[Ip-health] GSK Changes Approach To Patents In Developing Countries

Heesob Nam hurips at gmail.com
Tue May 16 03:17:38 PDT 2017


Last Updated: 11 May 2017
Article by Annabel Beacham

GlaxoSmithKline (GSK), one of the world's leading pharmaceutical
companies, recently announced that it is adopting a new approach to
patenting its products around the world with the aim of widening
access to its medicines in the world's poorest countries.

In future, GSK will not file patents for its medicinal products in
Least Developed Countries (LDCs) and Low Income Countries (LICs).  The
World Bank currently defines such countries as those having a gross
national income (GNI) per capita of USD 1045 or less in 2014.  GSK
hopes that this will encourage generic companies to manufacture and
supply generic versions of its medicines in these countries, the
majority of which are in Africa.

At the same time, in Lower Middle Income Countries (defined as those
having a GNI between USD 1045 and 4125 in 2014), GSK will file for
patents but will generally seek to offer and agree licences to allow
supplies of generic versions of its medicines for 10 years.  GSK
intends to seek a small royalty on such licensed sales.  GSK will
however continue to seek full patent protection for its products in
High Income and Upper Middle Income countries and in the G20
countries.  Importantly, this includes India, China and Brazil which
are all members of the G20.

This change in patent policy by GSK may not have an immediate effect
on the availability of medicines in the world's poorest countries, as
the major generics companies are unlikely to have significant
manufacturing capability in these countries at present.  Generic
companies will still therefore have to consider the patent situation
in the countries where they manufacture any generic GSK products.  In
this they will be assisted by GSK's simultaneous commitment to making
information regarding its current and future patent portfolio freely
available to 3rd parties.

In the longer term, and particularly if other innovative
pharmaceutical companies follow GSK's lead, supply of affordable
generic medicines in the world's poorest countries should increase.

The changes in GSK's patent filing policy go hand-in-hand with a
commitment to make its future portfolio of cancer treatments available
for patent pooling to help address the increasing burden of cancer in
developing countries.  The Medicines Patent Pool (MPP) is an UN-backed
initiative which was established in 2010 and has been successful in
accelerating access to HIV, TB and hepatitis C medicines in low and
middle-income countries through voluntary patent licensing
arrangements.  Expanding this approach to cancer treatments will
enable generic versions of GSK's next generation of cancer therapies,
currently in clinical development, to be made available to LDCs, LICs
and certain middle-income countries once they receive regulatory

In addition, as part of its long term strategy to provide medicines in
some of the poorest nations, GSK was one of the major pharmaceutical
companies leading the research and development into an Ebola vaccine
(ChAd3-ZEBOV) during the 2015 crisis, working in collaboration with
the US National Institute of Allergy and Infectious Diseases (NIAID).

>From an IP perspective, GSK's most recent announcement also highlights
how important strong patent protection for their products in the
world's major economies continues to be for innovative pharmaceutical
companies. Only by maintaining exclusivity in major markets through IP
protection can innovative pharmaceutical companies continue to fund
investment in the research and development of new medicines, such as
the Ebola vaccine, whilst making current medicines available in poorer

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