E-DRUG: Gilead denied patent for hepatitis C drug sofosbuvir in India-response
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
'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
'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
Médecins Sans Frontières - Access Campaign
P: +41 22 849 87 45
M: +41 79 203 13 02