Gilead's Sovaldi is a highly effective treatment against hepatitis C, but it is priced at $1,000 a pill in the United States. The standard 12-week course results in $84,000 in expenses. This high cost has Initiatives for Medicines, Access & Knowledge (I-MAK) worried because it would mean limited access to the drug.
As a result, I-MAK is working on blocking Gilead's patents for Sovaldi in five countries which, if successful, could make cheaper generic versions of the drug accessible to nearly 60 million afflicted with the disease. Patent oppositions have been filed in Ukraine, Russia, China, Brazil and Argentina, with local activist groups in all said countries (except in China) helping out.
Gilead had already agreed to make Sovaldi more affordable across 91 developing countries, but I-MAK claims the lower prices are still out of reach for the millions who have low income around the world.
In January, a patent application for Sovaldi was not awarded to Gilead, with India's patent office saying the drug is not innovative enough. In the country, a patent opposition is carried out as a form of citizen review, showing a certain application does not meet grounds set forth by the Patents Act of India.
"India's patent law does not give monopolies for old science or for compounds that are already in the public domain," explained Tahir Amin, a lawyer and I-MAK's director. "We believe [patent] ... does not deserve to be granted in India and have the legal grounds to prove it."
Olga Stefanishina from the Ukrainian Community Advisory Board said the patent opposition in India is the beginning of a fight to receive better and more affordable treatment that governments can provide for their citizens. She added that low-cost generic versions of drugs should be available to all countries with a high burden for hepatitis C without discrimination.
Earlier in May, the World Health Organization (WHO) included sofosbuvir, the generic name for Sovaldi, on its essential medicines list. Being included on the list promotes the use of a drug for off-label purposes, meaning medication may be prescribed not for the specific application it was approved for.
Hepatitis C is a liver disease brought about by the hepatitis C virus. Transmission normally occurs when an individual comes into contact with blood from an infected person. The sharing of needles, childbirth, organ transplants and blood transfusions are all means of spreading hepatitis C. At the moment, no vaccine exists to prevent the disease.
Photo: Nick St. Charles | Flickr