Patent Challenge Hearing on Gilead Hepatitis C Drug Sofosbuvir Starts in India


New York/New Delhi—In proceedings that could have major implications for millions of people waiting for affordable access to a lifesaving hepatitis C drug, the Indian Patent Office this week began hearings to determine whether US pharmaceutical company Gilead Sciences deserves a patent for sofosbuvir, a hepatitis C drug for which the company currently charges $1,000 per pill in the US.

Today’s hearings are in relation to a "patent opposition" filed by lawyers from the Initiative for Medicines, Access & Knowledge (I-MAK) in November 2013, together with the Delhi Network of Positive People (DNP+). In it, lawyers argued that sofosbuvir was “old science” and did not meet the standard needed for patenting in India. The international medical humanitarian organization Doctors Without Borders/Medecins Sans Frontieres (MSF), which relies on generic medicines for its medical activities around the world, supports this effort to ensure that open generic production of sofosbuvir is possible. Patents for sofosbuvir have been rejected in Egypt, China, and Ukraine, and further patent oppositions have been filed in Argentina, Brazil, Russia, Thailand, and the EU.

Protesters living with hepatitis C and HIV rallied outside the Delhi patent office, urging officials not to cave in to pressure on the Indian government to blindly and speedily grant patents to multinational drug companies. India continues to come under tremendous pressure from such companies and the US government to dilute its patent policies in order to ensure that patents are granted far more easily to companies.

"Gilead is charging exorbitant prices in many countries and using patents to block people in other countries from buying low-cost yet equally effective versions of this medicine," said Loon Gangte of DNP+. "This is global treatment rationing. I feel like I’m back in the early days of the battle for HIV treatment, where you live or die based on where you live."

Gilead launched sofosbuvir in late 2013 at a price of $1,000 per pill ($84,000 for a 12-week treatment) in the US, and has charged similarly high prices across developed countries. Gilead has entered licensing deals with several manufacturers in India who have developed and are starting to market generic versions, but the deals exclude a number of middle-income countries with very high burdens of hepatitis C. This leaves around 49 million people in such countries, representing more than 40 percent of the global hepatitis C burden, without access to this drug.

"Gilead wants the world to think their licensing deals have solved the global problem of access to this medicine, but today countries like Thailand, Malaysia, and Brazil are being asked to pay thousands of dollars for sofosbuvir from Gilead when Indian generic versions of the drug are now available for as little as $335 per 12-week treatment," said Tahir Amin, lawyer and co-founder of I-MAK. "These licensing deals are a way for Gilead to control their competitors in India, and are an attempt to persuade the patent office that they deserve a patent for a compound that is based on old science."

It is estimated that 150 million people globally are infected with hepatitis C, and 700,000 die from the disease each year. Untreated, it can cause liver cirrhosis and cancer. Previous treatments only managed to cure people half the time, and could cause intolerable side effects. Sofosbuvir and other "direct-acting antivirals" now cure people in 12 to 24 weeks. But because of price, people in rich and poor countries are being told they cannot receive the treatment.

"Gilead says this drug is priced based on the value it provides, but a cure hardly anybody can afford is worthless," said Isabelle Andrieux-Meyer, viral hepatitis advisor at MSF. "We have started treating people with hepatitis C in several countries, and want to expand, but we can only convince governments to do this if there is affordable access to treatment everywhere people need it. Patents and restrictive licensing agreements should not stand in the way of middle-income countries’ efforts to provide people the treatment they need to stay alive."

India has been called the "pharmacy of the developing world" because it produces many affordable generic versions of drugs patented elsewhere. More than 80 percent of the HIV medicines used in developing countries come from India, which is able to produce these medicines because its patent law sets the bar high for which medicines do and do not merit patenting, allowing generic manufacturers to compete for the market and drive prices down.

"Hepatitis C drugs like sofosbuvir are compounds that are relatively simple and cheap to make," said Dr. Andrew Hill, a pharmacologist at Liverpool University who has published a study showing that sofosbuvir could be produced for as little as $101 for a 12-week treatment course. "Gilead has already sold over $32 billion of two hepatitis C treatments in just over two years, with profit last year of $18 billion. The continued profit projections for the oral hepatitis C drugs are staggering, and stand in no relation to what it costs to make these drugs."

Protesters living with hepatitis C and HIV rallied outside the Delhi patent office, urging the officials not to cave in to pressure on the Indian government to blindly and speedily grant patents to multinational drug companies.