[Ip-health] AIDS patent pool gets green-light, but some countries could be left out

[James Love]

AIDS patent pool gets green-light, but some countries could be left out
15 December 2009

Elizabeth Sukkar
The board of UNITAID, the drug purchasing facility, decided last night
to officially set up and fund its AIDS medicines patent pool, giving it
$4 million over the next year. The pool could include 19 products from
nine pharmaceutical firms (see table 1).

The board stressed that the pool =E2=80=93 which aims to kick-start the
development of much needed fixed-dose combinations (FDCs) of
antiretrovirals by pooling patent rights =E2=80=93 would include all develo=
ping
countries (see table 2 for full details), but some NGOs have pointed out
that pharmaceutical firms could exclude some middle-income countries
from benefiting depending on the terms of their licences
( scripnews.com, December 8th, 2009).Dr Tido von Schoen-Angerer,
executive director of M=C3=A9decins Sans Fronti=C3=A8res (MSF)'s campaign f=
or
access to essential medicines, said: "Although these are early days, the
patent pool could become a mechanism that systematically offers licences
to generic manufacturers, reducing prices and facilitating the
combination of drugs from different makers into fixed-dose or one-pill
combinations."So far, the most advanced talks have taken place with ARV
manufacturers Gilead Sciences, Tibotec (Johnson & Johnson), Merck & Co
and Sequoia, and it is hoped they will put their patents into the
voluntary pool, which would allow generic firms to develop low-cost FDCs
after paying a royalty. Ellen 't Hoen, head of the patent pool project,
said: "We're now ready to move to the next phase =E2=80=93 reaching agreeme=
nts
with companies to get the drugs out."Asked whether it supported the
patent pool, the European pharmaceutical federation, EFPIA, told Scrip
that as patent pools are a commercial issue it could not take a position
on this. "It is down to individual companies whether they choose to
participate or not." In leaked documents last week, the international
pharmaceutical federation (IFPMA) said that the patent pool did not
follow "past or current pool structures" ( scripnews.com, December 11th,
2009).

Viiv Healthcare, a HIV joint venture between GlaxoSmithKline and Pfizer,
told Scrip that it was "open to and actively seeking opportunities to
meet with UNITAID and other stakeholders to discuss a proposed patent
pool for HIV medicines."

It said it had met with UNITAID a number of times to "better understand
its objectives and learn of the mechanisms to underpin its vision of
delivering new FDCs and paediatric formulations, and ensuring those most
in need have access to these new products".

The question of middle-income countries' inclusion is key. James Love,
director of the not-for-profit NGO Knowledge Ecology International (KEI)
=E2=80=93 which first proposed the patent pool idea to UNITAID with humanit=
arian
body MSF =E2=80=93 noted that it would "be a challenge for the patent pool =
to
acquire rights from patent owners".
The KEI says UNITAID "should ask for rights in all developing countries,
but accept whatever the patent owner offers" as it does not believe a
non-negotiable offer for all developing countries would be successful.
Some countries that NGOs are worried could be excluded include key
emerging markets for the pharmaceutical industry, such as India, China
and Brazil. KEI also believes that should UNITAID classify developing
countries, this would be counterproductive.

Both KEI and MSF advise countries to rely on other tools to improve
access to medicines to patients in developing countries should the
patent pool fail; this could include compulsory licensing actions in the
countries excluded.
supportBefore the board approved the patent pool, it received a number
of letters of support, including one from global financier and
philanthropist, George Soros, through his foundation, Open Society
Institute. In a letter, dated November 23rd, he said: "The UNITAID
medicines patent pool is a strategic opportunity to establish long-term
solutions to excessively high priced AIDS medicines, and could foster
innovative and needs-driven R&D to generate new AIDS drugs. It will be
essential for the patent pool to cover not only low-income countries but
all middle-income countries where access to essential medicines remains
a challenge for the poorest and marginalised." He also believes that the
patent pool could also serve as a model for other diseases in future.In
addition, two US members of Congress, Henry Waxman and Barbara Lee, have
supported the patent pool in a letter (dated December 11th) to Dr Eric
Goosby, US Global AIDS Coordinator, and Hillary Clinton, US secretary of
state. "We believe it is a promising example of a way to promote drug
access and innovation while appropriately protecting intellectual
property rights and stimulating further research and development. The US
is not an official partner in UNITAID, but our programs and partner
countries could benefit from the expanded availability a patent pool
could provide."

Table 1: Products for potential inclusion in the AIDS medicines patent
pool
Compound =09Company

Lopinavir =09Abbott

Ritonavir (r)  =09Abbott

Nevirapine  =09Boehringer- Ingelheim

Atazanavir  =09Bristol Myers Squibb

GS-9350  =09Gilead

Elvitegravir  =09Gilead

Tenofovir  =09Gilead

Emtricitabine  =09Gilead

Efavirenz  =09Merck & Co

Raltegravir  =09Merck & Co

Vicriviroc  =09Merck & Co (Schering-Plough)

Saquinavir  =09Roche

Etravirine  =09Tibotec/Johnson & Johnson

Darunavir  =09Tibotec/J&J

Rilpivirine  =09Tibotec/J&J

Lamivudine  =09Viiv (GSK)

Abacavir  =09Viiv (GSK)

Fosamprenavir  =09Viiv (GSK)

Maraviroc  =09Viiv (Pfizer)
 Source: UNITAID


Table 2: UNITAID's board decision on AIDS medicines patent pool

The board said the performance of the patent pool would be judged in
December 2010 against a number of criteria (it said the patent pool will
not inhibit in any way any countries' abilities to use the World Trade
Organization's TRIPS flexibilities). Some of these criteria include:

at least three patent-holding entities commit in writing to license
their patents to the pool entity by October 2010.

licence agreements concluded covering at least five products by December
2010

revised economic justification based on products licensed to the pool in
December 2010.

Definition of additional incentives that might be needed.

 Source: UNITAID


--
James Love, Director, Knowledge Ecology International
http://www.keionline.org | http://www.twitter.com/jamie_love
Wk: +1.202.332.2670 | US Mobile +1.202.361.3040 | Geneva Mobile +41.76.413.=
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