[Ip-health] Working Group on Intellectual Property of REBRIP welcomes the patent rejection for the antiretroviral Tenofovir in Brazil

[Francisco Viegas Neves da Silva]

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*Working Group on Intellectual Property of REBRIP welcomes the patent
rejection for the antiretroviral Tenofovir*

Essential medicine can now be obtained in generic versions at affordable
prices or
produced locally

The National Institute on Industrial Property (INPI, acronym in Portuguese)
published on June 30th the patent rejection for Tenofovir (Viread), produce=
d
by Gilead, which is used for HIV/AIDS treatment. According to data from the
Ministry of Health=92s STD and AIDS Department, Tenofovir accounts for 14,9=
4%
of the budget for the purchase of antiretrovirals (ARVs), being one of the
most expensive medicines for treatment. The Brazilian government had alread=
y
declared its public interest in Tenofovir in April 2008,
considering it to be an essential drug.

Not only have Tenofovir=92s active pharmaceutical ingredient and its
antiretroviral activity been known since 1985, but also the additional
patent applications filed by Gilead do not fulfill the requirements of
inventiveness and novelty =96 basic requirements for the
grant of a patent in Brazil. The application for Tenofovir=92s patent in
Brazil has been contested by several civil society organizations, members o=
f
the Working Group on Intellectual Property (GTPI) of REBRIP and also by
Farmanguinhos (Technological Institute in Medicines) of the Oswaldo Cruz
Foundation since 2006. The laboratory as well as civil society organization=
s
presented arguments to support INPI=92s examination, pointing out the probl=
ems
in the patent application and the grant=92s potential impact on the
sustainability of the universal access to ARVs policy.

The rejection of a patent that does not fulfill the legal requirements is a=
n
important achievement for society as a whole because it prevents a single
company from having exclusive rights for 20 years. With the decision adopte=
d
by INPI, the country gains the option to buy affordable generic versions
through importation or through local production.

In India, the Tenofovir patent is also being contested by civil society
organizations. In 2008, The Indian NGO Sahara Centre for Residential Care &
Rehabilitation (SAHARA) and the Brazilian Interdisciplinary Association for
AIDS (ABIA) submitted a pre-granted opposition in India against the grant o=
f
two other patent applications for Tenofovir, based on the arguments that
this medicine is a known compound and should not be considered an invention
according to the Indian Patent Law. These patents, contested in India and
Brazil, have also been contested in the USA and the USPTO have also
published decisions against
its granting.

Tenofovir=92s case is a clear example of how the patent system is being use=
d
by companies to obtain unjustified monopolies of essential products. Even i=
f
these products do not fulfill the minimum requirements for a patent grant,
the mere expectation of a grant denotes a monopoly and has made the purchas=
e
of affordable versions through the public health system unviable. Utilizing
this strategy, the pharmaceutical company Gilead, on July 10th, 2008, filed
a divison patent application for Tenofovir, which had been previously
deferred (PI9816239-0). The application not yet been analyzed by the INPI.
It is expected that this application will not be granted , reinforcing the
sustainability of the national policy on universal access to ARVs.

For more information: + 55 21 22231040 (Renata Reis). E-mail:
abia@abiaids.org.br

Francisco Viegas Neves da Silva
Project Assistant
Working Group on Intellectual Property (GTPI/REBRIP)
francisco@abiaids.org.br