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[e-drug] Gilead denied patent for hepatitis C drug sofosbuvir in India -response

E-DRUG: Gilead denied patent for hepatitis C drug sofosbuvir in India-response
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https://www.msfaccess.org/about-us/media-room/press-releases/gilead-denied-patent-hepatitis-c-drug-sofosbuvir-india
 

The Indian Patent Controller has today rejected one of Gilead's key patent 
applications which covered  the drug sofosbuvir, used to treat hepatitis C 
(HCV). The oral drug, which first received regulatory approval in the US 
in November 2013, and has been priced by Gilead at US$84,000 for a 
treatment course, or $1,000 per pill in the US, has caused a worldwide 
debate on the pricing of patented medicines. A study from Liverpool 
University showed that sofosbuvir could be produced for as little as $101 
for a three-month treatment course.
 
Challenges to some of the most important patent applications on sofosbuvir 
(a 'patent opposition' - a form of citizen review allowed in many 
countries) were filed in India by the Initiative for Medicines, Access & 
Knowledge (I-MAK) and the Delhi Network of Positive People (DNP+) in 
November 2013 and March 2014.

Gilead has signed voluntary licence agreements with multiple generic 
producers in India, but these agreements impose many restrictions, 
including which countries can access the drugs produced under these 
licences, as well as invasive restrictions on medical providers and 
patients with respect to distribution and use of the drug. With the patent 
being denied, other companies that have not signed the licence are now 
free to produce. Entry by additional generic manufacturers should increase 
the open competition needed to bring prices down dramatically, especially 
in those countries that have been excluded from the voluntary licence 
agreement, and thereby increase access to the medicine. Countries where 
the drug is unaffordable, and which were excluded from the licences, 
should make every effort to import more affordable generic versions from 
other producers who did not sign a licence in India.
 
Médecins Sans Frontières (MSF) is in the process of expanding treatment 
for people with hepatitis C in nine countries, and has been negotiating 
access to this medicine, which is expected to become the backbone of any 
HCV regimen in the coming years.

Below are responses to the news by Médecins Sans Frontières (MSF), the 
Initiative for Medicines, Access &Knowledge (I-MAK.org), the Delhi Network 
of Positive People (DNP+), and Dr. Andrew Hill, Researcher at Liverpool 
University:

 'Sofosbuvir has proved to be a billion-dollar blockbuster drug and we 
hope today's decision opens the floodgates for more open competition that 
could rapidly lower the price. This drug makes hepatitis C treatment more 
effective and easier for patients and doctors, so broad access to 
affordable versions will allow treatment to be scaled up dramatically. 
Gilead's drug access programme for developing countries is already showing 
its limitations, with the company planning to impose conditions for the 
supply and distribution of the drug to patients and treatment providers in 
developing countries, in order to protect the company?s ability to charge 
unaffordable prices in wealthy countries. Getting sofosbuvir out of the 
stronghold of Gilead's monopoly will be crucial to expanding treatment for 
people with hepatitis C globally.
 
'India's status as the 'pharmacy of the developing world' is once again in 
the spotlight and this is a good opportunity for generic producers in 
India to swiftly ramp up production to levels needed to treat the 185 
million people infected with hepatitis C worldwide.' 
Dr. Manica Balasegaram, Executive Director, MSF Access Campaign

 'The move to reject Gilead's patent application really opens up the 
playing field, so we hope to now see many other generic companies starting 
to produce more affordable versions of this drug.  The bottom line here is 
that India's patent law doesn't give monopolies for old science, for 
compounds that are already in the public domain. Gilead's strategy of 
charging as much as US$84,000 per treatment for a drug that is predicted 
to be simple and cheap to produce, and is now un-patentable in India, has 
been exposed for what it is 'seeking to squeeze as much profit out of the 
sick as possible.'
Tahir Amin, lawyer and Director of the Initiative for Medicines, Access 
&Knowledge (I-MAK.org)

 'This is a happy day for the millions of people who urgently need 
hepatitis C treatment across the globe. People with hepatitis C everywhere 
should be able to have access to this treatment, but millions of our 
friends in middle-income countries have been left out in the cold by 
Gilead. This decision provides hope that people in countries that have 
been excluded from Gilead's licensing deals will be able to access 
low-cost generic versions of sofosbuvir.'
Vikas Ahuja, Delhi Network of Positive People (DNP+)

 'We know from various manufacturers in India that they could produce this 
drug in the future for as little as $101 for the full three month 
treatment course.  That's roughly $1 per pill, which is a big improvement 
over the $1,000 per pill Gilead is charging in some countries. At the 
current prices, sofosbuvir is unaffordable for widespread use in most 
countries of the world.'
Dr. Andrew Hill, Senior Research Fellow, Department of Pharmacology and 
Therapeutics, Liverpool University

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

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