Patent Challenges In Five Countries Dispute Validity Of Gilead's Claims To Hep C Drug Patents That Block Treatment For Up To 59 Million People

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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.

SOURCE I-MAK