Patent claim on hepatitis C drug questioned in many countries

With hepatitis C killing at least 700,000 people every year, civil society has strengthened efforts to make the drug accessible

By Kundan Pandey
Published: Friday 22 May 2015


American biotech company, Gilead Sciences, Inc., is facing the heat in five countries over its patent claim for the Hepatitis C drug, sofosbuvir, marketed under brand name Sovaldi.

Civil society groups in Argentina, Brazil, China, Russia and Ukraine have challenged the patent claim, accusing Gilead of seeking a patent on existing public knowledge. The groups claim it is an abuse of patent laws.

The Initiative for Medicines, Access and Knowledge (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 patent challenges in recent weeks. 

“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.”

Though it has impressive medical benefits, sofosbuvir was developed using previously published information and an existing compound, says the statement published by I-MAK. I-MAK challenged the patent claim last year with Médecins du Monde in Europe and with the Delhi Network of Positive People in India. The patent claim for sofosbuvir is still pending in India.

“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,” she added.

The hepatitis C virus, which the World Health Organization (WHO) has called a “viral time bomb”, affects around 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 diseased has reached epidemic proportions, with more than 59 million people affected by the virus. 

Earlier this month, WHO added hepatitis C treatment drugs, including sofosbuvir, to its list of essential medicines and called for lower prices to help every person who needs the medicine to get it.

The civil society groups say Gilead is demanding up to $1,000 per pill, an amount that is out of reach for most people in the United States. The price will be similarly exorbitant in developing countries too, where most people with hepatitis C live.

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.


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