Gilead has just released the text of its hepatitis C license. Although there has been some praise for Gilead offering expanded generic access in 91 countries where over 100 million people living with hepatitis C live, there has also been mounting criticism over its exclusion of 51 middle-income countries with 49 million infected.
This paper closely analyzes the license to see what its impact might be, paying close attention to its definition of covered patent rights and illusory mechanisms that might eventually allow supply in some excluded territories.
Gilead’s assertion of control over country sales and collection of royalties rests on a foundation of pending patent rights, including key patent applications in India that are being challenged. The limited coverage of the license will inevitably mean that generic markets and competition will not be a robust as they might have been. At the same time, Gilead is reserving the 51 excluded countries as “commercial markets” where it intends to grant price discounts over those charged in the US and Europe but still largely unaffordable to many patients and governments. It also intends to charge more in private market sectors than in government and NGO sectors. Gilead has gone part way, but not far enough and its territorial exclusions and protections of unperfected patent rights will undermine the beneficial impact of its license even in licensed territories. Not only will there not be universal access to affordable hepatitis C medicines, but the ultimate goal of eradication will be delayed by Gilead’s fractured approach.