[Ip-health] Generics companies join the Medicines Patent Pool

Kaitlin Mara kmara at medicinespatentpool.org
Tue Oct 11 08:52:38 PDT 2011

Dear all,

The Medicines Patent Pool has signed our first major sublicensing
agreement with Aurobindo, an important generic manufactuer in India.
Aurobindo has also elected to take advantage of a key provision in the
Pool's licences in order to sell tenofovir to a larger number of countries
and without paying royalties, provided there are no patent barriers in
those countries. 

The Pool's patent status database indicates that there are several
significant middle-income countries that were excluded from the Gilead
licence that may now be able to purchase tenofovir from Aurobindo.

These countries include: Argentina, Brazil, Chile, Colombia, Malaysia,
Peru, Philippines, Ukraine, and Uruguay. In addition, there are several
middle income countries on which we do not have definitive patent data but
on which there are potentially no TDF patents, including Egypt, Jordan,
Morocco, Panama, and Russia.

Please find below our statement on the agreement:


GENEVA, 11 OCTOBER 2011: Aurobindo Pharma Limited, a key producer of
generic medicines, has signed an agreement with the Medicines Patent Pool
for the manufacture of several antiretroviral medicines. This will speed
access to critical HIV medicines in developing countries, in particular to
new medicines still in development.

The agreement will enable Aurobindo to manufacture products licensed to
the Pool by Gilead Sciences in July: emtricitabine (FTC), cobicistat
(COBI), elvitegravir (EVG), and the fixed-dose combination of these
medicines known as the Quad (a combination of FTC, COBI, EVG, and
tenofovir). COBI, EVG and the Quad are new products in development. Their
uptake by generic manufacturers will help close the gap between the
arrival of new medical technology in developed country markets and its
often delayed arrival in developing countries.

Aurobindo has chosen to take advantage of a key provision negotiated by
the Pool so it can sell tenofovir to a larger number of countries and
without paying royalties [see note].

³We are pleased with the rapid uptake of our first licences by generic
companies,² said Medicines Patent Pool Executive Director Ellen ¹t Hoen.

³Generic medicines producers have a key role to play in ensuring the
availability of low cost medicines for the treatment of HIV.²

³We are excited about both the public health and business opportunities
provided by the Patent Pool licences. Aurobindo looks forward to
increasing its manufacture of HIV-related products, and expanding its work
to cover promising new treatments, for the millions of people living with
HIV across the globe,² said P.V. Ramaprasad Reddy, chairman of Aurobindo.

³UNITAID welcomes this new agreement, which will increase the number of
manufacturers of new products to treat HIV infections,² said Denis Broun,
executive director of UNITAID. ³Competition from generic producers has
been one of the most powerful tools to reduce drug prices. This agreement
shows that generic manufacturers believe in the Patent Pool, and this is
good news for people living with HIV across the developing world who will
be able to access affordable, quality medicines.²

The Pool signed its first licence agreement with a pharmaceutical company,
Gilead Sciences, in July 2011, securing several public-health related
improvements on the status quo for voluntary licences.

Today¹s announcement concerns the other critically important part of the
Pool¹s work ‹ using licences in the Pool to encourage and expand increased
generic production of antiretrovirals. Aurobindo has an established record
in producing quality generic drugs for HIV, including fixed-dose
combinations and pediatric formulations.

Generic producer MedChem has also entered into an agreement with the Pool.
MedChem is a new player in the HIV field. Attracting generic producers
will help increase production capacity, which is needed to meet treatment

The Medicines Patent Pool, founded with the support of UNITAID in 2010,
aims to bring down the prices of HIV medicines, and stimulate the
development of needed new formulations, through access-oriented voluntary
licences. The Pool¹s voluntary licences are negotiated to maximise their
public health impact, and the full terms and conditions of each licence
agreement are made public on the Pool¹s website.

Note for the editor:
The Pool negotiated for its licences with Gilead to be "unbundled" - this
means a generic manufacturer can elect to uptake licences on a
product-by-product basis. Aurobindo chose to take licences covering
emtricitabine, cobicistat, elvitegravir, and the Quad and not to take a
licence on tenofovir, on which there is currently no product patent in
India. This means that Aurobindo should be able to sell tenofovir to a
larger number of countries than it was able to sell to before.

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