[Ip-health] Matrix of Export Possibilities under Gilead HCV Licence

Jamie Love james.love at keionline.org
Thu Oct 2 03:19:27 PDT 2014

Source URL: http://keionline.org/node/2104

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
[2], 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.

See: Matrix of Export Possibilities under Gilead HCV Licence [3].

The memo on the license presents a matrix that describes the freedom or
restrictions that exist for making and supplying generic 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.


James Love.  Knowledge Ecology International
KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile:
+41.76.413.6584, twitter.com/jamie_love

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