NEW YORK, May 20, 2015 /PRNewswire/ -- Pharmaceutical
corporation Gilead (NASDAQ:GILD) is seeking illegitimate patents
for hepatitis C medicine sofosbuvir, blocking millions of people
around the world from getting the treatment they need to get well,
say attorneys and scientists from the Initiative for Medicines,
Access & Knowledge (I-MAK). I-MAK and its partners, including
Grupo de Trabalho sobre Propriedade Intelectual (GTPI),
All-Ukrainian Network of People Living with HIV/AIDS, Treatment
Preparedness Coalition and Fundación Grupo Efecto Positivo
(Fundación GEP), have filed a series of new, coordinated patent
challenges in recent weeks that has major implications for the
global fight against an exploding hepatitis C epidemic that is
killing 700,000 people every year.
I-MAK and its partners, including people with hepatitis C and
patient advocates, have filed challenges in Argentina, Brazil, China, Russia
and Ukraine detailing how Gilead
is abusing patent laws by claiming existing public knowledge as its
own—thereby preventing people with hepatitis C from getting
treatment. The challenges against Gilead's patent applications for
sofosbuvir—marketed under the brand name Sovaldi —demonstrate that,
despite its medical benefits, sofosbuvir was developed using
previously published information and an existing compound. The
filings build on patent challenges I-MAK filed last year in Europe
with Médecins du Monde and in India with the Delhi Network of
Positive People, where the patent for sofosbuvir is still pending.
Following the challenges in India,
Egypt in 2014 rejected the
sofosbuvir patent. More than 59 million people are living with the
hepatitis C virus in Argentina,
Brazil, China, India,
Russia and Ukraine.
"The global criteria for patents are clear: They are reserved
for drugs that are proven to be novel, non-obvious and useful,"
said Tahir Amin, I-MAK co-founder
and director of intellectual property. "By seeking exclusivity
on science that is already in the public domain, Gilead is acting
like a landlord charging exorbitant rent for property it doesn't
legitimately own."
"In the face of an escalating global public health crisis
affecting 150 million people, illegitimate patents are blocking
people with hepatitis C from the treatment they need to survive and
get well, " said Priti Radhakrishnan, I-MAK co-founder and
director of treatment access. "By freeing sofosbuvir from
unjustified patents, we can fight this deadly disease and get more
people the medicine they need to live healthy, productive lives.
Millions of lives are at stake—especially in middle income
countries like Brazil,
Argentina and Ukraine, where the disease is
concentrated."
As part of the growing movement against Gilead's business
practices that come at the expense of people's health, people with
hepatitis C, their families and patient advocates are holding
demonstrations today in Bangkok,
Thailand, protesting the company's abuse of an unjustified
patents that block patients from getting care. Leading NGOs and
public health leaders have also sent a petition to Gilead calling
for an end to patent abuse, while the company faces a rising
backlash against high drug prices in the United States.
The hepatitis C virus, which the World Health Organization has
called a "viral time bomb," affects about 150 million people
globally. When left untreated, the virus can lead to liver disease
or liver cancer, which kills approximately 700,000 people each
year. In Argentina, Brazil, China, India,
Russia and Ukraine, the epidemic has exploded, with more
than 59 million people affected by the virus. Earlier this month,
the World Health Organization added hepatitis C treatments,
including sofosbuvir, to its list of essential medicines and called
for lower prices to help ensure every person who needs the medicine
can get it.
"Instead of ensuring treatment for all who need it, Gilead
instead chooses to seek unjustified patents for sofosbuvir," said
Alex Freyre, who lives with
hepatitis C and works with treatment advocates in Argentina and Latin
America from Fundación GEP and RedLAM to remove
barriers to treatment. "Millions of lives are hanging in the
balance. By blocking people from getting a cure to hepatitis C,
Gilead is weakening our ability to fight this global pandemic."
Using illegitimate patents, Gilead is demanding a price out of
reach for most people – up to $1,000 per pill in the U.S. and
similarly exorbitant pricing in developing countries where the most
people with hepatitis C live. According to analysis by Doctors
Without Borders/Médecins Sans Frontières, Gilead is expected to
demand anywhere between $2,000 and
$15,000 for a 12-week sofosbuvir treatment in countries like
Brazil, Argentina and China where some of the world's poorest people
live on less than $1.50 a day. In the
last 15 months alone, Gilead has posted record-breaking profits of
$16 billion – thanks in large part to sales of
sofosbuvir.
A recent University of Liverpool
study found that generic manufacturers could produce a 12-week
treatment course for as little as $101.
In the United States, Gilead
and Sovaldi are the subjects of growing outrage and scrutiny over
the past year, with state governments and Congressional leaders
calling for greater transparency into the company's high prices for
sofosbuvir while Institutional Shareholder Services has advised the
Board of Directors take steps to mitigate business risk due to
prices few can afford. While Gilead brings in more than
$1 billion in profits each month, the
company avoids billions of dollars in U.S. taxes by storing $2
trillion offshore.
"The only drug that offers benefit is a drug that patients can
access," said Dr. Jennifer Cohn,
Access Campaign Medical Director for Doctors Without
Borders/Médecins Sans Frontières (MSF) which is scaling up
treatment to people with hepatitis C in several countries.
"It's deeply unsettling to see that the high price of hepatitis C
treatment has led to treatment rationing. With millions of people
in developing countries in need of treatment, there needs to be a
concerted global effort to ensure effective medicines are available
to as many people as possible, as soon as possible."
The growing global movement to challenge meritless patents for
hepatitis C medicine builds on the efforts by patent attorneys,
doctors, scientists and patient advocates to get HIV drugs to
millions more people after patent challenges starting in the late
1990s began removing barriers to treatment in countries around the
world.
"People living with HIV and hepatitis C will defend our right to
health," said Lorena Di Giano,
executive director of Fundación Grupo Efecto Positivo.
"With this patent challenge, we will ensure that Gilead cannot use
unjustified patents to charge outrageous prices for hepatitis C
treatment while blocking us from getting generic versions. Gilead
is standing in the way of not only people in Argentina with hepatitis C, but also of the 73
percent of all people with hepatitis C who live in middle-income
countries. Together, we will fight these illegitimate patents and
save lives."
"While we know that sofosbuvir can be produced for as little as
$101 per treatment, Gilead is
planning to demand $7,500 in
Brazil," said Marcela Vieira, attorney coordinator of
Grupo de Trabalho sobre Propriedade Intelectual. "With over
1.5 million people with hepatitis C in Brazil, the cost of sofosbuvir in our country
is unconscionable: It will mean that only a small fraction of
people will be able to get the treatment they need. Illegitimate
patents represent a violation not only of patent law, but also of
the principles of the Brazilian public health system. We are filing
this case for all Brazilians in need of hepatitis C treatment to
ensure this Gilead's extortionate pricing does not violate
Brazil's legal principle of
universality."
"Today, we stand in solidarity with people with hepatitis C
around the world," said Sergey
Kondratyuk, head of legal support for the All-Ukrainian
Network of People Living with HIV/AIDS. "While Gilead's profits
are soaring, people are suffering. Seven hundred thousand people
are dying each year worldwide without hepatitis C treatment. All
people deserve to get the treatment they need to live healthy
lives. We have filed a patent challenge to Gilead's patent
application in Ukraine because we
believe corporations do not deserve to use unjustified patents to
block people from treatment. We are fighting a serious health
crisis in Ukraine, and we call on
Gilead to stop pursuing illegitimate patents that create barriers
to health."
"Today, we are fighting for the rights of all people in
Russia to get the sofosbuvir
treatment they need to get well," said Sergey Golovin, senior advocacy manager for the
Treatment Preparedness Coalition. "Nearly 6 million people in
Russia, and 9 million in
Eastern Europe and Central Asia, live with hepatitis C. The cost
of Gilead's abuse of patents is too high: millions of lives are at
stake. We call on Gilead to stop pursuing patents that are not
justified under the law and stop standing in the way of people with
hepatitis C living healthy lives."
I-MAK is a team of lawyers and scientists at
the leading edge of a global movement to ensure people with
hepatitis C and HIV get the medicine they need to survive and lead
healthy lives. In 2009, I-MAK, along with civil society
groups in India, won an important
HIV patent challenge against Gilead's branded drug Viread. I-MAK
selectively intervenes to block unjustified drug patents that are
preventing people from getting the treatment they need.
For more information on how I-MAK is fighting to end
Gilead's pursuit of meritless patents, please go to
i-mak.org.
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SOURCE I-MAK