Last week, the Indian Patent Office began hearings to determine whether U.S. pharmaceutical company Gilead Sciences can keep its patent for the hepatitis C virus (HCV) treatment sofosbuvir in the country, according to a press release from Doctors Without Borders/Medecins Sans Frontiers, a main supporter of the patent opposition.
The hearings are in relation to an official opposition filed by lawyers from the Initiative for Medicines, Access & Knowledge (I-MAK) and the Delhi Network of Positive People (DNP+) in November 2013, alleging that the formula for sofosbuvir was based on “old science” and did not meet Indian patent standards. If successful, the hearings could open generic production of sofosbuvir in the country, joining places like Egypt, China and Ukraine, where Gilead’s patents on the drug have already been rejected.
Gilead launched sofosbuvir under the brand name Sovaldi in December 2013 at a U.S. list price of $1,000 per pill, or $84,000 for a standard 12-week course of treatment. Since then, the pharmaceutical company has entered licensing deals with several generic drug manufacturers in India to provide the hepatitis C treatment to 92 low-income countries around the world. However, protesters argue the decision still leaves around 49 million people living with hepatitis C in middle-income countries unable to access affordable treatment.
Currently, it is estimated that 150 million people globally are living with hepatitis C, 40 percent of whom in are middle-income countries like Brazil, Thailand and Malaysia that are not covered under Gilead’s current licensing agreement. An estimated 700,000 people die from the liver virus every year.