[Ip-health] Tenofovir patent denied in Brazil

[gabriela@abiaids.org.br]

O Estado de S. Paulo (newspaper)
Vida 02/SETEMBRO/08

INPI denies patent for the anti-retroviral Tenofovir
Medicine is one of the most expensive of the anti-Aids cocktail; company ha=
s 60
days to appeal

L=EDgia Formenti

The National Institute of Industrial Property (INPI) denied the patent gran=
ting
for the anti-retroviral Tenofovir, one of the most expensive and important
medicine used by the STD/Aids National Program. The producer company, Gilea=
d,
has 60 days to appeal, affirmed INPI's press office. However, for those
monitoring the process, there are very little chances to revert the decisio=
n.

Tenefovir is currently used by 31,3 thousand patients, accounting for US$ 4=
3,4
millions (around R$ 72 millions) for the government. It is estimated that b=
y
the end of this year, this number will go to 37 thousand people.

Even with the possibility of appeal, the INPI's decision brings a new
perspective to price negotiation of Tenofovir in Brazil. The Secretary of
Science, Technology and Strategic Products from the Ministry of Health,
Reinaldo Guimar=E3es, affirmed that the agreement with Gilead is ending ver=
y
soon. "We will certainly ask for a lower price compared to what is charged
today: US$ 3,25 the dose (R$ 5,40)", affirmed. The generic produced by the
Indian company Ranbaxy costs US$ 0,4 (R$ 0,66) per dose. Meanwhile, Brazil
cannot change supplier. Ranbaxy has signed an agreement with Gilead that
prohibits the commercialization of the product in Brazil.

There is another producer, the Indian company Cipla. However, the generic
produced by this company has not yet received the pre-qualification of the
World Health Organization, essential requirement for the commercialization =
of
the product in the Country. The conclusion of the prequalification might al=
so
take place before the end the year. "Any decision will have to be taken
cautiously. The most important is that there will be no shortage of the
medicine, with whatever decision that will be taken", said the Secretary.

The reportage could not contact Gilead yesterday. The analysis of Tenofovir=
's
patent began in 1998, but only in April (of 2008) the process was speed- up=
.
The Ministry of Health declared the medicine of public interest and, with t=
hat
act, obtained the priority status (for analysis) at the INPI. Another reaso=
n
for the Ministry of Health to ask for the speeding up of the analysis has b=
een
the intention of Gilead to restrict the use by the national aids programme =
of
generic versions of Tenofovir. In 2006, the company granted a voluntary lic=
ense
to Indian producers, under the condition that the medicine could not be sol=
d to
Brazil.

"It is a victory. Now, producers will think twice before filing a patent
application for a medicine that doesn=B4t bring innovation, for the sake of
keeping their monopolies.", said the lawyer from the Rebrip's Working Group=
 on
Intellectual Property (GTPI) and member of the Brazilian Interdisciplinar A=
ids
Association (ABIA), Renata Reis. In 2007, ABIA and the Oswaldo Cruz Foundat=
ion
introduced technical arguments to INPI, showing that the formulation of
Tenofovir did not bring any technological innovation, one of the requiremen=
ts
for the granting of a patent, according to the Industrial Property Act.

Health declared the public interest

The Ministry of Health published, in April 2008, a decree declaring Tenofov=
ir
as a medicine of public interest. The anti-retroviral is one of the most
expensive and important for the National SDT/Aids Programme. Produced by th=
e
company Gilead, it is used by 30 thousand patients in Brazil and accounts,
alone, for 10% of the expenses of medicines in the programme.

The drug patent was already denied in United States and the expectation is =
that
the same happens in Brazil. The National Institute of Industrial Property
(INPI) did, also in April, a report not favourable to the granting of this
right.

In June, the Brazilian Interdisciplinary Aids Association (Abia) introduced=
 in
India an opposition against the granting of the patent, which is under anal=
yses
in that country. If the right is granted in India, Brazil will not be able =
to
import generic versions of Tenofovir produced there.

Abia argues that the medicine does not bring innovation, essential requirem=
ent
to have the patent granted. The active ingredient of Tenofovir is already k=
nown
since the eighties .