[Ip-health] I-MAK and MSF reaction: After initially rejecting patent, Indian patent office grants patent on hep C drug sofosbuvir

Joanna Keenan joanna.l.keenan at gmail.com
Tue May 10 09:15:06 PDT 2016

Late yesterday, news came through that after initally rejecting the patent,
the Indian patent office has granted the patent on the base compound of
hepatitis C drug sofosbuvir. Please see below for more info and reaction
from Médecins Sans Frontières and I-MAK.  Previous press releases on this
story can be found here
and here

*After initially rejecting patent, Indian patent office grants Gilead
Sciences patent on base compound of sofosbuvir hepatitis C drug*



Gilead Sciences has been seeking patents in India for the hepatitis C drug
sofosbuvir. The patent applications have been challenged by groups of
people living with hepatitis C and HIV through ‘pre-grant oppositions.’ The
patent just granted by India’s patent office was initially rejected in
January 2015, just before President Obama’s visit to India, which was seen
as vexing the US. Gilead appealed the rejection and the patent has now been

Patents for sofosbuvir have been rejected in Egypt, China and Ukraine, and
further patent oppositions have been filed in Argentina, Brazil, Russia,
Thailand and the EU. Another key application on the prodrug of sofosbuvir
is pending before the Kolkata patent office in India, and several
oppositions to its grant have been filed by patient and public interest

While Gilead has signed licences with multiple generic manufacturers in
India to produce the drug and sell it in the world’s poorest countries,
these producers are prohibited from selling more affordable versions of
sofosbuvir to many middle-income countries, where approximately 50 million
people with hepatitis C live. This is leaving people in these countries
vulnerable to the high prices Gilead chooses to charge.

Gilead has priced sofosbuvir at US$1,000 per pill or $84,000 per 12-week
treatment course in the US, and has earned more than $15.5 billion in sales
from the drug over 2014 and 2015 alone.

*Quotes from two organisations (I-MAK, Médecins Sans Frontières) follow:*

“Sofosbuvir is not deserving of a patent – it was developed using
previously published techniques that have been used repeatedly in other
antiviral drugs. In fact, Gilead’s unjustified patents on sofosbuvir have
already been rejected by China, Ukraine and Egypt. Unfortunately, the
Indian patent office’s decision is flawed, ignores the scientific facts and
fails to uphold the standards of Indian patent law to ensure only new
inventions are patented. I-MAK and the Delhi Network of Positive People
(DNP+) will appeal the decision to ensure the Indian patent system stays
accountable to the integrity of the law and to the public's health.”

*Tahir Amin, Co-founder and Director of Intellectual Property, Initiative
for Medicines, Access & Knowledge (I-MAK) *

“This patent decision is bad news for people living with hepatitis C in
many developing countries; MSF is currently treating people living with
hepatitis C in India, Pakistan and Myanmar, but we know there are millions
of people in other countries who now won’t have affordable access because
of this decision. Medical humanitarian and patient groups have been worried
that the Indian government will cave into US pressure to dilute the
independent functioning of the patent office in a way that patent claims
are granted far more easily to US companies. This decision will now stop
those Indian generic companies which were planning to enter the market
independently from suppling not just patients in India but also those in
middle-income countries with large numbers of people living with hepatitis
C, which Gilead currently forbids from receiving sofosbuvir produced under
Gilead’s licensing deal.”

*Leena Menghaney, South Asia Regional Head, MSF Access Campaign*

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: @joanna_keenan


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