[Ip-health] Statement by MTAAG & TWN on Gilead License

Sangeeta Shashikant sangeeta at twnetwork.org
Mon Sep 22 06:32:14 PDT 2014

Statement by the Malaysian Treatment Access and Advocacy Group (MTAAG) &
the Third
World Network

Globally it is estimated that around 170-200 million individuals around
the world are
currently living with the hepatitis C virus (HCV), with an additional 3-4
million becoming infected every year and
350,000+ deaths annually. HCV is clearly one of the greatest public health
threats of this century and possibly even the next.
Unlike HIV, HCV is curable.

In Malaysia, it is estimated that as at 2010 the HCV infections were at
397 515.
According to a report in The Star dated 8 June 2014[1] <#_ftn1>, the
present rate of infection is likely to be much higher
as often many infected with hepatitis C are not aware of their status.

In this context,new oral medicines bring significant new hope for many
people infected with the
hepatitis C virus with its better cure rates and lesser side effects.
However hopes
for universal affordable curable treatment were dashed with Gilead¹s
announcement on 15th September of a voluntary license on two
direct-acting oral antivirals (DAAs) used to treat HCV infections,
(Sovaldi®) and ledipasvir. This license contains restrictive terms aimed at
limiting generic competition (that would increase the supply of the much
medicines) and maintaining Gilead¹s market monopoly, condemning to death
many of
the 50 million HCV patients living in territories excluded from the scope
the voluntary license such as Malaysia, Thailand, Philippines and China.

It is particularly appalling that Gilead¹s market hold is based on
patents: Pre-grant patent oppositions have been filed with the Indian
Office while in Egypt the sofosbuvir patent was rejected. In most
including many in the list covered by the Gilead voluntary licence, the
applications are still under consideration. Yet, based on these ³patents²,
Gilead licence locks in leading generic producers making it very difficult
them to produce generic versions of the anti-virals for the excluded
countries. The terms of the license are such that generic competition will
be maximized, and consequently affordable prices cannot materialize

Gilead has undermined generic competition, which is key to bringing down
prices and
increasing access to the new medicines. A study by researchers at
Liverpool University (UK) has found that with
large-scale generic production, a twelve-week course of sofosbuvir could
as low as US$101 and ledipasvir only US$93. Currently sofosbuvir is priced
Gilead at US$1,000 per pill in high-income countries, or US$84,000 for 12
weeks¹ treatment, and around US$900 for the same in low-income countries.
Developing countries, which are categorized as ³middle-income² (such as
Malaysia) are likely to pay prices significantly higher than the US$900
especially in the private market.

We urgently call on the Malaysian Government to use
available flexibilities in the World Trade Organization Agreement on
Trade-related Aspects of Intellectual Property Rights, including compulsory
licence to ensure access to affordable new oral medicines for Hepatitis C.

We also urge the Malaysian Intellectual Property Office to adopt strict
patentability criteria with
the aim of avoiding secondary patents and patent evergreening.
(Evergreening is a term popularly used to
describe patenting strategies that are intended to extend the patent term
the same compound.).

For further information please contact:
Edward Low: +6012-3278812 or Chee Yoke Ling: +60123768858

[1] <#_ftnref1> 

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