In recent weeks, the international non-governmental organisation Médecins Sans Frontières (MSF) announced that it supports the ‘patent opposition’ which has been filed recently at India’s Patent Office by the Initiative for Medicines, Access & Knowledge (I-MAK). The application aims to prevent US pharma company Gilead/Pharmasset from gaining a patent in India on sofosbuvir, a drug for hepatitis C, which will be launched here soon. Sofosbuvir is the first of several oral hepatitis C drugs expected to come to market in the coming year. It cures hepatitis C in a much shorter time period than today’s available treatment.
Gilead is expected to charge around $80,000 for one treatment course of sofosbuvir in the US. As mentioned in this article in the Times of India, even if offered at a fraction of this price in developing countries, this drug would be unaffordable. However, as we note below, companies have a long history of offering steep discounts to countries which take treatment access initiatives. India does not seem to have even approached any of the innovator companies.
The patent opposition offers technical grounds to show a drug does not merit patenting under India’s Patents Act. It is an “old science, known compound,” said Tahir Amin, lawyer and director of US-based I-MAK.org. “India’s patent law doesn’t give monopolies for old science or for compounds that are already in the public domain. We believe this patent on sofosbuvir does not deserve to be granted in India and have the legal grounds to prove it,”he said in a statement by MSF . This argument is a familiar one: it is the basis on which, for example, Roche’s Gleevec was denied an Indian patent : the Court ruled that the underlying discovery predated India’s acceptance of WTO rules on intellectual property in 1995.
However, in the U.S and Europe, sofosbuvir is seen as a breakthrough treatment that will not only shorten the duration of therapy and make it more tolerable, but improve cure rates as well. Doctors have been waiting in anticipation of its approval, along with other new-generation hepatitis C oral treatments. Gilead has put sofosbuvir through its paces with an ambitious and costly development program.
The World Health Organization estimates there are 184 million people infected with hepatitis C worldwide, with the disease causing half a million deaths each year. According to an article published in the Economic Times, nearly 96,000 people die annually in India due to Hepatitis C, which has become a hidden epidemic and a silent killer.
The Government of India has been criticised for having no national plan to identify, monitor, diagnose or treat Hepatitis C. Patient groups such as the World Hepatitis Alliance say that these plans are essential. The WHA is working with many actors to improve access although, strangely, it gets no mention from either I-MAK or MSF. The number of “no” and blank answers to a 2012 WHO questionnaire certainly seem to suggest failings on the part of both the Union and state governments. Some countries with comprehensive treatment plans have been able to negotiate with the discoverers of treatments to secure highly discounted prices and to get financial help in kick-starting patient outreach.