustainable quantities within India.
“We have been following this case closely because newer drugs to treat HIV
are patented in India, and as a result are priced out of reach,” said Dr
Tido von Schoen-Angerer, Director of the Médecins Sans Frontières (MSF)
Access Campaign. “But this decision marks a precedent that offers hope: it
shows that new drugs under patent can also be produced by generic makers at
a fraction of the price, while royalties are paid to the patent holder.
This compensates patent holders while at the same time ensuring that
competition can bring down prices.”
Competition from the generic version will bring the price of the drug in
India down dramatically, from over US$5,500 per month to close to $175 per
month – a price reduction of nearly 97 per cent.
“This decision serves as a warning that when drug companies are price
gouging and limiting availability, there is a consequence: the Patent
Office can and will end monopoly powers to ensure access to important
medicines,” said Michelle Childs, Director of Policy/Advocacy at the MSF
Access Campaign. “If this precedent is applied to other drugs and expanded
to include exports, it would have a direct impact on affordability of
medicines used by MSF and give a real boost to accessing the drugs that are
critically needed in countries where we work.”
Under the World Trade Organization’s TRIPS Agreement which governs trade
and intellectual property rules, compulsory licences are a legally
recognised means to overcome barriers in accessing affordable medicines.
The Indian decision in fact mirrors similar moves made in other countries,
including the US. In February 2011, the US Patent Office decided not to
prevent a “generic” medical device used for skin grafts from being sold,
but rather insisted that its manufacturer pay royalties to the patent
holder.
“Behind this action is the idea that the public has a right to access
innovative health products and they should not be blocked from benefiting
from new products by excessive prices,” said Michelle Childs. “If more
compulsory licences are granted in this vein, the answer to the question of
how to ensure affordable access to new medicines could radically shift.”
Today’s system is one where new medicines are patented, and drug companies
aggressively defend their monopolies, at the expense of patients who can’t
afford the high prices charged. Instead, we could move to a more equitable
system where new medicines have multiple producers, who each pay royalties
to the patent holder, helping them not only to recoup their development
costs but ensuring that people in developing countries have access.
This move marks the first time India’s patent law has been used to allow
generic production when a drug is unaffordable. “More generic companies
should now come forward to apply for compulsory licences, including on HIV
medicines, if they can’t get appropriate voluntary licences,” said Dr Tido von Schoen-Angerer.
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
order of the compulsory licence can be found here:
http://www.ipindia.nic.in/ipoNew/compulsory_License_12032012.pdf
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 170,000 people in its HIV projects across 19 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
high.
In a separate case also with important ramifications for access to
medicines across the developing world, Novartis is currently challenging
India's decision to not grant patents on medicines that according to the
patent law aren't innovative enough to deserve a patent. Even Novartis has
said India’s right to use compulsory licences should not be touched.
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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