[Ip-health] Medicines Patent Pool Signs Licence Agreement with Gilead to Increase Access to HIV/AIDS Medicines

Kaitlin Mara kmara at medicinespatentpool.org
Tue Jul 12 01:30:12 PDT 2011

Dear all,
Please see our press release below.
For more information, including the full text of the licences, see our website here:



Medicines Patent Pool Signs Licence Agreement with Gilead to Increase
Access to HIV/AIDS Medicines

The Pool and UNITAID Announce First Agreement with a Pharmaceutical Company

London, 12 July 2011  The Medicines Patent Pool and UNITAID today
announce the first agreement between the Medicines Patent Pool and a
pharmaceutical company - Gilead Sciences - to improve access to HIV and
Hepatitis B treatment in developing countries.

The agreement allows for the production of the HIV medicines tenofovir,
emtricitabine, cobicistat, and elvitegravir as well as a combination of
these products in a single pill known as the ³Quad.² Cobicistat,
elvitegravir and the Quad are products still in clinical development. The
licence also allows for the development and manufacture of other
combinations that include these medicines. Tenofovir is also licenced for
use in Hepatitis B.

³Today marks a milestone in managing patents for public health. The
licence agreement with Gilead Sciences will help make medicines available
at a lower-cost and in easier to use formulations without delays,² said
Ellen Œt Hoen, executive director of the Medicines Patent Pool. ³In
particular, the licensing of elvitegravir, cobicistat and the Quad while
they are still in clinical development should significantly accelerate
availability. People in developing countries often have to wait for years
before they can access new health technologies. Today¹s agreement changed

³We believe the Pool is an innovative mechanism to increase access to
patented medicines in a way that works for the pharmaceutical industry and
people living with HIV,² said Gregg Alton, Executive Vice President,
Corporate and Medical Affairs for Gilead Sciences.  ³We are pleased to
enter into this collaboration, and we hope to see the Pool become an
effective mechanism for providing access to an increasingly broader range
of antiretrovirals to treat HIV in resource-limited parts of the world.²

"UNITAID has worked for four years to develop the Medicines Patent Pool
concept.  Today we are proud to see that it is becoming a tangible
reality," said Philippe Douste-Blazy, chair of the UNITAID Executive
Board.  "I salute this first important step by Gilead and urge other
pharmaceutical companies to place their intellectual property at the
service of global public health."

"The United Kingdom has been a strong supporter of the Medicines Patent
Pool from day one. We welcome the news of their first pharmaceutical
company licence.   We will continue to support the Pool as an important
contribution to ensuring that the largest number of people living with HIV
get access to the treatments they need," said Stephen O'Brien, Minister of
International Development for the UK.

Key features of the licence include:

* Inclusion of pipeline products cobicistat, elvitegravir, and the Quad:
Public health-oriented licensing of products in clinical development is
rare and is an important advance in a field where many potentially
valuable medicines are still in the developmental phase. This licence will
allow for generic versions of new products to enter the market shortly
after the products are available in rich countries.

* Preservation of key public health safeguards in intellectual property:
For example, the agreement preserves the ability of generic companies to
supply countries if governments issue compulsory licences. It also waives
data exclusivity rights where they exist.

* The Pool is committed to promoting transparency in licensing practices
and will publish the licences on its website, welcoming feedback and
suggested improvements from all stakeholders.

* The licence allows for the first time the sale and use of generic
tenofovir to cover the treatment of people with Hepatitis B as well as HIV.

*  Royalties are 3 to 5 per cent of generic sales, with royalties waived
for any new paediatric formulations.

* Expansion in the number of countries included in the geographic scope as
compared to Gilead¹s earlier licences.  The licences will allow for the
supply of tenofovir and emtricitabine in 111 countries, for cobicistat in
102 countries, and for elvitegravir and the Quad in 99 countries.
However, the licences do not include all developing countries.

³We will continue to work with Gilead and others to expand access to all
people living with HIV in developing countries,² said Œt Hoen. The Pool is
currently in negotiations with 6 other patent holders.

For more information, contact:

Samantha Bolton:
+44 (0)79 724 28 633
sbolton at medicinespatentpool.org<mailto:sbolton at medicinespatentpool.org>

Kaitlin Mara:
+41 (0)79 825 4786
kmara at medicinespatentpool.org<mailto:kmara at medicinespatentpool.org>

Daniela Bagozzi:
+41 (0)79 475 54 90
bagozzid at who.int<mailto:bagozzid at who.int>

Note for the editor: This release uses the international non-proprietary
names for medicines. Tenofovir is marketed by Gilead Sciences under the
trade name Viread; emtricitabine is marketed under the trade name Emtriva.
Cobicistat and elvitegravir as pipeline products do not yet have trade

About the Medicines Patent Pool:
The Medicines Patent Pool, founded by UNITAID in 2010, aims to stimulate
innovation and improve access to HIV medicines through the negotiation of
voluntary licenses on medicines patents that enable robust generic
competition and facilitate the development of new formulations.  The
Medicines Patent Pool was recently endorsed by the G8 and the UN High
Level Meeting on AIDS as a promising innovative approach to improve access
to HIV medicines.

UNITAID is a global health initiative established to increase access to
quality-assured treatments for HIV/AIDS, malaria and tuberculosis through
sustainable financing and market interventions. In less than five years
since its inception, UNITAID has committed US$ 800 million for AIDS
treatment in 52 low- and middle-income countries.  UNITAID developed the
concept of the Medicines Patent Pool as part of its market strategy, which
is to stimulate market competition, ramp up production and increase
availability of newer and better medicines at affordable prices. In
December 2009, the UNITAID Executive Board[1] voted in principle to create
the Medicines Patent Pool, which became a separate legal entity in July

[1] African Union, Brazil, Chile, France, Norway, South Korea, Spain,
United Kingdom, Communities living with the diseases, NGOs, Gates

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