[Ip-health] Patent Barriers and the Clinton Foundation announcement

[robert weissman]

Patent Barriers Pose Threat to Realizing Benefits of Generic Competition
for Second-Generation/Second-Line Therapies

Robert Weissman, Essential Action
May 8, 2007

Today's announcement from the Clinton Foundation and UNITAID means that
developing countries have in their grasp the opportunity to benefit from
price-lowering generic competition for second-generation and second-line
HIV/AIDS drugs.

Patent barriers may stand in the way, however. Among the medicines for
which the Clinton Foundation has announced price discounts, lamivudine
(3TC), abacavir (ABC) and emtricitabine (FTC) appear to be heavily
patented, in both larger developing countries and throughout the poor,
high-HIV-incidence countries in Africa.

Achieving the gains possible from efficient generic competition will
require countries to overcome existing patent barriers. This means
countries must identify patents in force within their borders; and,
where there are patent barriers, countries will need to issue compulsory
licenses to overcome them.

ASCERTAINING PATENT STATUS

Ascertaining patent status for any particular drug in many developing
countries is very difficult -- often beyond the capacity of national
patent offices. National governments should ask brand-name companies to
identify patents they claim on HIV/AIDS (and other new and important)
medicines, and adopt policies that make it clear they will not enforce
medicine patents that are not disclosed.

PATENT BARRIERS ON IMPORTANT PRODUCTS

Considerable information is available on the patent status of two Gilead
products, tenofovir and FTC. Gilead's closed licensing scheme with a
limited number of generic firms has been made public, and includes
information on patent status. (1) Tenofovir does not appear to be widely
patented in developing countries, but, according to Gilead, it is
patented (or a patent application is pending) in India and Indonesia.
The Gilead materials leave unclear whether tenofovir is patented in the
several dozen countries not included in the licensing scheme.

The patent in India is not likely to constitute a significant barrier,
because under India law tenofovir if patented is likely subject to an
automatic compulsory license. But Indonesia will need to obtain or issue
a license if it hopes to benefit from the generic prices and
combinations available through the Clinton Foundation agreements.

FTC is much more widely patented. The Gilead licensing documents
indicate patents have been granted or filed on the product in: Barbados,
Benin, Botswana, Burkina Faso, Burundi, Cameroon, Central African
Republic, Chad, Congo, Democratic Republic of Congo, Egypt, Equatorial
Guinea, Gabon, Gambia, Ghana, Guinea Bissau, Indonesia, Kenya,
Kyrgyzstan, Lesotho, Madagascar, Malawi, Mali, Mauritania, Moldova,
Morocco, Mozambique, Namibia, Nicaragua, Niger, Nigeria, Pakistan,
Senegal, Sierra Leone, South Africa, Sudan, Swaziland, Tajikistan,
Tanzania, Togo, Tunisia, Uganda, Uzbekistan, Vietnam, Zambia and
Zimbabwe. The Gilead materials leave unclear whether FTC is patented in
the several dozen countries not included in the licensing scheme.

Key second-line products for which the Clinton Foundation has announced
major price reductions are ABC and 3TC. Both of these products appear to
be widely patented in the developing world, including throughout Africa.
There are two regional patent offices in Africa: the African
Intellectual Property Organization (known by its French acronym, OAPI)
and the African Regional Intellectual Property Organization (ARIPO).
Both regional offices have approved or granted patents for ABC and 3TC.
Patents on ABC are also reportedly in effect in Brazil, China, South
Africa and Ukraine, with the status in many other countries unknown.
Patents on 3TC are also reportedly in effect in China, South Africa and
Ukraine, with the status in many other countries unknown. (2)

CONCLUSION

The door is now open for developing countries to maintain treatment for
people with HIV/AIDS as they move to second-generation treatments.
Thailand, Brazil, Indonesia, Malaysia, Mozambique, Zambia, Ghana,
Eritrea, South Africa and others have shown that issuing compulsory
licenses is politically feasible. It is time for individual and
coordinated action among developing countries -- and international
agencies -- to prioritize public health over the narrow commercial
interests of Big Pharma.

The benefits of generic competition have again been illustrated today
with the Clinton Foundation/Unitaid announcement. But fully realizing
that potential will require governments to act.

(1) See Knowledge Ecology International, "KEI Request for Investigation
Into Anticompetitive Aspects of Gilead Voluntary Licenses for Patents on
Tenofovir and Emtricitabine, February 12, 2007, Attachments 1 and 2,
available at: www.keionline.org/misc-docs/ftcgilead12feb07.pdf.

(2) WHO-MSF-UNAIDS, "Determining the Patent Status of Essential
Medicines in Developing Countries," WHO/EDM/PAR/2004.6, 2004, available
at:
<mednet2.who.int/sourcesprices/DeterminingEssMedPatentStatusW_Depliant.pdf>

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Robert Weissman
Essential Action
Tel: 1-202-387-8030
E-mail: robe@essential.org