KEI was asked to make a presentation on Hepatitis C, on September 30, 2014, at a lunch seminar at UNITAID. I am attaching a PDF of the slides I used, as well as an eight page memo that takes a look at the recent Gilead license. The memo on the license was last edited on September 30, 2014, and is presented as a draft that may be revised in the future.
The memo on the license presents a matrix that describes the freedom or restrictions that exist for making and supplying generic drugs or APIs for sofosbuvir (SOF) and ledipasvir (LDV), under the Gilead voluntary license (VL), to and from countries outside the 91 countries in the licensed territory. The matrix only addresses patent related issues, and does not extend to other barriers, such the requirements to register products with drug regulators.
For an importing country outside of the licensed territory, we considered cases where the country has granted patents, where patents have been not been granted and are not expected to be granted, and where the patents have been filed, but have an uncertain status. For countries seeking to supply the countries outside of the territory, we consider each of the same scenarios. Collectively, this involves (3+3) x 3 = 18 different scenarios.
We have shared earlier drafts of this memo with a diverse groups of experts following this issue, and with Gilead.
More from KEI on hepatitis here: /hepatitis