Gilead has been busy building positive publicity for its proposed license on two new direct-acting oral antivirals used to treat infections with the hepatitis C virus (HCV), sofosbuvir (Sovaldi®) and ledipasvir, that will allow Indian generic manufacturers to produce and sell individual versions and a combination of the two medicines in a subset of low- and middle-income countries (LMICs). News stories have been uncritically positive so far about the still-secret license, and Gilead is quite coy with respect to key details. Health reporters and hep C activists should raise pointed questions about the scope and impact of the proposed license during Gilead’s press conference, now scheduled for 3:00 p.m. September 15, 2014 in India.
Gilead’s proposed license, and its limitations, is important because Gilead has applied for patents on Sovaldi® and ledipasvir in many countries, although a number of countries in the probable licensed territory are without patents. As a patent holder, Gilead generally has rights to exclude competitors and charge monopoly prices on these life-saving medicines. The anticipated license will set precise terms on which companies can make generic equivalents and where and under what circumstances those generics can be sold. In other words, Gilead sits in the driver’s seat and has enormous power to decide who does and doesn’t get more affordable access to generics of assured quality.
Early disclosures of select license terms by Gilead shows that the planned license falls far short of universal access in LMICs. When armed with actual details, critics should demand that Gilead modify the license to hit the target in the bulls eye: all people living with HCV in LMICs gain access to its life-saving medicines which in turn will have a major impact on the future eradication of this deadly and debilitating liver disease.