Civil society challenges Gilead patents on Hepatitis C to guarantee access to treatment worldwide

Rio de Janeiro, May 20th 2015 – Multinational company Gilead is illegitimately applying for patents for sofosbuvir, a key drug for Hepatitis C treatment, and this may prevent thousands of people in Brazil from getting the treatment they need according to the Working Group on Intellectual Property of the Brazilian Network for the Integration of Peoples (GTPI/REBRIP). GTPI is opposing Gilead’s patent applications as part of a global action led by civil society that has major implications in the fight against the growing HepC epidemic, which kills more than 700,000 people per year worldwide.

The GTPI, Fundación Grupo Efecto Positivo (FGEP), the Ukrainian Network of People Living with HIV / AIDS, International Treatment Preparedness Coalition (ITPC) and I-MAK (Initiative for Medicines Access and Knowledge) filed pre-grant patent oppositions in Argentina, Brazil, China, Russia and Ukraine, proving how Gilead is trying to abuse national patent laws by claiming ownership of knowledge that is already in the public domain – and in doing so reducing access to treatment of Hepatitis C. The oppositions against patents for Sovaldi – sofosbuvir’s brand name – demonstrate that, despite the positive medical benefits sofosbuvir has, it was developed using previously published information and is based on already known compounds. These cases are linked to patent oppositions filed last year in Europe and India, where the decision on the patent is still pending. After protests in India, Egypt rejected a patent application for sofosbuvir last year.


Brazil is among the countries with the highest percentage of Hepatitis C infection. It is estimated there are over 1.5 million people live with Hepatitis C in the country, but most are unaware of their status. At present, only 15,000 people are under treatment. The Brazilian Government is making efforts to include new treatment options with a greater chance of cure such as sofosbuvir in the public health system, and to expand the number of patients under treatment. However, the price of U$S 7,500 set by Gilead for the 12-week treatment with sofosbuvir (recently revealed by the National Commission for the Integration of Technology in SUS) will lead to the rationing of this medicine: only patients in a more advanced stage of the disease or at increased risk of progression, as co-infected with HIV and Hepatitis, would be eligible. And even for patients under these circumstances there is no guarantee of access at all: estimates indicate that, on average, 146,000 people may be co-infected with Hepatitis C and HIV, but with current prices and budgets only 30,000 people will be eligible for treatment in the short term.

‘Studies show that sofosbuvir may be manufactured for about U$S100, though, Gilead is charging U$S7.500 in Brazil’ said Marcela Vieira, lawyer and coordinator of GTPI. ‘With nearly 1.5 million people infected with Hepatitis C in Brazil, the price charged by Gilead is absolutely unfair. This will mean that only a small fraction of these patients will be able to get the treatment they need. Undeserved patents not only represent a violation of patent laws but also of the principles of the SUS, the public health system in Brazil. We are presenting this patent opposition for the benefit of all Brazilians who need HepC treatment and to ensure that the exorbitant prices charged by Gilead do not violate the legal principle of universality that Brazil has adopted.’

As part of the growing movement against this business practices by Gilead, which are carried out at the expense of public health, people living with Hepatitis C and their families, NGOs and social movements of patients are calling for ongoing protests in Thailand today to challenge abuses by companies in their attempt to obtain illegitimate patents that prevent patients from receiving treatment. NGOs and health experts from ​​that country sent a petition to Gilead asking for an end to their patent-related abuses.

The Hepatitis C virus, which the World Trade Organization has called a ‘viral time bomb’, affects about 150 million people worldwide. Untreated, the disease can lead to liver damage or even liver cancer, and kills about 700,000 people each year. Earlier this month, the World Health Organization added the treatment for Hepatitis C, including sofosbuvir, to its list of essential drugs and called for lower prices to ensure that all people who need the drug are able to have access to it.

Through illegitimate patents, Gilead is demanding a price beyond the reach of many people – reaching $ 1,000 per tablet in the US – And equally high prices in developing countries, where most people with Hepatitis C live. Only in the last 15 months, Gilead declared record profits of U$S 16 billion – largely due to sales of sofosbuvir.

A recent study by the University of Liverpool reported that generic manufacturers can produce the 12-week treatment for U$S101.

‘The global approach to patents is clear: they are reserved for drugs that have proven not to be obvious, to be new and to be useful’ said Tahir Amin, co-founder and I-MAK’s director of intellectual property. ‘When seeking exclusivity of scientific knowledge that is already in the public domain, Gilead resembles a landlord who charges a very expensive rent for a land for which is not the rightful owner’.

public health crisis in expansion, which affects 150 million people, patents are preventing people with Hepatitis C from accessing the treatment they need to survive and get well’ said Priti Radhakrishnan, I-MAK’s co-founder and director of access to treatment. ‘By releasing the sofosbuvir of undeserved patents, we help in the fight against this deadly disease and contribute for people to get the medicine they need to live a healthy and productive life. Millions of lives are at stake – especially in developing countries like Brazil, Argentina and Ukraine, where the disease is concentrated.’

‘The only medication that offers benefits is that accessible to patients ” said Dr. Jennifer Cohn, medical director of the Doctors without Borders (MSF) Campaign for Access to Essential Medicines, who is expanding projects of HepC treatment in several countries. ‘It is very worrying to see that the high price of drugs against hepatitis has led to rationing treatment. With millions of people needing treatment in developing countries, a global coordinated effort is necessary to ensure that effective drugs are available for many people and as soon as possible’.

The growing global movement against illegitimate patents on Gilead’s Hepatitis C medicines goes back to the efforts of doctors, scientists, lawyers and patient groups in the late 90s to make HIV drugs accessible for millions of people through disputes to eliminate patents that blocked access to AIDS treatment worldwide.